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

Intraoperative Use of Fibrin Glue Sealant Combined With Sharp Dissection Technique as a Preventative Measure for Seromas

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

Study Overview

• Status: Terminated
• Conditions: Breast Cancer; Perioperative/Postoperative Complications
• Intervention / Treatment: Drug: fibrin sealant (Beriplast P, TISSEEL VH); Procedure: breast reconstruction; Procedure: breast reconstruction

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • OHSU Knight Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (fibrin sealant); Patients undergo sharp dissection technique with fibrin sealant closure.	Drug: fibrin sealant (Beriplast P, TISSEEL VH); Applied topically; Other Names: Beriplast P; TISSEEL VH; Procedure: breast reconstruction; Undergo sharp dissection technique; Other Names: Mammaplasty; Procedure: breast reconstruction; Undergo electrocoagulation dissection technique; Other Names: Mammaplasty
Active Comparator: Arm II (standard electrocoagulation); Patients undergo standard electrocoagulation dissection technique.	Procedure: breast reconstruction; Undergo sharp dissection technique; Other Names: Mammaplasty; Procedure: breast reconstruction; Undergo electrocoagulation dissection technique; Other Names: Mammaplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patients in Each Arm Who Develop Post-operative Seromas	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.	Up to day 180 post-operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patients Who Experienced Wound Infections, Wound Separation, or Any Other Surgical Complications	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.	Up to day 180 post-operation
Quantity of Post-operative Drainage	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.	Up to day 10 post-operation
Serious and Nonserious Adverse Events and Complications		Up to day 180 post-operation

Collaborators and Investigators

• Sponsor: OHSU Knight Cancer Institute
• Collaborators: Oregon Health and Science University
• Investigators: Principal Investigator: Juliana Hansen, OHSU Knight Cancer Institute

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: July 20, 2012
• First Submitted That Met QC Criteria: July 24, 2012
• First Posted (Estimate): July 25, 2012

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: October 10, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Hemostatics; Coagulants; Fibrin Tissue Adhesive
• Other Study ID Numbers: IRB00006606; NCI-2012-00809 (Registry Identifier: CTRP (Clinical Trial Reporting Program))