Chlorhexidine Gluconate Oral Care for Adults Experiencing Trauma

St. Joseph's Hospital and Medical Center, Phoenix

Status: Completed

Conditions: Ventilator Associated Pneumonia

Treatments: Other: Toothpaste; Drug: Chlorhexidine gluconate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01382446

IRB#09NU127

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Standard Oral Care Regimen

Active Comparator group

Description:

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.

Treatment:

Other: Toothpaste

Chlorhexidine Oral Care Regimen

Experimental group

Description:

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.

Treatment:

Drug: Chlorhexidine gluconate