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

NCT00987402 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 3317

Last updated 2012-08-21

Study results available
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Summary

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.

Conditions

  • Postoperative Wound Infection

Interventions

OTHER

Plain soap and water (PSW)

Presence or absence of infection

OTHER

Alcohol-based hand rub (ABHR)

Presence or absence of infection

Sponsors & Collaborators

Principal Investigators

  • Peter M Nthumba, MD · AIC Kijabe Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2007-11-30
Completion
2007-11-30

Countries

  • Kenya

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00987402 on ClinicalTrials.gov