Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT03432858
Status:
COMPLETED
Last Update Posted:
2021-11-10
First Post:
2018-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Preoperative Antibiotics for Carpal Tunnel Release Surgery
Sponsor:
Organization:
Raw JSON
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'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cbush@wellspan.org', 'phone': '(717) 851-7634', 'title': 'Clinical Research Associate', 'organization': 'WellSpan Health'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 weeks post procedure', 'eventGroups': [{'id': 'EG000', 'title': 'Active Comparator 1', 'description': 'Vancomycin: 1-gram dosing', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Active Comparator 2', 'description': 'Cefazolin: 2-gram dosing for patients \\<120 kg 3-gram dosing for patients 120 kg or greater', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 0, 'seriousNumAtRisk': 72, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Saline Solution: Placebo', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 2, 'seriousNumAtRisk': 72, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pyogenic granuloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Postoperative splinting', 'notes': 'Subject experienced wrist pain unrelated to wound or procedure.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Surgical Site Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Comparator 1', 'description': 'Vancomycin: 1-gram dosing'}, {'id': 'OG001', 'title': 'Active Comparator 2', 'description': 'Cefazolin: 2-gram dosing for patients \\<120 kg 3-gram dosing for patients 120 kg or greater'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Saline Solution: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 weeks post-operative', 'description': 'Definitive diagnosis of infection of surgical site -wounds determined to be infected will be divided into superficial or deep infections and treated according to the standard of care at WellSpan health.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Surgical Site Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Comparator 1', 'description': 'Vancomycin: 1-gram dosing'}, {'id': 'OG001', 'title': 'Active Comparator 2', 'description': 'Cefazolin: 2-gram dosing for patients \\<120 kg 3-gram dosing for patients 120 kg or greater'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Saline Solution: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks post-operative', 'description': 'Definitive diagnosis of infection of surgical site -Definitive diagnosis of infection of surgical site -wounds determined to be infected will be divided into superficial or deep infections and treated according to the standard of care at WellSpan health.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Diabetes Diagnosis and Surgical Site Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Comparator 1', 'description': 'Vancomycin: 1-gram dosing'}, {'id': 'OG001', 'title': 'Active Comparator 2', 'description': 'Cefazolin: 2-gram dosing for patients \\<120 kg 3-gram dosing for patients 120 kg or greater'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Saline Solution: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 weeks post-operative', 'description': 'Number of patients with surgical site infection that have diabetes', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Diabetes Diagnosis and Surgical Site Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Comparator 1', 'description': 'Vancomycin: 1-gram dosing'}, {'id': 'OG001', 'title': 'Active Comparator 2', 'description': 'Cefazolin: 2-gram dosing for patients \\<120 kg 3-gram dosing for patients 120 kg or greater'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Saline Solution: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks post-operative', 'description': 'Number of patients with surgical site infection that have diabetes', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Surgical Site Infections That Use Tobacco', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Comparator 1', 'description': 'Vancomycin: 1-gram dosing'}, {'id': 'OG001', 'title': 'Active Comparator 2', 'description': 'Cefazolin: 2-gram dosing for patients \\<120 kg 3-gram dosing for patients 120 kg or greater'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Saline Solution: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 weeks post-operative', 'description': 'Number of patients with surgical site infections that use tobacco products', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Surgical Site Infections That Use Tobacco', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Comparator 1', 'description': 'Vancomycin: 1-gram dosing'}, {'id': 'OG001', 'title': 'Active Comparator 2', 'description': 'Cefazolin: 2-gram dosing for patients \\<120 kg 3-gram dosing for patients 120 kg or greater'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Saline Solution: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks post-operative', 'description': 'Number of patients with surgical site infections that use tobacco products', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Chronic Obstructive Pulmonary Disease Diagnosis and Surgical Site Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Comparator 1', 'description': 'Vancomycin: 1-gram