Fibrin Sealant in Preventing Fluid Build Up During Surgery in Patients Undergoing Breast Reconstruction
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Breast Cancer Perioperative/Postoperative Complications||Drug: fibrin sealant (Beriplast P, TISSEEL VH) Procedure: breast reconstruction|
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|
|Primary Completion Date :||January 2012|
|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|