Trial Outcomes & Findings for The Paediatric EVICEL® Soft Tissue and Parenchymal Organ Bleeding Study (NCT NCT02227706)
NCT ID: NCT02227706
Last Updated: 2020-08-31
Results Overview
Absolute time to haemostasis, defined as absolute time when there was no detectable bleeding at the Target Bleeding Site (TBS).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
40 participants
Primary outcome timeframe
From randomisation (identification of appropriate target bleeding site) to final fascial closure (median study procedure time 164.0 minutes [range 47.0 - 506.0 minutes])
Results posted on
2020-08-31
Participant Flow
Subjects were screened up to 21 days prior to surgery and attended a baseline visit within 24 hours of surgery. Both visits took place at a clinic within the hospital where surgery also took place. Subjects were followed until discharge and requested to attend a visit at 30 days (+/- 14 days) post surgery either at the hospital or via telephone.
Subjects required to meet pre-defined inclusion/exclusion criteria prior to randomization. Subjects required to have an appropriate mild or moderate target bleeding site identified intra-operatively. Subjects were excluded if the target bleeding site was in an actively infected field or if the bleeding was at an anastomotic bleeding site.
Participant milestones
| Measure |
EVICEL®
EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.
|
SURGICEL®
SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Paediatric EVICEL® Soft Tissue and Parenchymal Organ Bleeding Study
Baseline characteristics by cohort
| Measure |
EVICEL®
n=20 Participants
EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.
|
SURGICEL®
n=20 Participants
SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.4 Years
n=5 Participants
|
9.0 Years
n=7 Participants
|
9.2 Years
n=5 Participants
|
|
Age, Customized
Neonate (Birth to 30 Days)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
Infants and toddlers (31 days-<24 months)
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Customized
Children (2-11 years)
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Customized
Adolescents (12-17 years)
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomisation (identification of appropriate target bleeding site) to final fascial closure (median study procedure time 164.0 minutes [range 47.0 - 506.0 minutes])Population: Full Analysis Set (all randomized subjects)
Absolute time to haemostasis, defined as absolute time when there was no detectable bleeding at the Target Bleeding Site (TBS).
Outcome measures
| Measure |
EVICEL®
n=20 Participants
EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.
|
SURGICEL®
n=20 Participants
SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.
|
|---|---|---|
|
Absolute Time to Haemostasis
|
4.0 Minutes
Interval 3.3 to 4.7
|
4.0 Minutes
Interval 2.9 to 8.1
|
SECONDARY outcome
Timeframe: Intra-operatively from randomisation to 4 minutes after randomisationPopulation: Full Analysis Set (all randomized subjects)
Number of participants achieving haemostasis at target bleeding site at 4 minutes. This endpoint is assessing haemostasis at 4 minutes only and not maintenance of haemostasis following this timepoint. As rebleeding may occur between timepoints, subsequent rebleeding (if any) is detailed in treatment failure analysis.
Outcome measures
| Measure |
EVICEL®
n=20 Participants
EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.
|
SURGICEL®
n=20 Participants
SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.
|
|---|---|---|
|
Number of Participants Achieving Haemostasis at 4 Minutes
|
16 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Intra-operatively from randomisation to 7 minutes after randomisationPopulation: Full Analysis Set (all randomized subjects)
Number of Participants Achieving Haemostasis at Target Bleeding Site at 7 Minutes. This endpoint is assessing haemostasis at 7 minutes only and is not affected by haemostasis assessment prior to 7 minutes or maintenance of haemostasis following this 7 minute assessment. As rebleeding may occur between timepoints, subsequent rebleeding (if any) is detailed in treatment failure analysis.
