Surgical Site Infections: a Cluster-randomized, Cross-over Study of the Efficacy of Plain Soap and Water Versus Alcohol-based Rubs for Surgical Hand Preparation
Sponsor study identifier
interventional
3,317
1 country
1
Study Start
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2007
Actual (reported)Study Completion
November 2007
Actual (reported)Surgical site infections (SSI) constitute a significant health-economic and clinical challenge. The investigators conducted a cluster-randomized, cross-over study to compare the efficacy of plain soap and water (PSW), used ubiquitously across sub-Saharan Africa for surgical hand preparation, to alcohol-based hand rub (ABHR), with SSI rates as the main outcome measure. A total of 3317 patients undergoing clean and clean-contaminated surgery were included in the study and followed up for 30 days.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2007
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
November 2007
Actual (reported)November 2007
Actual (reported)September 30, 2009
Actual (reported)October 1, 2009
Actual (reported)August 21, 2012
Actual (reported)Surgical Site Infection
255 (8.1%) patients developed SSIs. Rates for the two study arms were similar (8.3% for alcohol-based handrub versus 8.0% for plain soap and water; odds ratio, 1.03; 95% CI, 0.80 - 1.33).
30 days post-operatively
Cost of Hand Preparation Agent
30 days
Surgical hand preparation with plain soap and water
Surgical hand preparation with alcohol based alcohol hand rub
Presence or absence of infection
Presence or absence of infection
Africa Inland Church Kijabe Hospital
Kijabe, Central, 00220, Kenya
Wood JH, Nthumba PM, Stepita-Poenaru E, Poenaru D. Pediatric surgical site infection in the developing world: a Kenyan experience. Pediatr Surg Int. 2012 May;28(5):523-7. doi: 10.1007/s00383-012-3058-x.
Nthumba PM, Stepita-Poenaru E, Poenaru D, Bird P, Allegranzi B, Pittet D, Harbarth S. Cluster-randomized, crossover trial of the efficacy of plain soap and water versus alcohol-based rub for surgical hand preparation in a rural hospital in Kenya. Br J Surg. 2010 Nov;97(11):1621-8. doi: 10.1002/bjs.7213.
Most cases, post-discharge monitoring was not conducted by outpatient clinic visits following a standard protocol, some data was not collected, and routine microbiologic cultures were not obtained.
Peter M Nthumba, MD
AIC Kijabe Hospital
3,317 participants (actual enrollment reported by the registry).
First Submitted
September 30, 2009
First Posted
October 1, 2009
Study Start
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
Wick vs. No Wick: Does Method of Closure Affect Rate of Wound Infection?
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Primary Completion
November 2007
Actual (reported)Study Completion
November 2007
Actual (reported)Last Updated
August 21, 2012
Results First Posted
August 21, 2012
Record last verified: 2009-11
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Source: ClinicalTrials.gov.
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