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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01184196
Other study ID # 10-008
Secondary ID
Status Terminated
Phase Phase 4
First received August 16, 2010
Last updated April 15, 2013
Start date November 2009
Est. completion date December 2012

Study information

Verified date April 2013
Source Central DuPage Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


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Study Design


Intervention

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.
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.

Locations

Country Name City State
United States Central DuPage Hospital Winfield Illinois

Sponsors (1)

Lead Sponsor Collaborator
Central DuPage Hospital

Country where clinical trial is conducted

United States, 

References & Publications (8)

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Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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
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