Different Oral Colonization of Gram-negative Bacteria in ICU Patients When Using Chlorhexidine at 0.12% Versus Chlorhexidine at 2.0%

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2019-12-31

Brief Summary

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This study will assess the utility of different chlorhexidine mouthwash concentrations on ICU patients to decolonize their oral cavities from gram-negative bacteria, since this is a non-desirable condition that leads to higher mortality rates and longer hospitalization times. One group will receive the 0.12% chlorhexidine mouthwash and the other group will receive the 2% chlorhexidine mouthwash.

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Detailed Description

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Conditions

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Chlorhexidine Ventilator Associated Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Chlorhexidine 2%

Subjects in this arm will receive standard care plus mouth rinse every 12 hours via spray with 2% chlorhexidine concentration, one week intervention, Drug: Chlorhexidine gluconate at 2%

Group Type EXPERIMENTAL

Chlorhexidine gluconate at 2%

Intervention Type DRUG

Mouth Rinse with Chlorhexidine gluconate at 2% every 12 hours, one week.

Chlorhexidine 0.12%

Subjects in this arm will receive standard care plus mouth rinse every 12 hours via spray with 0.12% chlorhexidine concentration, one week intervention, Drug: Chlorhexidine gluconate at 0.12%

Group Type ACTIVE_COMPARATOR

Chlorhexidine gluconate at 0.12%

Intervention Type DRUG

Mouth Rinse with Chlorhexidine gluconate at 0.12% every 12 hours, one week.

Interventions

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Chlorhexidine gluconate at 2%

Mouth Rinse with Chlorhexidine gluconate at 2% every 12 hours, one week.

Intervention Type DRUG

Chlorhexidine gluconate at 0.12%

Mouth Rinse with Chlorhexidine gluconate at 0.12% every 12 hours, one week.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with minimum required age of consent that were admitted to the intensive care unit and who received at least 48 hours of mechanical ventilation.