ChloraPrep Versus Betadine for Elective Knee Replacement Surgery

April 15, 2013 updated by: Central DuPage Hospital

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Winfield, Illinois, United States, 60190
        • Central DuPage Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Chlorhexadine Gluconate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central DuPage Hospital

Investigators

  • Principal Investigator: Scott Sporer, MD, Midwest Orthopaedics at Rush

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

August 16, 2010

First Submitted That Met QC Criteria

August 17, 2010

First Posted (Estimate)

August 18, 2010

Study Record Updates

Last Update Posted (Estimate)

April 16, 2013

Last Update Submitted That Met QC Criteria

April 15, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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