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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:
Collaborators:
World Health Organization
AIC Kijabe Hospital
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00987402
First received: September 30, 2009
Last updated: August 20, 2012
Last verified: November 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (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:

MedlinePlus related topics: Drinking Water
U.S. FDA Resources

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Surgical Site Infection [ Time Frame: 30 days post-operatively ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University Hospital, Geneva

Additional 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
Study First Received: September 30, 2009
Results First Received: October 7, 2009
Last Updated: August 20, 2012
Health Authority: Kenya: Ministry of Health

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:
Surgical Wound Infection
Wound Infection
Infection
Postoperative Complications
Pathologic Processes
Wounds and Injuries
Ethanol
 Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013