Trial of 2% Chlorhexidine Bathing on Nosocomial Infections in the Surgical Intensive Care Unit
|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.|
|ClinicalTrials.gov Identifier: NCT01640925|
Recruitment Status : Completed
First Posted : July 16, 2012
Results First Posted : May 22, 2015
Last Update Posted : April 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cross Infection Pneumonia, Ventilator-associated Catheter-related Infections Infection Due to Indwelling Urinary Catheter Surgical Wound Infection||Drug: Chlorhexidine gluconate Other: Standard bathing||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Controlled Trial of 2% Chlorhexidine Bathing on Nosocomial Infections in the Surgical Intensive Care Unit|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||September 2014|
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.
Drug: Chlorhexidine gluconate
Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours
Other Name: Bactoshield 4%
Placebo Comparator: Standard bathing
Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily.
Other: Standard bathing
The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily.
- 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)
- Primary Bloodstream Infection
- Catheter Related Urinary Tract Infection
- Ventilator-Associated Pneumonia**
- Surgical Site 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.
- 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.
- 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.
- Number of Patients With In-hospital Mortality [ Time Frame: up to 28 days or until first hospital discharge ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01640925
|United States, Texas|
|Surgical Intensive Care Unit, The Methodist Hospital|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Joshua T Swan, Pharm.D.||The Methodist Hospital, Texas Southern University|