The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval to Cohera Medical to initiate the first no-drain clinical trial of its internal surgical adhesive.
The CE-marked TissuGlu surgical adhesive is designed for use during abdominoplasty surgeries to help reduce 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.
The controlled, multicentre, non-inferiority and prospective study will enrol 130 patients undergoing abdominoplasty to compare the standard wound closure technique with drains (control) to the standard wound closure technique including TissuGlu and no drains (test).
The study, which is expected to begin in early 2013, will randomise patients into either a treatment group with the application of TissuGlu or a control group without the use of TissuGlu.
The Hunstad-Kortesis Centre spokesperson Dr 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 said.
Cohera Medical president and CEO 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.”