Oral Care Study on Burn Patients

NCT01302457 | Withdrawn

• 1 other identifier: 609-036
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Burn

Keywords

Thermal Burn Trauma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients age must be 19 and older.
• Patients must be on a ventilator in the burn or intensive care unit.
• 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.

You may not qualify if:

• Unable to complete Informed Consent Process

Sponsors & Collaborators

• Saint Elizabeth Regional Medical Center: lead

Study Sites (1)

Saint Elizabeth Regional Medical Center

Lincoln, Nebraska, 68510, United States

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Brian Burgess, D.D.S.

  Saint Elizabeth Regional Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 9, 2011
• First Posted: February 24, 2011
• Study Start: September 1, 2007
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2013
• Last Updated: October 13, 2016

Record last verified: 2016-10

Locations

US (1)