BREAST ADM Trial for Alloplastic Breast Reconstruction

Conditions de participation

• Sexe:

  FEMALE

• Âges admissibles:

  21 to 65

Critères de participation

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.