Bioprosthetic Mesh to Expand the Lower Pole in Tissue Expander Reconstruction: A Blinded, Prospective, Randomized, Controlled Trial
If you agree to take part in this study, you will be randomly assigned (as in the roll of a
dice) to receive Surgimend mesh or Alloderm mesh.
Breast Reconstruction Surgery:
All techniques of the breast reconstruction surgery are considered to be standard of care.
You will be given a separate consent form to sign that explains the procedure and risks in
Information about you will be collected, including your age, height, weight, breast size,
past medical and smoking history, tumor size and location, and the surgical method used for
the breast reconstruction surgery.
Information about the breast reconstruction surgery, such as what type of expanders are
used, the surgical methods, and your recovery from the surgery will also be collected.
About 1 week after the breast reconstruction surgery is complete, you will come in for a
follow-up visit and the surgical team will check the surgery incision site and tissue used
for the breast reconstruction surgery for any possible complications.
About 2 weeks after the breast reconstruction surgery, the expansion process will begin, as
long as you do not have any complications that would prevent beginning the expansion
process. During the expansion process, the surgeon will adjust the tissue expanders to
stretch the area under the skin and muscle to make room for a breast implant(s).
After you begin the expansion process, you will return to the clinic 1 time each week for
additional expansion until the desired size is reached. During each of the expansion
process visits, you will be checked for any side effects, including fluid build up and
After the expansion process is complete, you will return to the clinic 3 months later to
receive your implant(s). About 1 to 12 months after you receive the implant(s), you will
return to the clinic and 5 photographs will be taken to evaluate the appearance of the new
implant(s). The photographs will be taken of the front, right and left sides of the
implant(s) site and will be taken against a blue background. Your private areas will be
covered (as much as possible). Your confidentiality will be protected at all times. You
will not be identifiable personally from the discussion or presentation of the data. Unique
study numbers will be assigned to the photographs.
Length of Study:
Your participation on this study will be over after you have received your permanent breast
implant(s) and the photographs have been taken.
This is an investigational study.
Up to 398 patients will take part in this study. All will be enrolled at M. D. Anderson.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Overall Complication Rate Post-Tissue Expander Reconstruction Surgery
The primary endpoint, overall complication after tissue expander implant is defined as any of the following complications: seroma, cellulitis, abscess, red breast syndrome, implant malposition, capsular contracture, and hematoma, seen during weekly postoperative visits.
1 week after the breast reconstruction surgery
Mark W. Clemens, MD
UT MD Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|