ChloraPrep Versus Betadine for Elective Knee Replacement Surgery

This study has been terminated.
(ChloroPrep Wipes no longer available)
Sponsor:
Information provided by (Responsible Party):
Central DuPage Hospital
ClinicalTrials.gov Identifier:
NCT01184196
First received: August 16, 2010
Last updated: April 15, 2013
Last verified: April 2013

August 16, 2010
April 15, 2013
November 2009
December 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01184196 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Arthroplasty, Knee Replacement
  • Replacement, Total Knee
  • Total Knee Replacement
  • 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 Name: 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 Name: Chlorhexadine Gluconate
  • Active Comparator: Arm 1
    Subjects randomized to Arm 1 will receive Betadine surgical scrub at the time of primary total knee arthroplasty.
    Intervention: Drug: Swab area with Betadine
  • Active Comparator: Arm 2
    Subjects in Arm 2 will receive ChloraPrep surgical scrub prior to elective primary total knee arthroplasty.
    Intervention: Drug: Swab area with ChloraPrep

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
55
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01184196
10-008
No
Central DuPage Hospital
Central DuPage Hospital
Not Provided
Principal Investigator: Scott Sporer, MD Midwest Orthopaedics at Rush
Central DuPage Hospital
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP