Cohera Medical has completed patient enrolment for a US clinical study of its internal TissuGlu surgical adhesive, designed to help eliminate fluid accumulation and the need for post surgical drains while performing large flap surgeries such as abdominoplasty (tummy tuck).
TissuGlu adheres the tissue flap created during the procedure to the underlying tissue and helps in reducing the accumulation of fluid. This enables comfortable recovery and a quicker return to normal activity for patients, according to the company.
The randomised trial, which has 150 enrolled patients in Atlanta, Baltimore, Charlotte, St. Louis and Washington DC, US, is designed to evaluate effectiveness of CE-marked TissuGlu on the reduction of wound drainage and post-surgical complications in abdominoplasty surgeries.
Hunstad-Kortesis Centre plastic surgery spokesman Dr Joseph Hunstad said the clinical trial of TissuGlu has the potential to eliminate wound drainage issues from large flap procedures.
"The trial results so far are very promising for both the surgeons and the patients," Hunstad said.
Cohera Medical president and chief executive officer Patrick Daly said enrolling 150 patients in 90 days was a testament to the surgeons and the company’s team.
"We are encouraged by the positive feedback from the TissuGlu investigators, and look forward to our work with the FDA to make TissuGlu available to surgeons and patients throughout the US," Daly added.
The company plans to use results from the study in TissuGlu’s premarket approval application with the FDA.
TissuGlu and other Cohera products, which are currently indicated for investigational use, are not available for sale outside the EU.