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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
2
Applied topically
Undergo sharp dissection technique
Undergo electrocoagulation dissection technique
OHSU Knight Cancer Institute
Portland, Oregon, United States
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.
Time frame: Up to day 180 post-operation
Proportion of Patients Who Experienced Wound Infections, Wound Separation, or Any Other Surgical Complications
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.
Time frame: Up to day 180 post-operation
Quantity of Post-operative Drainage
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.
Time frame: Up to day 10 post-operation
Serious and Nonserious Adverse Events and Complications
Time frame: Up to day 180 post-operation
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