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

University Hospital, Geneva1 site in 1 country3,317 target enrollmentJanuary 2007

ConditionsPostoperative Wound Infection

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Postoperative Wound Infection
Sponsor: University Hospital, Geneva
Enrollment: 3317
Locations: 1
Primary Endpoint: Surgical Site Infection
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

January 2007

End Date

November 2007

Last Updated

13 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

University Hospital, Geneva

Eligibility 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

Outcomes

Primary Outcomes

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).