Outcome measures
| Measure |
EVICEL®
n=20 Participants
EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.
|
SURGICEL®
n=20 Participants
SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.
|
|---|---|---|
|
Number of Participants Achieving Haemostasis at 7 Minutes
|
20 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Intra-operatively from randomisation to 10 minutes after randomisationPopulation: Full Analysis Set (all randomized subjects)
Number of Participants Achieving Haemostasis at Target Bleeding Site at 10 Minutes. This endpoint is assessing haemostasis at 10 minutes only and is not affected by haemostasis assessments prior to 10 minutes or maintenance of haemostasis following this 10 minute assessment. As rebleeding may occur between timepoints, subsequent rebleeding (if any) is detailed in treatment failure analysis).
Outcome measures
| Measure |
EVICEL®
n=20 Participants
EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.
|
SURGICEL®
n=20 Participants
SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.
|
|---|---|---|
|
Number of Participants Achieving Haemostasis at 10 Minutes
|
19 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 10 minutesPopulation: Full Analysis Set (all randomized subjects) Note: Two subjects in the control arm were haemostatic at the TBS at 10 minutes however they subsequently rebled requiring additional treatment and were conservatively considered a failure for the secondary endpoint of Incidence of Treatment Failures.
Defined as haemostasis not achieved within 10 minutes or bleeding requiring treatment other than re-application of the assigned haemostatic adjunct within 10 minutes.
Outcome measures
| Measure |
EVICEL®
n=20 Participants
EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.
|
SURGICEL®
n=20 Participants
SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.
|
|---|---|---|
|
Incidence of Treatment Failures (Number of Participants)
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: During surgical procedure (first incision to final fascial closure (median study procedure time 164.0 minutes [range 47.0 - 506.0 minutes])Population: Full Analysis Set (all randomized subjects)
Blood loss during surgical procedure (includes but not limited to the target bleeding site)
Outcome measures
| Measure |
EVICEL®
n=20 Participants
EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.
|
SURGICEL®
n=20 Participants
SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.
|
|---|---|---|
|
Estimated Blood Loss
|
50.0 mL
Interval 0.0 to 2000.0
|
50.0 mL
Interval 0.0 to 400.0
|
SECONDARY outcome
Timeframe: From surgical procedure to 30 day (+/-14 day) follow-up visitPopulation: Full Analysis Set (all randomized subjects)
Participants requiring a blood transfusion
Outcome measures
| Measure |
EVICEL®
n=20 Participants
EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.
|
SURGICEL®
n=20 Participants
SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.
|
|---|---|---|
|
Blood Transfusion
Yes (Blood Transfusion Received)
|
7 Participants
|
3 Participants
|
|
Blood Transfusion
No (Blood Transfusion Not Received)
|
13 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: From surgery to 30 day (+/-14 day) follow-up visitPopulation: Full Analysis Set (all randomized subjects with data)
Details of blood products received (if any)
Outcome measures
| Measure |
EVICEL®
n=20 Participants
EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.
|
SURGICEL®
n=20 Participants
SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.
|
|---|---|---|
|
Participants Receiving a Blood Transfusion
Packed Red Blood Cells 0 Units
|
3 Participants
|
0 Participants
|
|
Participants Receiving a Blood Transfusion
Packed Red Blood Cells 1 Unit
|
4 Participants
|
1 Participants
|
|
Participants Receiving a Blood Transfusion
Packed Red Blood Cells 2 Units
|
0 Participants
|
2 Participants
|
|
Participants Receiving a Blood Transfusion
Whole Blood 0 Units
|
4 Participants
|
3 Participants
|
|
Participants Receiving a Blood Transfusion
Whole Blood 1 Unit
|
0 Participants
|
0 Participants
|
|
Participants Receiving a Blood Transfusion
Whole Blood 2 Units
|
3 Participants
|
0 Participants
|
|
Participants Receiving a Blood Transfusion
Fresh Frozen Plasma 0 Units
|
6 Participants
|
3 Participants
|
|
Participants Receiving a Blood Transfusion
Fresh Frozen Plasma 1 Unit
|
0 Participants
|
0 Participants
|
|
Participants Receiving a Blood Transfusion
Fresh Frozen Plasma 2 Units
|
1 Participants
|
0 Participants
|
|
Participants Receiving a Blood Transfusion
Platelets 0 Units
|
6 Participants
|
3 Participants
|
|
Participants Receiving a Blood Transfusion
Platelets 1 Unit
|
1 Participants
|
0 Participants
|
|
Participants Receiving a Blood Transfusion
Cryoprecipitates 0 Units
|
7 Participants
|
3 Participants
|
|
Participants Receiving a Blood Transfusion
Other 0 Units
|
7 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)Population: Safety Set (all subjects who received treatment)
Laboratory parameter changes from baseline to post operative hospital discharge (Haemoglobin and Mean Corpuscular Haemoglobin Concentration)
Outcome measures
| Measure |
EVICEL®
n=20 Participants
EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.
