Trial Outcomes & Findings for Analgesic Efficacy of Liposomal Bupivacaine vs. Bupivacaine HCL as a Tap Block After Abdominally Based Autologous Breast Reconstruction (NCT NCT02662036)
NCT ID: NCT02662036
Last Updated: 2019-02-18
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
70 participants
Primary outcome timeframe
Up to day of discharge from hospital (expected hospital stay of 5 days)
Results posted on
2019-02-18
Participant Flow
Participant milestones
| Measure |
Group 1: Bupivicaine
-TAP block of 30 cc of 0.25% bupivicaine
|
Group 2: Liposomal Bupivacaine
-TAP block of 266 mg/30 cc liposomal bupivacaine
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
22
|
22
|
|
Overall Study
NOT COMPLETED
|
13
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
10 patients had their surgeries scheduled after the trial closed, 8 were deemed ineligible because they were later found to take preoperative narcotics daily, deviated significantly from the enhanced recovery protocol, or developed recurrent disease prior to surgery. 4 patients withdrew consent and another 4 had missing data.
Baseline characteristics by cohort
| Measure |
Group 1: Bupivicaine
n=35 Participants
-TAP block of 30 cc of 0.25% bupivicaine
|
Group 2: Liposomal Bupivacaine
n=35 Participants
-TAP block of 266 mg/30 cc liposomal bupivacaine
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51 years
n=35 Participants
|
47 years
n=35 Participants
|
48.5 years
n=70 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=35 Participants
|
35 Participants
n=35 Participants
|
70 Participants
n=70 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=35 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=70 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=35 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=70 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=35 Participants
|
34 Participants
n=35 Participants
|
66 Participants
n=70 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=35 Participants
|
1 Participants
n=35 Participants
|
3 Participants
n=70 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=35 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=70 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=35 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=70 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=35 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=70 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=35 Participants
|
5 Participants
n=35 Participants
|
9 Participants
n=70 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=35 Participants
|
28 Participants
n=35 Participants
|
58 Participants
n=70 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=35 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=70 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=35 Participants
|
1 Participants
n=35 Participants
|
2 Participants
n=70 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=35 Participants
|
35 participants
n=35 Participants
|
70 participants
n=70 Participants
|
|
Baseline QoR
|
134 score on a scale
n=22 Participants • 10 patients had their surgeries scheduled after the trial closed, 8 were deemed ineligible because they were later found to take preoperative narcotics daily, deviated significantly from the enhanced recovery protocol, or developed recurrent disease prior to surgery. 4 patients withdrew consent and another 4 had missing data.
|
140 score on a scale
n=22 Participants • 10 patients had their surgeries scheduled after the trial closed, 8 were deemed ineligible because they were later found to take preoperative narcotics daily, deviated significantly from the enhanced recovery protocol, or developed recurrent disease prior to surgery. 4 patients withdrew consent and another 4 had missing data.
|
136 score on a scale
n=44 Participants • 10 patients had their surgeries scheduled after the trial closed, 8 were deemed ineligible because they were later found to take preoperative narcotics daily, deviated significantly from the enhanced recovery protocol, or developed recurrent disease prior to surgery. 4 patients withdrew consent and another 4 had missing data.
