Cohera Medical has received approval from the United States Food and Drug Administration to begin the first no-drain clinical trial for its TissuGlu Surgical Adhesive product in the U.S. The randomized, controlled, prospective multicenter non-inferiority study will compare the standard wound closure technique with drains (control) to the standard wound closure technique including TissuGlu and no drains (test) during abdominoplasty procedures.
The study will begin in early 2013 and take place at five prominent surgery centers in the following regions: Washington, DC; Baltimore, MD; Charlotte, NC; Los Angeles, CA; and Dallas, TX. A total of 130 patients undergoing abdominoplasty procedures will be randomized and divided into either a treatment group with the application of TissuGlu or a control group without the use of TissuGlu.
“Drain management and discomfort is the leading patient complaint for plastic surgery procedures according to the top plastic surgery publications,” said Joseph P. Hunstad MD, FACS, of the The Hunstad-Kortesis Center, Charlotte, NC. “We are excited to begin enrolling patients and we believe that completely eliminating the use of drains would significantly improve patient care and satisfaction.”
According to Cohera, TissuGlu adheres the tissue flap created during the procedure to the underlying tissue, helping to reduce the fluid that can accumulate in the space during healing and ultimately reducing the need for postoperative drains to remove the fluid.