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

18 Years
Not Enrolling
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


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:


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:


Principal Investigator

Juliana Hansen

Investigator Role:

Principal Investigator

Investigator Affiliation:

OHSU Knight Cancer Institute


United States: Federal Government

Study ID:




Start Date:

January 2011

Completion Date:

January 2012

Related Keywords:

  • Breast Cancer
  • Perioperative/Postoperative Complications
  • Breast Neoplasms
  • Postoperative Complications



OHSU Knight Cancer InstitutePortland, Oregon  97239