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Study of the Efficacy of Plain Soap and Water Versus Alcohol-based Rubs for Surgical Hand Preparation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00987402
First Posted: October 1, 2009
Last Update Posted: August 21, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
World Health Organization
AIC Kijabe Hospital
Information provided by:
University Hospital, Geneva
  Purpose

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.


Condition Intervention Phase
Postoperative Wound Infection Other: Plain soap and water (PSW) Other: Alcohol-based hand rub (ABHR) Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Surgical Site Infection [ Time Frame: 30 days post-operatively ]
    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).


Secondary Outcome Measures:
  • Cost of Hand Preparation Agent [ Time Frame: 30 days ]
    Average weekly costs were estimated for the plain soap and water used each week in the operating room as well as for the procurement, preparation and dispensing of the alcohol-based handrub to enable a comparison between the two study arms.


Enrollment: 3317
Study Start Date: January 2007
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Plain soap and water
Surgical hand preparation with plain soap and water
Other: Plain soap and water (PSW)
Presence or absence of infection
Other Names:
  • Plain bar soap
  • WHO recommended alcohol based hand rub formulation II
Active Comparator: Alcohol based hand rubs
Surgical hand preparation with alcohol based alcohol hand rub
Other: Alcohol-based hand rub (ABHR)
Presence or absence of infection

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients undergoing clean or clean-contaminated surgery at AIC Kijabe Hospital

Exclusion Criteria:

  • All patients undergoing contaminated, dirty surgeries and those undergoing repeat procedures within 2 weeks after the initial surgical intervention.
  • Patients who did not consent to participate in the study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00987402


Locations
Kenya
Africa Inland Church Kijabe Hospital
Kijabe, Central, Kenya, 00220
Sponsors and Collaborators
University Hospital, Geneva
World Health Organization
AIC Kijabe Hospital
Investigators
Principal Investigator: Peter M Nthumba, MD AIC Kijabe Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peter M. Nthumba, M.D., Africa Inland Church Kijabe Hospital
ClinicalTrials.gov Identifier: NCT00987402     History of Changes
Other Study ID Numbers: KH-PSW-ABHR
First Submitted: September 30, 2009
First Posted: October 1, 2009
Results First Submitted: October 7, 2009
Results First Posted: August 21, 2012
Last Update Posted: August 21, 2012
Last Verified: November 2009

Keywords provided by University Hospital, Geneva:
Surgery
hand scrubbing
post-operative infection
surgical site infection
surgical hand preparation
plain soap and water
alcohol-based hand rub
Cost of surgical hand preparation agent
Side effects of use of hand preparation agent

Additional relevant MeSH terms:
Infection
Communicable Diseases
Wound Infection
Surgical Wound Infection
Wounds and Injuries
Postoperative Complications
Pathologic Processes
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs


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