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

Postoperative Wound Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00987402
• Other study ID #: KH-PSW-ABHR
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 30, 2009
• Last updated: August 20, 2012
• Start date: January 2007
• Est. completion date: November 2007

Study information

• Verified date: November 2009
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kenya: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3317
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infection
• Postoperative Wound Infection
• Surgical Wound Infection
• Wound Infection

Intervention

Other:
• Plain soap and water (PSW)
Presence or absence of infection
• Alcohol-based hand rub (ABHR)
Presence or absence of infection

Locations

Country	Name	City	State
Kenya	Africa Inland Church Kijabe Hospital	Kijabe	Central

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Geneva	AIC Kijabe Hospital, World Health Organization

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical Site Infection	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	Yes
Secondary	Cost of Hand Preparation Agent	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	No