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

Phase 1

Completed

• Conditions: Postoperative Wound Infection

• Registration Number: NCT00987402
• Lead Sponsor: University Hospital, Geneva

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Study First Submitted: 2009-09-30
• Study First Submitted QC: 2009-09-30
• Study First Posted: 2009-10-01
• Results First Submitted: 2009-10-07
• Status Verified: 2009-11
• Results First Submitted QC: 2012-08-20
• Last Update Submitted: 2012-08-20
• Results First Posted: 2012-08-21
• Last Update Posted: 2012-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3317

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Surgical Site Infection	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

Name	Time	Method
Cost of Hand Preparation Agent	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.

Trial Locations

Locations (1)

Africa Inland Church Kijabe Hospital; 🇰🇪 Kijabe, Central, Kenya