ChloraPrep Versus Betadine for Elective Knee Replacement Surgery
Information source: Central DuPage Hospital
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Arthroplasty, Knee Replacement; Replacement, Total Knee; Total Knee Replacement
Intervention: Swab area with Betadine (Drug); Swab area with ChloraPrep (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Central DuPage Hospital Official(s) and/or principal investigator(s):
Scott Sporer, MD, Principal Investigator, Affiliation: Midwest Orthopaedics at RUSH
Overall contact:
Scott Sporer, MD, Phone: 630-339-2225, Email: scottsporer@gmail.com
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.
Clinical Details
Official title: A Comparison of Chlorhexadine Gluconate Versus Povidone Iodine Surgical Preparation in Skin Bacterial Colony Counts for Elective Knee Replacement Surgery
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: 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.
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Scott Sporer, MD, Phone: 630-339-2225, Email: scottsporer@gmail.com
Central DuPage Hospital, Winfield, Illinois 60190, United States; Recruiting
Scott Sporer, MD, Principal Investigator
Additional Information
Midwest Ortho at RUSH
Related publications: 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. 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. 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. Kaul AF, Jewett JF. Agents and techniques for disinfection of the skin. Surg Gynecol Obstet. 1981 May;152(5):677-85. Review. 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. 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. 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.
Starting date: November 2009
Last updated: June 17, 2011
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