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Study of Bathing With Chlorhexidine Impregnated Cloths on Nosocomial Infections in the Pediatric Intensive Care Unit

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00549393
First Posted: October 25, 2007
Last Update Posted: June 14, 2017
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.
Collaborator:
Sage Products, Inc.
Information provided by (Responsible Party):
Johns Hopkins University
Results First Submitted: March 31, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Nosocomial Infections
Intervention: Drug: 2% Chlorhexidine gluconate cloth

  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
The hospital ICU units underwent a crossover study design, so the ICUs recruited participants in the assigned treatment or control group, then the unit had a washout period, then the unit switched to the alternative assignment of intervention or control for a separate population of participants that were admitted into the ICU.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
5659 enrolled visits in the study, but 712 were excluded from analysis as they did not meet the eligibility criteria

Reporting Groups
  Description
2% Chlorhexidine Gluconate Cloth

Daily bathing with 2% chlorhexidine gluconate

2% Chlorhexidine gluconate cloth: Daily bathing

Standard Bath Standard bathing with soap and water basin or disposable cloth

Participant Flow for 3 periods

Period 1:   Period 1 (6 Months)
    2% Chlorhexidine Gluconate Cloth   Standard Bath
STARTED   1319 [1]   1199 [2] 
Per Protocol   880   1199 
COMPLETED   1319   1199 
NOT COMPLETED   0   0 
[1] intention to treat (ITT)
[2] ITT

Period 2:   Period 2 Washout (2 Weeks)
    2% Chlorhexidine Gluconate Cloth   Standard Bath
STARTED   0   0 
COMPLETED   0   0 
NOT COMPLETED   0   0 

Period 3:   Period 3 (6 Months)
    2% Chlorhexidine Gluconate Cloth   Standard Bath
STARTED   1103 [1]   1326 [1] 
Per Protocol   667   1326 
COMPLETED   1103   1326 
NOT COMPLETED   0   0 
[1] number not equal to period 1 due to unit cross over design



  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
Treatment Arm

Daily bathing with 2% chlorhexidine gluconate

2% Chlorhexidine gluconate cloth: Daily bathing

Control Arm Standard bathing with soap and water basin or disposable cloth
Total Total of all reporting groups

Baseline Measures
   Treatment Arm   Control Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 2422   2525   4947 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 4.8 
 (1.1 to 12.9) 
 4.8 
 (1.1 to 12.7) 
 4.8 
 (1.1 to 12.9) 
Sex/Gender, Customized 
[Units: Participants]
     
Male   1389   1388   2777 
Female   1033   1137   2170 
Race/Ethnicity, Customized 
[Units: Participants]
     
Caucasian   1271   1269   2540 
non-Caucasian   1151   1256   2407 
PRISM III Score [1] 
[Units: Score]
Median (Inter-Quartile Range)
 5 
 (0 to 13) 
 5 
 (0 to 11) 
 5 
 (0 to 12) 
[1] Severity score that predicts mortality. Range 0 (lowest mortality risk) to 74 (highest mortality risk)


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Bacteremia   [ Time Frame: participants were followed for the duration of ICU stay, median stay 3 days ]

2.  Secondary:   Central Line Associated-bloodstream Infection (CLABSI)   [ Time Frame: participants were followed for the duration of ICU stay, median stay 3 days ]

3.  Other Pre-specified:   Bacteremia   [ Time Frame: duration of ICU stay, median 3 days ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  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.


Results Point of Contact:  
Name/Title: Dr. Aaron Milstone
Organization: Johns Hopkins University
phone: 4106143917
e-mail: amilsto1@jhmi.edu


Publications of Results:

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00549393     History of Changes
Other Study ID Numbers: NA_00006799
First Submitted: October 24, 2007
First Posted: October 25, 2007
Results First Submitted: March 31, 2015
Results First Posted: October 2, 2015
Last Update Posted: June 14, 2017