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

OHSU Knight Cancer Institute

Status: Terminated

Conditions: Breast Cancer; Perioperative/Postoperative Complications

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01649505

IRB00006606

NCI-2012-00809 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 2 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

Arm I (fibrin sealant)

Experimental group

Description:

Patients undergo sharp dissection technique with fibrin sealant closure.

Treatment:

Drug: fibrin sealant (Beriplast P, TISSEEL VH)

Procedure: breast reconstruction

Procedure: breast reconstruction

Arm II (standard electrocoagulation)

Active Comparator group

Description:

Patients undergo standard electrocoagulation dissection technique.

Treatment:

Procedure: breast reconstruction

Procedure: breast reconstruction