Trial Outcomes & Findings for Fibrin Sealant in Preventing Fluid Build Up During Surgery in Patients Undergoing Breast Reconstruction (NCT NCT01649505)
NCT ID: NCT01649505
Last Updated: 2022-11-02
Results Overview
Computed with 95% confidence interval using exact method. The difference of seroma rate in the two groups will be computed with 95% confidence interval using exact method. Two-sided Fisher's exact test will be used to evaluate whether the seroma rate are significantly different for the two treatment groups.
TERMINATED
NA
2 participants
Up to day 180 post-operation
2022-11-02
Participant Flow
Participant milestones
| Measure |
Arm I (Fibrin Sealant)
Patients undergo sharp dissection technique with fibrin sealant closure.
breast reconstruction : Undergo sharp dissection technique
fibrin sealant (Beriplast P, TISSEEL VH) : Applied topically
|
Arm II (Standard Electrocoagulation)
Patients undergo standard electrocoagulation dissection technique.
breast reconstruction : Undergo electrocoagulation dissection technique
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fibrin Sealant in Preventing Fluid Build Up During Surgery in Patients Undergoing Breast Reconstruction
Baseline characteristics by cohort
| Measure |
Arm I (Fibrin Sealant)
n=1 Participants
Patients undergo sharp dissection technique with fibrin sealant closure.
breast reconstruction : Undergo sharp dissection technique
fibrin sealant (Beriplast P, TISSEEL VH) : Applied topically
|
Arm II (Standard Electrocoagulation)
n=1 Participants
Patients undergo standard electrocoagulation dissection technique.
breast reconstruction : Undergo electrocoagulation dissection technique
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
44 years
n=99 Participants
|
44 years
n=107 Participants
|
44 years
STANDARD_DEVIATION 0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to day 180 post-operationPopulation: Data was not collected due to early termination and very low accrual
Computed with 95% confidence interval using exact method. The difference of seroma rate in the two groups will be computed with 95% confidence interval using exact method. Two-sided Fisher's exact test will be used to evaluate whether the seroma rate are significantly different for the two treatment groups.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to day 180 post-operationPopulation: Data was not collected due to early termination and very low accrual
Computed with 95% confidence interval using exact method. Two-sided Fisher's exact test will be used to evaluate whether the wound complication rate are significantly different for the two treatment groups, and the odds ratio with 95% confidence interval will be computed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to day 10 post-operationPopulation: Data was not collected due to early termination and very low accrual
Defined as total volume of drainage recorded (in ml) by nurses while the patient is in the hospital and by patient himself/herself when discharged home, until the removal of the drain by a doctor once it reaches less than 50 ml per day. Wilcoxon rank sum test will be used to compare the drainage volume of the two groups.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to day 180 post-operationPopulation: Data was not collected due to early termination and very low accrual
Outcome measures
Outcome data not reported
Adverse Events
Arm I (Fibrin Sealant)
Arm II (Standard Electrocoagulation)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Juliana Hansen
Oregon Health and Science University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place