Chlorhexidine Gluconate Oral Care for Adults Experiencing Trauma

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-04-30

Brief Summary

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Examine the use of 0.12% Chlorhexidine Gluconate as an adjunct to current oral care protocol for trauma patients on ventilator support to decrease the incidence of Ventilator Associated Pneumonia and oral bacterial load.

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Detailed Description

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To see a significant decrease in the bacterial load in the oral mucosa and subsequently, a decrease in the pathogenesis of Ventilator Associated Pneumonia through the use of an oral rinse containing 0.12% Chlorhexidine Gluconate as part of an oral care protocol. Current oral care protocol includes the use of 1.5% H2O2-coated swabs every four hours, toothbrushing with toothpaste every 12 hours, and use of continuous subglottic suction apparatus.

Conditions

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Ventilator Associated Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard Oral Care Regimen

Current oral care protocol includes the use of 1.5% H2O2-coated swabs every four hours, toothbrushing with toothpaste every 12 hours, and use of continuous subglottic suction apparatus.

Group Type ACTIVE_COMPARATOR

Toothpaste

Intervention Type OTHER

Brushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste.

Chlorhexidine Oral Care Regimen

This study will compare our current oral care practice with the use of Chlorhexidine Gluconate 0.12% (Peridex, 3M Corporation) Twice daily in addition to regularly scheduled oral care as a means to decrease the incidence of VAP utilizing evidence-based strategies.

Group Type EXPERIMENTAL

Chlorhexidine gluconate

Intervention Type DRUG

0.12% Chlorhexidine Gluconate 15ml Twice Daily, administered via toothbrushing and swabbing teeth, tongue, gingiva, and oral mucosa.

Interventions

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Chlorhexidine gluconate

0.12% Chlorhexidine Gluconate 15ml Twice Daily, administered via toothbrushing and swabbing teeth, tongue, gingiva, and oral mucosa.

Intervention Type DRUG

Toothpaste

Brushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste.

Intervention Type OTHER

Other Intervention Names

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Peridex

Eligibility Criteria

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Inclusion Criteria

* Adults admitted to ICUs located in Tower Two Critical Care Units: Medical, Surgical, Medical #2, and Trauma Intensive Care Units.
* Patients will be randomized to either treatment or standard group based on day of admission to Intensive Care Units. No limitation regarding gender, race, and ethnicity so that the sample will reflect "typical" Trauma population.

Exclusion Criteria

* All patients admitted under "Doe" Status
* All patients with acute cervical spine injuries or facial fractures that oral care will create further harm to the patient (physician order stating "no oral care to be given" will be in chart)
* All patients with Oral Trauma or Oral Surgery
* All minors (Study will be completed in Adult Critical Care Units)
* Patients with allergy to chlorhexidine
* Patients without Teeth, or with fewer than 6 teeth

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No