BREAST ADM Trial for Alloplastic Breast Reconstruction
Trial Parameters
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Brief Summary
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.
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 reconstr