Bioprosthetic Mesh to Expand the Lower Pole in Tissue Expander Reconstruction: A Blinded, Prospective, Randomized, Controlled Trial
18 Years
N/A
Female
Breast Cancer
Trial Information
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
more detail.
Data Collection:
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.
Follow-Up Visits:
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 M. D. Anderson.
Inclusion Criteria:
1. Patients undergoing immediate tissue expander reconstruction following mastectomy by
any of the surgeon co-investigators are eligible for the study.
2. Patients 18 years of age or older are eligible for the study.
3. Patients undergoing skin-sparing mastectomy utilizing bioprosthetic mesh are eligible
for the study.
4. Patients who have not undergone autologous tissue breast reconstruction and intend to
undergo implant only breast reconstruction.
5. Patients who intend to remain under the MDACC surgeon's care until completion of the
reconstruction.
Exclusion Criteria:
1. Patients with prior radiation to the breast/chest wall of the ipsilateral breast .
2. Patients who cannot be effectively reconstructed without the use of bioprosthetic
mesh.
3. Patients who are current smokers.
4. Patients requiring additional intra-operative skin resections of greater than 1cm
beyond the skin edge as a result of mastectomy flap devascularization.
5. Patients who have a history of breast tissue expander or implant placement.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Overall Complication Rate Post-Tissue Expander Reconstruction Surgery
Outcome Description:
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.
Outcome Time Frame:
1 week after the breast reconstruction surgery
Safety Issue:
Yes
Principal Investigator
Mark W. Clemens, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
UT MD Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2010-0324
NCT ID:
NCT01310075
Start Date:
February 2011
Completion Date:
Related Keywords:
- Breast Cancer
- Mastectomy
- Bioprosthetic Mesh
- Breast Reconstruction
- Tissue Expander
- Alloderm
- Surgimend
- Breast Neoplasms
Name | Location |
|---|---|
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
