Bioprosthetic Mesh to Expand the Lower Pole in Tissue Expander Reconstruction

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01310075
First received: March 3, 2011
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

The goal of this clinical research study is to learn if the complication rate and post-surgical appearance differ based on what type of mesh is used for breast reconstruction surgery.


Condition Intervention
Breast Cancer
Device: Alloderm
Device: Surgimend

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 398
Study Start Date: February 2011
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: Alloderm
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.
Device: Surgimend
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)

Detailed Description:

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 the MD Anderson main campus or one of the MD Anderson regional care centers.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01310075

Contacts
Contact: Mark W. Clemens, MD 713-794-1247

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Mark W. Clemens, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01310075     History of Changes
Other Study ID Numbers: 2010-0324, NCI-2011-01477
Study First Received: March 3, 2011
Last Updated: August 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Mastectomy
Bioprosthetic Mesh
Breast Reconstruction
Tissue Expander
Alloderm
Surgimend

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014