Cohera Medical, a developer of absorbable surgical adhesives and sealants, has completed enrollment for its U.S. No-Drain Study for its lead product, TissuGlu Surgical Adhesive. The study has enrolled 130 patients at five centers in the U.S. and is investigating the safety and effectiveness of TissuGlu in the reduction of wound drainage, seroma development and other complications in abdominoplasty patients without the use of postoperative drains.
Cohera Medical will use the results from the study to submit a PMA application for TissuGlu with the FDA. There are currently no medical devices approved by the FDA, or in clinical trials, for a synthetic adhesive indicated for approximation of tissues in large flap surgeries.
Cohera Medical received CE Marking approval for TissuGlu and began selling product to hospitals and surgeons in Germany in September 2011. TissuGlu has been used successfully in surgical procedures in Germany by plastic and reconstructive surgeons.
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 reducing 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.