BREAST ADM Trial for Alloplastic Breast Reconstruction

Launched by UNIVERSITY OF BRITISH COLUMBIA · Dec 3, 2020

Keywords

ClinConnect Summary

The BREAST ADM Trial is a study designed to compare the results of four different types of acellular dermal matrices (ADMs) used during breast reconstruction surgery. These matrices help support the breast pocket when using tissue expanders or implants after a mastectomy, which is the surgical removal of one or both breasts. The trial aims to find out which ADM leads to fewer complications and better recovery experiences for women undergoing breast reconstruction.

To be eligible for this study, women must be between 21 and 65 years old and are planning to have breast reconstruction after a mastectomy. Participants will go through a two-step process where they first receive tissue expanders, followed by an exchange to breast implants. It's important to note that women with certain medical histories, such as previous breast reconstruction, radiation treatment, or specific allergies, may not be able to participate. Those who join the trial can expect to be followed for two years to monitor their recovery and any issues that may arise. This study is currently recruiting participants who want to help improve breast reconstruction outcomes for future patients.

Gender

FEMALE

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.