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Chlorhexidine Gluconate Oral Care for Adults Experiencing Trauma

Primary Purpose

Ventilator Associated Pneumonia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chlorhexidine gluconate
Toothpaste
Sponsored by
St. Joseph's Hospital and Medical Center, Phoenix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventilator Associated Pneumonia focused on measuring Trauma, Mechanical Ventilation, Ventilator Associated Pneumonia, Oral Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • St. Joseph's Hospital and Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Oral Care Regimen

Chlorhexidine Oral Care Regimen

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 23, 2011
Last Updated
December 12, 2016
Sponsor
St. Joseph's Hospital and Medical Center, Phoenix
Collaborators
3M
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1. Study Identification

Unique Protocol Identification Number
NCT01382446
Brief Title
Chlorhexidine Gluconate Oral Care for Adults Experiencing Trauma
Official Title
Evaluating Effectiveness of Chlorhexidine Gluconate Oral Care for Adults
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Joseph's Hospital and Medical Center, Phoenix
Collaborators
3M

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator Associated Pneumonia
Keywords
Trauma, Mechanical Ventilation, Ventilator Associated Pneumonia, Oral Care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Oral Care Regimen
Arm Type
Active Comparator
Arm 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.
Arm Title
Chlorhexidine Oral Care Regimen
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine gluconate
Other Intervention Name(s)
Peridex
Intervention Description
0.12% Chlorhexidine Gluconate 15ml Twice Daily, administered via toothbrushing and swabbing teeth, tongue, gingiva, and oral mucosa.
Intervention Type
Other
Intervention Name(s)
Toothpaste
Intervention Description
Brushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste.
Primary Outcome Measure Information:
Title
Effectiveness of Chlorhexidine Gluconate Oral Care for Trauma Patients
Description
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.
Time Frame
18 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tracy Thomas, MSN
Organizational Affiliation
St. Joseph's Hospital and Medical Center, Phoenix
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Chlorhexidine Gluconate Oral Care for Adults Experiencing Trauma

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