Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-02-21 @ 12:14 AM
Study NCT ID:
NCT01860469
Status:
UNKNOWN
Last Update Posted:
2013-05-22
First Post:
2013-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reducing Mesh Infections in Open Hernia Repairs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'lastUpdateSubmitDate': '2013-05-18', 'studyFirstSubmitDate': '2013-05-18', 'studyFirstSubmitQcDate': '2013-05-18', 'lastUpdatePostDateStruct': {'date': '2013-05-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mesh infections', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'hernia recurrence', 'timeFrame': '6 months'}, {'measure': 'postoperative seroma formation', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Patients Undergoing Open Hernia Repair', 'Patients Undergoing Ventral or Inguinal Hernia Repair']}, 'descriptionModule': {'briefSummary': 'Soaking meshes in a vancomycin solution just prior to their use in open hernia repairs will decrease rates of mesh infection'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* open ventral or inguinal hernia repair\n\nExclusion Criteria:\n\n* laparoscopic hernia repair\n* non ventral or inguinal hernia repairs'}, 'identificationModule': {'nctId': 'NCT01860469', 'briefTitle': 'Reducing Mesh Infections in Open Hernia Repairs', 'organization': {'class': 'OTHER', 'fullName': 'University of Saskatchewan'}, 'officialTitle': 'Does Soaking Synthetic Mesh in Vancomycin Solution Reduce Mesh Infections in Open Hernia Repairs?', 'orgStudyIdInfo': {'id': 'MeshVanco'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'plain mesh', 'description': 'standard practice of using plain mesh (non vancomycin-soaked) for open hernia repair', 'interventionNames': ['Procedure: plain mesh']}, {'type': 'EXPERIMENTAL', 'label': 'vancomycin-soaked mesh', 'description': 'use of vancomycin-soaked mesh for open hernia repair', 'interventionNames': ['Procedure: vancomycin-soaked mesh']}], 'interventions': [{'name': 'vancomycin-soaked mesh', 'type': 'PROCEDURE', 'armGroupLabels': ['vancomycin-soaked mesh']}, {'name': 'plain mesh', 'type': 'PROCEDURE', 'otherNames': ['non vancomycin-soaked mesh'], 'armGroupLabels': ['plain mesh']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S6H 1H3', 'city': 'Moose Jaw', 'state': 'Saskatchewan', 'country': 'Canada', 'contacts': [{'name': 'Ali Cadili, MD, FRCSC', 'role': 'CONTACT', 'email': 'alicadili1@gmail.com', 'phone': '3066940200'}, {'name': 'Ali Cadili, MD, FRCSc', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Nishaan Cheddie, MD, FRCSc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'George B Miller, MD, FRCSc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Five Hills Health Region', 'geoPoint': {'lat': 50.40005, 'lon': -105.53445}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Saskatchewan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Ali Cadili', 'investigatorAffiliation': 'University of Saskatchewan'}}}}