ChloraPrep Versus Betadine for Elective Knee Replacement Surgery

Central DuPage Hospital

Status and phase: Terminated; Phase 4

Conditions: Arthroplasty, Knee Replacement; Replacement, Total Knee; Total Knee Replacement

Treatments: Drug: Swab area with ChloraPrep; Drug: Swab area with Betadine

Study type: Interventional

Funder types: Other

Identifiers

NCT01184196

10-008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

Arm 1

Active Comparator group

Description:

Subjects randomized to Arm 1 will receive Betadine surgical scrub at the time of primary total knee arthroplasty.

Treatment:

Drug: Swab area with Betadine

Arm 2

Active Comparator group

Description:

Subjects in Arm 2 will receive ChloraPrep surgical scrub prior to elective primary total knee arthroplasty.

Treatment:

Drug: Swab area with ChloraPrep