Fibrin Sealant in Preventing Fluid Build Up During Surgery in Patients Undergoing Breast Reconstruction
|ClinicalTrials.gov Identifier: NCT01649505|
Recruitment Status : Terminated (Low patient enrollment and no clinical findings.)
First Posted : July 25, 2012
Results First Posted : March 15, 2013
Last Update Posted : March 15, 2013
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Perioperative/Postoperative Complications||Drug: fibrin sealant (Beriplast P, TISSEEL VH) Procedure: breast reconstruction||Not Applicable|
I. To evaluate differing surgical techniques (sharp dissection v. electrosurgical, use of fibrin glue) in latissimus dorsi donor flap harvest and their effect, if any on the prevention of post-operative seromas.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo sharp dissection technique with fibrin sealant closure.
ARM II: Patients undergo standard electrocoagulation dissection technique.
After completion of study treatment, patients are followed up for 90-180 days.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Intraoperative Use of Fibrin Glue Sealant Combined With Sharp Dissection Technique as a Preventative Measure for Seromas|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
Experimental: Arm I (fibrin sealant)
Patients undergo sharp dissection technique with fibrin sealant closure.
Drug: fibrin sealant (Beriplast P, TISSEEL VH)
Other Names:Procedure: breast reconstruction
Undergo sharp dissection technique
Other Name: Mammaplasty
Active Comparator: Arm II (standard electrocoagulation)
Patients undergo standard electrocoagulation dissection technique.
Procedure: breast reconstruction
Undergo electrocoagulation dissection technique
Other Name: Mammaplasty
- Proportion of Patients in Each Arm Who Develop Post-operative Seromas [ Time Frame: Up to day 180 post-operation ]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.
- Proportion of Patients Who Experienced Wound Infections, Wound Separation, or Any Other Surgical Complications [ Time Frame: Up to day 180 post-operation ]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.
- Quantity of Post-operative Drainage [ Time Frame: Up to day 10 post-operation ]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.
- Serious and Nonserious Adverse Events and Complications [ Time Frame: Up to day 180 post-operation ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01649505
|United States, Oregon|
|OHSU Knight Cancer Institute|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Juliana Hansen||OHSU Knight Cancer Institute|