Cohera Medical, Inc. has completed enrollment for its prospective, multicenter, randomized clinical trial of TissuGlu for reduction of wound-drainage and postsurgical complications in abdominoplasty surgeries. The study includes 150 patients from five sites throughout the US, including Atlanta, Baltimore, Charlotte, St Louis, and Washington, DC. The first patient was treated in May 2012.
Cohera plans to use the results from this study to submit a pre-market approval application for TissuGlu with the FDA.
Currently, most patients who undergo abdominoplasty procedures and other large-flap procedures require the insertion of drains to remove fluids that accumulate under the skin at the surgical site. In some cases, drainage is inadequate and the excess fluid accumulation (seroma) requires additional procedures for removal. TissuGlu adheres the tissue flap created during the procedure to the underlying tissue, helping to reduce the fluid that can accumulate in the space and ultimately reduce the time to drain removal. The use of TissuGlu may shorten the length of time that drains need to be in place, leading to a more comfortable recovery and a quicker return to normal activity for patients.
Cohera Medical recently received CE Marking approval for TissuGlu and began selling this product to hospitals and surgeons in Germany in 2011. To date, TissuGlu has been used successfully in more than 500 surgical procedures in Germany by leading plastic and reconstructive surgeons.