|
SURGICEL®
n=20 Participants
SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.
|
|---|---|---|
|
Changes in Laboratory Parameters Haemoglobin and Mean Corpuscular Haemoglobin Concentration
Haemoglobin g/L
|
-13.2 g/L
Standard Deviation 21.5
|
-10.6 g/L
Standard Deviation 8.9
|
|
Changes in Laboratory Parameters Haemoglobin and Mean Corpuscular Haemoglobin Concentration
Mean Corpuscular Haemoglobin Concentration g/L
|
-5.3 g/L
Standard Deviation 6.7
|
-3.4 g/L
Standard Deviation 11.9
|
SECONDARY outcome
Timeframe: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)Population: Safety Set (all subjects who received treatment)
Change in red blood cell proportion in volume in the blood from baseline to post operative hospital discharge
Outcome measures
| Measure |
EVICEL®
n=20 Participants
EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.
|
SURGICEL®
n=20 Participants
SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.
|
|---|---|---|
|
Changes in Laboratory Parameters Haematocrit
|
-0.0 L/L
Standard Deviation 0.0
|
-0.0 L/L
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours)Population: Safety Set (all subjects who received treatment)
Laboratory parameter changes from baseline to post operative hospital discharge
Outcome measures
| Measure |
EVICEL®
n=20 Participants
EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.
|
SURGICEL®
n=20 Participants
SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.
|
|---|---|---|
|
Changes in Laboratory Parameters Platelet Count and White Cell Count
White Blood Cell Count *10^9/L
|
2.0 Cells*10^9/L
Standard Deviation 5.2
|
1.4 Cells*10^9/L
Standard Deviation 4.3
|
|
Changes in Laboratory Parameters Platelet Count and White Cell Count
Platelet Count *10^9/L
|
27.4 Cells*10^9/L
Standard Deviation 159.3
|
7.6 Cells*10^9/L
Standard Deviation 96.3
|
SECONDARY outcome
Timeframe: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)Population: Safety Set (all subjects who received treatment)
Laboratory parameter changes from baseline to post operative hospital discharge
Outcome measures
| Measure |
EVICEL®
n=20 Participants
EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.
|
SURGICEL®
n=20 Participants
SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.
|
|---|---|---|
|
Changes in Laboratory Parameters Red Blood Cell Count
|
-0.3 Cells*10^12/L
Standard Deviation 0.5
|
-0.4 Cells*10^12/L
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)Population: Safety Set (all subjects who received treatment)
Laboratory parameter changes from baseline to post operative hospital discharge
Outcome measures
| Measure |
EVICEL®
n=20 Participants
EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.
|
SURGICEL®
n=20 Participants
SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.
|
|---|---|---|
|
Changes in Laboratory Parameters Mean Corpuscular Haemoglobin
|
-0.1 pg
Standard Deviation 1.1
|
0.2 pg
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)Population: Safety Set (all subjects who received treatment)
Laboratory parameter changes from baseline to post operative hospital discharge
Outcome measures
| Measure |
EVICEL®
n=20 Participants
EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.
|
SURGICEL®
n=20 Participants
SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.
|
|---|---|---|
|
Changes in Laboratory Parameters Mean Corpuscular Volume
|
0.9 f/L
Standard Deviation 2.6
|
1.5 f/L
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)Population: Safety Set (all subjects who received treatment)
Laboratory parameter changes in volume from baseline to post operative hospital discharge (Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils)
Outcome measures
| Measure |
EVICEL®
n=20 Participants
EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.
|
SURGICEL®
n=20 Participants
SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.
|
|---|---|---|
|
Changes in Laboratory Parameters Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Neutrophils %
|
9.0 Percent Volume
Standard Deviation 17.1
|
10.1 Percent Volume
Standard Deviation 19.4
|
|
Changes in Laboratory Parameters Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Lymphocytes %
|
-7.2 Percent Volume
Standard Deviation 13.1
|
-11.6 Percent Volume
Standard Deviation 17.3
|
|
Changes in Laboratory Parameters Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Monocytes %
|
-0.8 Percent Volume
Standard Deviation 6.4
|
1.5 Percent Volume
Standard Deviation 2.1
|
|
Changes in Laboratory Parameters Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Basophils %
|
-0.1 Percent Volume
Standard Deviation 0.4
|
-0.3 Percent Volume
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)Population: Safety Set (all subjects who received treatment)
Laboratory parameter changes from baseline to post operative hospital discharge (Activated Partial Thromboplastin Time and Prothrombin Time)
Outcome measures
| Measure |
EVICEL®
n=20 Participants
EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.
|
SURGICEL®
n=20 Participants
SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.
|
|---|---|---|
|
Changes in Laboratory Parameters Activated Partial Thromboplastin Time and Prothrombin Time
Activated Partial Thromboplastin Time seconds
|
-0.9 Seconds
Standard Deviation 4.2
|
-2.2 Seconds
Standard Deviation 4.2
|
|
Changes in Laboratory Parameters Activated Partial Thromboplastin Time and Prothrombin Time
Prothrombin Time seconds
|
0.7 Seconds
Standard Deviation 3.0
|
0.1 Seconds
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)Population: Safety Set (all subjects who received treatment)
Standardized measurement of the change in blood clotting time from baseline to post operative hospital discharge
Outcome measures
| Measure |
EVICEL®
n=20 Participants
EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.
|
SURGICEL®
n=20 Participants
SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.
|
|---|---|---|
|
Changes in Laboratory Parameters International Normalised Ratio
|
0.1 Ratio
Standard Deviation 0.2
|
-0.0 Ratio
Standard Deviation 0.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomisation up to 30 days (+/- 14 days) following surgeryPopulation: Safety Set (all subjects who received treatment)
Number of Participants with a Thrombotic Event.
Outcome measures
| Measure |
EVICEL®
n=20 Participants
EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.
|
SURGICEL®
n=20 Participants
SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.
|
|---|---|---|
|
Number of Participants With a Thrombotic Event
Number of subjects with thrombotic events
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomisation to 30 days (+/- 14 days) following surgeryPopulation: Safety Set (all subjects who received treatment)
Number of Participants with an Adverse Event Related to Re-bleeding at Target Bleeding Site.
Outcome measures
| Measure |
EVICEL®
n=20 Participants
EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.
|
SURGICEL®
n=20 Participants
SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.
|
|---|---|---|
|
Number of Participants With an Adverse Event Related to Re-bleeding at Target Bleeding Site
Subjects with AE related to re-bleeding at TBS
|
1 Participants
|
2 Participants
|
Adverse Events
EVICEL®
Serious events: 4 serious events
Other events: 18 other events
Deaths: 0 deaths
SURGICEL®
Serious events: 3 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EVICEL®
n=20 participants at risk
EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.
|
SURGICEL®
n=20 participants at risk
SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.
