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Oral Care Study on Burn Patients

This study is currently recruiting participants.
Verified February 2011 by Saint Elizabeth Regional Medical Center
Sponsor:
Information provided by:
Saint Elizabeth Regional Medical Center
ClinicalTrials.gov Identifier:
NCT01302457
First received: February 9, 2011
Last updated: February 18, 2011
Last verified: February 2011
History of Changes
  Purpose

There have been multiple articles done regarding oral hygiene on patients in burn and intensive care patients. All articles agree the need for good oral hygiene in these special needs patients. They also note that more research needs to be done on this subject, yet have no direction of how to proceed in this research. Currently, no research has been done on the burn/intensive care patient to see if there is a difference form the non-hospitalized patient which oral hygiene protocol is based on.


Condition
Burn

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Oral Care Study on Burn Patients

Resource links provided by NLM:

MedlinePlus related topics: Burns Dental Health
U.S. FDA Resources

Further study details as provided by Saint Elizabeth Regional Medical Center:

Primary Outcome Measures:
  • Patient's Oral Condition [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    The primary purpose of this prospective study is to determine if the burn/intensive care patient's oral condition is similar or different from the normal standard.


Estimated Enrollment: 25
Study Start Date: September 2007
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy Same Subjects
The control group will be 19 years or older and be randomly picked from from volunteer staff at Saint Elizabeth Regional Medical Center. This is a prospective study that will look at the similarities and difference of both groups. This will help us determine if there is a need to improve oral hygiene protocol given to burn/intensive care patients. Each group will consist of 25 subjects
Health Volunteers

The control group will be 19 years or older and be randomly picked from volunteer staff at Saint Elizabeth Regional Medical Center.

DESIGN This is a prospective study that will look at the similarities and difference of both groups. This will help us determine if there is a need to improve oral hygiene protocol given to burn/intensive care patients. Each group will consist of 25 subjects

Detailed Description:

BACKGROUND IMFORATION AND INTRODUCTION There have been multiple articles done regarding oral hygiene on patients in burn and intensive care patients. All articles agree the need for good oral hygiene in these special needs patients. They also note that more research needs to be done on this subject, yet have no direction of how to proceed in this research. Currently, no research has been done on the burn/intensive care patient to see if there is a difference form the non-hospitalized patient which oral hygiene protocol is based on.

OJECTIVE The primary purpose of this prospective study is to determine if the burn/intensive care patient's oral condition is similar or different from the normal standard.

PATIENT SELECTION CRITERIA

  1. Patients age must be 19 and older.
  2. Patients must be on a ventilator in the burn or intensive care unit.
  3. The control group will be 19 years or older and be randomly picked from from volunteer staff at Saint Elizabeth Regional Medical Center.

DESIGN This is a prospective study that will look at the similarities and difference of both groups. This will help us determine if there is a need to improve oral hygiene protocol given to burn/intensive care patients. Each group will consist of 25 subjects

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

PATIENT SELECTION CRITERIA

  1. Patients age must be 19 and older.
  2. Patients must be on a ventilator in the burn or intensive care unit.
  3. The control group will be 19 years or older and be randomly picked from volunteer staff at Saint Elizabeth Regional Medical Center.
Criteria

Inclusion Criteria:PATIENT SELECTION CRITERIA

  1. Patients age must be 19 and older.
  2. Patients must be on a ventilator in the burn or intensive care unit.
  3. The control group of Healthy Volunteers will be 19 years or older and be randomly picked from volunteer staff at Saint Elizabeth Regional Medical Center.

Exclusion Criteria:

  • Unable to complete Informed Consent Process
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302457

Contacts
Contact: Brian Burgess, D.D.S 402-219-8000 doc1360@aol.com
Contact: Paul Edwards, CCRC 402-219-7677 pedwards@stez.org

Locations
United States, Nebraska
Saint Elizabeth Regional Medical Center Recruiting
Lincoln, Nebraska, United States, 68510
Contact: Paul Edwards, CCRC     422-219-7677     pedwards@stez.org    
Sponsors and Collaborators
Saint Elizabeth Regional Medical Center
Investigators
Principal Investigator: Brian Burgess, D.D.S. Saint Elizabeth Regional Medical Center
  More Information

No publications provided

Responsible Party: Saint Elizabeth Regional Medical Center
ClinicalTrials.gov Identifier: NCT01302457     History of Changes
Other Study ID Numbers: 609-036
Study First Received: February 9, 2011
Last Updated: February 18, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Saint Elizabeth Regional Medical Center:
Thermal Burn Trauma

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on June 18, 2013