dosing'}, {'id': 'OG001', 'title': 'Active Comparator 2', 'description': 'Cefazolin: 2-gram dosing for patients \\<120 kg 3-gram dosing for patients 120 kg or greater'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Saline Solution: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 weeks post-operative', 'description': 'Number of patients with surgical site infections that have chronic obstructive pulmonary disease', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Chronic Obstructive Pulmonary Disease Diagnosis and Surgical Site Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Comparator 1', 'description': 'Vancomycin: 1-gram dosing'}, {'id': 'OG001', 'title': 'Active Comparator 2', 'description': 'Cefazolin: 2-gram dosing for patients \\<120 kg 3-gram dosing for patients 120 kg or greater'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Saline Solution: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks post-operative', 'description': 'Number of patients with surgical site infections that have chronic obstructive pulmonary disease', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anemia Diagnosis and Surgical Site Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Comparator 1', 'description': 'Vancomycin: 1-gram dosing'}, {'id': 'OG001', 'title': 'Active Comparator 2', 'description': 'Cefazolin: 2-gram dosing for patients \\<120 kg 3-gram dosing for patients 120 kg or greater'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Saline Solution: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 weeks post-operative', 'description': 'Number of patients with surgical site infections that have anemia', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anemia Diagnosis and Surgical Site Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Comparator 1', 'description': 'Vancomycin: 1-gram dosing'}, {'id': 'OG001', 'title': 'Active Comparator 2', 'description': 'Cefazolin: 2-gram dosing for patients \\<120 kg 3-gram dosing for patients 120 kg or greater'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Saline Solution: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks post-operative', 'description': 'Number of patients with surgical site infections that have anemia', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Comparator 1', 'description': 'Vancomycin: 1-gram dosing'}, {'id': 'OG001', 'title': 'Active Comparator 2', 'description': 'Cefazolin: 2-gram dosing for patients \\<120 kg 3-gram dosing for patients 120 kg or greater'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Saline Solution: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 weeks post-operative', 'description': 'Number of patients with surgical site infections that have peripheral artery disease', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Comparator 1', 'description': 'Vancomycin: 1-gram dosing'}, {'id': 'OG001', 'title': 'Active Comparator 2', 'description': 'Cefazolin: 2-gram dosing for patients \\<120 kg 3-gram dosing for patients 120 kg or greater'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Saline Solution: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks post-operative', 'description': 'Number of patients with surgical site infections that have peripheral artery disease', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Surgical Site Infection and a History of Arthroplasty', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Comparator 1', 'description': 'Vancomycin: 1-gram dosing'}, {'id': 'OG001', 'title': 'Active Comparator 2', 'description': 'Cefazolin: 2-gram dosing for patients \\<120 kg 3-gram dosing for patients 120 kg or greater'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Saline Solution: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 weeks post-operative', 'description': 'Number of patients with surgical site infections with history of arthroplasty', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Surgical Site Infection and History of Arthroplasty', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Comparator 1', 'description': 'Vancomycin: 1-gram dosing'}, {'id': 'OG001', 'title': 'Active Comparator 2', 'description': 'Cefazolin: 2-gram dosing for patients \\<120 kg 3-gram dosing for patients 120 kg or greater'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Saline Solution: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks post-operative', 'description': 'Number of patients with surgical site infections with history of arthroplasty', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Comparator 1', 'description': 'Vancomycin: 1-gram dosing'}, {'id': 'OG001', 'title': 'Active Comparator 2', 'description': 'Cefazolin: 2-gram dosing for patients \\<120 kg 3-gram dosing for patients 120 kg or greater'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Saline Solution: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 weeks post-operative', 'description': 'Number of patients with surgical site infections with valvular disease', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Comparator 1', 'description': 'Vancomycin: 1-gram dosing'}, {'id': 'OG001', 'title': 'Active Comparator 2', 'description': 'Cefazolin: 2-gram dosing for patients \\<120 kg 3-gram dosing for patients 120 kg or greater'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Saline Solution: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks