BREAST ADM Trial for Alloplastic Breast Reconstruction (NCT04661501)
🩺 Plain-English Summary (8th-Grade Level)
This study is a randomized single blinded prospective clinical trial comparing the surgical outcomes of four different acellular dermal matrixes (ADMs) after primary breast reconstruction. ADMs are used in conjunction with tissue expanders or breast implants to reinforce the recreated breast pocket. Currently, 4 different ADMS are commercially available: AlloDerm, DermaCell, Allomax and Flex HD. It is unclear which ADM is clinically superior. The objective of the study is to compare the complications and post-op care of 4 different ADMs within a 2 year follow up to elucidate their surgical outcomes.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (2 items) and avoid the listed exclusions (10 items).
Location: Mount Saint Joseph's Hospital — Vancouver, British Columbia
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Patients undergoing autologous reconstruction either at the time of mastectomy or in a delayed fashion.
- Patients with a history of previous breast reconstruction procedures.
- Patients with prior radiation treatment to the breast or with prior mantle radiation
- Any patient with a contraindication to breast reconstruction
- Patients undergoing an axillary node dissection with clearance
- Patients with an allergy to Polysporin or any of its ingredients.
- Patients with contraindications to any of the acellular dermal matrices:
- DermACELL: Allergy to Gentamicin, Vancomycin\[12\]
- The surgeon performing the breast reconstruction may also deem a patient ineligible if intraoperatively, there is evidence of significant mastectomy flap ischemia prior to the initiation of the breast reconstruction procedure.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (4 Sites)
- Mount Saint Joseph's Hospital — Vancouver, British Columbia
- Vancouver General Hospital — Vancouver, British Columbia
- UBC Hospital — Vancouver, British Columbia
- Saint Paul's Hospital — Vancouver, British Columbia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.