ChloraPrep Versus Betadine for Elective Knee Replacement Surgery
NCT ID: NCT01184196
Last Updated: 2013-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
55 participants
INTERVENTIONAL
2009-11-30
2012-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Arm 1
Subjects randomized to Arm 1 will receive Betadine surgical scrub at the time of primary total knee arthroplasty.
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.
Arm 2
Subjects in Arm 2 will receive ChloraPrep surgical scrub prior to elective primary total knee arthroplasty.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18 or over
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Central DuPage Hospital
OTHER
Responsible Party
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Principal Investigators
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Scott Sporer, MD
Role: PRINCIPAL_INVESTIGATOR
Midwest Orthopaedics at Rush
Locations
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Central DuPage Hospital
Winfield, Illinois, United States
Countries
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References
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Ostrander RV, Botte MJ, Brage ME. Efficacy of surgical preparation solutions in foot and ankle surgery. J Bone Joint Surg Am. 2005 May;87(5):980-5. doi: 10.2106/JBJS.D.01977.
Edwards PS, Lipp A, Holmes A. Preoperative skin antiseptics for preventing surgical wound infections after clean surgery. Cochrane Database Syst Rev. 2004;(3):CD003949. doi: 10.1002/14651858.CD003949.pub2.
Aly R, Maibach HI. Comparative antibacterial efficacy of a 2-minute surgical scrub with chlorhexidine gluconate, povidone-iodine, and chloroxylenol sponge-brushes. Am J Infect Control. 1988 Aug;16(4):173-7. doi: 10.1016/0196-6553(88)90029-6.
Kaul AF, Jewett JF. Agents and techniques for disinfection of the skin. Surg Gynecol Obstet. 1981 May;152(5):677-85. No abstract available.
Grabsch EA, Mitchell DJ, Hooper J, Turnidge JD. In-use efficacy of a chlorhexidine in alcohol surgical rub: a comparative study. ANZ J Surg. 2004 Sep;74(9):769-72. doi: 10.1111/j.1445-1433.2004.03154.x.
Nishimura C. Comparison of the antimicrobial efficacy of povidone-iodine, povidone-iodine-ethanol and chlorhexidine gluconate-ethanol surgical scrubs. Dermatology. 2006;212 Suppl 1:21-5. doi: 10.1159/000089195.
Geelhoed GW, Sharpe K, Simon GL. A comparative study of surgical skin preparation methods. Surg Gynecol Obstet. 1983 Sep;157(3):265-8.
Keblish DJ, Zurakowski D, Wilson MG, Chiodo CP. Preoperative skin preparation of the foot and ankle: bristles and alcohol are better. J Bone Joint Surg Am. 2005 May;87(5):986-92. doi: 10.2106/JBJS.D.02695.
Related Links
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Midwest Ortho at RUSH
Other Identifiers
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10-008
Identifier Type: -
Identifier Source: org_study_id
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