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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-09-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Chlorhexidine gluconate

Intervention Type DRUG

Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours

Standard bathing

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

Group Type PLACEBO_COMPARATOR

Standard bathing

Intervention Type OTHER

The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily.

Interventions

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Chlorhexidine gluconate

Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours

Intervention Type DRUG

Standard bathing

The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily.

Intervention Type OTHER

Other Intervention Names

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Bactoshield 4%

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No