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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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.
Up to day 180 post-operation
OHSU Knight Cancer Institute
United States: Federal Government
|OHSU Knight Cancer Institute||Portland, Oregon 97239|