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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00987402
Other study ID # KH-PSW-ABHR
Secondary ID
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


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
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