Conditions: Breast Cancer Perioperative/Postoperative Complications
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Patients undergo sharp dissection technique with fibrin sealant closure. arm 2: Patients undergo standard electrocoagulation dissection technique.

Interventions: intervention 1: fibrin sealant (Beriplast P, TISSEEL VH) intervention 2: breast reconstruction intervention 3: breast reconstruction
Intervention descriptions: intervention 1: Applied topically intervention 2: Undergo sharp dissection technique intervention 3: Undergo electrocoagulation dissection technique

Protocol document: