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
Verified date | April 2013 |
Source | Central DuPage Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Central DuPage Hospital | Winfield | Illinois |
Lead Sponsor | Collaborator |
---|---|
Central DuPage Hospital |
United States,
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
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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