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

NCT ID: NCT00987402

Last Updated: 2012-08-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

3317 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-11-30

Brief Summary

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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

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Conditions

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Postoperative Wound Infection

Keywords

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Surgery hand scrubbing post-operative infection surgical site infection surgical hand preparation plain soap and water alcohol-based hand rub Cost of surgical hand preparation agent Side effects of use of hand preparation agent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Plain soap and water

Surgical hand preparation with plain soap and water

Group Type ACTIVE_COMPARATOR

Plain soap and water (PSW)

Intervention Type OTHER

Presence or absence of infection

Alcohol based hand rubs

Surgical hand preparation with alcohol based alcohol hand rub

Group Type ACTIVE_COMPARATOR

Alcohol-based hand rub (ABHR)

Intervention Type OTHER

Presence or absence of infection

Interventions

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Plain soap and water (PSW)

Presence or absence of infection

Intervention Type OTHER

Alcohol-based hand rub (ABHR)

Presence or absence of infection

Intervention Type OTHER

Other Intervention Names

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Plain bar soap WHO recommended alcohol based hand rub formulation II

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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World Health Organization

OTHER

Sponsor Role collaborator

AIC Kijabe Hospital

OTHER

Sponsor Role collaborator

University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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Africa Inland Church Kijabe Hospital

Principal Investigators

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Peter M Nthumba, MD

Role: PRINCIPAL_INVESTIGATOR

AIC Kijabe Hospital

Locations

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Africa Inland Church Kijabe Hospital

Kijabe, Central, Kenya

Site Status

Countries

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Kenya

References

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Wood JH, Nthumba PM, Stepita-Poenaru E, Poenaru D. Pediatric surgical site infection in the developing world: a Kenyan experience. Pediatr Surg Int. 2012 May;28(5):523-7. doi: 10.1007/s00383-012-3058-x.

Reference Type DERIVED
PMID: 22297835 (View on PubMed)

Nthumba PM, Stepita-Poenaru E, Poenaru D, Bird P, Allegranzi B, Pittet D, Harbarth S. Cluster-randomized, crossover trial of the efficacy of plain soap and water versus alcohol-based rub for surgical hand preparation in a rural hospital in Kenya. Br J Surg. 2010 Nov;97(11):1621-8. doi: 10.1002/bjs.7213.

Reference Type DERIVED
PMID: 20878941 (View on PubMed)

Other Identifiers

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KH-PSW-ABHR

Identifier Type: -

Identifier Source: org_study_id