|
|---|---|---|
|
Infections and infestations
Varicella
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Nervous system disorders
Brain Injury
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Infections and infestations
Clostridium difficile infection
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Surgical and medical procedures
Ureteral stent removal
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Renal and urinary disorders
Urinary incontinence
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Castleman's disease
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
Other adverse events
| Measure |
EVICEL®
n=20 participants at risk
EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.
|
SURGICEL®
n=20 participants at risk
SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.
|
|---|---|---|
|
Blood and lymphatic system disorders
Coagulopathy
|
10.0%
2/20 • Number of events 2 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
10.0%
2/20 • Number of events 2 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Cardiac disorders
Tachycardia
|
15.0%
3/20 • Number of events 3 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
30.0%
6/20 • Number of events 6 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Eye disorders
Conjunctivitis
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
5/20 • Number of events 5 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
15.0%
3/20 • Number of events 3 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
10.0%
2/20 • Number of events 2 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
10.0%
2/20 • Number of events 2 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.0%
3/20 • Number of events 3 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
20.0%
4/20 • Number of events 4 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Gastrointestinal disorders
Mucous stools
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
2/20 • Number of events 2 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
10.0%
2/20 • Number of events 2 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Gastrointestinal disorders
Teething
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Gastrointestinal disorders
Vomiting
|
15.0%
3/20 • Number of events 3 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
30.0%
6/20 • Number of events 6 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
General disorders
Chest pain
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
General disorders
Device occlusion
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
General disorders
Pain
|
10.0%
2/20 • Number of events 2 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
General disorders
Pyrexia
|
40.0%
8/20 • Number of events 9 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
30.0%
6/20 • Number of events 7 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
General disorders
Swelling
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Infections and infestations
Candidiasis
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Infections and infestations
Infection
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Infections and infestations
Orchitis
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Infections and infestations
Urinary tract infection
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Infections and infestations
Viral infection
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Infections and infestations
Wound infection
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
35.0%
7/20 • Number of events 8 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
25.0%
5/20 • Number of events 5 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Injury, poisoning and procedural complications
Wound complication
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Investigations
Haemoglobin decreased
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
10.0%
2/20 • Number of events 2 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Investigations
Oxygen saturation decreased
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
10.0%
2/20 • Number of events 3 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Investigations
Respiratory rate decreased
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Investigations
Respiratory rate increased
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Investigations
Urine output decreased
|
10.0%
2/20 • Number of events 2 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Investigations
White blood cell count increased
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Metabolism and nutrition disorders
Fluid overload
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Metabolism and nutrition disorders
Hyponatraemic syndrome
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
15.0%
3/20 • Number of events 3 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Metabolism and nutrition disorders
Polydipsia
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
10.0%
2/20 • Number of events 2 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Nervous system disorders
Hypoaesthesia
|
10.0%
2/20 • Number of events 2 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Psychiatric disorders
Anxiety
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
10.0%
2/20 • Number of events 2 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
15.0%
3/20 • Number of events 3 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal aspiration
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Skin and subcutaneous tissue disorders
Blister
|
10.0%
2/20 • Number of events 2 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Skin and subcutaneous tissue disorders
Livedo reticularis
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
2/20 • Number of events 2 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
10.0%
2/20 • Number of events 2 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Surgical and medical procedures
Wound drainage
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Vascular disorders
Haemorrhage
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
10.0%
2/20 • Number of events 2 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Vascular disorders
Hypertension
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
10.0%
2/20 • Number of events 2 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Vascular disorders
Hypotension
|
10.0%
2/20 • Number of events 2 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
10.0%
2/20 • Number of events 3 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
0.00%
0/20 • Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information: Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication based on the results obtained at the trial site (or group of sites) shall not be made before the first multi-centre publication. During the review period of a proposed publication, the Sponsor is entitled to request that publication be delayed for a period of up to six months from the date of first submission to the Sponsor to enable the Sponsor to take steps to protect its proprietary information and/or Intellectual Property Rights and Know How.
- Publication restrictions are in place
Restriction type: OTHER