|
PRIMARY outcome
Timeframe: Up to day of discharge from hospital (expected hospital stay of 5 days)Outcome measures
| Measure |
Group 1: Bupivicaine
n=22 Participants
-TAP block of 30 cc of 0.25% bupivicaine
|
Group 2: Liposomal Bupivacaine
n=22 Participants
-TAP block of 266 mg/30 cc liposomal bupivacaine
|
|---|---|---|
|
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Opioid Use During Hospital Stay
Intraoperative
|
99.5 mg
Interval 15.0 to 220.0
|
110.0 mg
Interval 42.0 to 215.0
|
|
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Opioid Use During Hospital Stay
Postoperative acute care unit
|
0 mg
Interval 0.0 to 45.0
|
10 mg
Interval 0.0 to 100.0
|
|
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Opioid Use During Hospital Stay
Postoperative floor
|
165 mg
Interval 25.0 to 570.0
|
138.8 mg
Interval 37.5 to 470.0
|
|
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Opioid Use During Hospital Stay
Total
|
300 mg
Interval 108.0 to 684.0
|
283 mg
Interval 90.0 to 765.0
|
SECONDARY outcome
Timeframe: Up to day of discharge from hospital (expected hospital stay of 5 days)Outcome measures
| Measure |
Group 1: Bupivicaine
n=22 Participants
-TAP block of 30 cc of 0.25% bupivicaine
|
Group 2: Liposomal Bupivacaine
n=22 Participants
-TAP block of 266 mg/30 cc liposomal bupivacaine
|
|---|---|---|
|
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Antiemetic Use During the Hospital Stay
Total
|
1 mg
Interval 0.0 to 8.0
|
1 mg
Interval 0.0 to 13.0
|
|
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Antiemetic Use During the Hospital Stay
Postoperative acute care unit
|
0 mg
Interval 0.0 to 2.0
|
0 mg
Interval 0.0 to 1.0
|
|
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Antiemetic Use During the Hospital Stay
Floor
|
1 mg
Interval 0.0 to 6.0
|
1 mg
Interval 0.0 to 13.0
|
SECONDARY outcome
Timeframe: Up to day of discharge from hospital, up to 7 daysOutcome measures
| Measure |
Group 1: Bupivicaine
n=22 Participants
-TAP block of 30 cc of 0.25% bupivicaine
|
Group 2: Liposomal Bupivacaine
n=22 Participants
-TAP block of 266 mg/30 cc liposomal bupivacaine
|
|---|---|---|
|
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Length of Hospital Stay
|
3.56 days
Interval 2.64 to 4.84
|
2.91 days
Interval 1.92 to 6.74
|
SECONDARY outcome
Timeframe: Up to 2 weeks post-operationOutcome measures
| Measure |
Group 1: Bupivicaine
n=22 Participants
-TAP block of 30 cc of 0.25% bupivicaine
|
Group 2: Liposomal Bupivacaine
n=22 Participants
-TAP block of 266 mg/30 cc liposomal bupivacaine
|
|---|---|---|
|
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Time Until Ambulation
|
2.20 days
Interval 0.9 to 3.72
|
1.81 days
Interval 1.09 to 3.67
|
SECONDARY outcome
Timeframe: Up to 2 weeks post-operationOutcome measures
| Measure |
Group 1: Bupivicaine
n=22 Participants
-TAP block of 30 cc of 0.25% bupivicaine
|
Group 2: Liposomal Bupivacaine
n=22 Participants
-TAP block of 266 mg/30 cc liposomal bupivacaine
|
|---|---|---|
|
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Duration of Urinary Catheter
|
1.27 days
Interval 0.75 to 3.68
|
1.02 days
Interval 0.14 to 5.55
|
SECONDARY outcome
Timeframe: 12 hours after surgery* Pain scale uses Wong-Baker FACES Pain Rating Scale * The scale uses cartoon faces ranging from 0-10 with 0 meaning no pain and 10 meaning worst possible pain
Outcome measures
| Measure |
Group 1: Bupivicaine
n=22 Participants
-TAP block of 30 cc of 0.25% bupivicaine
|
Group 2: Liposomal Bupivacaine
n=22 Participants
-TAP block of 266 mg/30 cc liposomal bupivacaine
|
|---|---|---|
|
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores
|
2.0 score on a scale
Interval 0.0 to 9.0
|
0 score on a scale
Interval 0.0 to 8.0
|
SECONDARY outcome
Timeframe: 24 hours after surgery* Pain scale uses Wong-Baker FACES Pain Rating Scale * The scale uses cartoon faces ranging from 0-10 with 0 meaning no pain and 10 meaning worst possible pain
Outcome measures
| Measure |
Group 1: Bupivicaine
n=22 Participants
