OCEANSIDE, NY and GARDEN CITY, NY, Jun 19, 2012 (MARKETWIRE via COMTEX) –South Nassau Communities Hospital and Long Island Plastic SurgicalGroup are enrolling mastectomy patients into a clinical studydesigned to evaluate a new tissue expansion method for those whochoose to undergo breast reconstruction. this randomized, controlledclinical study is designed to directly compare the outcomes of thetraditional saline tissue expansion method to an investigational,remote-controlled, needle-free, carbon dioxide-based tissue expansionsystem known as The AeroForm(TM) Patient Controlled Tissue ExpanderSystem.
Tissue expansion is a process required to stretch the skin and tissueat the site of a mastectomy so that a standard saline or siliconebreast implant can be placed.
“Traditionally, women undergoing breast reconstruction have had toendure a long process of inconvenient and often painful weeklyinflations using conventional saline expanders to create a pocket fora standard implant following a mastectomy,” said Kaveh Alizadeh, MD,president of Long Island Plastic Surgical Group. “Thisinvestigational system eliminates the need for saline injections byallowing the patient to trigger the release of small amounts ofcompressed carbon-dioxide through the valve of a tiny chamber locatedinside the expander. The patient uses the remote control to graduallyinflate the investigational expander in small, pre-set amounts on adaily basis at home, eliminating the need for weekly doctor visits.”
During a clinical study in Australia, the average expansion timeassociated with the remote-controlled tissue expander was 15 days, afraction of the time required using traditional expanders which cantake months to achieve full expansion.
The current standard of care in tissue expansion involves implantinga saline expander under the skin and pectoral muscle following amastectomy procedure. The patient returns to her doctor weekly forsaline injections, which many patients say is the most painful,difficult part of the reconstruction process. The traditional salineprocess can take as long as five to six months, Dr. Alizadehexplained.
Maureen Cori, a 48-year old mother of two from Woodmere, Long Islandunderwent a double mastectomy after hearing that she had breastcancer. After her mastectomies, Cori decided to pursue breastreconstruction, which involved expanding her breasts over time withtraditional saline expanders.
“I faced so many complications with saline expanders at the outset,”Cori said. “I developed infections and my surgeon had to remove bothexpanders shortly after they were initially implanted. It was also aconstant challenge for my surgeon to inject the saline during myweekly follow-up appointments.”
Cori believes that a product like AeroForm holds promise as analternative choice for women who choose breast reconstruction in thefuture.
“This is an important study for women’s health because it gives thepatient the opportunity to control the expansion,” she said.”Everyone has different pain thresholds. with AeroForm, the expansionprocess can be managed with significantly less discomfort and becausethere are no injections, risk of infection is decreased. I believe itis critical that we find more options for women during thischallenging and emotional time.”
South Nassau Communities Hospital, Long Island Surgical Group, P.C.and other hospitals across the U.S. are participating in the study.Enrollment will continue until a total of 92 AeroForm expanders and46 saline expanders have been implanted in patients around thecountry. AeroForm will be evaluated based on its ability tosuccessfully and safely expand the tissue to the point that theexpander can be replaced with a standard breast implant. Secondarymeasurements will include the average number of days needed toachieve the desired expansion, total reconstruction time, pain andpatient satisfaction.
The AeroForm Patient Controlled Tissue Expander was designed andmanufactured by AirXpanders, a medical device company in Palo Alto,CA. The U.S. Food and Drug Administration (FDA) has grantedAirXpanders an Investigational Device Exemption (IDE) to conduct thestudy and it has been approved for enrollment at Long Island PlasticSurgical Group and South Nassau by an Institutional Review Board(IRB).
for more information on the study, please visit clinicaltrials.gov(NCT01425268).
If you or someone you know is interested in joining the study, pleasecall 516-504-3014.
South Nassau Communities Hospital South Nassau Communities Hospitalis one of the region’s largest hospitals, with 435 beds, more than900 physicians and 3,000 employees. Located in Oceanside, NY, thehospital is an acute-care, not-for-profit teaching hospital thatprovides state-of-the-art care in cardiac, oncologic, orthopedic,bariatric, pain management, mental health and emergency services. Inaddition to its extensive outpatient specialty centers, South Nassauprovides emergency and elective angioplasty and is the only hospitalon Long Island with the Novalis Tx(TM) and Gamma Knife(R) Perfexionradiosurgery technologies. South Nassau is a designated Stroke Centerby the new York State Department of Health and ComprehensiveCommunity Cancer Center by the American College of Surgeons and isrecognized as a Bariatric Surgery Center of Excellence by theAmerican Society for Metabolic and Bariatric Surgery. for moreinformation, visit www.southnassau.org .
Long Island Plastic Surgical Group Established in 1948, Long IslandPlastic Surgical Group is the largest and longestcontinuously-running practice of its kind in North America. for morethan 60 years, Long Island Plastic Surgical Group has been dedicatedto providing compassionate and comprehensive care, while pioneeringand performing the most advanced reconstructive and cosmetic surgicalprocedures for more than half a million patients. The group’sdiversity of expertise is reflected in its nine Centers ofExcellence: Skincare and Age Management; Non-invasive and SurgicalFacial Rejuvenation; Pediatric Plastic and Craniofacial Surgery;Facial Reanimation and Peripheral Nerve Repair; Microsurgery and HandReconstruction; Breast and Body Cosmetic Surgery; Burns and ComplexWound Management; Breast Reconstruction Surgery; and Post-Weight LossCosmetic and Reconstructive Surgery. for more information, visit www.lipsg.com .
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SOURCE: LIPGS/ Nassau
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