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


N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Perioperative/Postoperative Complications

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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 InstitutePortland, Oregon  97239