-TAP block of 30 cc of 0.25% bupivicaine
|
Group 2: Liposomal Bupivacaine
n=22 Participants
-TAP block of 266 mg/30 cc liposomal bupivacaine
|
|---|---|---|
|
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores
|
2.0 score on a scale
Interval 0.0 to 9.0
|
3 score on a scale
Interval 0.0 to 7.0
|
SECONDARY outcome
Timeframe: 48 hours after surgery* Pain scale uses Wong-Baker FACES Pain Rating Scale * The scale uses cartoon faces ranging from 0-10 with 0 meaning no pain and 10 meaning worst possible pain
Outcome measures
| Measure |
Group 1: Bupivicaine
n=22 Participants
-TAP block of 30 cc of 0.25% bupivicaine
|
Group 2: Liposomal Bupivacaine
n=22 Participants
-TAP block of 266 mg/30 cc liposomal bupivacaine
|
|---|---|---|
|
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores
|
2 score on a scale
Interval 0.0 to 7.0
|
2 score on a scale
Interval 0.0 to 7.0
|
SECONDARY outcome
Timeframe: 72 hours after surgery* Pain scale uses Wong-Baker FACES Pain Rating Scale * The scale uses cartoon faces ranging from 0-10 with 0 meaning no pain and 10 meaning worst possible pain
Outcome measures
| Measure |
Group 1: Bupivicaine
n=22 Participants
-TAP block of 30 cc of 0.25% bupivicaine
|
Group 2: Liposomal Bupivacaine
n=22 Participants
-TAP block of 266 mg/30 cc liposomal bupivacaine
|
|---|---|---|
|
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores
|
2 score on a scale
Interval 0.0 to 4.0
|
0.5 score on a scale
Interval 0.0 to 7.0
|
SECONDARY outcome
Timeframe: At post operative day 2, discharge, and at 1-2 week follow-up* Quality of Recovery -15 questionnaire * Part A has 10 questions that asks how the participant has been feeling in the last 24 hours with answers ranging from 0=none of the time to 10=all of the time * Part B has 5 questions asking the participant if they have had any of the following including pain, nausea, vomiting, anxiety, and depression) with answers ranging from 0=none of the time to 10=all of the time. * The total score allowed is 150 (range 0-150) with the higher the number the worse the participant is feeling and the lower the number the better the participant is feeling
Outcome measures
| Measure |
Group 1: Bupivicaine
n=22 Participants
-TAP block of 30 cc of 0.25% bupivicaine
|
Group 2: Liposomal Bupivacaine
n=22 Participants
-TAP block of 266 mg/30 cc liposomal bupivacaine
|
|---|---|---|
|
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Change From Baseline in Patient Satisfaction With Recovery
Post-operative day 2
|
-33 score on a scale
Interval -95.0 to 15.0
|
-24 score on a scale
Interval -68.0 to 0.0
|
|
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Change From Baseline in Patient Satisfaction With Recovery
Discharge
|
-10 score on a scale
Interval -52.0 to 36.0
|
-6 score on a scale
Interval -45.0 to 9.0
|
|
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Change From Baseline in Patient Satisfaction With Recovery
1-2 week follow-up
|
-18.5 score on a scale
Interval -59.0 to 37.0
|
-10 score on a scale
Interval -41.0 to 8.0
|
SECONDARY outcome
Timeframe: Up to 2 weeks post-operationPopulation: Data was not collected for this outcome measure. There was no funding to collect or analyze the data. Also it was determined that the concept of cost was highly variable at the hospital and any data that was obtained would lack granular costs on most items. Lacking this granularity would make any results meaningless.
Outcome measures
Outcome data not reported
Adverse Events
Group 1: Bupivicaine
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 2: Liposomal Bupivacaine
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1: Bupivicaine
n=22 participants at risk
-TAP block of 30 cc of 0.25% bupivicaine
|
Group 2: Liposomal Bupivacaine
n=22 participants at risk
-TAP block of 266 mg/30 cc liposomal bupivacaine
|
|---|---|---|
|
Injury, poisoning and procedural complications
Failed Flap
|
9.1%
2/22 • Adverse events were tracked from first administration of study drug until 30 days following the day of surgery.