post-operative', 'description': 'Number of patients with surgical site infections with valvular disease', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Surgical Site Infection That Underwent Single Incision Endoscopic Carpal Tunnel Release', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Comparator 1', 'description': 'Vancomycin: 1-gram dosing'}, {'id': 'OG001', 'title': 'Active Comparator 2', 'description': 'Cefazolin: 2-gram dosing for patients \\<120 kg 3-gram dosing for patients 120 kg or greater'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Saline Solution: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 weeks post-operative', 'description': 'Number of patients with surgical site infections with single incision ECTR', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Surgical Site Infection That Underwent Single Incision Endoscopic Carpal Tunnel Release', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Comparator 1', 'description': 'Vancomycin: 1-gram dosing'}, {'id': 'OG001', 'title': 'Active Comparator 2', 'description': 'Cefazolin: 2-gram dosing for patients \\<120 kg 3-gram dosing for patients 120 kg or greater'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Saline Solution: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks post-operative', 'description': 'Number of patients with surgical site infections with single incision ECTR', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Surgical Site Infection That Underwent Double Incision Endoscopic Carpal Tunnel Release', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Comparator 1', 'description': 'Vancomycin: 1-gram dosing'}, {'id': 'OG001', 'title': 'Active Comparator 2', 'description': 'Cefazolin: 2-gram dosing for patients \\<120 kg 3-gram dosing for patients 120 kg or greater'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Saline Solution: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 weeks post-operative', 'description': 'Number of patients with surgical site infections with double incision ECTR', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Surgical Site Infection That Underwent Double Incision Endoscopic Carpal Tunnel Release', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Comparator 1', 'description': 'Vancomycin: 1-gram dosing'}, {'id': 'OG001', 'title': 'Active Comparator 2', 'description': 'Cefazolin: 2-gram dosing for patients \\<120 kg 3-gram dosing for patients 120 kg or greater'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Saline Solution: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks post-operative', 'description': 'Number of patients with surgical site infections with double incision ECTR', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time From Last Cortisone Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Comparator 1', 'description': 'Vancomycin: 1-gram dosing'}, {'id': 'OG001', 'title': 'Active Comparator 2', 'description': 'Cefazolin: 2-gram dosing for patients \\<120 kg 3-gram dosing for patients 120 kg or greater'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Saline Solution: Placebo'}], 'timeFrame': '2 weeks post-operative', 'description': 'For patients sustaining surgical site infection, the time from their last cortisone injection', 'reportingStatus': 'POSTED', 'populationDescription': 'No patients sustained surgical site infections and data were not collected for this Outcome Measure.'}, {'type': 'SECONDARY', 'title': 'Time From Last Cortisone Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Comparator 1', 'description': 'Vancomycin: 1-gram dosing'}, {'id': 'OG001', 'title': 'Active Comparator 2', 'description': 'Cefazolin: 2-gram dosing for patients \\<120 kg 3-gram dosing for patients 120 kg or greater'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Saline Solution: Placebo'}], 'timeFrame': '6 weeks post-operative', 'description': 'For patients sustaining surgical site infection, the time from their last cortisone injection', 'reportingStatus': 'POSTED', 'populationDescription': 'No patients sustained surgical site infections and data were not collected for this Outcome Measure.'}, {'type': 'SECONDARY', 'title': 'Acuity of Carpal Tunnel Syndrome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Comparator 1', 'description': 'Vancomycin: 1-gram dosing'}, {'id': 'OG001', 'title': 'Active Comparator 2', 'description': 'Cefazolin: 2-gram dosing for patients \\<120 kg 3-gram dosing for patients 120 kg or greater'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Saline Solution: Placebo'}], 'timeFrame': '2 weeks post-operative', 'description': 'For patients sustaining surgical site infection, the acuity of their carpal tunnel syndrome', 'reportingStatus': 'POSTED', 'populationDescription': 'No patients sustained surgical site infections and data were not collected for this Outcome Measure.'