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Completed

NCT Number: NCT01382446

Chlorhexidine Gluconate Oral Care for Adults Experiencing Trauma

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chlorhexidine gluconate

Drug

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

Other names: Peridex

toothpaste

Other

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

Primary outcomes

  1. Effectiveness of Chlorhexidine Gluconate Oral Care for Trauma Patients

    Time frame: 18 Months

    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.

Sponsors and collaborators

Lead sponsor

St. Joseph's Hospital and Medical Center, Phoenix

Other

Collaborators

  • 3M

Registry information

Official study title

Evaluating Effectiveness of Chlorhexidine Gluconate Oral Care for Adults

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 27, 2011
Registry last updated
Feb 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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