Comparing different acellular dermal matrices for breast reconstruction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: nancy@vanlaeken.com
• Phone: 604-669-1633

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.