Comparing different acellular dermal matrices for breast reconstruction

The BREAST Trial: A Randomized, Non-inferiority, Study Comparing the Complication Profile of Four Commercially Available Acellular Dermal Matrixes Used in Alloplastic Breast Reconstruction

This study is testing which of four different materials used in breast reconstruction helps prevent fluid buildup after surgery in women undergoing this procedure.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 328 (estimated)
• Ages: 21 Years to 65 Years
• Sex: Female
• Sponsor: University of British Columbia (Academic / other)
• Drugs / interventions: radiation
• Locations: 4 sites (Vancouver, British Columbia and 3 other locations)
• Trial ID: NCT04661501 on ClinicalTrials.gov

What this trial studies

This clinical trial is a randomized single-blinded prospective study that evaluates the surgical outcomes of four different acellular dermal matrices (ADMs) used in alloplastic breast reconstruction. Participants will be randomly assigned to receive one of the four ADMs: AlloDerm, AlloMax, DermACELL, or Flex HD, during a two-stage reconstruction process involving tissue expanders. The primary focus is to compare the incidence of clinically significant post-operative seromas requiring intervention over a two-year follow-up period. The trial will begin with a pilot phase targeting 40 patients to assess feasibility and establish necessary protocols.

Who should consider this trial

Good fit: Ideal candidates are women aged 21 to 65 undergoing unilateral or bilateral mastectomy with plans for alloplastic breast reconstruction using ADM.

Not a fit: Patients undergoing autologous reconstruction or those with contraindications to the ADMs will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help identify the most effective ADM for breast reconstruction, potentially reducing complications and improving patient outcomes.

How similar studies have performed: While this approach is being tested in this specific context, previous studies have shown varying outcomes with different ADMs, indicating that this comparison could provide valuable insights.

Eligibility criteria

Inclusion Criteria:

* All woman aged 21 years or older but less that 65 undergoing unilateral or bilateral mastectomy with alloplastic breast reconstruction using ADM.
* Breast reconstruction must be done by means of a two staged process using tissue expanders and ADM based reconstruction followed by implant tissue expander to implant exchange.

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.

Where this trial is running

Vancouver, British Columbia and 3 other locations

• Mount Saint Joseph's Hospital — Vancouver, British Columbia, Canada (Recruiting)
• Vancouver General Hospital — Vancouver, British Columbia, Canada (Recruiting)
• UBC Hospital — Vancouver, British Columbia, Canada (Recruiting)
• Saint Paul's Hospital — Vancouver, British Columbia, Canada (Recruiting)

Study contacts

• Principal investigator: Dr. Nancy Van Laeken — University of British Columbia
• Study coordinator: Dr. Nancy Van Laeken

Conditions Breast Reconstruction