ChloraPrep Versus Betadine for Elective Knee Replacement Surgery

Total Knee Replacement Clinical Trial

Official title:

A Comparison of Chlorhexadine Gluconate Versus Povidone Iodine Surgical Preparation in Skin Bacterial Colony Counts for Elective Knee Replacement Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01184196
• Other study ID #: 10-008
• 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
• 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty, Knee Replacement
• Replacement, Total Knee
• Total Knee Replacement

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)

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. — View Citation

Edwards PS, Lipp A, Holmes A. Preoperative skin antiseptics for preventing surgical wound infections after clean surgery. Cochrane Database Syst Rev. 2004;(3):CD003949. Review. Update in: Cochrane Database Syst Rev. 2013;3:CD003949. — View Citation

Geelhoed GW, Sharpe K, Simon GL. A comparative study of surgical skin preparation methods. Surg Gynecol Obstet. 1983 Sep;157(3):265-8. — View Citation

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. — View Citation

Kaul AF, Jewett JF. Agents and techniques for disinfection of the skin. Surg Gynecol Obstet. 1981 May;152(5):677-85. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

External Links

•   Midwest Ortho at RUSH