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Chlorhexidine Gluconate Oral Care for Adults Experiencing Trauma

This study has been completed.
Sponsor:
Collaborator:
3M
Information provided by (Responsible Party):
Toby L. Anchie, R.N., MAEd, St. Joseph's Hospital and Medical Center, Phoenix
ClinicalTrials.gov Identifier:
NCT01382446
First received: June 23, 2011
Last updated: September 10, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention
Ventilator Associated Pneumonia
 Drug: Chlorhexidine gluconate
Other: Toothpaste

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluating Effectiveness of Chlorhexidine Gluconate Oral Care for Adults

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Joseph's Hospital and Medical Center, Phoenix:

Primary Outcome Measures:
  • Evaluating Effectiveness of Chlorhexidine Gluconate Oral Care for Adults Experiencing Trauma [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
    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.


Enrollment: 88
Study Start Date: July 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
 Other: Toothpaste
Brushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste.
Experimental: 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.
 Drug: Chlorhexidine gluconate
0.12% Chlorhexidine Gluconate 15ml Twice Daily, administered via toothbrushing and swabbing teeth, tongue, gingiva, and oral mucosa.
Other Name: Peridex

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 (60 subjects in each group, yielding a power of >.80) 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01382446

Locations
United States, Arizona
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
Sponsors and Collaborators
St. Joseph's Hospital and Medical Center, Phoenix
3M
Investigators
Principal Investigator: Tracy Thomas, MSN St. Joseph's Hospital and Medical Center, Phoenix
  More Information

No publications provided

Responsible Party: Toby L. Anchie, R.N., MAEd, Accountable Executive, St. Joseph's Hospital and Medical Center, Phoenix
ClinicalTrials.gov Identifier: NCT01382446     History of Changes
Other Study ID Numbers: IRB#09NU127
Study First Received: June 23, 2011
Last Updated: September 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by St. Joseph's Hospital and Medical Center, Phoenix:
Trauma
Mechanical Ventilation
Ventilator Associated Pneumonia
Oral Care

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury
 Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on May 22, 2013