Cohera Medical has gained investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to commence the first no-drain clinical trial of its internal surgical adhesive.
Designed for use during abdominoplasty surgeries, the CE-marked TissuGlu surgical adhesive reduces fluid accumulation and the need for post surgical drains.
TissuGlu’s Chemical composition, 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 controlled, multicenter, non-inferiority and prospective study, which will enroll 130 patients, will compare standard wound closure technique with drains (control) to the standard wound closure technique including TissuGlu and no drains (test).
Expected to begin in early 2013, the study will randomize patients into either a treatment group with the application of TissuGlu or a control group without the use of TissuGlu.
The Hunstad-Kortesis Center plastic surgeon Joseph Hunstad said mostly patients complain about the drain management and discomfort caused during abdominoplasty surgeries.
"We are excited to begin enrolling patients and we believe that completely eliminating the use of drains would significantly improve patient care and satisfaction," Hunstad added.
Cohera Medical president and chief executive officer Patrick Daly said, "We believe that the elimination of post-surgical drains has the potential to positively impact surgeries and the recovery of millions of patients worldwide."