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

August 20, 2012 updated by: University Hospital, Geneva

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3317

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
    • Central
      • Kijabe, Central, Kenya, 00220
        • Africa Inland Church Kijabe Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
30 days post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Collaborators

World Health Organization
AIC Kijabe Hospital

Investigators

  • Principal Investigator: Peter M Nthumba, MD, AIC Kijabe Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

September 30, 2009

First Submitted That Met QC Criteria

September 30, 2009

First Posted (Estimate)

October 1, 2009

Study Record Updates

Last Update Posted (Estimate)

August 21, 2012

Last Update Submitted That Met QC Criteria

August 20, 2012

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KH-PSW-ABHR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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