Intraoperative Use of Fibrin Glue Sealant Combined With Sharp Dissection Technique as a Preventative Measure for Seromas
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- OHSU Knight Cancer Institute
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Proportion of Patients in Each Arm Who Develop Post-operative Seromas
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Arm I (fibrin sealant)
Patients undergo sharp dissection technique with fibrin sealant closure.
Intervention: fibrin sealant (Beriplast P, TISSEEL VH) (Drug)
Arm I (fibrin sealant)
Patients undergo sharp dissection technique with fibrin sealant closure.
Intervention: breast reconstruction (Procedure)
Arm II (standard electrocoagulation)
Patients undergo standard electrocoagulation dissection technique.
Intervention: breast reconstruction (Procedure)
Outcomes
Primary Outcomes
Proportion of Patients in Each Arm Who Develop Post-operative Seromas
Time Frame: 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 Outcomes
- Quantity of Post-operative Drainage(Up to day 10 post-operation)
- Proportion of Patients Who Experienced Wound Infections, Wound Separation, or Any Other Surgical Complications(Up to day 180 post-operation)
- Serious and Nonserious Adverse Events and Complications(Up to day 180 post-operation)
Investigators
Juliana Hansen
Principal Investigator
OHSU Knight Cancer Institute