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

Not Applicable

Terminated

Interventions: Drug: fibrin sealant (Beriplast P, TISSEEL VH)
Procedure: breast reconstruction

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.

Recruitment & Eligibility

Inclusion Criteria

Patients who will be undergoing latissimus dorsi donor flap harvest reconstruction and evaluated by the Department of Plastic and Reconstructive Surgery at Oregon Health and Science University (OHSU)
These patients will be undergoing reconstructive surgery for a mastectomy/wide local excision of breast cancer defect or other soft tissue defect resulting from trauma, infection, undesirable surgical outcome, oncologic resection, etc.
Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

Patients who will not qualify for latissimus dorsi donor flap reconstruction based on anatomical limitations specific the subjects respectively; to be evaluated by the plastic surgeon
History of allergic reactions attributed to compounds of similar chemical or biologic composition to fibrin glue sealant
Patients with evidence of hematological disorders resulting in deficient coagulation whereby sharp dissection would result in undesirable bleeding otherwise performed more safely with electrosurgery

Arm && Interventions

Group	Intervention	Description
Arm I (fibrin sealant)	fibrin sealant (Beriplast P, TISSEEL VH)	Patients undergo sharp dissection technique with fibrin sealant closure.
Arm II (standard electrocoagulation)	breast reconstruction	Patients undergo standard electrocoagulation dissection technique.
Arm I (fibrin sealant)	breast reconstruction	Patients undergo sharp dissection technique with fibrin sealant closure.

Primary Outcome Measures

Name	Time	Method
Proportion of Patients in Each Arm Who Develop Post-operative Seromas	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.

Secondary Outcome Measures

Name	Time	Method
Quantity of Post-operative Drainage	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.
Proportion of Patients Who Experienced Wound Infections, Wound Separation, or Any Other Surgical Complications	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.
Serious and Nonserious Adverse Events and Complications	Up to day 180 post-operation