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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01649505
• Other study ID #: IRB00006606
• Secondary ID: NCI-2012-00809
• Status: Terminated
• Phase: N/A
• Start date: January 2011
• Est. completion date: January 2012

Study information

• Verified date: October 2022
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Perioperative/Postoperative Complications
• Postoperative Complications

Intervention

Drug:
• fibrin sealant (Beriplast P, TISSEEL VH)
Applied topically

Procedure:
• breast reconstruction
Undergo sharp dissection technique
• breast reconstruction
Undergo electrocoagulation dissection technique

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Serious and Nonserious Adverse Events and Complications		Up to day 180 post-operation