Trial Outcomes & Findings for The EVARREST® Paediatric Mild/Moderate Liver and Soft Tissue Bleeding Study (NCT NCT02227992)
NCT ID: NCT02227992
Last Updated: 2023-09-08
Results Overview
Absolute TTH, defined as the absolute time elapsed from randomization to the last moment in time at which detectable bleeding at the target bleeding site (TBS) was observed.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
40 participants
Primary outcome timeframe
Up to 1 day (Intraoperative)
Results posted on
2023-09-08
Participant Flow
Participant milestones
| Measure |
EVARREST Sealant Matrix
Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
|
SURGICEL Absorbable Hemostat (Control)
Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
19
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
EVARREST Sealant Matrix
Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
|
SURGICEL Absorbable Hemostat (Control)
Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
The EVARREST® Paediatric Mild/Moderate Liver and Soft Tissue Bleeding Study
Baseline characteristics by cohort
| Measure |
EVARREST Sealant Matrix
n=20 Participants
Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
|
SURGICEL Absorbable Hemostat (Control)
n=20 Participants
Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
3.0 years
n=5 Participants
|
4.0 years
n=7 Participants
|
3.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 1 day (Intraoperative)Population: The Full Analysis Set (FAS; equivalent to the Intent-to-Treat \[ITT\] set) consisted of all randomized participants. Participants who did not complete the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis.
Absolute TTH, defined as the absolute time elapsed from randomization to the last moment in time at which detectable bleeding at the target bleeding site (TBS) was observed.
Outcome measures
| Measure |
EVARREST Sealant Matrix
n=20 Participants
Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
|
SURGICEL Absorbable Hemostat (Control)
n=20 Participants
Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
|
|---|---|---|
|
Absolute Time to Haemostasis (TTH)
|
4.0 Minutes
Interval 4.0 to 117.0
|
4.0 Minutes
Interval 4.0 to 39.0
|
PRIMARY outcome
Timeframe: Up to 1 day (Intraoperative)Population: The Full Analysis Set (FAS; equivalent to the ITT set) consisted of all randomized participants. Participants who did not complete the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis. Here 'n' (number analyzed) signifies number of participants analyzed for specified categories.
Absolute TTH, defined as the absolute time elapsed from randomization to the last moment in time at which detectable bleeding at the TBS was observed.
Outcome measures
| Measure |
EVARREST Sealant Matrix
n=20 Participants
Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
|
SURGICEL Absorbable Hemostat (Control)
n=20 Participants
Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
|
|---|---|---|
|
Absolute Time to Haemostasis (TTH) by Age Group
Adolescent (12 to less than 18 years)
|
4.0 Minutes
Interval 4.0 to 7.5
|
4.0 Minutes
Interval 4.0 to 10.0
|
|
Absolute Time to Haemostasis (TTH) by Age Group
Infants and toddlers (28 days to less than 24 months)
|
4.0 Minutes
Interval 4.0 to 4.0
|
4.0 Minutes
Interval 4.0 to 6.9
|
|
Absolute Time to Haemostasis (TTH) by Age Group
Children (2 to 11 years)
|
4.0 Minutes
Interval 4.0 to 117.0
|
4.0 Minutes
Interval 4.0 to 39.0
|
SECONDARY outcome
Timeframe: 4 minutes post randomization (up to 1 day; intraoperative)Population: The FAS (equivalent to the ITT set) consisted of all randomized participants. Participants who did not complete the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis.
Percentage of participants achieving haemostatic success at 4 minutes following randomization with no bleeding requiring treatment at the TBS occurring any time prior to final fascial closure were reported.
Outcome measures
| Measure |
EVARREST Sealant Matrix
n=20 Participants
Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
|
SURGICEL Absorbable Hemostat (Control)
n=20 Participants
Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
|
|---|---|---|
|
Percentage of Participants Achieving Haemostatic Success at 4 Minutes Following Randomization With No Bleeding Requiring Treatment at the Target Bleeding Site Occurring Any Time Prior to Final Fascial Closure
|
80.0 Percentage of Participants
Interval 56.3 to 94.3
|
60.0 Percentage of Participants
Interval 36.1 to 80.9
|
SECONDARY outcome
Timeframe: 10 minutes post randomization (up to 1 day; intraoperative)Population: The FAS (equivalent to the ITT set) consisted of all randomized participants. Participants who did not complete the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis.
