Impact of Acellular Dermal Matrix in Reduction of Surgical Complexity of Breast Reconstructions With Implants
This study is designed to compare the clinical outcomes of patients undergoing mastectomy
followed by a direct to implant breast reconstruction with Strattice™ Reconstructive Tissue
Matrix to patients undergoing a standard two-stage reconstruction without Strattice™ or any
other mesh or tissue flap.
Potential candidates for the study will be identified through routine practice. Women who
meet the inclusion and exclusion criteria will be invited to participate in the study. A
screening visit will take place maximally 30 days prior to surgery.
Randomization will occur maximally 7 days prior to the mastectomy procedure. As some women
may have to undergo bilateral mastectomy and reconstruction, the randomization scheme will
ensure that both breasts will be reconstructed with the same surgical approach.
The Day of Surgery consists of both a mastectomy and a breast reconstruction. The surgical
site and the breasts will be evaluated on the day of hospital discharge and at postoperative
days 14 and 30 for all patients after each hospital admission. During these visits, the
breasts will be examined and an Acute Inflammatory Assessment (AIR) will be completed. In
addition the breast flaps and incisions will be evaluated for signs of infection, seroma,
hematoma or skin necrosis.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Number of surgeries where a differentiation will be made between major and minor depending upon the requirement to enter the breast pocket under general anesthesia.
Total numbers of major and of minor surgeries for each patient during the full trial period and including any surgeries that the PI determines are clinically still necessary at the end of the trial period. Major procedures are defined as those involving the patient to be treated in the OR: re-entering the implant pocket; soft-tissue flaps not performed under local anesthesia; general anesthesia; or procedures requiring inpatient admission. Other procedures, including for instance CT-guided percutaneous drainage or breast fat grafting (lipofilling), are defined as minor procedures.
At month 36 post-implant placement
Maurizio B Nava
Fondazione IRCCS Instituto Nazionale dei Tumori
Italy: Ethics Committee