search
Back to results

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

Primary Purpose

Breast Cancer, Perioperative/Postoperative Complications

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
fibrin sealant (Beriplast P, TISSEEL VH)
breast reconstruction
breast reconstruction
Sponsored by
OHSU Knight Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • OHSU Knight Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (fibrin sealant)

Arm II (standard electrocoagulation)

Arm Description

Patients undergo sharp dissection technique with fibrin sealant closure.

Patients undergo standard electrocoagulation dissection technique.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Serious and Nonserious Adverse Events and Complications

Full Information

First Posted
July 20, 2012
Last Updated
October 10, 2022
Sponsor
OHSU Knight Cancer Institute
Collaborators
Oregon Health and Science University
search

1. Study Identification

Unique Protocol Identification Number
NCT01649505
Brief Title
Fibrin Sealant in Preventing Fluid Build Up During Surgery in Patients Undergoing Breast Reconstruction
Official Title
Intraoperative Use of Fibrin Glue Sealant Combined With Sharp Dissection Technique as a Preventative Measure for Seromas
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
Low patient enrollment and no clinical findings.
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
Oregon Health and Science University

4. Oversight

Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Perioperative/Postoperative Complications

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (fibrin sealant)
Arm Type
Experimental
Arm Description
Patients undergo sharp dissection technique with fibrin sealant closure.
Arm Title
Arm II (standard electrocoagulation)
Arm Type
Active Comparator
Arm Description
Patients undergo standard electrocoagulation dissection technique.
Intervention Type
Drug
Intervention Name(s)
fibrin sealant (Beriplast P, TISSEEL VH)
Other Intervention Name(s)
Beriplast P, TISSEEL VH
Intervention Description
Applied topically
Intervention Type
Procedure
Intervention Name(s)
breast reconstruction
Other Intervention Name(s)
Mammaplasty
Intervention Description
Undergo sharp dissection technique
Intervention Type
Procedure
Intervention Name(s)
breast reconstruction
Other Intervention Name(s)
Mammaplasty
Intervention Description
Undergo electrocoagulation dissection technique
Primary Outcome Measure Information:
Title
Proportion of Patients in Each Arm Who Develop Post-operative Seromas
Description
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.
Time Frame
Up to day 180 post-operation
Secondary Outcome Measure Information:
Title
Proportion of Patients Who Experienced Wound Infections, Wound Separation, or Any Other Surgical Complications
Description
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.
Time Frame
Up to day 180 post-operation
Title
Quantity of Post-operative Drainage
Description
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.
Time Frame
Up to day 10 post-operation
Title
Serious and Nonserious Adverse Events and Complications
Time Frame
Up to day 180 post-operation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliana Hansen
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs