A Study of an Antibiotic Implant in General Surgical Subjects at Higher Risk for Surgical Wound Infection

Summary

The purpose of this study is to determine whether the gentamicin-collagen sponge is safe and effective for preventing surgical wound infections in patients undergoing colorectal surgery.

Timeline

Start

2008-01

Primary completion

2009-03

Completion

2010-09

Outcome

Missed primary endpoint

paper The incidence of surgical-site infection was higher in the sponge group (90 of 300 patients [30.0%]) than in the control group (63 of 302 patients [20.9%], P=0.01). PMID 20825316 ↗

paper Our large, multicenter trial shows that the gentamicin-collagen sponge is not effective at preventing surgical-site infection in patients who undergo colorectal surgery PMID 20825316 ↗

Publications

• Bennett-Guerrero E, Pappas TN, Koltun WA, Fleshman JW, Lin M, Garg J, Mark DB, Marcet JE, Remzi FH, George VV, Newland K, Corey GR; SWIPE 2 Trial Group. Gentamicin-collagen sponge for infection prophylaxis in colorectal surgery. N Engl J Med. 2010 Sep 9;363(11):1038-49. doi: 10.1056/NEJMoa1000837. Epub 2010 Aug 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gentamicin	Small molecule	260 mg	Topical

Indications

No indication recorded.