Only adverse events deemed to be serious, unexpected, severe, and related to the study drug will be recorded. Specifically, bleeding requiring blood transfusion, infection requiring readmission or surgery, life-threatening arrhythmias, would healing problems requiring surgical intervention, and reconstructive failures due to flap loss will be recorded and evaluated for relatedness.
|
13.6%
3/22 • Adverse events were tracked from first administration of study drug until 30 days following the day of surgery.
Only adverse events deemed to be serious, unexpected, severe, and related to the study drug will be recorded. Specifically, bleeding requiring blood transfusion, infection requiring readmission or surgery, life-threatening arrhythmias, would healing problems requiring surgical intervention, and reconstructive failures due to flap loss will be recorded and evaluated for relatedness.
|
|
Injury, poisoning and procedural complications
Wound dehiscence (abdomen requiring local debridement)
|
18.2%
4/22 • Adverse events were tracked from first administration of study drug until 30 days following the day of surgery.
Only adverse events deemed to be serious, unexpected, severe, and related to the study drug will be recorded. Specifically, bleeding requiring blood transfusion, infection requiring readmission or surgery, life-threatening arrhythmias, would healing problems requiring surgical intervention, and reconstructive failures due to flap loss will be recorded and evaluated for relatedness.
|
4.5%
1/22 • Adverse events were tracked from first administration of study drug until 30 days following the day of surgery.
Only adverse events deemed to be serious, unexpected, severe, and related to the study drug will be recorded. Specifically, bleeding requiring blood transfusion, infection requiring readmission or surgery, life-threatening arrhythmias, would healing problems requiring surgical intervention, and reconstructive failures due to flap loss will be recorded and evaluated for relatedness.
|
|
Injury, poisoning and procedural complications
Medical Flap Necrosis requiring debridement
|
0.00%
0/22 • Adverse events were tracked from first administration of study drug until 30 days following the day of surgery.
Only adverse events deemed to be serious, unexpected, severe, and related to the study drug will be recorded. Specifically, bleeding requiring blood transfusion, infection requiring readmission or surgery, life-threatening arrhythmias, would healing problems requiring surgical intervention, and reconstructive failures due to flap loss will be recorded and evaluated for relatedness.
|
9.1%
2/22 • Adverse events were tracked from first administration of study drug until 30 days following the day of surgery.
Only adverse events deemed to be serious, unexpected, severe, and related to the study drug will be recorded. Specifically, bleeding requiring blood transfusion, infection requiring readmission or surgery, life-threatening arrhythmias, would healing problems requiring surgical intervention, and reconstructive failures due to flap loss will be recorded and evaluated for relatedness.
|
|
Injury, poisoning and procedural complications
Flap Necrosis
|
0.00%
0/22 • Adverse events were tracked from first administration of study drug until 30 days following the day of surgery.
Only adverse events deemed to be serious, unexpected, severe, and related to the study drug will be recorded. Specifically, bleeding requiring blood transfusion, infection requiring readmission or surgery, life-threatening arrhythmias, would healing problems requiring surgical intervention, and reconstructive failures due to flap loss will be recorded and evaluated for relatedness.
|
4.5%
1/22 • Adverse events were tracked from first administration of study drug until 30 days following the day of surgery.
Only adverse events deemed to be serious, unexpected, severe, and related to the study drug will be recorded. Specifically, bleeding requiring blood transfusion, infection requiring readmission or surgery, life-threatening arrhythmias, would healing problems requiring surgical intervention, and reconstructive failures due to flap loss will be recorded and evaluated for relatedness.
|
|
Injury, poisoning and procedural complications
Flap hematoma requiring evacuation
|
0.00%
0/22 • Adverse events were tracked from first administration of study drug until 30 days following the day of surgery.
