ARTICLE | Clinical News

Gentamicin Surgical Implant: Phase III data

August 9, 2010 7:00 AM UTC

Researchers from the Duke Clinical Research Institute and colleagues reported that the double-blind, multi-center, U.S. Phase III INN-SWI-002 trial in 602 patients undergoing open or laparoscopically assisted colorectal surgery showed that Innocoll's gentamicin-collagen sponge implant performed worse than no intervention on the primary and multiple secondary endpoints. On the primary endpoint, the sponge group had a significantly higher rate of surgical-site infections occurring within 60 days after surgery vs. no intervention (30% vs. 20.9%, p=0.01).

On secondary endpoints, patients in the sponge group had a significantly higher incidence of superficial surgical-site infection vs. no intervention (20.3% vs. 13.6%, p=0.03), and a non-significantly higher incidence of deep surgical-site infection (8.3% vs. 6%, p=0.26). Furthermore, a significantly greater proportion of patients in the sponge group visited an emergency room or surgeon's office due to wound-related signs or symptoms vs. no intervention (19.7% vs. 11%, p=0.004). Subjects received 2 sponge implants above the fascia at the time of surgical closure or no intervention in addition to standard care, which included prophylactic systemic antibiotics. Data were published in the New England Journal of Medicine. ...