NCT01649505

Fibrin Sealant in Preventing Fluid Build Up During Surgery in Patients Undergoing Breast Reconstruction

Intraoperative Use of Fibrin Glue Sealant Combined With Sharp Dissection Technique as a Preventative Measure for Seromas

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the efficacy of an alternative surgical technique and the use of fibrin sealant in preventing post-operative seroma formation. A seroma is a build-up of clear bodily fluids in a place on the body where tissue has been removed by surgery. Seromas can happen after breast surgeries. Seromas can appear about 7 to 10 days after surgery, after the drainage tubes have been removed. The breast area involved in the surgery may have a spot that's swollen and feels like there is liquid under the skin

Detailed description

PRIMARY OBJECTIVES: 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.

Conditions

• Breast Cancer
• Perioperative/Postoperative Complications

Interventions

Type	Name	Description
DRUG	fibrin sealant (Beriplast P, TISSEEL VH)	Applied topically
PROCEDURE	breast reconstruction	Undergo sharp dissection technique
PROCEDURE	breast reconstruction	Undergo electrocoagulation dissection technique

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2012-07-25
• Last updated: 2022-11-02
• Results posted: 2013-03-15

Locations

1 site across 1 country: United States