Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 8:39 AM
Study NCT ID:
NCT01017094
Status:
COMPLETED
Last Update Posted:
2009-11-20
First Post:
2009-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pin Site Infection Prevention for Open Tibial Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013978', 'term': 'Tibial Fractures'}, {'id': 'D005597', 'term': 'Fractures, Open'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-11-19', 'studyFirstSubmitDate': '2009-11-17', 'studyFirstSubmitQcDate': '2009-11-19', 'lastUpdatePostDateStruct': {'date': '2009-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of pin site infection', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'type of organism', 'timeFrame': '2 years'}, {'measure': 'severity of pin site infection', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pin-site infection', 'silversulfadiazine', 'open fracture', 'open tibial fracture underwent external fixator'], 'conditions': ['Tibial Fracture']}, 'descriptionModule': {'briefSummary': 'This study aimed to compare the efficacy of pin-tract infection prevention between silversulfadiazine and dry dressing.\n\nMethods: 30 patients with an open tibial fracture admitted to Songklanagarind hospital from September 2007 to June 2008 and treated by emergency debridement and external fixation were randomized into two groups, one treated with silversulfadiazine for infection prophylaxis (15) and a control group treated with dry dressing only (15). All patients were followed until the external fixator was removed. Pin-site infections were assessed and graded at each follow-up visit by an orthopaedist blinded to the mode of treatment. A culture from the pin site was done if an infection occurred.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Open tibial fracture treated with external fixator age between 15-60 years\n\nExclusion Criteria:\n\n* Immunocompromised patients (diabetes, HIV or malignancy)'}, 'identificationModule': {'nctId': 'NCT01017094', 'briefTitle': 'Pin Site Infection Prevention for Open Tibial Fracture', 'organization': {'class': 'OTHER', 'fullName': 'Prince of Songkla University'}, 'officialTitle': 'Can Silversulfadiazine Prevent Pin-site Infection in Open Tibial Fracture?: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'EC 50/369-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dry dressing', 'description': 'local application', 'interventionNames': ['Drug: silversulfadiazine']}], 'interventions': [{'name': 'silversulfadiazine', 'type': 'DRUG', 'description': 'apply once a day', 'armGroupLabels': ['dry dressing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90110', 'city': 'Hat Yai', 'state': 'Changwat Songkhla', 'country': 'Thailand', 'facility': 'Prince of Songkla University', 'geoPoint': {'lat': 7.00836, 'lon': 100.47668}}], 'overallOfficials': [{'name': 'Boonsin Tangtrakulwanich, MD.,Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine, Prince of Songkla University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prince of Songkla University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Secretariate,Department of Orthopaedic Surgery', 'oldOrganization': 'Faculty of Medicine, Prince of Songkla University'}}}}