Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 11:15 PM
Study NCT ID:
NCT05441293
Status:
COMPLETED
Last Update Posted:
2022-07-01
First Post:
2022-06-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Determinants of the Success of Flap Reconstruction: Outcome Analysis of 484 Surgeries for Pressure Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003668', 'term': 'Pressure Ulcer'}], 'ancestors': [{'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 484}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-28', 'studyFirstSubmitDate': '2022-06-28', 'studyFirstSubmitQcDate': '2022-06-28', 'lastUpdatePostDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete wound healing', 'timeFrame': 'from January 2016 to December 2021', 'description': 'no presentation of wound drainage or wound dehiscence at the surgical site 14 days after drainage tube removal.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pressure Injury']}, 'descriptionModule': {'briefSummary': "Background: Pressure injury (PI) mainly occurs in bedridden older adults or those with physical limitations. PI treatment is typically long-term, requiring coordination between health-care workers and the patient's caregiver. Here, we aimed to determine the appropriate timing to conduct flap reconstruction in patients with PIs and identify factors affecting surgical outcomes.\n\nMaterials and Methods: We retrospectively reviewed the data of all patients who received debridement or flap reconstruction surgery for PIs in our hospital from January 2016 to December 2021. The extracted data included patient demographics, surgical records, blood test results, vital signs, and flap outcomes. Next, these characteristics including the flap outcomes of our patients with PIs were analyzed, along with the risk factors for poor wound healing and complications."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all patients who received debridement or flap reconstruction surgery for Pressure injury in Wan Fang Hospital from January 2016 to December 2021', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nall patients who received debridement or flap reconstruction surgery for Pressure injury in Wan Fang Hospital from January 2016 to December 2021\n\nExclusion Criteria:\n\nthe patients who did not received debridement or flap reconstruction surgery for Pressure injury'}, 'identificationModule': {'nctId': 'NCT05441293', 'briefTitle': 'Determinants of the Success of Flap Reconstruction: Outcome Analysis of 484 Surgeries for Pressure Injury', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University WanFang Hospital'}, 'officialTitle': 'b Division of Plastic Surgery, Department of Surgery, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan', 'orgStudyIdInfo': {'id': 'WanFangW2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'debridements group', 'description': 'During study peroid, the patient who received debridement surgery for pressure injury', 'interventionNames': ['Procedure: flap reconstruction']}, {'label': 'flap reconstructions group', 'description': 'During study peroid, the patient who received flap reconstruction surgery for pressure injury', 'interventionNames': ['Procedure: flap reconstruction']}], 'interventions': [{'name': 'flap reconstruction', 'type': 'PROCEDURE', 'description': 'received flap reconstruction over sacrum, back, trochanter, ischium, elbow, and lower extremities', 'armGroupLabels': ['debridements group', 'flap reconstructions group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'the data are not available for sharing.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University WanFang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}