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

Phase 3 Completed 602 enrolled Innocoll Duke University · collab Premier Research · collab

RandomizedParallel-groupDouble-blindPrevention

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

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.