NCT00290290

Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections

Chlorhexidine-Alcohol Versus Povidone-Iodine for Surgical-Site Antisepsis:A Prospective, Randomized, Multicenter Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 849 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Most cases of infection of clean-contaminated wounds (wounds without gross spillage of organisms from the gastrointestinal tract) are thought to originate from the skin. Therefore, it is conceivable that application of an optimal antiseptic agent can reduce the rate of surgical wound infections. This trial is to compare the impact of disinfecting the skin with Chloraprep (2%chlorhexidine and 70% isopropyl alcohol) vs. Betadine on the rates of infection of clean-contaminated surgical wounds. The study will also assess the occurrence of adverse effects on the skin from either antiseptic agent and the cost-savings associated with the use of Chloraprep vs Betadine.

Detailed description

This is a prospective, randomized, multicenter clinical trial. All adult patients, who are scheduled for a clean-contaminated surgical procedure of the alimentary, respiratory, reproductive or urinary tract will be asked to participate.

Conditions

• Postoperative Wound Infection

Interventions

Type	Name	Description
DRUG	chlorhexidine-alcohol	Preoperative skin preparation with scrub and paint technique
DRUG	Povidone-Iodine	preoperative skin preparation with scrub and paint technique

Timeline

• Start date: 2003-09-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2006-02-13
• Last updated: 2014-09-18
• Results posted: 2014-08-11

Locations

6 sites across 1 country: United States