Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT06267105
Status:
RECRUITING
Last Update Posted:
2024-08-15
First Post:
2024-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Study to Compare Functional Outcomes After Surgery Using a Transverse or Longitudinal Surgical Incision in the Skin.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-13', 'studyFirstSubmitDate': '2024-01-31', 'studyFirstSubmitQcDate': '2024-02-16', 'lastUpdatePostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional improvement of the patient after surgery', 'timeFrame': 'Immediately after surgery', 'description': 'functional improvement of the patient after surgery, which will be assessed with the Dash scale, 1 being difficult while 5 being unable'}], 'secondaryOutcomes': [{'measure': 'Surgeon comfort', 'timeFrame': 'Immediately after surgery', 'description': 'Ecellent, good, poor'}, {'measure': 'Resolution', 'timeFrame': '1, 3 and 6 months', 'description': 'Presence or absence of engagment'}, {'measure': 'Flushed', 'timeFrame': '1, 3 and 6 months', 'description': 'Red or not red'}, {'measure': 'Pain feeling', 'timeFrame': '1, 3 and 6 months', 'description': 'EVA scale from 0 to 10, being 10 a lot of pain'}, {'measure': 'Contracture', 'timeFrame': '1, 3 and 6 months', 'description': 'Range of motion in degrees'}, {'measure': 'Infection', 'timeFrame': '1, 3 and 6 months', 'description': 'Septic signs such the area is red, hot, swelling or has drain pus'}, {'measure': 'Nerve injury', 'timeFrame': '1, 3 and 6 months', 'description': 'Allen test to evaluate correct circulation, the hand should turn white when pressing'}, {'measure': 'Return to work', 'timeFrame': '1, 3 and 6 months', 'description': 'How many weeks after surgery'}, {'measure': 'Reincorporation to activities', 'timeFrame': '1, 3 and 6 months', 'description': 'How many weeks after surgery'}, {'measure': 'Sensitivity Test', 'timeFrame': '1, 3 and 6 months', 'description': 'In a scale from 0 to 10'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Functional Disturbance as Result']}, 'referencesModule': {'references': [{'pmid': '30852960', 'type': 'BACKGROUND', 'citation': 'Mohd Rashid MZ, Sapuan J, Abdullah S. A randomized controlled trial of trigger finger release under digital anesthesia with (WALANT) and without adrenaline. J Orthop Surg (Hong Kong). 2019 Jan-Apr;27(1):2309499019833002. doi: 10.1177/2309499019833002.'}, {'pmid': '31272265', 'type': 'BACKGROUND', 'citation': 'Kazmers NH, Holt D, Tyser AR, Wang A, Hutchinson DT. A prospective, randomized clinical trial of transverse versus longitudinal incisions for trigger finger release. J Hand Surg Eur Vol. 2019 Oct;44(8):810-815. doi: 10.1177/1753193419859375. Epub 2019 Jul 4.'}, {'pmid': '26926477', 'type': 'BACKGROUND', 'citation': 'Kloeters O, Ulrich DJ, Bloemsma G, van Houdt CI. Comparison of three different incision techniques in A1 pulley release on scar tissue formation and postoperative rehabilitation. Arch Orthop Trauma Surg. 2016 May;136(5):731-7. doi: 10.1007/s00402-016-2430-z. Epub 2016 Feb 29.'}]}, 'descriptionModule': {'briefSummary': 'Trigger finger is a common pathology in the hand. Patients suffer from pain and depending on which tasks, patients have difficulty to perform them. Its treatment in initial and less serious phases includes conservative measures, but failure of these may require releasing the trigger finger with surgery. The surgical technique performed for trigger finger is the opening of the A1 pulley, the skin incisions used for this surgery are various (transverse, longitudinal, oblique). Trigger finger surgery presents good results in terms of resolution, but complications may also occur. The reason for this study is to assess whether there are functional differences using the Dash scale when we perform a transverse or longitudinal incision in trigger finger surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients over 18 years of age.\n* Clinical diagnosis of trigger finger grade II to IV.\n\nGrade I (pre-trigger) Pain, history of entrapment, but not demonstrable on physical examination, tenderness over the A1 pulley.\n\nGrade II (active) Demonstrable entrapment, but the patient can actively extend the finger.\n\nGrade III (passive) Demonstrable entrapment, patient requires passive extension IIIA or inability to actively flex IIIB.\n\nGrade IV (contracture) Demonstrable entrapment with fixed flexion contracture of the PIP.\n\nExclusion Criteria:\n\n* Thumb\n* Polydigital\n* Allergy to local anesthetics and/or vasoconstrictor agents.\n* Previous surgery\n* Patients who, in the researcher's opinion, are not good candidates for the study (e.g. inability to comply with the follow-up program, comorbidity, poor physical or mental health in general, drug or alcohol abuse problems...)."}, 'identificationModule': {'nctId': 'NCT06267105', 'briefTitle': 'A Clinical Study to Compare Functional Outcomes After Surgery Using a Transverse or Longitudinal Surgical Incision in the Skin.', 'organization': {'class': 'OTHER', 'fullName': 'Corporacion Parc Tauli'}, 'officialTitle': 'Clinical Study to Compare Functional Results in Patients Affected by Trigger Finger When Surgery is Performed Through a Transverse or Longitudinal Surgical Incision in the Skin.', 'orgStudyIdInfo': {'id': 'A1-LORT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Longitudinal incision', 'description': 'Incision performed longitudinally', 'interventionNames': ['Procedure: Longitudinal incision']}, {'type': 'EXPERIMENTAL', 'label': 'Transverse incision', 'description': 'Incision performed transversally', 'interventionNames': ['Procedure: Transverse incision']}], 'interventions': [{'name': 'Longitudinal incision', 'type': 'PROCEDURE', 'description': 'Incision performed longitudinally', 'armGroupLabels': ['Longitudinal incision']}, {'name': 'Transverse incision', 'type': 'PROCEDURE', 'description': 'Incision performed transversally', 'armGroupLabels': ['Transverse incision']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08208', 'city': 'Sabadell', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Mireia', 'role': 'CONTACT', 'phoneExt': '21660'}], 'facility': 'Hospital Parc taulí', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}], 'centralContacts': [{'name': 'Mireia Vinas', 'role': 'CONTACT', 'email': 'mmvinas@tauli.cat', 'phone': '+34 93 723 10 10', 'phoneExt': '21652'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corporacion Parc Tauli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Corona Poy', 'investigatorAffiliation': 'Corporacion Parc Tauli'}}}}