Intraoperative Use of Fibrin Glue Sealant Combined With Sharp Dissection Technique as a Preventative Measure for Seromas
18 Years
N/A
Female
Breast Cancer, Perioperative/Postoperative Complications
Trial Information
Intraoperative Use of Fibrin Glue Sealant Combined With Sharp Dissection Technique as a Preventative Measure for Seromas
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Proportion of Patients in Each Arm Who Develop Post-operative Seromas
Outcome 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.
Outcome Time Frame:
Up to day 180 post-operation
Safety Issue:
No
Principal Investigator
Juliana Hansen
Investigator Role:
Principal Investigator
Investigator Affiliation:
OHSU Knight Cancer Institute
Authority:
United States: Federal Government
Study ID:
6606
NCT ID:
NCT01649505
Start Date:
January 2011
Completion Date:
January 2012
Related Keywords:
- Breast Cancer
- Perioperative/Postoperative Complications
- Breast Neoplasms
- Postoperative Complications
Name | Location |
|---|---|
| OHSU Knight Cancer Institute | Portland, Oregon 97239 |
