Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2025-12-27 @ 7:34 AM
Study NCT ID:
NCT01302457
Status:
WITHDRAWN
Last Update Posted:
2016-10-13
First Post:
2011-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Care Study on Burn Patients
Sponsor:
Saint Elizabeth Regional Medical Center
Organization:
Study Overview
Official Title:
Oral Care Study on Burn Patients
Status:
WITHDRAWN
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: