Cohera Medical is moving ahead with a new “no-drain” clinical trial of TissuGlu® Surgical Adhesive.
The newly initiated study of 30 tummy tuck patients from two surgery centers in Germany will determine the safety and effectiveness of the adhesive in the reduction of wound drainage, post operative seroma and related complications in abdominoplasty patients — without the use of drains.
TissuGlu adheres the tissue flap created during surgery to the underlying tissue to help reduce the space where fluids can accumulate, and eliminate the need for drains. The ability to perform the procedure without drains would lead to a more comfortable recovery and a quicker return to normal activity for patients.
In fact, drain management and discomfort is the leading complaint for plastic surgery procedures. In addition, complication rates from seroma formation range from 15 percent to 52 percent following abdominoplasty procedures.
Cohera Medical has received CE Marking approval for TissuGlu in Europe, and began selling the product to hospitals and surgeons throughout Germany in September 2011. TissuGlu has been used successfully in more than 450 surgical procedures in Germany. CE Marking refers to a manufacturer’s declaration that the product complies with the essential requirements of the relevant European governing bodies.
The company has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration to start a prospective, randomized clinical trial of 150 abdominoplasty patients. There are currently no FDA-approved medical devices for a synthetic adhesive indicated for approximation of tissues in large flap surgeries.
[Source: Cohera Medical]