FOR IMMEDIATE RELEASE CONTACT: Rob Whitehouse, 216/444-8927 January 20, 1998 Jim Armstrong, 216/444-9455
The Cleveland Clinic, in conjunction with the Cleveland Clinic-Florida, has begun an FDA-approved study testing a drug that may reduce inflammation and enhance healing among patients undergoing reconstructive surgery immediately following a mastectomy.
"Enhancing the healing process may reduce scarring, as well as have a positive impact on the shape and consistency of the new breast," said the study's principal investigator, Maria Siemionow, M.D., of the Cleveland Clinic's Department of Plastic and Reconstructive Surgery.
During the randomized, double-blinded study, 60 women who choose to undergo a TRAM flap transfer immediately following a mastectomy will be given a synthetic sulfated version of the naturally occurring adrenal steroid hormone dehydroepiandrosterone (DHEA), known as PB-005. PB-005 (developed by Pharmadigm Inc.) has been shown in various animal models to accelerate tissue repair and reduce scarring, as well as inhibit ischemia-mediated tissue damage. The compound is also being studied in burn patients. This is the first clinical study examining its ability to promote healing following surgery.
A TRAM flap transfer is a method of breast reconstruction that involves removing a portion of muscle in the abdomen and using it to rebuild the breast. Often, the TRAM flap transfer is performed in conjunction with a mastectomy, although some women choose to wait for the reconstructive surgery. The study will only include women between the ages of 18 and 65 who have been diagnosed with breast cancer and choose to undergo the TRAM flap procedure immediately after a mastectomy.
Of the 60 women selected for the study, 48 will be patients at the Cleveland Clinic in Ohio and 12 at the Cleveland Clinic-Florida. Patients will be given five, 30-minute intravenous doses of the study agent or a placebo. The first dose will be given at the time of surgery, while the remaining doses will be given daily for the next four days.
"Following a TRAM flap transfer, two areas of the body require healing -- the area around the breast and the abdomen. If we can promote faster healing, perhaps hospital stays following this surgery can be reduced," said Dr. Siemionow.
The Cleveland Clinic Foundation, founded in 1921, integrates clinical and hospital care with research and education in a private, non-profit group practice. Last year at the Cleveland Clinic and Cleveland Clinic-Florida, over 850 full-time salaried physicians representing more than 100 medical specialties and subspecialties provided for 1,182,300 outpatient visits and 49,987 hospital admissions for patients from throughout the United States and more than 80 countries. In 1997, the Cleveland Clinic Health System -- comprising The Cleveland Clinic Foundation and Fairview, Health Hill Hospital for Children, Lakewood, Lutheran, Marymount, Meridia Euclid, Meridia Hillcrest, Meridia Huron and Meridia South Pointe hospitals -- was formed. With 2,957 staffed beds, the Cleveland Clinic Health System offers broad geographic coverage, a full continuum of care, improved quality and lower cost of care to Northeast Ohio residents.
###
RSS