NCT01184196

ChloraPrep Versus Betadine for Elective Knee Replacement Surgery

A Comparison of Chlorhexadine Gluconate Versus Povidone Iodine Surgical Preparation in Skin Bacterial Colony Counts for Elective Knee Replacement Surgery

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Central DuPage Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will enroll patients who will be receiving primary total knee replacements. Subjects will be randomized into two groups: Betadine surgical scrub preparation and ChloraPrep preparation prior to total knee replacements. Study hypothesis: When used as a surgical scrub preparation prior to primary total knee arthroplasties, ChloraPrep (2% chlorhexadine gluconate and 70% isopropyl alcohol) is superior to Betadine (10% povidone iodine) in reducing incision site bacterial colony counts.

Detailed description

Swabs will be taken over the operative knee by study personnel for a bacterial colony count immediately before surgical site preparation is started, after the surgery prep is complete, and 24 hours post surgery prep. Swabs will be sent to the lab for quantitative colony counts and all 3 measurements will be compared and analyzed.

Conditions

• Arthroplasty, Knee Replacement
• Replacement, Total Knee
• Total Knee Replacement

Interventions

Type	Name	Description
DRUG	Swab area with Betadine	A swab will be taken over the operative knee before surgical site preparation is started, after preparation has taken place, and 24 hours post-surgery.
DRUG	Swab area with ChloraPrep	A swab will be taken over the operative knee before surgical site preparation is started, after preparation has taken place, and 24 hours post-surgery.

Timeline

• Start date: 2009-11-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2010-08-18
• Last updated: 2013-04-16

Locations

1 site across 1 country: United States