Breast reconstruction after mastectomy has been shown to provide psychosocial benefits to breast cancer patients and is considered an integral part of breast cancer treatment. In general, breast reconstruction can be accomplished using the patients own tissues or implantable prosthetic devices. Various acellular dermal matrices (ADMs) are offered on the market and the costs vary widely despite very similar qualities. The two most commonly used ADM products in North America by far are Dermacell and Alloderm. The difference between the two products include a) level of sterility, with Dermacell being sterilized to 10-9 while Alloderm is sterilized to 10-6 and b) the consistency and thickness of the biologic material and c) a significant different in cost ($2200 CAD vs $3600, respectively). Each product has shown to be safe and effective. As such, clinical equipoise exists. This will be a pragmatic trial to evaluate Dermacell with Alloderm in a head to head randomized fashion, with regards to the postoperative complications, namely infection, seroma formation (as measured by drain duration and output), loss of implant, incidence of revisional surgery and capsular contracture.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
62
The Ottawa Hospital
Ottawa, Ontario, Canada
Postoperative Duration of Drain Placements
Postoperative duration of drain placements for each postoperative breast.
Time frame: within 6 months of initial surgery
Number of Breasts With an Episode of Seroma Formation Requiring Aspiration
Time frame: within 6 months of initial surgery
Number of Breasts With Loss of Implant
Time frame: within 6 months of initial surgery
Number of Breasts With Events of Revisional Surgery/ Return to Operating Room
Time frame: within 6 months of initial surgery
Number of Breasts With Wound Dehiscence or Debridement
Wound dehiscence is a post-operative complication. Wound debridement is a procedure. This outcome was collected on a post-surgery case report form.
Time frame: within 6 months of initial surgery
Number of Breasts With Capsular Contracture (as Identified by the Plastic Surgeon)
Capsular contracture is a post-operative complication identified by the plastic surgeon. This outcome was collected on a post-surgery case report form.
Time frame: within 6 months of initial surgery
Number of Plastic Surgeon Visits
Time frame: within 6 months of initial surgery
Economics of Total Costs
Economic impact will be assessed based on calculation of total costs with each material used to include the material costs, duration of operative room use, clinic and inpatient hospital costs, surgical billing costs and anaesthesia costs
Time frame: 2 years
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