Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2026-01-25 @ 6:32 AM
Study NCT ID:
NCT01867268
Status:
UNKNOWN
Last Update Posted:
2015-04-21
First Post:
2013-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Acetazolamide & Position in CSF Leakage and Collection and Wound Dehiscence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C537030', 'term': 'Lipomyelomeningocele'}, {'id': 'D009436', 'term': 'Neural Tube Defects'}, {'id': 'D016136', 'term': 'Spina Bifida Occulta'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D065634', 'term': 'Cerebrospinal Fluid Leak'}], 'ancestors': [{'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D016135', 'term': 'Spinal Dysraphism'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000086', 'term': 'Acetazolamide'}, {'id': 'D016684', 'term': 'Prone Position'}], 'ancestors': [{'id': 'D013830', 'term': 'Thiadiazoles'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011187', 'term': 'Posture'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 144}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-04-17', 'studyFirstSubmitDate': '2013-05-29', 'studyFirstSubmitQcDate': '2013-05-31', 'lastUpdatePostDateStruct': {'date': '2015-04-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cerebrospinal fluid leakage', 'timeFrame': '1month', 'description': 'leakage of CSF during 1 months following surgery'}, {'measure': 'Cerebrospinal fluid collection', 'timeFrame': '1 month', 'description': 'collection of the CSF beneath the skin during 1 month following the surgery'}, {'measure': 'wound dehiscence', 'timeFrame': '1 month', 'description': 'dehiscence of the surgical wound during the first month following surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acetazolamide administration', 'prone positioning', 'Cerebrospinal fluid leakage', 'Cerebrospinal fluid collection', 'wound dehiscence'], 'conditions': ['Fibrolipoma of Filum Terminale', 'Lipomyelomeningocele', 'Split Cord Malformation', 'Dermal Sinus', 'Tethered Cord Syndrome', 'Tumor']}, 'referencesModule': {'references': [{'pmid': '21721886', 'type': 'BACKGROUND', 'citation': 'Chern JJ, Tubbs RS, Patel AJ, Gordon AS, Bandt SK, Smyth MD, Jea A, Oakes WJ. Preventing cerebrospinal fluid leak following transection of a tight filum terminale. J Neurosurg Pediatr. 2011 Jul;8(1):35-8. doi: 10.3171/2011.4.PEDS10502.'}, {'pmid': '26824595', 'type': 'DERIVED', 'citation': 'Shahjouei S, Hanaei S, Habibi Z, Hoseini M, Ansari S, Nejat F. Randomized clinical trial of acetazolamide administration and/or prone positioning in mitigating wound complications following untethering surgeries. J Neurosurg Pediatr. 2016 Jun;17(6):659-66. doi: 10.3171/2015.8.PEDS15393. Epub 2016 Jan 29.'}]}, 'descriptionModule': {'briefSummary': '* Purpose of study : to determine the preventive effect of acetazolamide administration, prone positioning, and the combination of both following the neurosurgical interventions in lumbosacral region for cerebrospinal fluid (CSF) leak, CSF collection and wound dehiscence.\n* Sample size: 144\n* intervention groups:\n\n * Group A: Acetazolamide administration for 10 days\n * Group B: prone positioning for 10 days\n * Group C: Acetazolamide administration and prone positioning for 10 days\n * Group D: no intervention\n* Period of study: Autumn 2012 to the end of winter of 2015', 'detailedDescription': 'The purpose of this study is to evaluate the effect of Acetazolamide administration and prone positioning following lumbosacral spinal surgery in preventing cerebro-spinal fluid leakage and collection and wound dehissence in children admitted to Children Medical Center of Tehran since Autumn 2012 to the end of winter of 2015.The study is run under 4 categories of intervention:\n\n* Group A: Acetazolamide administration for 10 days\n* Group B: prone positioning for 10 days\n* Group C: Acetazolamide administration and prone positioning for 10 days\n* Group D: no intervention All patients are randomly assigned to these groups and when the patients faced with any of these complications, the protocol changes to Acetazolamide administration and prone positioning and the patient is considered as the failure of the protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Untethering surgery for primary tethered cord caused by thick filum\n* Lipomyelomeningocele\n* Split cord malformation management\n* Untethering surgery in uncomplicated Dermal sinus\n* Tumors needing intradural management in lumbosacral region\n* Having any other disease with similar management technique\n\nExclusion Criteria:\n\n* Infected dermoid tumors\n* Intramedullary abscess\n* Myelomeningocele surgery and related reoperation\n* Meningocele\n* Presence of hydrocephalus'}, 'identificationModule': {'nctId': 'NCT01867268', 'briefTitle': 'Effect of Acetazolamide & Position in CSF Leakage and Collection and Wound Dehiscence', 'organization': {'class': 'OTHER', 'fullName': 'Tehran University of Medical Sciences'}, 'officialTitle': 'Evaluating the Effect of Acetazolamide Administration and Prone Positioning Following Lumbosacral Spinal Surgery in Preventing Cerebro Spinal Fluid Leakage and Collection and Wound Dehiscence in Children.', 'orgStudyIdInfo': {'id': '2137'}, 'secondaryIdInfos': [{'id': '21843', 'type': 'OTHER', 'domain': 'Tehran University of Medical Sciences'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acetazolamide', 'description': 'administration of Acetazolamide for 10 days following the surgery', 'interventionNames': ['Drug: Acetazolamide']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'control group without any intervention'}, {'type': 'EXPERIMENTAL', 'label': 'Prone positioning', 'description': 'Positioning the patient following surgery for 10 days', 'interventionNames': ['Other: prone positioning']}, {'type': 'EXPERIMENTAL', 'label': 'Acetazolamide and Prone positioning', 'description': 'applying both Acetazolamide and prone positioning', 'interventionNames': ['Other: Acetazolamide+ prone positioning']}], 'interventions': [{'name': 'Acetazolamide', 'type': 'DRUG', 'otherNames': ['Diamox'], 'description': 'Acetazolamide administration for 10 days adjust dosage with weight of the patient', 'armGroupLabels': ['Acetazolamide']}, {'name': 'prone positioning', 'type': 'OTHER', 'description': 'prone positioning the patient for 10 days following the surgery', 'armGroupLabels': ['Prone positioning']}, {'name': 'Acetazolamide+ prone positioning', 'type': 'OTHER', 'description': 'administration of acetazolamide and position the patient for 10 days following the surgery', 'armGroupLabels': ['Acetazolamide and Prone positioning']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'state': 'Tehran Province', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'role': 'CONTACT', 'phone': '+98 21 61479'}, {'name': 'Shima Shahjouei, Student', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children'S Medical Center", 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'centralContacts': [{'name': 'Farideh Nejat, MD', 'role': 'CONTACT', 'email': 'nejat@tums.ac.ir', 'phone': '+98 912 1494064'}], 'overallOfficials': [{'name': 'Farideh Nejat, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tehran University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tehran University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}