LOS ANGELES, CA -- (Marketwired) -- 08/21/13 -- Susan Downey Plastic Surgeon is enrolling mastectomy patients into a clinical study designed to evaluate a new tissue expansion method for those who choose to undergo breast reconstruction. This randomized, controlled clinical study is designed to directly compare the outcomes of the traditional saline tissue expansion method to an investigational, remote-controlled, needle-free, carbon dioxide-based tissue expansion system known as The AeroForm Patient Controlled Tissue Expander System.
Tissue expansion is a process required to stretch the skin and tissue at the site of a mastectomy so that a standard saline or silicone breast implant can be placed.
"Traditionally, women undergoing breast reconstruction have had to endure a long process of inconvenient and often painful weekly inflations using conventional saline expanders to create a pocket for a standard implant following a mastectomy," said Susan Downey, M.D., breast plastic surgeon. "This investigational system eliminates the need for injections by allowing the patient to dose small amounts of compressed carbon-dioxide into the expander. The patient uses a remote control to deliver gradually daily doses to the implant at home or the office which can reduce the need for weekly doctor visits."
Patients in the study will be randomly selected to receive the investigational expander or a traditional saline expander. The patients who receive the AeroForm will use a wireless remote control to trigger the release of small, regulated amounts of carbon-dioxide to fill the tissue expander, according to a protocol directed by Dr. Downey. Once the patient's tissue is adequately expanded, she will return to have the expander removed and a permanent implant placed.
During a clinical study in Australia, the average expansion time associated with the remote-controlled tissue expander was 17 days, a fraction of the time required using traditional expanders which can take months to achieve full expansion.
The current standard of care in tissue expansion involves implanting a saline expander under the skin and pectoral muscle following a mastectomy procedure. The patient returns to her doctor weekly for bolus saline injections, which many patients say is the most painful, difficult part of the reconstruction process. The traditional saline process can take as long as five to six months, Dr. Downey explained.
Susan Downey Plastic Surgery and other hospitals across the U.S. are participating in the study. Enrollment will continue until a total of 92 AeroForm patients and 46 saline patients have been enrolled. AeroForm will be evaluated based on its ability to successfully and safely expand the tissue to the point that the expander can be replaced with a standard breast implant. Secondary measurements will include the average number of days needed to achieve the desired expansion, total reconstruction time, pain and patient satisfaction.
The AeroForm Patient Controlled Tissue Expander was designed and manufactured by AirXpanders, a medical device company in Palo Alto, CA. The U.S. Food and Drug Administration (FDA) have granted AirXpanders an Investigational Device Exemption (IDE) to conduct the study and it has been approved for enrollment.
For more information on the study, please visit clinicaltrials.gov (NCT01425268).
If you or someone you know is interested in joining the study, please call 323-468-0127.
About Susan Downey
Dr. Susan Downey is a board certified plastic surgeon who has been in practice in the Los Angeles area for 20 years. Dr Downey's practice covers the full range of plastic surgery from cosmetic surgery such as facelifts, breast augmentations, and abdominoplasties, and other body contouring procedures to reconstructive procedures such as breast reductions and breast reconstruction after cancer treatments. Dr. Downey is Board Certified by the American Board of Plastic Surgery and is an active member of numerous professional societies including the California Society of Plastic Surgery, the American Society of Plastic Surgery (ASPS) and the American Society for Aesthetic Plastic Surgery (ASAPS). She is currently Co-Chair of the Bariatric Task Force for ASAPS as well as Co-Chair of the ASAPS Women's Health Advocacy Committee. Dr. Downey is a Clinical Associate professor of Plastic Surgery at the University of Southern California's Keck School of Medicine. Dr. Downey received her undergraduate degree from Smith College in Northampton, MA and earned her medical degree from Columbia University's College of Physicians and Surgeons in New York City. She completed her residency in General Surgery at the University of Pennsylvania Hospital in Philadelphia and a residency in Plastic Surgery at the Columbia University - Presbyterian Hospital in New York. Continuing her education, Dr. Downey completed a Fellowship in Pediatric Plastic Surgery at Children's Hospital in Los Angeles, California.