At a glance
ClinicalIndex Comparison Record- ✓Female patient
- ✓Ages 20-90
- ✓Undergoing mastectomy for breast cancer or prophylaxis with immediate implant-based reconstruction
- ✓Able to provide verbal consent
- ✕Prior chest wall radiation on the reconstructed side
- ✕Not undergoing immediate breast reconstruction at time of mastectomy
- ✕Any contraindication to immediate breast reconstruction
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomised Controlled Trial Comparing the Use of Alloderm Versus Dermacell in Immediate Implant Based Breast Reconstruction
In Brief
A clinical study evaluating Alloderm and Dermacell for Breast Reconstruction. Completed, enrolled 62 participants across 1 site.
Detailed 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 Details
Timeline
Interventions
Reconstruction material
Reconstruction material