Clinical trial NCT01184196: ChloraPrep Versus Betadine for Elective Knee Replacement Surgery
Official title: A Comparison of Chlorhexadine Gluconate Versus Povidone Iodine Surgical Preparation in Skin Bacterial Colony Counts for Elective Knee Replacement Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Arthroplasty, Knee Replacement
Replacement, Total Knee
Total Knee Replacement
Keywords: knee replacement
knee arthroplasty
total knee replacement
arthroplasty, knee replacement
Lead sponsor: Central DuPage Hospital
Sponsor class: OTHER
First posted: 2010-08-18
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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

Primary outcomes:
measure: 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.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Winfield
country: United States
facility: Central DuPage Hospital
state: Illinois
Study officials:
affiliation: Midwest Orthopaedics at Rush
name: Scott Sporer, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.2106/JBJS.D.01977.
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. doi: 10.1002/14651858.CD003949.pub2.
citation: 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.
citation: Kaul AF, Jewett JF. Agents and techniques for disinfection of the skin. Surg Gynecol Obstet. 1981 May;152(5):677-85. No abstract available.
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. doi: 10.1111/j.1445-1433.2004.03154.x.
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. doi: 10.1159/000089195.
citation: Geelhoed GW, Sharpe K, Simon GL. A comparative study of surgical skin preparation methods. Surg Gynecol Obstet. 1983 Sep;157(3):265-8.
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. doi: 10.2106/JBJS.D.02695.