NCT00987402

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,317

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2009

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

August 21, 2012

Completed
Last Updated

August 21, 2012

Status Verified

November 1, 2009

Enrollment Period

10 months

First QC Date

September 30, 2009

Results QC Date

October 7, 2009

Last Update Submit

August 20, 2012

Conditions

Postoperative Wound Infection

Keywords

Surgeryhand scrubbingpost-operative infectionsurgical site infectionsurgical hand preparationplain soap and wateralcohol-based hand rubCost of surgical hand preparation agentSide effects of use of hand preparation agent

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Cost of Hand Preparation Agent

    30 days

Study Arms (2)

Plain soap and water

ACTIVE COMPARATOR

Surgical hand preparation with plain soap and water

Other: Plain soap and water (PSW)

Alcohol based hand rubs

ACTIVE COMPARATOR

Surgical hand preparation with alcohol based alcohol hand rub

Other: Alcohol-based hand rub (ABHR)

Interventions

Plain soap and water (PSW)OTHER

Presence or absence of infection

Also known as: Plain bar soap, WHO recommended alcohol based hand rub formulation II
Plain soap and water
Alcohol-based hand rub (ABHR)OTHER

Presence or absence of infection

Alcohol based hand rubs

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients undergoing clean or clean-contaminated surgery at AIC Kijabe Hospital

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Africa Inland Church Kijabe Hospital

Kijabe, Central, 00220, Kenya

Location

Related Publications (2)

  • 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.

    PMID: 22297835DERIVED

  • 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.

    PMID: 20878941DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

WaterEthanol

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen CompoundsAlcoholsOrganic Chemicals

Limitations and Caveats

Most cases, post-discharge monitoring was not conducted by outpatient clinic visits following a standard protocol, some data was not collected, and routine microbiologic cultures were not obtained.

Results Point of Contact

Title
Stephan Harbarth MD
Organization
University Hospital, Geneva
stephan.harbarth@hcuge.ch
+41-22-372.3357

Study Officials

  • Peter M Nthumba, MD

    AIC Kijabe Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 30, 2009

First Posted

October 1, 2009

Study Start

January 1, 2007

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

August 21, 2012

Results First Posted

August 21, 2012

Record last verified: 2009-11

Locations

KE(1)