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

Primary Purpose

Postoperative Wound Infection

Status
Completed
Phase
Phase 1
Locations
Kenya
Study Type
Interventional
Intervention
Plain soap and water (PSW)
Alcohol-based hand rub (ABHR)
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Wound Infection focused on measuring 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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Africa Inland Church Kijabe Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Plain soap and water

Alcohol based hand rubs

Arm Description

Surgical hand preparation with plain soap and water

Surgical hand preparation with alcohol based alcohol hand rub

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
September 30, 2009
Last Updated
August 20, 2012
Sponsor
University Hospital, Geneva
Collaborators
World Health Organization, AIC Kijabe Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00987402
Brief Title
Study of the Efficacy of Plain Soap and Water Versus Alcohol-based Rubs for Surgical Hand Preparation
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Geneva
Collaborators
World Health Organization, AIC Kijabe Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Wound Infection
Keywords
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
3317 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Plain soap and water
Arm Type
Active Comparator
Arm Description
Surgical hand preparation with plain soap and water
Arm Title
Alcohol based hand rubs
Arm Type
Active Comparator
Arm Description
Surgical hand preparation with alcohol based alcohol hand rub
Intervention Type
Other
Intervention Name(s)
Plain soap and water (PSW)
Other Intervention Name(s)
Plain bar soap, WHO recommended alcohol based hand rub formulation II
Intervention Description
Presence or absence of infection
Intervention Type
Other
Intervention Name(s)
Alcohol-based hand rub (ABHR)
Intervention Description
Presence or absence of infection
Primary Outcome Measure Information:
Title
Surgical Site Infection
Description
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).
Time Frame
30 days post-operatively
Secondary Outcome Measure Information:
Title
Cost of Hand Preparation Agent
Description
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.
Time Frame
30 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter M Nthumba, MD
Organizational Affiliation
AIC Kijabe Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Africa Inland Church Kijabe Hospital
City
Kijabe
State/Province
Central
ZIP/Postal Code
00220
Country
Kenya

12. IPD Sharing Statement

Citations:
PubMed Identifier
22297835
Citation
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.
Results Reference
derived
PubMed Identifier
20878941
Citation
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.
Results Reference
derived

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

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