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Trial of 2% Chlorhexidine Bathing on Nosocomial Infections in the Surgical Intensive Care Unit

This study has been completed.
Sponsor:
Collaborator:
Texas Southern University
Information provided by (Responsible Party):
The Methodist Hospital System
ClinicalTrials.gov Identifier:
NCT01640925
First received: July 5, 2012
Last updated: March 14, 2016
Last verified: March 2016
History of Changes
Results First Received: April 15, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Cross Infection
Pneumonia, Ventilator-associated
Catheter-related Infections
Infection Due to Indwelling Urinary Catheter
Surgical Wound Infection
Interventions: Drug: Chlorhexidine gluconate
Other: Standard bathing

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Chlorhexidine Gluconate Bathing

Upon study enrollment, patients will be bathed with a 2% chlorhexidine gluconate solution on study day 1 and every 48 hours until study completion. The patient will be bathed using standard bathing (non-medicated cloths or soap and water) on study day 2 and every 48 hours after that.

Chlorhexidine gluconate: Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours
Standard Bathing

Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily.

Standard bathing: The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily.

Participant Flow:   Overall Study
    Chlorhexidine Gluconate Bathing     Standard Bathing  
STARTED     175     175  
COMPLETED     161     164  
NOT COMPLETED     14     11  
Withdrawal by Subject                 1                 0  
Previously enrolled in this trial                 13                 11  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Chlorhexidine Gluconate Bathing

Upon study enrollment, patients will be bathed with a 2% chlorhexidine gluconate solution on study day 1 and every 48 hours until study completion. The patient will be bathed using standard bathing (non-medicated cloths or soap and water) on study day 2 and every 48 hours after that.

Chlorhexidine gluconate: Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours
Standard Bathing

Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily.

Standard bathing: The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily.
Total Total of all reporting groups

Baseline Measures
    Chlorhexidine Gluconate Bathing     Standard Bathing     Total  
Number of Participants  
[units: participants]
 		  161     164     325  
Age  
[units: years]
Mean (Standard Deviation) 		  59.4  (15.9)     60.2  (16.5)     59.8  (16.2)  
Gender  
[units: participants]
 		     
Female     63     78     141  
Male     98     86     184  



  Outcome Measures

1.  Primary:   Incidence of Nosocomial Infection   [ Time Frame: Up to 28 days ]
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2.  Secondary:   Incidence of Skin Irritation   [ Time Frame: up to 28 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Blood Culture Contamination Rate   [ Time Frame: up to 28 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   ICU Length of Stay in Days   [ Time Frame: up to 28 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Number of Patients With In-hospital Mortality   [ Time Frame: up to 28 days or until first hospital discharge ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Joshua Swan
Organization: Houston Methodist Hospital
phone: 713-441-0165
e-mail: jtswan@houstonmethodist.org


Publications of Results:
Swan JT, Bui LN, Pham VP, Shirkey BA, Graviss EA, Hai SA, Ashton CM, Wray NP. "RCT of chlorhexidine versus soap & water bathing for prevention of hospital-acquired infections in SICU". Critical Care Medicine. 2014;42(12 supplement):abstract 4.


Responsible Party: The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT01640925     History of Changes
Other Study ID Numbers: Pro00006876
1211-0239 ( Other Identifier: HMRI IRB )
Study First Received: July 5, 2012
Results First Received: April 15, 2015
Last Updated: March 14, 2016
Health Authority: United States: Institutional Review Board