Chlorhexidine Gluconate Oral Care for Adults Experiencing Trauma

NCT01382446 | Completed Results

• 1 other identifier: IRB#09NU127
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator Associated Pneumonia

Keywords

Trauma; Mechanical Ventilation; Ventilator Associated Pneumonia; Oral Care

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Standard Oral Care Regimen

ACTIVE COMPARATOR

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

Chlorhexidine Oral Care Regimen

EXPERIMENTAL

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

Interventions

Chlorhexidine gluconate DRUG

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

Also known as: Peridex

Chlorhexidine Oral Care Regimen

Toothpaste OTHER

Brushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste.

Standard Oral Care Regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Joseph's Hospital and Medical Center, Phoenix: lead
• 3M: collaborator

Study Sites (1)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Wounds and Injuries

Interventions

chlorhexidine gluconate; Toothpastes

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dentifrices; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Limitations and Caveats

Enrolling of trauma patients - consenting patients with unknown identification or next of kin status led to small number of subjects analyzed

Results Point of Contact

• Title: Tracy L. Thomas MSN RN CCRN ACNS-BC
• Organization: SJHMC

Tracy.Thomas007@dignityhealth.org

602-406-2567

Study Officials

• Tracy Thomas, MSN

  St. Joseph's Hospital and Medical Center, Phoenix

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Clinician

Study Record Dates

• First Submitted: June 23, 2011
• First Posted: June 27, 2011
• Study Start: July 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: February 6, 2017
• Results First Posted: November 28, 2013

Record last verified: 2016-12

Locations

US (1)