Percentage of participants achieving haemostatic success at 10 minutes following randomization with no bleeding requiring treatment at the TBS occurring any time prior to final fascial closure were reported.
Outcome measures
| Measure |
EVARREST Sealant Matrix
n=20 Participants
Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
|
SURGICEL Absorbable Hemostat (Control)
n=20 Participants
Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
|
|---|---|---|
|
Percentage of Participants Achieving Haemostatic Success at 10 Minutes Following Randomization With No Bleeding Requiring Treatment at the Target Bleeding Site Occurring Any Time Prior to Final Fascial Closure
|
95.0 Percentage of Participants
Interval 75.1 to 99.9
|
90.0 Percentage of Participants
Interval 68.3 to 98.8
|
SECONDARY outcome
Timeframe: Up to 44 days post-surgery on Day 0Population: The FAS (equivalent to the ITT set) consisted of all randomized participants. Participants who did not complete the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis.
Percentage of participants with no re-bleeding at the TBS were reported.
Outcome measures
| Measure |
EVARREST Sealant Matrix
n=20 Participants
Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
|
SURGICEL Absorbable Hemostat (Control)
n=20 Participants
Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
|
|---|---|---|
|
Percentage of Participants With No Re-bleeding at the Target Bleeding Site
|
95.0 Percentage of Participants
|
85.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 44 days post-surgery on Day 0Population: The safety analysis set consists of all participants who received treatment.
Number of participants With AEs that were potentially related to bleeding at the TBS were reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Outcome measures
| Measure |
EVARREST Sealant Matrix
n=20 Participants
Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
|
SURGICEL Absorbable Hemostat (Control)
n=20 Participants
Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) That Were Potentially Related To Bleeding at the TBS
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 44 days post-surgery on Day 0Population: The safety analysis set consists of all participants who received treatment.
Number of participants with AEs that were potentially related to thrombotic events (sponsor assessment) were reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Outcome measures
| Measure |
EVARREST Sealant Matrix
n=20 Participants
Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
|
SURGICEL Absorbable Hemostat (Control)
n=20 Participants
Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
|
|---|---|---|
|
Number of Participants With AEs That Were Potentially Related To Thrombotic Events
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 44 days post-surgery on Day 0Population: The safety analysis set consists of all participants who received treatment.
Number of participants who required re-treatment at the TBS were reported.
Outcome measures
| Measure |
EVARREST Sealant Matrix
n=20 Participants
Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
|
SURGICEL Absorbable Hemostat (Control)
n=20 Participants
Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
|
|---|---|---|
|
Number of Participants Who Required Re-treatment At The Target Bleeding Site
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 44 days post-surgery on Day 0Population: The safety analysis set consists of all participants who received treatment.
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Outcome measures
| Measure |
EVARREST Sealant Matrix
n=20 Participants
Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
|
SURGICEL Absorbable Hemostat (Control)
n=20 Participants
Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
18 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: From baseline up to hospital discharge (up to Day 44 post-surgery on Day 0)Population: The safety analysis set consists of all participants who received treatment. Here, 'N' (number of participants analyzed) signifies number of participants who were analyzed for this outcome measure.
Change from baseline to post-surgery in haemoglobin were reported.
Outcome measures
| Measure |
EVARREST Sealant Matrix
n=19 Participants
Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
|
SURGICEL Absorbable Hemostat (Control)
n=20 Participants
Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
|
|---|---|---|
|
Change From Baseline to Post-surgery in Haemoglobin
|
0.0 grams/liter (g/L)
Interval -56.0 to 43.0
|
-10.0 grams/liter (g/L)
Interval -150.0 to 44.0
|
SECONDARY outcome
Timeframe: From baseline up to hospital discharge (up to Day 44 post-surgery on Day 0)Population: The safety analysis set consists of all participants who received treatment. Here, 'N' (number of participants analyzed) signifies number of participants who were analyzed for this outcome measure.
Change from baseline to post-surgery in Haematocrit was reported.
Outcome measures
| Measure |
EVARREST Sealant Matrix
n=19 Participants
Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
|
SURGICEL Absorbable Hemostat (Control)
n=20 Participants
Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
|
|---|---|---|
|
Change From Baseline to Post-surgery in Haematocrit
|
0.0 Liter of cells per liter of blood (L/L)
Interval -0.2 to 0.1
|
-0.0 Liter of cells per liter of blood (L/L)
Interval -0.1 to 0.1
|
SECONDARY outcome
Timeframe: From baseline up to hospital discharge (up to Day 44 post-surgery on Day 0)Population: The safety analysis set consists of all participants who received treatment. Here, 'N' (number of participants analyzed) signifies number of participants who were analyzed for this outcome measure.
Change from baseline to post-surgery in platelet count was reported.
Outcome measures
| Measure |
EVARREST Sealant Matrix
n=19 Participants
Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
|
SURGICEL Absorbable Hemostat (Control)
n=20 Participants
Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
|
|---|---|---|
|
Change From Baseline to Post-surgery in Platelet Count
|
-89.0 10^9 cells per liter
Interval -531.0 to 112.0
|
-71.5 10^9 cells per liter
Interval -259.0 to 386.0
|
SECONDARY outcome
Timeframe: Up to 1 day (intraoperative)Population: The FAS consisted of all randomized participants. Participants who did not completed the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis.
Estimated volume of intra-operative blood loss (including but not limited to the TBS) was reported.
Outcome measures
| Measure |
EVARREST Sealant Matrix
n=20 Participants
Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
|
SURGICEL Absorbable Hemostat (Control)
n=20 Participants
Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
|
|---|---|---|
|
Estimated Volume of Blood Loss
|
100.0 Milliliter (mL)
Full Range 0.0 • Interval 0.0 to 800.0
|
200.0 Milliliter (mL)
Full Range 15.0 • Interval 15.0 to 2000.0
|
SECONDARY outcome
Timeframe: Up to 44 days post-surgery on Day 0Population: The FAS consisted of all randomized participants. Participants who did not completed the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis.
Number of participants who received blood transfusions (red blood cells \[RBCs\], whole blood, fresh frozen plasma, platelets, and cryoprecipitates) were reported.
Outcome measures
| Measure |
EVARREST Sealant Matrix
n=12 Participants
Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
|
SURGICEL Absorbable Hemostat (Control)
n=11 Participants
Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
|
|---|---|---|
|
Number of Participants Who Received Blood Transfusions
Packed RBCs (0 Unit)
|
3 Participants
|
2 Participants
|
|
Number of Participants Who Received Blood Transfusions
Packed RBCs (1 Unit)
|
4 Participants
|
4 Participants
|
|
Number of Participants Who Received Blood Transfusions
Packed RBCs (2 Units)
|
4 Participants
|
3 Participants
|
|
Number of Participants Who Received Blood Transfusions
Packed RBCs (3 Units)
|
1 Participants
|
1 Participants
|
|
Number of Participants Who Received Blood Transfusions
Packed RBCs (6 Units)
|
0 Participants
|
1 Participants
|
|
Number of Participants Who Received Blood Transfusions
Whole Blood (0 Unit)
|
9 Participants
|
9 Participants
|
|
Number of Participants Who Received Blood Transfusions
Whole Blood (1 Unit)
|
2 Participants
|
1 Participants
|
|
Number of Participants Who Received Blood Transfusions
Whole Blood (2 Units)
|
1 Participants
|
1 Participants
|
|
Number of Participants Who Received Blood Transfusions
Fresh Frozen Plasma (0 Unit)
|
10 Participants
|
11 Participants
|
|
Number of Participants Who Received Blood Transfusions
Fresh Frozen Plasma (2 Units)
|
1 Participants
|
0 Participants
|
|
Number of Participants Who Received Blood Transfusions
Fresh Frozen Plasma (5 Units)
|
1 Participants
|
0 Participants
|
|
Number of Participants Who Received Blood Transfusions
Platelets (0 Units)
|
8 Participants
|
9 Participants
|
|
Number of Participants Who Received Blood Transfusions
Platelets (1 Unit)
|
3 Participants
|
1 Participants
|
|
Number of Participants Who Received Blood Transfusions
Platelets (2 Units)
|
1 Participants
|
0 Participants
|
|
Number of Participants Who Received Blood Transfusions
Platelets (3 Units)
|
0 Participants
|
1 Participants
|
|
Number of Participants Who Received Blood Transfusions
Cryoprecipitates (0 Units)
|
12 Participants
|
11 Participants
|
Adverse Events
EVARREST Sealant Matrix
Serious events: 4 serious events
Other events: 18 other events
Deaths: 0 deaths
SURGICEL Absorbable Hemostat (Control)
Serious events: 5 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EVARREST Sealant Matrix
n=20 participants at risk
Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
|
SURGICEL Absorbable Hemostat (Control)
n=20 participants at risk
Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Investigations
Weight Decreased
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Infections and infestations
Device related infection
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroblastoma
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Renal and urinary disorders
Hematuria
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Gastrointestinal disorders
Intussusception
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Gastrointestinal disorders
Localised intraabdominal fluid collection
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Infections and infestations
Urinary tract infection
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Vascular disorders
Bloody Discharge
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
Other adverse events
| Measure |
EVARREST Sealant Matrix
n=20 participants at risk
Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
|
SURGICEL Absorbable Hemostat (Control)
n=20 participants at risk
Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
