WORCESTER, MA--(Marketwire - June 13, 2012) - The University of Massachusetts Medical School (UMMS) and UMass Memorial Medical Center have enrolled their first participant in a clinical study designed to evaluate a new tissue expansion method for breast reconstruction after a mastectomy. The 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, 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 inflations using conventional saline expanders to create a pocket for a standard implant following a mastectomy," said John Castle, MD, clinical assistant professor of surgery at UMMS and plastic surgery director at the UMass Memorial Comprehensive Breast Center. "This investigational system eliminates the need for saline injections by allowing the patient to trigger the release of small amounts of compressed carbon-dioxide through the valve of a tiny chamber located inside the expander. The patient uses the remote control to gradually inflate the investigational expander in small, pre-set amounts on a daily basis at home, eliminating the need for weekly doctor visits."
Participants in this clinical trial will undergo outpatient surgery to have the investigational tissue expansion device implanted. They will then use a wireless dose controller to trigger the release of small, regulated amounts of carbon-dioxide to fill the tissue expander, according to a protocol directed by their surgeon. Once the tissue is adequately expanded, participants will return to UMass Memorial Medical Center to have the implant surgically inserted. During earlier feasibility trials, the average expansion time associated with the remote-controlled tissue expander was 15 days, a fraction of the time required using traditional expanders which can take months to achieve full expansion.
Patients in the study will be randomly selected to receive the investigational expander or a traditional saline expander. The patients who receive the investigational expander 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. Castle. Once the tissue is adequately expanded, the patient will return to have the expander removed and a standard implant placed.
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.
UMass Memorial Medical Center and other hospitals across the U.S. are participating in the study. Enrollment will continue until a total of 92 AeroForm expanders and 46 saline expanders have been implanted in patients. 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) has granted AirXpanders an Investigational Device Exemption (IDE) to conduct the study and it has been approved for enrollment by the U Mass Memorial Medical Center Review Board.
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 508-334-7692.
About the University of Massachusetts Medical School
The University of Massachusetts Medical School, one of the fastest growing academic health centers in the country, has built a reputation as a world-class research institution, consistently producing noteworthy advances in clinical and basic research. The Medical School attracts more than $270 million in research funding annually, 80 percent of which comes from federal funding sources. The mission of the Medical School is to advance the health and well-being of the people of the commonwealth and the world through pioneering education, research, public service and health care delivery with its clinical partner, UMass Memorial Health Care. For more information, visit www.umassmed.edu.
About UMass Memorial Medical Center
UMass Memorial Medical Center is the region's trusted academic medical center, committed to improving the health of the people of Central New England through excellence in clinical care, service, teaching and research. As the hub of an integrated health care system, we are proud to partner with our four community member hospitals: Clinton Hospital, HealthAlliance Hospital, Marlborough Hospital and Wing Memorial Hospital. Plus, we are the clinical partner of the University of Massachusetts Medical School. Through this relationship our physicians and staff teach tomorrow's physicians, nurses and other health care professionals. They also participate in research efforts that bring our patients the very latest diagnostic and treatment protocols. Our Medical Center includes three campuses located in Worcester: our University Campus, Memorial Campus and Hahnemann Campus. In addition, our network of care includes community-based physician practices, home health, hospice, rehabilitation and behavioral health services. The Medical Center offers a full complement of sophisticated technology and support services, providing the region with specialists renowned for their expertise in clinical areas including cardiology, orthopedics, cancer, emergency medicine, surgery, women's health and children's medical services.