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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01640925
First Posted: July 16, 2012
Last Update Posted: October 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Texas Southern University
The Methodist Hospital System
Information provided by (Responsible Party):
Joshua Swan, The Methodist Hospital System
Results First Submitted: April 15, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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.
No text entered.

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 
Overall Participants Analyzed 
[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 ]
  Show Outcome Measure 1

2.  Secondary:   Incidence of Skin Irritation   [ Time Frame: up to 28 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

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

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

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.  


  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: Joshua Swan, The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT01640925     History of Changes
Other Study ID Numbers: Pro00006876
1211-0239 ( Other Identifier: HMRI IRB )
First Submitted: July 5, 2012
First Posted: July 16, 2012
Results First Submitted: April 15, 2015
Results First Posted: May 22, 2015
Last Update Posted: October 27, 2016