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NCT01302457 Clinical Trial

Oral Care Study on Burn Patients

Burn Clinical Trial

Official title:
Oral Care Study on Burn Patients

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01302457
Other study ID # 609-036
Secondary ID
Status Withdrawn
Phase N/A
First received February 9, 2011
Last updated October 12, 2016
Start date September 2007
Est. completion date September 2013

Study information
Verified date October 2016
Source Saint Elizabeth Regional Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date September 2013
Est. primary completion date September 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 19 Years and older
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Saint Elizabeth Regional Medical Center Lincoln Nebraska

Sponsors (1)
Lead Sponsor Collaborator
Saint Elizabeth Regional Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
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