Chlorhexidine Gluconate Oral Care for Adults Experiencing Trauma

Study Overview
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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.

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.

Official Title
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Evaluating Effectiveness of Chlorhexidine Gluconate Oral Care for Adults

Conditions
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Ventilator Associated Pneumonia

Intervention / Treatment
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* Drug: Chlorhexidine gluconate
* Other: Toothpaste


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Oral Care Regimen<br>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. | Other: Toothpaste<br>* Brushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste.<br>|
| Experimental: Chlorhexidine Oral Care Regimen<br>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. | Drug: Chlorhexidine gluconate<br>* 0.12% Chlorhexidine Gluconate 15ml Twice Daily, administered via toothbrushing and swabbing teeth, tongue, gingiva, and oral mucosa.<br>* Other names: Peridex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of Chlorhexidine Gluconate Oral Care for Trauma Patients | Examination of number of participants who do not develop oral bacteria and Ventilator Associated Pneumonia when an oral rinse containing 0.12% Chlorhexidine Gluconate is used as part of a oral care protocol. | 18 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trauma, Mechanical Ventilation, Ventilator Associated Pneumonia, Oral Care