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A Systematic Oral Care Program in Post-Mechanically Ventilated, Post-Intensive Care Patients

NCT03886623 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2019-03-22

No results posted yet for this study

Summary

The purpose of this study is to see if a 4 day oral care program in patients who have been on a breathing machine results in better oral health, reduces the amount of certain bacteria in the mouth and reduces infection while in the hospital.

The plan is to test the specific hypotheses that a standardized oral care protocol:

1. Results in improved oral health compared to standard care,
2. Reduces the rate of Staphylococcus aureus / methicillin resistant Staphylococcus aureus, and
3. Reduces the risk of healthcare-associated infections.

Conditions

  • Methicillin-resistant Staphylococcus Aureus
  • Methicillin-Sensitive Staphylococcus Aureus Infection

Interventions

PROCEDURE

4-day systematic oral hygiene

he intervention proposed would include a 4-5 day systematic oral hygiene program. Using a pea-sized amount of Colgate Total Clean Mint Toothpaste with a Battery-operated Oral-B Pro-Health Type 3744 toothbrush, all surfaces, tongue-side, check-side, and biting surfaces of the participants teeth will be brushed. The tongue will be brushed with a GUM Dual Action Tongue Cleaner and flossing will be done with GUM Flossmate handle and Oral B Guide Floss in between the contacts of each tooth. The mouth will then be rinsed with Crest Pro-Health mouthwash rinse for 30 seconds twice daily. A Medline Remedy Phytoplex lip balm will then be applied.

OTHER

Standard of Care oral care

Standard of Care oral care. Currently, the intensive care units utilize a commercially available pre-package oral hygiene kit. This includes mouthwash swabbing every 2 hours with Careline Alcohol-Free mouthwash or Sage Alcohol Free mouthwash, teeth brushing (with Sage Toothette Oral Care, Sodium Bicarbonate Toothpaste and Sage Suction Toothbrush) every 12 hours, deep oral suctioning every 8 hours and prior to oral Endotracheal tube (ET) retaping, and Paroex Oral Rinse chlorohexidine gluconate (15ml) swabbed onto oral surfaces every 12 hours (SICU patients only). Mouth care is documented every two hours.

Sponsors & Collaborators

  • Ohio State University

    lead OTHER

Principal Investigators

  • Esther Chipps, RN,PhD · Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03886623 on ClinicalTrials.gov