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

This study has been terminated.
(Low patient enrollment and no clinical findings.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT01649505
First received: July 20, 2012
Last updated: March 13, 2013
Last verified: March 2013
  Purpose

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 Intervention
Breast Cancer
Perioperative/Postoperative Complications
Drug: fibrin sealant (Beriplast P, TISSEEL VH)
Procedure: breast reconstruction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:
  • Proportion of Patients in Each Arm Who Develop Post-operative Seromas [ Time Frame: Up to day 180 post-operation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to day 180 post-operation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to day 10 post-operation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to day 180 post-operation ] [ Designated as safety issue: Yes ]

Enrollment: 2
Study Start Date: January 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01649505

Locations
United States, Oregon
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Sponsors and Collaborators
OHSU Knight Cancer Institute
Investigators
Principal Investigator: Juliana Hansen OHSU Knight Cancer Institute
  More Information

No publications provided

Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT01649505     History of Changes
Other Study ID Numbers: 6606, NCI-2012-00809, P30CA069533
Study First Received: July 20, 2012
Results First Received: February 11, 2013
Last Updated: March 13, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Breast Neoplasms
Postoperative Complications
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pathologic Processes
Fibrin Tissue Adhesive
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014