A Randomised Controlled Trial Comparing the Use of Alloderm Versus Dermacell in Immediate Implant Based Breast Reconstruction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Postoperative Duration of Drain Placements
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 90 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female patient
- •Ages 20-90
- •All patients undergoing mastectomy for breast cancer or prophylaxis for breast cancer with immediate implant-based reconstruction
- •Able to provide verbal consent
Exclusion Criteria
- •Patients who have had prior chest wall or irradiation on the reconstructed side
- •Patients not undergoing immediate breast reconstruction at the time of mastectomy
- •Any patient with a contraindication to immediate breast reconstruction
Arms & Interventions
Dermacell
Device for immediate implant based breast reconstruction
Intervention: Dermacell (Device)
Alloderm
Device for immediate implant based breast reconstruction
Intervention: Alloderm (Device)
Outcomes
Primary Outcomes
Postoperative Duration of Drain Placements
Time Frame: within 6 months of initial surgery
Postoperative duration of drain placements for each postoperative breast.
Secondary Outcomes
- Number of Breasts With an Episode of Seroma Formation Requiring Aspiration(within 6 months of initial surgery)
- Number of Breasts With Loss of Implant(within 6 months of initial surgery)
- Number of Breasts With Events of Revisional Surgery/ Return to Operating Room(within 6 months of initial surgery)
- Number of Breasts With Wound Dehiscence or Debridement(within 6 months of initial surgery)
- Number of Breasts With Capsular Contracture (as Identified by the Plastic Surgeon)(within 6 months of initial surgery)
- Number of Plastic Surgeon Visits(within 6 months of initial surgery)
- Economics of Total Costs(2 years)