Bioprosthetic Mesh to Expand the Lower Pole in Tissue Expander Reconstruction

Completed · Not applicable

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT01310075

Run by

M.D. Anderson Cancer Center

People needed

90

Starts

2011-02-01

Expected to finish

2017-11-08

Last updated by the study team

2019-04-30

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients undergoing immediate tissue expander reconstruction following mastectomy by any of the surgeon co-investigators are eligible for the study.
• Patients 18 years of age or older are eligible for the study.
• Patients undergoing skin-sparing mastectomy utilizing bioprosthetic mesh are eligible for the study.
• Patients who have not undergone autologous tissue breast reconstruction and intend to undergo implant only breast reconstruction.
• Patients who intend to remain under the MDACC surgeon's care until completion of the reconstruction.

You may not qualify if…

• Patients with prior radiation to the breast/chest wall of the ipsilateral breast .
• Patients who cannot be effectively reconstructed without the use of bioprosthetic mesh.
• Patients who are current smokers.
• Patients requiring additional intra-operative skin resections of greater than 1cm beyond the skin edge as a result of mastectomy flap devascularization.
• Patients who have a history of breast tissue expander or implant placement.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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