Trial of 2% Chlorhexidine Bathing on Nosocomial Infections in the Surgical Intensive Care Unit

Joshua Swan

Status: Completed

Conditions: Cross Infection; Pneumonia, Ventilator-associated; Catheter-related Infections; Infection Due to Indwelling Urinary Catheter; Surgical Wound Infection

Treatments: Other: Standard bathing; Drug: Chlorhexidine gluconate

Study type: Interventional

Funder types: Other

Identifiers

NCT01640925

1211-0239 (Other Identifier)

Pro00006876

Details and patient eligibility

About

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).

Full 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.

Enrollment: 350 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 2 patient groups, including a placebo group

Chlorhexidine gluconate bathing

Active Comparator group

Description:

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.

Treatment:

Drug: Chlorhexidine gluconate

Standard bathing

Placebo Comparator group

Description:

Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily.

Treatment:

Other: Standard bathing