}, {'type': 'SECONDARY', 'title': 'Acuity of Carpal Tunnel Syndrome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Comparator 1', 'description': 'Vancomycin: 1-gram dosing'}, {'id': 'OG001', 'title': 'Active Comparator 2', 'description': 'Cefazolin: 2-gram dosing for patients \\<120 kg 3-gram dosing for patients 120 kg or greater'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Saline Solution: Placebo'}], 'timeFrame': '6 weeks post-operative', 'description': 'For patients sustaining surgical site infection, the acuity of their carpal tunnel syndrome', 'reportingStatus': 'POSTED', 'populationDescription': 'No patients sustained surgical site infections and data were not collected for this Outcome Measure'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active Comparator 1', 'description': 'Vancomycin: 1-gram dosing'}, {'id': 'FG001', 'title': 'Active Comparator 2', 'description': 'Cefazolin: 2-gram dosing for patients \\<120 kg 3-gram dosing for patients 120 kg or greater'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Saline Solution: Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '83'}, {'groupId': 'FG002', 'numSubjects': '89'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '72'}, {'groupId': 'FG002', 'numSubjects': '72'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Procedure canceled/rescheduled', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Required postop mobilization with splinting', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '154', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Active Comparator 1', 'description': 'Vancomycin: 1-gram dosing'}, {'id': 'BG001', 'title': 'Active Comparator 2', 'description': 'Cefazolin: 2-gram dosing for patients \\<120 kg 3-gram dosing for patients 120 kg or greater'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Saline Solution: Placebo'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '103', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.6', 'spread': '14.10', 'groupId': 'BG000'}, {'value': '59.0', 'spread': '15.37', 'groupId': 'BG001'}, {'value': '55.8', 'spread': '16.36', 'groupId': 'BG002'}, {'value': '57.5', 'spread': '15.70', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '138', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '133', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '154', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-10', 'size': 394778, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-01-26T11:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Principal investigator, co-investigators, and participants are blinded to study intervention'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 184}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-12', 'studyFirstSubmitDate': '2018-02-06', 'resultsFirstSubmitDate': '2021-01-26', 'studyFirstSubmitQcDate': '2018-02-12', 'lastUpdatePostDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-12', 'studyFirstPostDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Surgical Site Infection', 'timeFrame': '2 weeks post-operative', 'description': 'Definitive diagnosis of infection of surgical site -wounds determined to be infected will be divided into superficial or deep infections and treated according to the standard of care at WellSpan health.'}, {'measure': 'Number of Participants With Surgical Site Infection', 'timeFrame': '6 weeks post-operative', 'description': 'Definitive diagnosis of infection of surgical site -Definitive diagnosis of infection of surgical site -wounds determined to be infected will be divided into superficial or deep infections and treated according to the standard of care at WellSpan health.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Diabetes Diagnosis and Surgical Site Infection', 'timeFrame': '2 weeks post-operative', 'description': 'Number of patients with surgical site infection that have diabetes'}, {'measure': 'Number of Participants With Diabetes Diagnosis and Surgical Site Infection', 'timeFrame': '6 weeks post-operative', 'description': 'Number of patients with surgical site infection that have diabetes'}, {'measure': 'Number of Participants With Surgical Site Infections That Use Tobacco', 'timeFrame': '2 weeks post-operative', 'description': 'Number of patients with surgical site infections that use tobacco products'}, {'measure': 'Number of Participants With Surgical Site Infections That Use Tobacco', 'timeFrame': '6 weeks post-operative', 'description': 'Number of patients with surgical site infections that use tobacco products'}, {'measure': 'Number of Participants With Chronic Obstructive Pulmonary Disease Diagnosis and Surgical Site Infection', 'timeFrame': '2 weeks post-operative', 'description': 'Number of patients with surgical site infections that have chronic obstructive pulmonary disease'}, {'measure': 'Number of Participants With Chronic Obstructive Pulmonary Disease Diagnosis and Surgical Site Infection', 'timeFrame': '6 weeks post-operative', 'description': 'Number of patients with surgical site infections that have chronic obstructive pulmonary disease'}, {'measure': 'Number of Participants With Anemia Diagnosis and Surgical Site Infection', 'timeFrame': '2 weeks post-operative', 'description': 'Number of patients with surgical site infections that have anemia'}, {'measure': 'Number of Participants With Anemia Diagnosis and Surgical Site Infection', 'timeFrame': '6 weeks post-operative', 'description': 'Number of patients with surgical site infections that have anemia'}, {'measure': 'Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection', 'timeFrame': '2 weeks post-operative', 'description': 'Number of patients with surgical site infections that have peripheral artery disease'}, {'measure': 'Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection', 'timeFrame': '6 weeks post-operative', 'description': 