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WITHDRAWN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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-12', 'studyFirstSubmitDate': '2011-02-09', 'studyFirstSubmitQcDate': '2011-02-18', 'lastUpdatePostDateStruct': {'date': '2016-10-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Patient's Oral Condition", 'timeFrame': '30 days', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Thermal Burn Trauma'], 'conditions': ['Burn']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nOJECTIVE 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.\n\nPATIENT SELECTION CRITERIA\n\n1. Patients age must be 19 and older.\n2. Patients must be on a ventilator in the burn or intensive care unit.\n3. The control group will be 19 years or older and be randomly picked from from volunteer staff at Saint Elizabeth Regional Medical Center.\n\nDESIGN 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"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'PATIENT SELECTION CRITERIA\n\n1. Patients age must be 19 and older.\n2. Patients must be on a ventilator in the burn or intensive care unit.\n3. The control group will be 19 years or older and be randomly picked from volunteer staff at Saint Elizabeth Regional Medical Center.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:PATIENT SELECTION CRITERIA\n\n1. Patients age must be 19 and older.\n2. Patients must be on a ventilator in the burn or intensive care unit.\n3. 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.\n\nExclusion Criteria:\n\n* Unable to complete Informed Consent Process'}, 'identificationModule': {'nctId': 'NCT01302457', 'briefTitle': 'Oral Care Study on Burn Patients', 'organization': {'class': 'OTHER', 'fullName': 'Saint Elizabeth Regional Medical Center'}, 'officialTitle': 'Oral Care Study on Burn Patients', 'orgStudyIdInfo': {'id': '609-036'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Same Subjects', 'description': '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'}, {'label': 'Health Volunteers', 'description': 'The control group will be 19 years or older and be randomly picked from volunteer staff at Saint Elizabeth Regional Medical Center.\n\nDESIGN 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'}]}, 'contactsLocationsModule': {'locations': [{'zip': '68510', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Saint Elizabeth Regional Medical Center', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}], 'overallOfficials': [{'name': 'Brian Burgess, D.D.S.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saint Elizabeth Regional Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saint Elizabeth Regional Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Saint Elizabeth Regional Medical Center', 'oldOrganization': 'Saint Elizabeth Regional Medical Center'}}}}