ChloraPrep Versus Betadine for Elective Knee Replacement Surgery

• Status: Terminated
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Central DuPage Hospital
• Treatments: Chlorhexidine; Chlorhexidine gluconate; Povidone; Povidone-Iodine

Criteria

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