- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01640925
Trial of 2% Chlorhexidine Bathing on Nosocomial Infections in the Surgical Intensive Care Unit
Randomized Controlled Trial of 2% Chlorhexidine Bathing on Nosocomial Infections in the Surgical Intensive Care Unit
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Upon study enrollment, patients will be randomized to one of two study arms. Patients in study arm one will receive standard bathing (soap and water or non-medicated cloth) daily. Patients in study arm two will receive a 2% chlorhexidine bath on study day 1 and every 48 hours and a standard bath (soap and water or non-medicated cloths) on study day 2 and every 48 hours. Patients will be followed until ICU day 28 or discharged from the surgical ICU.
Hypothesis: Compared to standard daily bathing, chlorhexidine-based bathing on ICU admission and every 48 hours will decrease the incidence of nosocomial infections.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
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Houston, Texas, United States, 77030
- Surgical Intensive Care Unit, The Methodist Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Admission to the surgical intensive care unit at The Methodist Hospital (Houston, TX)
- Anticipated surgical intensive care unit length of stay of 48 hours or more
Exclusion Criteria:
- Pregnancy
- Age less than 18 years old
- Braden score of less than 9 upon admission to the surgical intensive care unit
- Known allergy to chlorhexidine gluconate
- Active skin irritation upon admission to the surgical intensive care unit
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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 2% solution applied topically for full body bathing once every 48 hours
Other Names:
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Placebo Comparator: Standard bathing
Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily.
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The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Nosocomial Infection
Time Frame: Up to 28 days
|
Proportion of patients with one or more incident nosocomial infections. Primary Efficacy Endpoints* (Composite of new nosocomial infection)
(*)Diagnosed using the Centers for Disease Control criteria for hospital acquired infections. Only infections that develop 48 hours or more after study enrollment will be counted as primary endpoints. (**)Ventilator associated pneumonia is defined as pneumonia that developed after 48 hours of mechanical ventilation. |
Up to 28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Skin Irritation
Time Frame: up to 28 days
|
The incidence of new onset skin irritation will be recorded and graded for severity using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03.
|
up to 28 days
|
ICU Length of Stay in Days
Time Frame: up to 28 days
|
Number of days in the ICU after enrollment in study until first ICU discharge.
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up to 28 days
|
Number of Patients With In-hospital Mortality
Time Frame: up to 28 days or until first hospital discharge
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up to 28 days or until first hospital discharge
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joshua T Swan, Pharm.D., The Methodist Hospital, Texas Southern University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Postoperative Complications
- Wounds and Injuries
- Disease Attributes
- Iatrogenic Disease
- Healthcare-Associated Pneumonia
- Infections
- Communicable Diseases
- Pneumonia
- Surgical Wound
- Surgical Wound Infection
- Wound Infection
- Catheter-Related Infections
- Pneumonia, Ventilator-Associated
- Cross Infection
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Dermatologic Agents
- Disinfectants
- Chlorhexidine
- Chlorhexidine gluconate
Other Study ID Numbers
- Pro00006876
- 1211-0239 (Other Identifier: HMRI IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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