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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-01-31

Brief Summary

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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

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Detailed Description

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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

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Breast Cancer Perioperative/Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arm I (fibrin sealant)

Patients undergo sharp dissection technique with fibrin sealant closure.

Group Type EXPERIMENTAL

fibrin sealant (Beriplast P, TISSEEL VH)

Intervention Type DRUG

Applied topically

breast reconstruction

Intervention Type PROCEDURE

Undergo sharp dissection technique

Arm II (standard electrocoagulation)

Patients undergo standard electrocoagulation dissection technique.

Group Type ACTIVE_COMPARATOR

breast reconstruction

Intervention Type PROCEDURE

Undergo electrocoagulation dissection technique

Interventions

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fibrin sealant (Beriplast P, TISSEEL VH)

Applied topically

Intervention Type DRUG

breast reconstruction

Undergo sharp dissection technique

Intervention Type PROCEDURE

breast reconstruction

Undergo electrocoagulation dissection technique

Intervention Type PROCEDURE

Other Intervention Names

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Beriplast P TISSEEL VH Mammaplasty Mammaplasty

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No