2/20 • Number of events 2 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Cardiac disorders
Bradycardia
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
15.0%
3/20 • Number of events 3 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Cardiac disorders
Tachycardia
|
50.0%
10/20 • Number of events 10 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
35.0%
7/20 • Number of events 9 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
2/20 • Number of events 2 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
10.0%
2/20 • Number of events 2 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
10.0%
2/20 • Number of events 2 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
2/20 • Number of events 2 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
20.0%
4/20 • Number of events 4 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
2/20 • Number of events 2 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
10.0%
2/20 • Number of events 2 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Gastrointestinal disorders
Vomiting
|
30.0%
6/20 • Number of events 7 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
30.0%
6/20 • Number of events 7 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
10.0%
2/20 • Number of events 2 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Vascular disorders
Hypotension
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
General disorders
Oedema peripheral
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
10.0%
2/20 • Number of events 2 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
General disorders
Pain
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
General disorders
Puncture site discharge
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
General disorders
Pyrexia
|
25.0%
5/20 • Number of events 5 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
45.0%
9/20 • Number of events 10 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Injury, poisoning and procedural complications
Procedural hypotention
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
15.0%
3/20 • Number of events 3 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
35.0%
7/20 • Number of events 7 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Injury, poisoning and procedural complications
Wound complication
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Injury, poisoning and procedural complications
Wound secretion
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Investigations
Blood alkaline phosphate decreased
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Investigations
Haemoglobin decreased
|
10.0%
2/20 • Number of events 2 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
10.0%
2/20 • Number of events 2 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Investigations
International normalized ratio increased
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Investigations
Neutrophil count increased
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
10.0%
2/20 • Number of events 2 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Investigations
Urine output decreased
|
10.0%
2/20 • Number of events 2 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Investigations
Blood pressure increased
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
10.0%
2/20 • Number of events 2 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
10.0%
2/20 • Number of events 2 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.0%
2/20 • Number of events 2 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
10.0%
2/20 • Number of events 2 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
10.0%
2/20 • Number of events 2 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Nervous system disorders
Horner's syndrome
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Reproductive system and breast disorders
Vulval oedema
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bradypnoea
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Gastrointestinal disorders
Constipation
|
10.0%
2/20 • Number of events 2 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
General disorders
Device occlusion
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Immune system disorders
Seasonal allergy
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Vascular disorders
Hypertension
|
15.0%
3/20 • Number of events 3 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
10.0%
2/20 • Number of events 2 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
15.0%
3/20 • Number of events 3 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
15.0%
3/20 • Number of events 3 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
2/20 • Number of events 2 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint instability
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Investigations
Blood potassium decreased
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Injury, poisoning and procedural complications
Anal injury
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Infections and infestations
Candidiasis
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Infections and infestations
Device related infection
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Infections and infestations
Oral candidiasis
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Infections and infestations
Urinary tract infection
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/20 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
5.0%
1/20 • Number of events 1 • Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication or other public presentation of results from this study requires prior review by ETHICON. Draft abstracts, manuscripts, and materials for presentation at scientific meetings must be sent to the sponsor at least 60 days prior to submission for publication, public dissemination, or review by a publication committee.
- Publication restrictions are in place
Restriction type: OTHER