Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Collaborators:
Texas Southern University
The Methodist Hospital System
Information provided by (Responsible Party):
Joshua Swan, The Methodist Hospital System
ClinicalTrials.gov Identifier:
NCT01640925
First received: July 5, 2012
Last updated: September 21, 2016
Last verified: September 2016
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
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.


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
  Hide Baseline Characteristics

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 ]

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


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide More Information

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:

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 )
Study First Received: July 5, 2012
Results First Received: April 15, 2015
Last Updated: September 21, 2016
Health Authority: United States: Institutional Review Board