Trial of 2% Chlorhexidine Bathing on Nosocomial Infections in the Surgical Intensive Care Unit
|ClinicalTrials.gov Identifier: NCT01640925|
Recruitment Status : Completed
First Posted : July 16, 2012
Results First Posted : May 22, 2015
Last Update Posted : October 27, 2016
|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.
- Blood Culture Contamination Rate [ Time Frame: 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.
- Number of Patients With In-hospital Mortality [ Time Frame: up to 28 days or until first hospital discharge ]
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|