'Number of patients with surgical site infections that have peripheral artery disease'}, {'measure': 'Number of Participants With Surgical Site Infection and a History of Arthroplasty', 'timeFrame': '2 weeks post-operative', 'description': 'Number of patients with surgical site infections with history of arthroplasty'}, {'measure': 'Number of Participants With Surgical Site Infection and History of Arthroplasty', 'timeFrame': '6 weeks post-operative', 'description': 'Number of patients with surgical site infections with history of arthroplasty'}, {'measure': 'Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection', 'timeFrame': '2 weeks post-operative', 'description': 'Number of patients with surgical site infections with valvular disease'}, {'measure': 'Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection', 'timeFrame': '6 weeks post-operative', 'description': 'Number of patients with surgical site infections with valvular disease'}, {'measure': 'Number of Participants With Surgical Site Infection That Underwent Single Incision Endoscopic Carpal Tunnel Release', 'timeFrame': '2 weeks post-operative', 'description': 'Number of patients with surgical site infections with single incision ECTR'}, {'measure': 'Number of Participants With Surgical Site Infection That Underwent Single Incision Endoscopic Carpal Tunnel Release', 'timeFrame': '6 weeks post-operative', 'description': 'Number of patients with surgical site infections with single incision ECTR'}, {'measure': 'Number of Participants With Surgical Site Infection That Underwent Double Incision Endoscopic Carpal Tunnel Release', 'timeFrame': '2 weeks post-operative', 'description': 'Number of patients with surgical site infections with double incision ECTR'}, {'measure': 'Number of Participants With Surgical Site Infection That Underwent Double Incision Endoscopic Carpal Tunnel Release', 'timeFrame': '6 weeks post-operative', 'description': 'Number of patients with surgical site infections with double incision ECTR'}, {'measure': 'Time From Last Cortisone Injection', 'timeFrame': '2 weeks post-operative', 'description': 'For patients sustaining surgical site infection, the time from their last cortisone injection'}, {'measure': 'Time From Last Cortisone Injection', 'timeFrame': '6 weeks post-operative', 'description': 'For patients sustaining surgical site infection, the time from their last cortisone injection'}, {'measure': 'Acuity of Carpal Tunnel Syndrome', 'timeFrame': '2 weeks post-operative', 'description': 'For patients sustaining surgical site infection, the acuity of their carpal tunnel syndrome'}, {'measure': 'Acuity of Carpal Tunnel Syndrome', 'timeFrame': '6 weeks post-operative', 'description': 'For patients sustaining surgical site infection, the acuity of their carpal tunnel syndrome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endoscopic Carpal Tunnel Release', 'Prophylactic Antibiotics'], 'conditions': ['Carpal Tunnel Syndrome']}, 'descriptionModule': {'briefSummary': 'This is a clinical trial to determine how effective antibiotics administered prior to endoscopic carpal tunnel release surgery are in preventing surgical site infections.', 'detailedDescription': 'Study participants will be randomized to a prophylactic IV antibiotic treatment arm (Vancomycin or Cefazolin) or a placebo IV saline solution. Subjects will be monitored following surgery for surgical site infections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* High probability (\\>12 points) on the Carpal Tunnel-6 diagnostic aide\n* Recommendation for carpal tunnel release\n* Capable of providing informed consent/LAR to act on subject's behalf\n\nExclusion Criteria:\n\n* Patients allergic to both penicillin/cephalosporins and vancomycin\n* Patient immobilized with splint or cast\n* Unwilling unable to provide informed consent\n* Children under the age of 18"}, 'identificationModule': {'nctId': 'NCT03432858', 'briefTitle': 'Preoperative Antibiotics for Carpal Tunnel Release Surgery', 'organization': {'class': 'OTHER', 'fullName': 'WellSpan Health'}, 'officialTitle': 'Endoscopic Carpal Tunnel Release, Infection Incidence, and Prophylactic Antibiotics: Indicated or Kick the Habit?', 'orgStudyIdInfo': {'id': 'Prophylactic Antibiotics: ESCR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vancomycin', 'interventionNames': ['Drug: Vancomycin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cefazolin', 'interventionNames': ['Drug: Cefazolin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'interventionNames': ['Drug: Saline Solution']}], 'interventions': [{'name': 'Vancomycin', 'type': 'DRUG', 'description': 'Vancomycin - 1-gram dosing', 'armGroupLabels': ['Vancomycin']}, {'name': 'Cefazolin', 'type': 'DRUG', 'description': '2-gram dosing for patients \\<120 kg 3-gram dosing for patients 120 kg or greater', 'armGroupLabels': ['Cefazolin']}, {'name': 'Saline Solution', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17404', 'city': 'York', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'WellSpan Surgery and Rehab Hospital', 'geoPoint': {'lat': 39.9626, 'lon': -76.72774}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'WellSpan Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Orthopedic Surgeon -WellSpan Orthopedics', 'investigatorFullName': 'Richard C Trevino, MD', 'investigatorAffiliation': 'WellSpan Health'}}}}