Cohera Medical has treated the first patient in a US no-drain clinical study of its TissuGlu Surgical Adhesive, designed for use during large flap surgeries such as abdominoplasty (tummy tuck).
The CE-marked internal surgical adhesive device, which adheres the tissue flap created during the procedure to the underlying tissue, reduces fluid accumulation and the need for post surgical drains, claims the company.
In addition, the chemical composition of TissuGlu forms a strong bond between underlying tissue layers to reduce the space where fluids can accumulate, and allows for natural healing.
The randomized, controlled, non-inferiority, multicenter study, which will take place at five US surgery centers, will enroll 130 patients and 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 Center plastic surgeon 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, "We're thrilled to kick off the first no-drain trial in the U.S., bringing us one step closer to facilitating a more natural healing process in large flap procedures."