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

• ClinicalTrials.gov Identifier: NCT01649505
• Recruitment Status: Terminated
• First Posted: July 25, 2012
• Results First Posted: March 15, 2013
• Last Update Posted: March 15, 2013
• Sponsor: OHSU Knight Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): OHSU Knight Cancer Institute

Study Description

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

Condition or disease	Intervention/treatment	Phase
Breast Cancer; Perioperative/Postoperative Complications	Drug: fibrin sealant (Beriplast P, TISSEEL VH); Procedure: breast reconstruction	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Intraoperative Use of Fibrin Glue Sealant Combined With Sharp Dissection Technique as a Preventative Measure for Seromas
• Study Start Date: January 2011
• Actual Primary Completion Date: January 2012
• Actual Study Completion Date: January 2012

Arms and Interventions

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 Name: Mammaplasty
Active Comparator: Arm II (standard electrocoagulation); Patients undergo standard electrocoagulation dissection technique.	Procedure: breast reconstruction; Undergo electrocoagulation dissection technique; Other Name: Mammaplasty

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Proportion of Patients Who Experienced Wound Infections, Wound Separation, or Any Other Surgical Complications [ Time Frame: 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.
2. Quantity of Post-operative Drainage [ Time Frame: 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.
3. Serious and Nonserious Adverse Events and Complications [ Time Frame: Up to day 180 post-operation ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Oregon

OHSU Knight Cancer Institute

Portland, Oregon, United States, 97239

Sponsors and Collaborators

OHSU Knight Cancer Institute

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Juliana Hansen; OHSU Knight Cancer Institute

More Information

• Responsible Party: OHSU Knight Cancer Institute
• ClinicalTrials.gov Identifier: NCT01649505
• Other Study ID Numbers: 6606; NCI-2012-00809 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); P30CA069533 ( U.S. NIH Grant/Contract )
• First Posted: July 25, 2012
• Results First Posted: March 15, 2013
• Last Update Posted: March 15, 2013
• Last Verified: March 2013

Additional relevant MeSH terms:

Postoperative Complications; Pathologic Processes; Fibrin Tissue Adhesive; Hemostatics; Coagulants