Bioprosthetic Mesh to Expand the Lower Pole in Tissue Expander Reconstruction
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Bioprosthetic Mesh to Expand the Lower Pole in Tissue Expander Reconstruction: A Blinded, Prospective, Randomized, Controlled Trial|
- Overall Complication Rate Post-Tissue Expander Reconstruction Surgery [ Time Frame: 1 week after the breast reconstruction surgery ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||February 2011|
|Estimated Primary Completion Date:||February 2017 (Final data collection date for primary outcome measure)|
Experimental: Alloderm Mesh
Alloderm Mesh - 6 x 12 cm piece or 6 x 16 cm piece is trimmed into a semicircle and sewn into the inframammary fold using vicryl. The smooth side is placed against the implant.
6 x 12 cm piece or 6 x 16 cm piece is trimmed into a semicircle and sewn into the inframammary fold using vicryl. The smooth side is placed against the implant.
Experimental: Surgimend Mesh
Surgimend Mesh - 10 x 15 cm piece of fenestrated material is sewn to the fold, curved side along the fold, using vicryl suture.
10 x 15 cm piece of fenestrated material is sewn to the fold, curved side along the fold, using vicryl suture.
|No Intervention: Control (no mesh)|
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 more detail.
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 infection.
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 the MD Anderson main campus or one of the MD Anderson regional care centers.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01310075
|Contact: Mark W. Clemens, MD||713-794-1247|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Mark W. Clemens, MD||M.D. Anderson Cancer Center|