Trial of 2% Chlorhexidine Bathing on Nosocomial Infections in the Surgical Intensive Care Unit
|Cross Infection Pneumonia, Ventilator-associated Catheter-related Infections Infection Due to Indwelling Urinary Catheter Surgical Wound Infection||Drug: Chlorhexidine gluconate Other: Standard bathing|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Official Title:||Randomized Controlled Trial of 2% Chlorhexidine Bathing on Nosocomial Infections in the Surgical Intensive Care Unit|
- 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 ]
|Study Start Date:||July 2012|
|Study Completion Date:||September 2014|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|