The trial is being conducted at approximately 50 hospital sites across the U.S. and has enrolled 1,500 diabetic and/or obese (BMI>30) patients undergoing cardiac surgery. Such patients are generally recognized to be at higher risk of developing sternal wound infections (SWI); a serious and potentially life-threatening complication of cardiac surgery. Patients in the treatment group have two Gentamicin Implants (260 mg total dose) placed between the sternal halves before chest closure and the primary endpoint is total incidence of SWI after 3 months post-surgery. The trial design was based on a published 2,000 patient clinical trial performed in
Patient enrolment in a second phase 3 trial being conducted in patients undergoing open colorectal surgery is expected to close later this month. Innocoll has appointed
About Gentamicin Surgical Implant
GENTAMICIN SURGICAL IMPLANT is a fully biodegradable, leave-behind surgical implant impregnated with the broad spectrum aminoglycoside antibiotic, gentamicin. It is designed to provide a high concentration of gentamicin (which has a concentration-dependent mechanism of action) directly to the target tissue for localized action, while maintaining low systemic levels well below the toxicity threshold. The product was developed using Innocoll's proprietary collagen-based drug delivery technology, CollaRx, and (outside of the U.S.) is indicated as an adjunct to systemic antibiotic therapy for the treatment of localized, deep tissue infections and the prevention of surgical site infections in both hard and soft tissues. GENTAMICIN SURGICAL IMPLANT is already approved in 49 countries spanning
About Innocoll, Inc.
Innocoll is a privately held, biopharmaceutical company focused on biodegradable surgical implants and topically applied healthcare products. The company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, CollaRx(R) and Liquicoll(R). Innocoll has licensed its US marketing rights to its lead product, CollaRx GENTAMICIN SURGICAL IMPLANT to Baxter Healthcare, a division of Baxter International Inc (NYSE: BAX) The product is currently in phase 3 development in the US for the prevention of surgical site infections. It is approved for sale in 49 countries in
SOURCE Innocoll, Inc.