Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-30 @ 12:31 AM
Study NCT ID:
NCT00645957
Status:
COMPLETED
Last Update Posted:
2013-11-21
First Post:
2008-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of Redrubber Versus Penrose Drains
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-19', 'studyFirstSubmitDate': '2008-03-05', 'studyFirstSubmitQcDate': '2008-03-25', 'lastUpdatePostDateStruct': {'date': '2013-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resolution of infection', 'timeFrame': 'several days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['drainage', 'irrigation'], 'conditions': ['Odontogenic Infection']}, 'descriptionModule': {'briefSummary': 'All patients presenting to Grady Memorial Hospital with an odontogenic (dental) infection that requires admission to the hospital and incision and drainage will be eligible for inclusion in this pilot study. The surgical method used for incision and drainage will be determined by the attending surgeon who will operate on the patient. The surgical procedure is a simple and universally standardized involving one or more small incisions in the mouth or in the upper neck and the placement of a drain(s) within the infected area to facilitate continued drainage of pus. Subjects will be randomized to either a red rubber or penrose drain(s). The drains are placed through the mouth or upper neck depending on the location of the infection and typically remain in place until the drainage has stopped (several days). All drains are secured with a single stitch through the gum or skin. The drain(s) will be removed bedside by removing a single suture and gently withdrawing the drain. The timing of this is determined by the clinical picture although this typically occurs within the first week. This is not a painful procedure. Currently some surgeons place red rubber drains which, after placement, allow the infection not only to drain but also be irrigated with saline both during the surgery and in the immediate post-operative period. Other surgeons place penrose drains, which, after placement, continue to allow the infection to drain but cannot be irrigated. Red rubber drains require daily irrigation and as such are labor intensive. Furthermore, drains that are irrigated may continue to drain the saline irrigant in the many hours after irrigation that upon clinical inspection may be difficult to distinguish from sero-sanguinous (pus) drainage. It is daily inspection of the drainage (or lack thereof) which determines the appropriate time to remove the drain(s). This in turn may influence time to discharge and ultimately hospital costs'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 16 and older\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT00645957', 'acronym': 'redrubber', 'briefTitle': 'A Comparison of Redrubber Versus Penrose Drains', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'A Comparison of Redrubber Versus Penrose Drains in the Management of Odontogenic (Dental) Infections', 'orgStudyIdInfo': {'id': 'IRB00006249'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'This group will have a red rubber drain(s) placed during surgery. This drain(s) will be irrigated intra and post-operatively', 'interventionNames': ['Procedure: red rubber drain']}, {'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'This group will have a penrose drain(s) placed during surgery to facilitate drainage post-operatively. This drain (s) will not be irrigated.', 'interventionNames': ['Procedure: penrose drain']}], 'interventions': [{'name': 'penrose drain', 'type': 'PROCEDURE', 'description': 'incision and drainage of the infection with placement of a penrose drain', 'armGroupLabels': ['1']}, {'name': 'red rubber drain', 'type': 'PROCEDURE', 'description': 'incision and drainage of infection and placement of a red rubber drain', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Grady Memorial Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gary F Bouloux MD, DDS, MDSc, FRACDS, FRACDS', 'investigatorAffiliation': 'Emory University'}}}}