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

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.
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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
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 ]

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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.  

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.

Swan JT, Ashton CM, Bui LN, Pham VP, Shirkey BA, Blackshear JE, Bersamin JB, Pomer RM, Johnson ML, Magtoto AD, Butler MO, Tran SK, Sanchez LR, Patel JG, Ochoa RA Jr, Hai SA, Denison KI, Graviss EA, Wray NP. Effect of Chlorhexidine Bathing Every Other Day on Prevention of Hospital-Acquired Infections in the Surgical ICU: A Single-Center, Randomized Controlled Trial. Crit Care Med. 2016 Oct;44(10):1822-32. doi: 10.1097/CCM.0000000000001820.

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