Cohera Medical, a developer of absorbable surgical adhesives and sealants, has treated the first patient in a randomised and controlled US no-drain clinical study of its internal surgical adhesive.
Designed for use during large flap surgeries such as abdominoplasty (tummy tuck), the CE-marked TissuGlu surgical adhesive reduces fluid accumulation and the need for post surgical drains.
The 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, according to the company.
The non-inferiority, multicentre study, which will include 130 patients, will take place at five US surgery centres in Washington, Baltimore, Charlotte, Los Angeles and Dallas.
The study will evaluate the safety and effectiveness of TissuGlu in the reduction of wound drainage, post operative seroma and related complications in abdominoplasty patients without the use of drains.
The Hunstad-Kortesis Centre plastic surgeon Dr Joseph Hunstad said; "Participating in this breakthrough study to eliminate postoperative drains is exciting, because TissuGlu is so easy to use and extremely valuable to the abdominoplasty procedure healing process."
Cohera Medical president and chief executive officer Patrick Daly said by using TissuGlu, millions of patients are recovering from surgeries.
"We’re thrilled to kick off the first no-drain trial in the US, bringing us one step closer to facilitating a more natural healing process in large flap procedures," Daly said.