Only adverse events deemed to be serious, unexpected, severe, and related to the study drug will be recorded. Specifically, bleeding requiring blood transfusion, infection requiring readmission or surgery, life-threatening arrhythmias, would healing problems requiring surgical intervention, and reconstructive failures due to flap loss will be recorded and evaluated for relatedness.
|
9.1%
2/22 • Adverse events were tracked from first administration of study drug until 30 days following the day of surgery.
Only adverse events deemed to be serious, unexpected, severe, and related to the study drug will be recorded. Specifically, bleeding requiring blood transfusion, infection requiring readmission or surgery, life-threatening arrhythmias, would healing problems requiring surgical intervention, and reconstructive failures due to flap loss will be recorded and evaluated for relatedness.
|
|
Infections and infestations
Breast reconstruction cellulitis
|
4.5%
1/22 • Adverse events were tracked from first administration of study drug until 30 days following the day of surgery.
Only adverse events deemed to be serious, unexpected, severe, and related to the study drug will be recorded. Specifically, bleeding requiring blood transfusion, infection requiring readmission or surgery, life-threatening arrhythmias, would healing problems requiring surgical intervention, and reconstructive failures due to flap loss will be recorded and evaluated for relatedness.
|
0.00%
0/22 • Adverse events were tracked from first administration of study drug until 30 days following the day of surgery.
Only adverse events deemed to be serious, unexpected, severe, and related to the study drug will be recorded. Specifically, bleeding requiring blood transfusion, infection requiring readmission or surgery, life-threatening arrhythmias, would healing problems requiring surgical intervention, and reconstructive failures due to flap loss will be recorded and evaluated for relatedness.
|
|
Infections and infestations
Abdominal wound cellulitis
|
0.00%
0/22 • Adverse events were tracked from first administration of study drug until 30 days following the day of surgery.
Only adverse events deemed to be serious, unexpected, severe, and related to the study drug will be recorded. Specifically, bleeding requiring blood transfusion, infection requiring readmission or surgery, life-threatening arrhythmias, would healing problems requiring surgical intervention, and reconstructive failures due to flap loss will be recorded and evaluated for relatedness.
|
4.5%
1/22 • Adverse events were tracked from first administration of study drug until 30 days following the day of surgery.
Only adverse events deemed to be serious, unexpected, severe, and related to the study drug will be recorded. Specifically, bleeding requiring blood transfusion, infection requiring readmission or surgery, life-threatening arrhythmias, would healing problems requiring surgical intervention, and reconstructive failures due to flap loss will be recorded and evaluated for relatedness.
|
|
Injury, poisoning and procedural complications
Abdominal hematoma requiring evacauation
|
0.00%
0/22 • Adverse events were tracked from first administration of study drug until 30 days following the day of surgery.
Only adverse events deemed to be serious, unexpected, severe, and related to the study drug will be recorded. Specifically, bleeding requiring blood transfusion, infection requiring readmission or surgery, life-threatening arrhythmias, would healing problems requiring surgical intervention, and reconstructive failures due to flap loss will be recorded and evaluated for relatedness.
|
4.5%
1/22 • Adverse events were tracked from first administration of study drug until 30 days following the day of surgery.
Only adverse events deemed to be serious, unexpected, severe, and related to the study drug will be recorded. Specifically, bleeding requiring blood transfusion, infection requiring readmission or surgery, life-threatening arrhythmias, would healing problems requiring surgical intervention, and reconstructive failures due to flap loss will be recorded and evaluated for relatedness.
|
|
Injury, poisoning and procedural complications
Partial Flap Loss
|
0.00%
0/22 • Adverse events were tracked from first administration of study drug until 30 days following the day of surgery.
Only adverse events deemed to be serious, unexpected, severe, and related to the study drug will be recorded. Specifically, bleeding requiring blood transfusion, infection requiring readmission or surgery, life-threatening arrhythmias, would healing problems requiring surgical intervention, and reconstructive failures due to flap loss will be recorded and evaluated for relatedness.
|
4.5%
1/22 • Adverse events were tracked from first administration of study drug until 30 days following the day of surgery.
