Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT04992351
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2021-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Wide-awake Local Anesthesia and no Tourniquet (WALANT) in Plastic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'targetDuration': '8 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2021-07-13', 'studyFirstSubmitQcDate': '2021-07-27', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'total operation time', 'timeFrame': 'through operation completion', 'description': 'the difference between skin incision and skin closure in minutes'}, {'measure': 'operation theatre time', 'timeFrame': 'through operation completion with exit from the operation theatre', 'description': 'the difference between entry and exit of the patient from the operation theatre in minutes'}, {'measure': 'Patient satisfaction', 'timeFrame': 'at 8 weeks', 'description': 'estimated by a 10-point visual analogue scale (1-10, 10 is the best outcome)'}, {'measure': 'feasibility of the WALANT method', 'timeFrame': 'through operation completion', 'description': 'percentage of cases, which could not be completed under WALANT with conversion to the traditional method of anesthesia'}], 'secondaryOutcomes': [{'measure': 'complications', 'timeFrame': 'at 8 weeks', 'description': 'number and type of complications in each group'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['WALANT', 'plastic surgery', 'upper limb', 'lower limb'], 'conditions': ['Upper Limb Wound', 'Lower Limb Wound', 'Anesthesia, Local']}, 'descriptionModule': {'briefSummary': 'Wide-awake local anesthesia no tourniquet (WALANT) was proposed and performed in hand operations.\n\nAim of this study is to present the use of WALANT in operations performed on the upper and lower limbs, evaluate its efficacy in terms of feasibility, total operation time, total operating room time, bleeding, patient discomfort and satisfaction and control for potential drawbacks. The hypothesis is that WALANT is a viable option in common operations performed by plastic surgeons on the upper and lower limbs.', 'detailedDescription': 'Wide-awake local anesthesia no tourniquet (WALANT) was proposed and performed in hand operations. Little has been studied, regarding its indications and efficacy in general plastic surgery operations.\n\nAim of this study is to present the use of WALANT in operations performed on the upper and lower limbs, evaluate its efficacy in terms of feasibility, total operation time, total operating room time, bleeding, patient discomfort and satisfaction and control for potential drawbacks. The hypothesis is that WALANT is a viable option in common operations performed by plastic surgeons on the upper and lower limbs.\n\nA prospective study will be conducted comparing the use of WALANT in operations performed on the upper and lower limbs to the traditional use of tourniquet with general or regional anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients who undergo general plastic surgery operations in the upper or lower limb', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* upper or lower limb operation\n* indication for flap or skin grafting\n* operated by the principal investigator\n\nExclusion Criteria:\n\n* other concomitant operations performed\n* known allergy to any of the ingredients of local anesthesia mixture'}, 'identificationModule': {'nctId': 'NCT04992351', 'briefTitle': 'Wide-awake Local Anesthesia and no Tourniquet (WALANT) in Plastic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ioannina'}, 'officialTitle': 'Wide-awake Local Anesthesia and no Tourniquet (WALANT) in Plastic Surgery: Indications, Clinical Applications and Outcomes', 'orgStudyIdInfo': {'id': '11335'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'WALANT group', 'description': 'WALANT was used exclusively as anesthesia method for the operation', 'interventionNames': ['Procedure: WALANT']}, {'label': 'control', 'description': 'tourniquet with regional or general anesthesia was used for the operation', 'interventionNames': ['Procedure: WALANT']}], 'interventions': [{'name': 'WALANT', 'type': 'PROCEDURE', 'description': 'WALANT as anesthesia method for upper and lower limb palstic surgery operations', 'armGroupLabels': ['WALANT group', 'control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ioannina', 'country': 'Greece', 'facility': 'Plastic Surgery Department', 'geoPoint': {'lat': 39.66341, 'lon': 20.85187}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ioannina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ass. Professor of Plastic Surgery', 'investigatorFullName': 'Konstantinos Seretis', 'investigatorAffiliation': 'University Hospital, Ioannina'}}}}