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
  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.


Condition Intervention Phase
Arthroplasty, Knee Replacement
Replacement, Total Knee
Total Knee Replacement
Drug: Swab area with Betadine
Drug: Swab area with ChloraPrep
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Comparison of Chlorhexadine Gluconate Versus Povidone Iodine Surgical Preparation in Skin Bacterial Colony Counts for Elective Knee Replacement Surgery

Resource links provided by NLM:


Further study details as provided by Central DuPage Hospital:

Primary Outcome Measures:
  • 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.


Enrollment: 55
Study Start Date: November 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
Subjects randomized to Arm 1 will receive Betadine surgical scrub at the time of primary total knee arthroplasty.
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
Active Comparator: Arm 2
Subjects in Arm 2 will receive ChloraPrep surgical scrub prior to elective primary total knee arthroplasty.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01184196

Locations
United States, Illinois
Central DuPage Hospital
Winfield, Illinois, United States, 60190
Sponsors and Collaborators
Central DuPage Hospital
Investigators
Principal Investigator: Scott Sporer, MD Midwest Orthopaedics at Rush
  More Information

Additional Information:
Publications:
Responsible Party: Central DuPage Hospital
ClinicalTrials.gov Identifier: NCT01184196     History of Changes
Other Study ID Numbers: 10-008
Study First Received: August 16, 2010
Last Updated: April 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Central DuPage Hospital:
knee replacement
knee arthroplasty
total knee replacement
arthroplasty, knee replacement

Additional relevant MeSH terms:
Povidone
Chlorhexidine
Chlorhexidine gluconate
Iodine
Povidone-Iodine
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014