One-stage Breast Reconstruction Using Dermal Matrix/Implant Versus Two-stage Expander/Implant Procedure
Condition: Breast Cancer
Study type: Interventional

Summary: 
      Currently the two-stage tissue expander/implant (TE/I) technique is the standard breast
      reconstructive option for breast cancer patients selected for immediate, skin-sparing
      mastectomy. This procedure has been demonstrated to be oncologically safe in patients with
      specific criteria for early stage breast cancer. The primary drawback, however, is that it
      requires two separate procedures under general anesthesia and multiple office visits for
      expander inflation to create the breast mound. Acellular dermal matrix has gained widespread
      acceptance for use in breast reconstruction and other areas and has the potential to provide
      support to the breast implant without tissue expansion in a one-stage procedure. The purpose
      of the study is to test this new procedure and to evaluate the impact of one-stage breast
      reconstruction using acellular dermis compared to the standard two-stage expander/implant
      technique on measures of patient satisfaction and quality of life.
    

Detailed description: 
      Recently, there has been significant focus on the performance of skin-sparing mastectomies in
      certain types of breast cancer patients. These treatments may be performed for prophylactic
      mastectomy but also have been demonstrated to be oncologically safe in patients with specific
      criteria for early stage breast cancer. Currently, the two-stage tissue expander/implant
      (TE/I) technique is the standard breast reconstructive option for breast cancer patients
      selected for immediate, skin-sparing mastectomy, however there are significant disadvantages
      as this technique requires two separate surgeries and multiple office visits to complete that
      may affect a patients quality of life. Medically safe compounds such as acellular dermal
      matrix have been developed that have the potential to support breast implants without
      requiring numerous tissue expansions and consequently providing the potential for a one-stage
      breast implant/reconstruction procedure for immediate, skin-sparing mastectomies.

      To examine patient satisfaction, quality of life and overall aesthetic outcome achieved using
      the acellular dermal matrix facilitated one-staged breast reconstruction at 2 weeks, 6 & 12
      months following completion of the reconstruction. Hypothesis 2: Patient satisfaction,
      quality of life and overall aesthetic outcome achieved using the acellular dermal matrix
      facilitated one-stage breast reconstruction is superior to that following the standard
      two-stage tissue expander/ implant breast reconstruction technique in selected mastectomy
      patients.

      To determine the short and long-term operative complication rates associated with the use of
      dermal matrix in one-stage immediate breast reconstruction following skin-sparing mastectomy.
      Hypothesis 1: The use of acellular dermal matrix in one-stage immediate prosthetic breast
      reconstruction is associated with decreased short and long-term postoperative complications
      compared with the traditional two staged tissue expander/implant procedure.
    

Intervention name(s): One-stage dermal matrix/implant procedure; Two-stage tissue expander/implant procedure
Intervention type(s): Procedure; Procedure
Intervention description(s): One-stage breast reconstruction with dermal matrix and implant; Two-stage breast reconstruction with tissue expander and implant
Other intervention name(s): Alloderm
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast reconstruction; Early stage; Skin-saving mastectomy; Prophylactic mastectomy; Acellular dermal matrix; BRCA Mutation Carriers