The trial is being conducted at approximately 45 hospital sites across the U.S. and has enrolled 600 patients undergoing open colorectal surgery, which is widely considered to be the most prone to surgical site infection (SSI). Patients in the treatment group have two Gentamicin Implants (260 mg total dose) implanted in the wound before abdominal closure and the primary endpoint is total incidence of SSI after 2 months post-surgery. The design of the trial is based upon an approved and well established use of GENTAMICIN SURGICAL IMPLANT for this indication in
Patient enrolment in the first phase 3 trial being conducted in diabetic and/or obese patients undergoing cardiac surgery closed earlier 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 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.