BREAST ADM Trial for Alloplastic Breast Reconstruction

This study is a randomized control trial and will include all patients who are agreeable and deemed appropriate for alloplastic breast reconstruction involving the use of an ADM with two stage tissue expander (TE) reconstruction. The ADMs used will be determined by random assignment to one of four available products being utilized within the study: AlloDerm, AlloMax, DermACELL and FlexHD. Each ADM product will comprise of an individual treatment arm. Participants undergoing bilateral reconstruction will have the same ADM used in each side. The four treatment arms will be compared to assess their impact on our primary outcome: proportion of clinically significant post-operative seroma requiring intervention. Analysis will be performed per surgeon to prevent post-operative outcomes from being confounded by the principle operator. The trial will initially be conducted as an internal pilot study. The study will initially target a study population of 40 patients for recruitment as a means to assess the feasibility of the study. In doing this, the pilot study will be able to establish the necessary protocol and administrative infrastructure that is needed to complete the trial in its entirety. This create a sample population for initial outcomes.

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.