Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT01310218
Status:
COMPLETED
Last Update Posted:
2011-03-08
First Post:
2011-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Length of Post Operative Dressing After Carpal Tunnel Release
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}], 'ancestors': [{'id': 'D020423', 'term': 'Median Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-04', 'studyFirstSubmitDate': '2011-02-23', 'studyFirstSubmitQcDate': '2011-03-04', 'lastUpdatePostDateStruct': {'date': '2011-03-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in Levine-Katz Scale assessed at different time points.', 'timeFrame': 'Levine-Katz Scale at baseline (pre-operation)', 'description': 'Symptom and function of Carpal Tunnel Syndrome'}, {'measure': 'Change in the Levine-Katz Scale from baseline(pre-operation) at 2 weeks', 'timeFrame': 'Baseline and two weeks.', 'description': 'Symptom and Function of Carpal Tunnel Syndrome'}, {'measure': 'Change in the Levine-Katz Scale from baseline(pre-operation) at 3 months', 'timeFrame': 'Baseline and three months.', 'description': 'Symptom and function of Carpal Tunnel Syndrome'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['orthopedics, carpal tunnel syndrome, postoperative care'], 'conditions': ['Carpal Tunnel Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to prospectively compare the functional, satisfaction, and wound outcomes of patients treated with one of two accepted methods of postoperative dressing following carpal tunnel release. Hypothesis: There will be no difference between the short term (approximately 2 - 3 days)and longer term (9 to 14 days)bulky dressing groups in terms of outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults\n* carpal tunnel syndrome\n\nExclusion Criteria:\n\n* previous surgery for Carpal Tunnel Syndrome\n* ipsilateral hand, arm, shoulder surgery with continued symptoms'}, 'identificationModule': {'nctId': 'NCT01310218', 'briefTitle': 'Length of Post Operative Dressing After Carpal Tunnel Release', 'organization': {'class': 'OTHER', 'fullName': 'UConn Health'}, 'officialTitle': 'Length of Postoperative Dressing After Mini-open Carpal Tunnel Release: A Randomized Prospective Comparison', 'orgStudyIdInfo': {'id': 'UCHC 09-158-1'}, 'secondaryIdInfos': [{'id': '185190', 'type': 'OTHER', 'domain': 'UCHC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'extended postoperative dressing', 'description': 'Bulky dressing for 2 weeks', 'interventionNames': ['Other: extended postoperative dressing']}, {'type': 'OTHER', 'label': 'short postoperative dressing', 'description': '2 day bulky dressing followed by bandaid.', 'interventionNames': ['Other: short postoperative dressing']}], 'interventions': [{'name': 'extended postoperative dressing', 'type': 'OTHER', 'description': '2 weeks of bulky dressing', 'armGroupLabels': ['extended postoperative dressing']}, {'name': 'short postoperative dressing', 'type': 'OTHER', 'description': '2 days bulky dressing followed by bandaid', 'armGroupLabels': ['short postoperative dressing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06030', 'city': 'Farmington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'University of Connecticut Health Center', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}], 'overallOfficials': [{'name': 'Craig Rodner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UConn Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UConn Health', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Craig Rodner MD', 'oldOrganization': 'Unniversity of Connecticut Health Center'}}}}