Safety and Efficacy of an Antibiotic Implant in Cardiac Surgical Subjects at Higher Risk for Sternal Wound Infection

Phase 3 Completed 1502 enrolled Innocoll Duke University · collab Premier Research · collab

RandomizedParallel-groupSingle-blindPrevention

Summary

The purpose of this study is to determine whether the gentamicin-collagen sponge is safe and effective in preventing sternal wound infections in patients undergoing cardiac surgery who are at a greater risk of developing sternal wound infections.

Timeline

Start: 2007-12
Primary completion: 2010-09
Completion: 2010-09

Outcome

Missed primary endpoint

paper 63 of 753 patients randomized to the gentamicin-collagen sponge group (8.4%) compared with 65 of 749 patients randomized to the control group (8.7%) (P = .83). PMID 20716738 ↗

paper the use of 2 gentamicin-collagen sponges compared with no intervention did not reduce the 90-day sternal wound infection rate. PMID 20716738 ↗

Publications

Bennett-Guerrero E, Ferguson TB Jr, Lin M, Garg J, Mark DB, Scavo VA Jr, Kouchoukos N, Richardson JB Jr, Pridgen RL, Corey GR; SWIPE-1 Trial Group. Effect of an implantable gentamicin-collagen sponge on sternal wound infections following cardiac surgery: a randomized trial. JAMA. 2010 Aug 18;304(7):755-62. doi: 10.1001/jama.2010.1152.

Drugs

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

Indications

No indication recorded.