Bioprosthetic Mesh to Expand the Lower Pole in Tissue Expander Reconstruction

April 5, 2019 updated by: M.D. Anderson Cancer Center

Bioprosthetic Mesh to Expand the Lower Pole in Tissue Expander Reconstruction: A Blinded, Prospective, Randomized, Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas Md Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Complications After Tissue Expander Replacement With Implant
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Mark W. Clemens, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2011

Primary Completion (Actual)

November 8, 2017

Study Completion (Actual)

November 8, 2017

Study Registration Dates

First Submitted

March 3, 2011

First Submitted That Met QC Criteria

March 4, 2011

First Posted (Estimate)

March 7, 2011

Study Record Updates

Last Update Posted (Actual)

April 30, 2019

Last Update Submitted That Met QC Criteria

April 5, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2010-0324
  • NCI-2011-01477 (Registry Identifier: NCI CTRP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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