Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT04491656
Status:
COMPLETED
Last Update Posted:
2020-07-29
First Post:
2020-07-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating Clinical Outcomes for Determining the Optimal Delay to Skin Incision Under WALANT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-27', 'studyFirstSubmitDate': '2020-07-23', 'studyFirstSubmitQcDate': '2020-07-27', 'lastUpdatePostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Complications', 'timeFrame': '24 weeks', 'description': 'Complications which may occur during the course of treatment and subsequent follow up of the patients which includes: wound complications, infection, stiffness, pain'}], 'primaryOutcomes': [{'measure': 'VRS Score', 'timeFrame': '24 weeks', 'description': 'Verbal Rating Scale\n\n1. 0 for no pain\n2. 1 for mild pain\n3. 2 for moderate pain\n4. 3 for severe pain\n5. 4 for very severe pain'}], 'secondaryOutcomes': [{'measure': 'Blood Loss', 'timeFrame': '24 weeks', 'description': 'Blood loss estimation using Gauze Visual Analogue Scale by Algadiem et.al.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hand Surgery', 'Orthopedic Surgery']}, 'descriptionModule': {'briefSummary': 'Further studies are needed to establish the effects of WALANT in performing most common hand surgeries, in relation to its clinical outcomes and intraoperative blood loss. Therefore, this study aims to identify the best interval time to perform elective hand surgeries using WALANT technique, document clinical outcomes and identify potential complications', 'detailedDescription': 'To propose the optimal time delay from the injection to skin incision for most WALANT surgeries of the hand or wrist by analyzing not only intraoperative blood loss, but also postoperative pain scores and complication rates\n\nTo determine if there is a difference between performing the WALANT technique with a waiting interval of 7 minutes as compared to 30 minutes prior to incision in relation to blood loss, pain scores, and complications.\n\nInitiate the use of WALANT technique and its application in practice of Orthopaedic Residents in East Avenue Medical Center'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. . Signed Consent Form\n2. Elective Hand Surgeries\n3. Minor Hand Surgeries\n4. Adult Male/Female ages 18 and above\n5. Multiply injured\n\nExclusion Criteria:\n\n1. No Consent\n2. Multiply injured patient\n3. Traumatic Hand Injuries\n4. Known allergic reaction to either Epinephrine or Lidocaine.\n5. Known heart condition\n6. Patients on anticoagulants\n7. Patients diagnosed with bleeding disorders'}, 'identificationModule': {'nctId': 'NCT04491656', 'acronym': 'WALANT', 'briefTitle': 'Evaluating Clinical Outcomes for Determining the Optimal Delay to Skin Incision Under WALANT', 'organization': {'class': 'OTHER_GOV', 'fullName': 'East Avenue Medical Center, Philippines'}, 'officialTitle': 'Evaluating Clinical Outcomes for Determining the Optimal Delay to Skin Incision Under WALANT: a Prospective Series of 34 Patients From a Low Resource Tertiary Setting', 'orgStudyIdInfo': {'id': 'EAMC IERB 2020 - 03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '7 minutes group', 'description': 'surgeries performed with this group would wait 7 minutes after lidocaine+epinephrine injection prior to skin incision', 'interventionNames': ['Other: WALANT Technique']}, {'type': 'ACTIVE_COMPARATOR', 'label': '30 minutes group', 'description': 'surgeries performed with this group would wait 30 minutes after lidocaine+epinephrine injection prior to skin incision', 'interventionNames': ['Other: WALANT Technique']}], 'interventions': [{'name': 'WALANT Technique', 'type': 'OTHER', 'description': 'A technique commonly used in hand surgeries where the combination of lidocaine and epinephrine is used for local blood control, thus performing the procedure without a tourniquet', 'armGroupLabels': ['30 minutes group', '7 minutes group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Quezon City', 'country': 'Philippines', 'facility': 'East Avenue Medical Center; Department of Orthopedics', 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}], 'overallOfficials': [{'name': 'Mamer S. Rosario, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'East Avenue Medical Center, Department of Orthopedics'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'August 2020', 'ipdSharing': 'YES', 'description': 'Patient DATA will remain anonymous during the study and to be coded. Outcome measures for all participants will be documented'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'East Avenue Medical Center, Philippines', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alvin A. Hernandez', 'investigatorAffiliation': 'East Avenue Medical Center, Philippines'}}}}