Clinical trial NCT01640925: Trial of 2% Chlorhexidine Bathing on Nosocomial Infections in the Surgical Intensive Care Unit
Official title: Randomized Controlled Trial of 2% Chlorhexidine Bathing on Nosocomial Infections in the Surgical Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cross Infection
Pneumonia, Ventilator-associated
Catheter-related Infections
Infection Due to Indwelling Urinary Catheter
Surgical Wound Infection
Keywords: nosocomial infection
hospital acquired infection
chlorhexidine
pneumonia, ventilator-associated
catheter-related infections
urinary tract infections, catheter-related
surgical site infection
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Texas Southern University
name: The Methodist Hospital Research Institute
First posted: 2012-07-16
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This prospective, randomized, controlled trial will compare the incidence of nosocomial infections (composite of primary bloodstream infections, catheter-associated urinary tract infections, ventilator-associated pneumonia, and surgical site infections) that occur in intensive care unit (ICU) patients bathed with 2% chlorhexidine solution versus patients who receive standard bathing (soap and water or non-medicated cloths).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Nosocomial Infection
timeFrame: Up to 28 days
Secondary outcomes:
measure: Incidence of Skin Irritation
timeFrame: up to 28 days
measure: ICU Length of Stay in Days
timeFrame: up to 28 days
measure: Number of Patients With In-hospital Mortality
timeFrame: up to 28 days or until first hospital discharge
Other outcomes:
Locations:
city: Houston
country: United States
facility: Surgical Intensive Care Unit, The Methodist Hospital
state: Texas
Study officials:
affiliation: The Methodist Hospital, Texas Southern University
name: Joshua T Swan, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.