Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-28 @ 7:42 PM
Study NCT ID:
NCT05959603
Status:
RECRUITING
Last Update Posted:
2024-11-27
First Post:
2021-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intra-wound Vancomycin Powder for Prevention of Surgical Site Infection Following Spinal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014640', 'term': 'Vancomycin'}], 'ancestors': [{'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 363}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-24', 'studyFirstSubmitDate': '2021-05-20', 'studyFirstSubmitQcDate': '2023-07-23', 'lastUpdatePostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of deep spinal infections', 'timeFrame': 'One year', 'description': 'According to Center for Disease Control and Prevention (CDC) criteria'}], 'secondaryOutcomes': [{'measure': 'Incidence of superficial spinal infections', 'timeFrame': 'One year', 'description': 'According to CDC criteria'}, {'measure': 'Individual components of the composite primary outcomes', 'timeFrame': 'One year', 'description': 'Deep surgical site infections and superficial surgical site infections separately'}, {'measure': 'Rate of Surgical site infection revisions', 'timeFrame': '30 days', 'description': 'Number of surgical site infection revisions'}, {'measure': 'Number of adverse events', 'timeFrame': 'Up to one week post-surgery', 'description': 'Number of adverse events Including rash, acute kidney injury (according to RIFLE criteria, see appendix), ototoxicity'}, {'measure': 'Length of hospitalization', 'timeFrame': 'From operation date to discharge (up to 4 weeks) or date of death', 'description': 'Length of hospitalization starting on operation date up to discharge or death'}, {'measure': 'Rate of mortality', 'timeFrame': 'One year', 'description': 'Rate of mortality among study participants within one year from operation date'}, {'measure': 'Rate of post-operative seroma', 'timeFrame': '30 days', 'description': 'Rate of post-operative seroma'}, {'measure': 'Concentration of creatinine (mg/dl), glucose (mg/dl) and albumin (g/dl)', 'timeFrame': 'Pre-operation, Post-operation Day 3, Post-operation Day 7, Post-operation Day 30', 'description': 'Creatinine, glucose and albumin lab results'}, {'measure': 'Serum vancomycin levels', 'timeFrame': '6 and 12 hours post op and then one test a day until vancomycin levels reach zero', 'description': 'Serum vancomycin levels'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vancomycin', 'Infections', 'Surgical Site'], 'conditions': ['Infection']}, 'descriptionModule': {'briefSummary': 'Cefazolin is given routinely pre and intraoperatively for patients undergoing spinal surgery to reduce the rate of infection. Intra-wound admission of Vancomycin powder has been suggested to reduce wound infection rates. Therefore, this study aims to compare the rate of wound-related complications between patients receiving standard treatment compared to patients receiving an addition of topical Vancomycin and to identify the optimal Vancomycin dosage. All groups will receive the recommended regimen of routine IV antibiotic prophylaxis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing posterior spinal fusion operation at the neurosurgery department at the Rabin Medical Center\n* Ability to understand and sign written informed consent by the patient or legal guardian\n\nExclusion Criteria:\n\n* Preoperative ongoing infectious disease present as judged by the primary surgeon (based on lab results and clinical assessment)\n* Receiving ongoing treatment of antibiotics for other infections\n* Sensitivity or allergy to vancomycin or cefazolin\n* Previous spine surgery at the index level within the last 90 days\n* Postoperative radiotherapy of the surgical site required (e.g. for tumor)\n* Renal insufficiency with stage 4 chronic kidney disease (CKD) with a glomerular filtration rate (GFR) of 15-30 ml/min or worse\n* Undergoing spinal decompression only\n* Trauma patients\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT05959603', 'briefTitle': 'Intra-wound Vancomycin Powder for Prevention of Surgical Site Infection Following Spinal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'Intra-wound Vancomycin Powder for Prevention of Surgical Site Infection Following Spinal Surgery - a Randomized Controlled Superiority Trial', 'orgStudyIdInfo': {'id': 'RMC 0103-20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard of care', 'description': '2 g of IV cefazolin will be administered within 60 minutes before surgical incision (3 g for pts weighing ≥120 kg), repeated dose in the operating room every four hours (allergic patients will receive 900 mg of clindamycin within 60 minutes which will be repeated every six hours or 15 mg/kg of vancomycin once within two hours before incision).'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention group: 500 mg vancomycin', 'description': 'Patients will receive 500 mg of powdered vancomycin to the surgical site in addition to standard of care IV prophylaxis', 'interventionNames': ['Drug: Vancomycin']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention group: 1 g vancomycin', 'description': 'Patients will receive one gram of powdered vancomycin to the surgical site in addition to standard of care IV prophylaxis', 'interventionNames': ['Drug: Vancomycin']}], 'interventions': [{'name': 'Vancomycin', 'type': 'DRUG', 'description': 'Powdered vancomycin will be locally administered once during surgery. The vancomycin will be placed in the surgical bed at several layers: around the hardware and before muscle apposition and above the fascia. This is done before the closure of the muscular fascia and skin by the neurosurgeon. The vancomycin will not be mixed in the bone graft.', 'armGroupLabels': ['Intervention group: 1 g vancomycin', 'Intervention group: 500 mg vancomycin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Petah Tikva', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Belaynesh Keren Melke, BSc', 'role': 'CONTACT'}], 'facility': 'Rabin Medical Center', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}], 'centralContacts': [{'name': 'Eyal Itshayek, MD', 'role': 'CONTACT', 'email': 'eyal.itshayek@gmail.com', 'phone': '+972-50-8946921'}, {'name': 'Shani Berkowitz, Msc', 'role': 'CONTACT', 'email': 'shanihberkowitz@gmail.com', 'phone': '+972528620737'}], 'overallOfficials': [{'name': 'Eyal Itshayek, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rabin Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Eyal Itshayek', 'investigatorFullName': 'Eyal Itshayek', 'investigatorAffiliation': 'Rabin Medical Center'}}}}