Patients With Breast Cancer Requiring Mastectomy and Suitable for Reconstruction Clinical Trial
Official title:
Impact of Acellular Dermal Matrix in Reduction of Surgical Complexity of Breast Reconstructions With Implants
The objective of this study is to demonstrate that acellular dermal matrix, Strattice™ Reconstructive Tissue Matrix, can reduce the surgical complexity and post-operative pain of breast reconstructions with implants by avoiding one more surgical step in the operating room.
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.
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