Only adverse events deemed to be serious, unexpected, severe, and related to the study drug will be recorded. Specifically, bleeding requiring blood transfusion, infection requiring readmission or surgery, life-threatening arrhythmias, would healing problems requiring surgical intervention, and reconstructive failures due to flap loss will be recorded and evaluated for relatedness.
|
|
Injury, poisoning and procedural complications
Late Flap Loss
|
0.00%
0/22 • Adverse events were tracked from first administration of study drug until 30 days following the day of surgery.
Only adverse events deemed to be serious, unexpected, severe, and related to the study drug will be recorded. Specifically, bleeding requiring blood transfusion, infection requiring readmission or surgery, life-threatening arrhythmias, would healing problems requiring surgical intervention, and reconstructive failures due to flap loss will be recorded and evaluated for relatedness.
|
4.5%
1/22 • Adverse events were tracked from first administration of study drug until 30 days following the day of surgery.
Only adverse events deemed to be serious, unexpected, severe, and related to the study drug will be recorded. Specifically, bleeding requiring blood transfusion, infection requiring readmission or surgery, life-threatening arrhythmias, would healing problems requiring surgical intervention, and reconstructive failures due to flap loss will be recorded and evaluated for relatedness.
|
|
Injury, poisoning and procedural complications
Delayed Pedicle TRAM Flap
|
4.5%
1/22 • Adverse events were tracked from first administration of study drug until 30 days following the day of surgery.
Only adverse events deemed to be serious, unexpected, severe, and related to the study drug will be recorded. Specifically, bleeding requiring blood transfusion, infection requiring readmission or surgery, life-threatening arrhythmias, would healing problems requiring surgical intervention, and reconstructive failures due to flap loss will be recorded and evaluated for relatedness.
|
0.00%
0/22 • Adverse events were tracked from first administration of study drug until 30 days following the day of surgery.
Only adverse events deemed to be serious, unexpected, severe, and related to the study drug will be recorded. Specifically, bleeding requiring blood transfusion, infection requiring readmission or surgery, life-threatening arrhythmias, would healing problems requiring surgical intervention, and reconstructive failures due to flap loss will be recorded and evaluated for relatedness.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.5%
1/22 • Adverse events were tracked from first administration of study drug until 30 days following the day of surgery.
Only adverse events deemed to be serious, unexpected, severe, and related to the study drug will be recorded. Specifically, bleeding requiring blood transfusion, infection requiring readmission or surgery, life-threatening arrhythmias, would healing problems requiring surgical intervention, and reconstructive failures due to flap loss will be recorded and evaluated for relatedness.
|
0.00%
0/22 • Adverse events were tracked from first administration of study drug until 30 days following the day of surgery.
Only adverse events deemed to be serious, unexpected, severe, and related to the study drug will be recorded. Specifically, bleeding requiring blood transfusion, infection requiring readmission or surgery, life-threatening arrhythmias, would healing problems requiring surgical intervention, and reconstructive failures due to flap loss will be recorded and evaluated for relatedness.
|
|
Injury, poisoning and procedural complications
Fascial dehiscence/hernia
|
4.5%
1/22 • Adverse events were tracked from first administration of study drug until 30 days following the day of surgery.
Only adverse events deemed to be serious, unexpected, severe, and related to the study drug will be recorded. Specifically, bleeding requiring blood transfusion, infection requiring readmission or surgery, life-threatening arrhythmias, would healing problems requiring surgical intervention, and reconstructive failures due to flap loss will be recorded and evaluated for relatedness.
|
0.00%
0/22 • Adverse events were tracked from first administration of study drug until 30 days following the day of surgery.
Only adverse events deemed to be serious, unexpected, severe, and related to the study drug will be recorded. Specifically, bleeding requiring blood transfusion, infection requiring readmission or surgery, life-threatening arrhythmias, would healing problems requiring surgical intervention, and reconstructive failures due to flap loss will be recorded and evaluated for relatedness.
|
Additional Information
Terence Myckatyn, M.D.
Washington University School of Medicine
Phone: 314-996-8800
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place