Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2025-12-26 @ 3:37 AM
Study NCT ID:
NCT01301118
Status:
SUSPENDED
Last Update Posted:
2012-01-10
First Post:
2011-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Graft Take and Microbiology in Burns
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil']}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'whyStopped': 'Technical problems with protocol.', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'lastUpdateSubmitDate': '2012-01-07', 'studyFirstSubmitDate': '2011-02-22', 'studyFirstSubmitQcDate': '2011-02-22', 'lastUpdatePostDateStruct': {'date': '2012-01-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-23', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Transplantation Infection', 'Wound of skin', 'Burns', 'Graft Loss', 'Infection'], 'conditions': ['Transplantation Infection', 'Wound of Skin', 'Burns', 'Graft Loss', 'Infection']}, 'descriptionModule': {'briefSummary': "SPLIT-THICKNESS SKIN GRAFT TAKE AND MICROBIOLOGICAL EVALUATION IN BURNED PATIENTS\n\nINTRODUCTION: Infection is cause of increased morbidity and mortality in burn patients, and its control is a major challenge also for skin graft integration. Wound and soft tissue infection rates are higher than microbiological diagnosis rates.\n\nPURPOSE: To evaluate partial skin graft integration in relation to microbiological analysis of wounds in burn patients.\n\nMETHODS: This project will be a transversal, prospective, analytical, controlled study in humans, conducted in a single center, at Burn Care Unit of Department of Plastic Surgery at Federal University of São Paulo from October, 2010 to October, 2011. Data will be collected to characterize demographic and clinical aspects. Data analysis will be performed using Student's t-test and Friedman analysis of variance.", 'detailedDescription': "SPLIT-THICKNESS SKIN GRAFT TAKE AND MICROBIOLOGICAL EVALUATION IN BURNED PATIENTS\n\nINTRODUCTION: Early excision and partial skin graft is state-of-the-art in burns treatment. Otherwise, infection is cause of increased morbidity and mortality in burn patients, and its control is a major challenge also for skin graft integration. Wound and soft tissue infection rates are higher than microbiological diagnosis rates. This difference is related to moderate sensibility of cultures in general. Precise bacterial diagnostic and its susceptibility to specific antibiotics are prerequisite for adequate treatment of burn patients and skin graft integration.\n\nPURPOSE: To evaluate partial skin graft integration in relation to microbiological analysis of wounds in burn patients.\n\nMETHODS: This project was approved at Ethics Committee at Federal University of São Paulo (1272/10). It will be a transversal, prospective, analytical, controlled study in humans, conducted in a single center, at Burn Care Unit of Department of Plastic Surgery at Federal University of São Paulo from October, 2010 to October, 2011. Thirty patients will be included in this study after reading and signing a consent form. Data will be collected using an evaluation sheet to characterize demographic and clinical aspects, including partial skin graft integration, use of topical and systemic antibiotics and infection rates in all sites (blood, urine, skin, tracheal aspirate and bronchial lavage). Data analysis will be performed using Student's t-test and Friedman analysis of variance."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ACUTE BURNED PATIENTS', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both gender\n* More than 18 years of age\n* Burned patient\n* Inpatient of Burn Center of Federal University of São Paulo\n* Upper 5% of TBSA\n* Debridement and skin graft indication and procedure realization\n\nExclusion Criteria:\n\n* Not interest in participating in research\n* Not have debridement or graft indication\n* Under 5% of TBSA\n* Skin disease\n* Clinical disease that contraindication procedure\n* Clinical disease that directly interferes with infectious process and wound healing'}, 'identificationModule': {'nctId': 'NCT01301118', 'briefTitle': 'Graft Take and Microbiology in Burns', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'Split Thickness Skin Graft Take and Microbiology Evaluation in Burned Patients', 'orgStudyIdInfo': {'id': 'Graft take in burns'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'ALFREDO GRAGNANI, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UFSaoPaulo'}, {'name': 'LYDIA M FERREIRA, MD Full Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'UFSaoPaulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated Professor', 'investigatorFullName': 'ALFREDO GRAGNANI FILHO', 'investigatorAffiliation': 'Federal University of São Paulo'}}}}