Cohera Medical has initiated a no-drain clinical trial at two prominent surgery centres in Germany, designed to evaluate TissuGlu surgical adhesive as a treatment for reducing complications in abdominoplasty procedures.
CE marked internal TissuGlu surgical adhesive is designed for use during certain types of surgery, such as abdominoplasty (also called a 'tummy tuck'), to help reduce fluid accumulation and the need for post surgical drains.
Chemical composition of TissuGlu, which is resorbable and non-toxic, forms a strong bond between underlying tissue layers to reduce the space where fluids can accumulate and allows for natural healing.
The study has enrolled 30 patients to demonstrate the safety and efficacy of TissuGlu surgical adhesive in the reduction of wound drainage, postoperative seroma and related complications in abdominoplasty patients, without the use of drains.
Dirk Richter, Dreifaltigkeits-Hospital plastic surgery department spokesperson, said the company looks forward to enrolling more patients and believes that conducting abdominoplasty procedures without the need for drains would represent a significant improvement in patient care and comfort in these procedures.
"The initial patients enrolled appear to be doing very well, with no seromas or complications reported in the first 48 hours after surgery," Richter added.
Patrick Daly, Cohera Medical president and chief executive officer, said: "We continue to make positive patient outcomes a priority and believe the elimination of post-surgical drains is an important milestone."
The company said it is planning to expand the commercial availability of TissuGlu to additional European markets in 2012.