Trial | NCT01184196  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    55
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.
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 Started
Nov 30
2009
Primary Completion
Dec 31
2012
Study Completion
Dec 31
2012
Last Update
Apr 16
2013
Estimate

Drug Swab area with Betadine

A swab will be taken over the operative knee before surgical site preparation is started, after preparation has taken place, and 24 hours post-surgery.

  • Other names: Povidone Iodine

Drug Swab area with ChloraPrep

A swab will be taken over the operative knee before surgical site preparation is started, after preparation has taken place, and 24 hours post-surgery.

  • Other names: Chlorhexadine Gluconate

Arm 1 Active Comparator

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

Arm 2 Active Comparator

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

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
No Results Posted