ChloraPrep Versus Betadine for Elective Knee Replacement Surgery

Phase 4

Terminated

• Conditions: Arthroplasty, Knee Replacement; Replacement, Total Knee; Total Knee Replacement
• Interventions: Drug: Swab area with Betadine; Drug: Swab area with ChloraPrep

• Registration Number: NCT01184196
• Lead Sponsor: Central DuPage Hospital

Brief 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.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-08-16
• Study First Submitted QC: 2010-08-17
• Study First Posted: 2010-08-18
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-15
• Last Update Posted: 2013-04-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• Scheduled to undergo primary total knee arthroplasty
• Age 18 or over

Exclusion Criteria

• Inability to provide informed consent or to comply with study assessments due to cognitive impairment or geographic distance
• Age 17 or younger
• Allergies to chlorhexadine gluconate or povidone iodine
• Topical antimicrobial use within 14 days of surgery
• Any active dermatoses or open wounds over the operative site
• Any condition requiring antibiotics 14 days prior to arriving for surgery
• Patients with chronic immunosuppression (such as HIV/AIDS)
• Unable to adhere to follow up schedule and treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Swab area with Betadine	Subjects randomized to Arm 1 will receive Betadine surgical scrub at the time of primary total knee arthroplasty.
Arm 2	Swab area with ChloraPrep	Subjects in Arm 2 will receive ChloraPrep surgical scrub prior to elective primary total knee arthroplasty.

Primary Outcome Measures

Name	Time	Method
Quantitative bacterial colony counts for aerobic and anaerobic culture swabs will be taken at 3 timeperiods to determine if ChloraPrep is superior to Betadine in reducing incision site bacterial colony counts.	24 hours	Subjects scheduled to undergo primary total knee arthroplasty will be randomized to receive either a Betadine surgical scrub or ChloraPrep surgical scrub at the time of surgery. Subjects will be enrolled until swab #3 is obtained, 24 hours post-surgery.

Trial Locations

Locations (1)

Central DuPage Hospital; 🇺🇸 Winfield, Illinois, United States