Baptist South Offers New At-Home Method of Tissue Expansion Prior Breast Reconstruction
May 2, 2012 | Jacksonville, FL
Baptist Medical Center South, in collaboration with the East Coast Research Institute, is the first hospital in Florida to participate in a new clinical trial that offer breast cancer survivors a less painful, more convenient methodfor tissue expansion in preparation for breast reconstruction surgery. It involves implanting a small device in the patient’s breast that allows the woman to use a hand-held remote control at home to gradually create a space within the chest wall for the breast implant.
The study’s principal investigator, Ankit Desai, MD and co-investigator Michael Fallucco, MD, board-certified plastic and reconstructive surgeons on staff at Baptist South, explain how this innovative new approach can benefit women whowant to have breast reconstruction after undergoing a mastectomy.
The current process that women must undergo prior to breast reconstruction involves having a saline tissue expander implanted in the breast by a plastic surgeon. The patient then must return for weekly office visits so the plastic surgeon can insert a needle through the skin into the tissue expander's port and inject as much saline into the implant as the woman can tolerate. This is an important limitation of the current technology and one that we are working with ECIR to overcome says Dr. Desai.
“This new system eliminates the need for weekly saline injections and needle sticks by enabling the patient to use a hand-held remote control on a daily basis to gradually release compressed carbon-dioxide through a small internal valve to fill the tissue expander."
In addition to increasing patient comfort and convenience, studies indicate that the time needed for tissue expansion can also be significantly reduced. During a feasibility trial in Australia, the average expansion time associated with the remote-controlled tissue expander was within weeks, as compared to the several months required with traditional saline expanders.
“This device is such a promising new approach to tissue expansion,” says Dr. Desai. “I think that the remote-controlled tissue expander will change the way plastic surgeons perform breast reconstruction.
The randomized, controlled clinical trial is designed to directly compare the outcomes of tissue expansion using the traditional saline expansion method to the investigational remote-controlled, needle-free tissue expander. New York-Presbyterian Hospital/Columbia University Medical Center was the first site to begin U.S. clinical trials. Baptist Medical Center South is currently one of only 10 sites across the country participating in the investigational trial and ECIR has been instrumental inboth obtaining and conducting the trial.
Patients who may be eligible for the trial include non-obese women from 18 to 65 years of age who do not smoke, have not had previous tissue expansion or radiation therapy, and who are opting for breast reconstruction with tissue expansion after mastectomy.
For more information on this study, call the East Coast Research Institute at 904.854.1354.