Chlorhexidine Gluconate Oral Care for Adults Experiencing Trauma

Ventilator Associated Pneumonia Clinical Trial

Official title:

Evaluating Effectiveness of Chlorhexidine Gluconate Oral Care for Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01382446
• Other study ID #: IRB#09NU127
• Status: Completed
• Phase: N/A
• First received: June 23, 2011
• Last updated: December 5, 2013
• Start date: July 2010
• Est. completion date: April 2012

Study information

• Verified date: December 2013
• Source: St. Joseph's Hospital and Medical Center, Phoenix
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Intervention

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

Other:
• Toothpaste
Brushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste.

Locations

Country	Name	City	State
United States	St. Joseph's Hospital and Medical Center	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
St. Joseph's Hospital and Medical Center, Phoenix	3M

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No