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

U

Universidad de Guanajuato

Status and phase

Unknown
Phase 3

Conditions

Ventilator Associated Pneumonia
Chlorhexidine

Treatments

Drug: Chlorhexidine gluconate at 0.12%
Drug: Chlorhexidine gluconate at 2%

Study type

Interventional

Funder types

Other

Identifiers

NCT03442023
SSGTO00153

Details and patient eligibility

About

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.

Enrollment

74 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Exclusion criteria

Patients who wish to withdraw consent and leave the study.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

74 participants in 2 patient groups

Chlorhexidine 2%
Experimental group
Description:
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%
Treatment:
Drug: Chlorhexidine gluconate at 2%
Chlorhexidine 0.12%
Active Comparator group
Description:
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%
Treatment:
Drug: Chlorhexidine gluconate at 0.12%

Trial contacts and locations

1

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Central trial contact

José A Álvarez, PhD; Marco A López, MD

Data sourced from clinicaltrials.gov

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