Study Investigated Safety And Effectiveness Of TissuGlu
(PRNewswire) Cohera Medical, Inc., a developer of absorbable surgical adhesives and sealants, has announced the start of a no-drain clinical trial in 30 patients at two prominent surgery centers in Germany. The study will investigate the safety and effectiveness of TissuGlu® Surgical Adhesive in the reduction of wound drainage, post-operative seroma and related complications in abdominoplasty patients without the use of drains.
Currently, most patients who undergo abdominoplasty procedures and other large flap procedures require the insertion of drains to remove fluids that accumulate under the skin at the surgical site. In some cases, drainage is inadequate and the excess fluid accumulation (seroma) requires additional procedures for removal. The drains are often painful for the patient, can lead to infection and can impact the recovery process. TissuGlu adheres the tissue flap created during the surgical procedure to the underlying tissue, helping to reduce the space where fluids can accumulate, thereby eliminating the need to use surgical drains. The ability to perform the procedure without drains would lead to a more comfortable recovery and a quicker return to normal activity for patients.
Drain management and discomfort is the leading patient complaint for plastic surgery procedures according to the top plastic surgery publications. In addition, complication rates from seroma formation range from 15 percent to 52 percent following abdominoplasty procedures.
Cohera Medical recently received Marking approval for TissuGlu and began selling product to hospitals and surgeons in Germany in September 2011. The Company plans to expand the commercial availability of TissuGlu to additional European markets in 2012. TissuGlu has been used successfully in over 450 surgical procedures in Germany by leading plastic and reconstructive surgeons.