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

This study has been completed.
Sponsor:
Collaborators:
World Health Organization
AIC Kijabe Hospital
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00987402
First received: September 30, 2009
Last updated: August 20, 2012
Last verified: November 2009
History of Changes
Results First Received: October 7, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Prevention
Condition: Postoperative Wound Infection
Interventions: Other: Plain soap and water (PSW)
Other: Alcohol-based hand rub (ABHR)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients undergoing surgery at AIC Kijabe Hospital recruited between January 2007 to November 2007

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients who declined consent for participation were excluded, as were those undergoing a second procedure within 2 weeks of the first.

Reporting Groups
  Description
Plain Soap and Water Surgical hand preparation with plain soap and water
Alcohol Based Hand Rubs Surgical hand preparation with alcohol based alcohol hand rub

Participant Flow:   Overall Study
    Plain Soap and Water     Alcohol Based Hand Rubs  
STARTED     1682 [1]   1635 [2]
COMPLETED     1596 [3]   1537 [4]
NOT COMPLETED     86     98  
Insufficient data entry                 86                 98  
[1] January 2007, with crossover every 2 months
[2] January 2007 with crossover every 2 months
[3] 86 patients did not have some data, and could not be evaluated
[4] 98 patients did not have sufficient data



  Baseline Characteristics
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Reporting Groups
  Description
Plain Soap and Water Surgical hand preparation with plain soap and water
Alcohol Based Hand Rubs Surgical hand preparation with alcohol based alcohol hand rub
Total Total of all reporting groups

Baseline Measures
    Plain Soap and Water     Alcohol Based Hand Rubs     Total  
Number of Participants  
[units: participants]
 		  1682     1635     3317  
Age  
[units: Participants]
Mean ± Standard Deviation 		  28  ± 23     29  ± 19     29  ± 22  
Gender  
[units: participants]
 		     
Female     964     908     1872  
Male     718     727     1445  
Region of Enrollment  
[units: participants]
 		     
Kenya     1682     1635     3317  



  Outcome Measures

1.  Primary:   Surgical Site Infection   [ Time Frame: 30 days post-operatively ]
  Show Outcome Measure 1

2.  Secondary:   Cost of Hand Preparation Agent   [ Time Frame: 30 days ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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:  
Name/Title: Stephan Harbarth MD
Organization: University Hospital, Geneva
phone: +41-22-372.3357
e-mail: stephan.harbarth@hcuge.ch


No publications provided by University Hospital, Geneva

Publications automatically indexed to this study:


Responsible Party: Peter M. Nthumba, M.D., Africa Inland Church Kijabe Hospital
ClinicalTrials.gov Identifier: NCT00987402     History of Changes
Other Study ID Numbers: KH-PSW-ABHR
Study First Received: September 30, 2009
Results First Received: October 7, 2009
Last Updated: August 20, 2012
Health Authority: Kenya: Ministry of Health