A Single Arm Prospective Multicenter Study Evaluating the Biodesign® Plastic Surgery Matrix

Topic of Study: Breast Cancer

Sponsor: Cook Biotech Incorporated

Principal Investigator: Brendan J. Collins, M.D., 401-332-9700

Research Coordinator: Irene van Gaalen, PA-C, 410-332-5488

For More Information: 410-951-7950

Coordinated Through: The Breast Reconstruction and Restoration Center at Mercy

This study is designed for patients desiring nipple reconstruction following surgery for breast cancer and breast reconstruction. Eligible patients will receive a surgical procedure to reconstruct one or both nipples utilizing the COOK® Biodesign® Plastic Surgery Matrix. The study is designed to evaluate the benefit of this device in achieving effective and aesthetic nipple reconstruction. Patients will be evaluated at the time of the procedure and at 1 week, 4 weeks, 3 months, 6 months, and 12 months after surgery to examine the projection of their reconstructed nipple(s) and patient satisfaction (Cook Medical Study 09-009; Clinicaltrials.gov ID#: NCT01216319).