Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-01-01 @ 3:20 AM
Study NCT ID:
NCT04231305
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2020-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antithrombotics and Complications in Skin Grafts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 172}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-14', 'studyFirstSubmitDate': '2020-01-14', 'studyFirstSubmitQcDate': '2020-01-14', 'lastUpdatePostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative bleeding', 'timeFrame': '5-7 postoperative day'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Skin Graft Complications']}, 'descriptionModule': {'briefSummary': 'Patients who were referred to cutaneous surgery and needed full thickness or split skin grafting and using antitrombotic or non-antitrombotic therapies were observed. Data on patient characteristics, diagnosis, location of surgery and surgery performed, antithrombotic medication and complications in skin grafts were collected. Skin grafts were traced on a transparent film and areas of unhealed skin graft were marked', 'detailedDescription': 'Use of anticoagulants is common and practice regarding continuation or discontinuation of the medication peri-operatively for cutaneous surgery lacks evidence-based consensus. Therefore, patients who were referred to cutaneous surgery and needed full thickness or split skin grafting and using antitrombotic or non-antitrombotic therapies were observed. Data on patient characteristics, diagnosis, location of surgery and surgery performed, antithrombotic medication and complications in skin grafts were collected. Skin grafts were traced on a transparent film and areas of unhealed skin graft were marked'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 172 patients (92 males and 80 females) having 187 skin grafts were included. Avarage size of the skin grafts were 1278 mm2 ranging from 52mm2 to 14283mm2. Skin grafts where the patients received no or paused antithrombotic treatment were 90 while 97 skin grafts belonged to patients in antithrombotic treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients referred to cutanous surgery with full thickness or split skin grafting. The excision should be performed on the levels of subcutis or perichondrium -\n\nExclusion Criteria:\n\nPatients having a pacemaker, needed skin graft on bare bone and patients with an INR above 3.5\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04231305', 'briefTitle': 'Antithrombotics and Complications in Skin Grafts', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University Hospital'}, 'officialTitle': 'Complications in Skin Grafts When Continuing Antithrombotic Therapy Prior to Cutaneous Surgery Requiring Skin Grafting: an Observational Study', 'orgStudyIdInfo': {'id': '2019-29-12'}}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Aalborg University Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}], 'overallOfficials': [{'name': 'Lene Birk-Sørensen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aalborg University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aalborg University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Post Doc in Clinical Nursing', 'investigatorFullName': 'Lene Birk-Sørensen', 'investigatorAffiliation': 'Aalborg University Hospital'}}}}