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

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Conditions:		Arthroplasty, Knee Replacement - Replacement, Total Knee - Total Knee Replacement
Purpose:		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.
Study Summary:		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.
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
NCT ID:		NCT01184196
Primary Contact:		Principal Investigator Scott Sporer, MD Midwest Orthopaedics at Rush
Backup Contact:		N/A
Location Contact:		Winfield, Illinois 60190 United States There is no listed contact information for this specific location. Site Status: N/A

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