A Comparison of Chlorhexadine Gluconate Versus Povidone Iodine Surgical Preparation in Skin Bacterial Colony Counts for Elective Knee Replacement Surgery
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Arm 1
Subjects randomized to Arm 1 will receive Betadine surgical scrub at the time of primary total knee arthroplasty.
Intervention: Swab area with Betadine (Drug)
Arm 2
Subjects in Arm 2 will receive ChloraPrep surgical scrub prior to elective primary total knee arthroplasty.
Intervention: Swab area with ChloraPrep (Drug)
Outcomes
Primary Outcomes
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.
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported