Oral Care Study on Burn Patients

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.

Study Overview

• Status: Withdrawn
• Conditions: Burn

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

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Saint Elizabeth Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's Oral Condition	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.	30 days

Collaborators and Investigators

• Sponsor: Saint Elizabeth Regional Medical Center
• Investigators: Principal Investigator: Brian Burgess, D.D.S., Saint Elizabeth Regional Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: February 9, 2011
• First Submitted That Met QC Criteria: February 18, 2011
• First Posted (Estimate): February 24, 2011

Study Record Updates

• Last Update Posted (Estimate): October 13, 2016
• Last Update Submitted That Met QC Criteria: October 12, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Thermal Burn Trauma
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: 609-036