Gentamicin-Collagen Sponge to Prevent Surgical-Site Infection?

In two multicenter, phase III trials in the U.S., the sponge was either ineffective or actually increased the risk for infection.

The gentamicin-collagen sponge is currently approved for use in 54 countries outside the U.S. and has been placed in more than one million patients. Researchers recently conducted two manufacturer-sponsored, multicenter, phase III trials designed to confirm previous findings of efficacy in reducing surgical-site infections (SSIs) after colorectal or cardiac surgery and to support regulatory approval of the product in this country.

In one trial, 602 adults who were undergoing open or laparoscopically assisted colorectal surgery were randomized to receive either two sponges (inserted anteriorly to the fascia, along the full length of the incision, immediately before wound closure) or no sponges. The primary endpoint was infection within the la…

Reviewing Author

Larry M. Baddour, MD

Disclosures

RoyaltiesUpToDate, Inc. (Authorship duties)

Larry M. Baddour, MD

Disclosures

RoyaltiesUpToDate, Inc. (Authorship duties)