Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT00966056
Status:
COMPLETED
Last Update Posted:
2011-07-08
First Post:
2009-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Mitomycin C and Nasal Splint to Treat Nasal Synechiae
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000267', 'term': 'Tissue Adhesions'}], 'ancestors': [{'id': 'D002921', 'term': 'Cicatrix'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016685', 'term': 'Mitomycin'}], 'ancestors': [{'id': 'D008937', 'term': 'Mitomycins'}, {'id': 'D045563', 'term': 'Indolequinones'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001389', 'term': 'Azirines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-07', 'studyFirstSubmitDate': '2009-08-25', 'studyFirstSubmitQcDate': '2009-08-25', 'lastUpdatePostDateStruct': {'date': '2011-07-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence or absence of synechiae', 'timeFrame': '1 week, 1 month, 2 months'}], 'secondaryOutcomes': [{'measure': 'Symptoms and complications', 'timeFrame': '1 week, 1 month, 2 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Nasal adhesions', 'Nasal synechiae', 'Mitomycin', 'Mitomycin c', 'Teflon', 'Splints', 'Septal splints'], 'conditions': ['Nasal Synechiae', 'Adhesions of Nasal Cavity', 'Nasal Adhesions', 'Tissue Adhesions']}, 'descriptionModule': {'briefSummary': 'This study evaluates whether Mitomycin C is an effective alternative to septal splints in the treatment of nasal synechiae.', 'detailedDescription': 'Nasal synechiae is an important cause for the failure of many a nasal surgery. Septal splints have been widely used for the treatment of nasal synechiae, but are associated significant morbidity until removal. To the best of our knowledge there are no studies in literature comparing Mitomycin C with septal splints as an atraumatic alternative in the treatment of nasal synechiae. This is a preliminary study taken up to evaluate the therapeutic efficacy of Mitomycin C in the treatment of nasal synechiae.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with nasal mucosal synechiae due to surgical or non-surgical trauma\n\nExclusion Criteria:\n\n* Patients with nasal vestibular stenosis\n* Patients with nasal synechiae due to diseases like Hansen's disease, Syphilis, Rhinoscleroma, Atrophic Rhinitis etc."}, 'identificationModule': {'nctId': 'NCT00966056', 'briefTitle': 'Study of Mitomycin C and Nasal Splint to Treat Nasal Synechiae', 'organization': {'class': 'OTHER', 'fullName': 'Karnataka Institute of Medical Sciences'}, 'officialTitle': 'Comparative Study of Mitomycin C and Internal Nasal Septal Splint in the Treatment of Nasal Synechiae', 'orgStudyIdInfo': {'id': '01_M012_3210'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mitomycin C', 'description': 'Cases recruited into this arm receive topical application of mitomycin c (1mg/ml)following surgical synechiolysis', 'interventionNames': ['Drug: Mitomycin C']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Teflon septal splint', 'description': 'Cases recruited into this arm receive insertion of teflon internal nasal septal splint following surgical synechiolysis', 'interventionNames': ['Device: Teflon nasal septal splint']}], 'interventions': [{'name': 'Mitomycin C', 'type': 'DRUG', 'otherNames': ['Mitomycin, Mitocin, MMC'], 'description': 'Cotton wick soaked with 1mg/ml of mitomycin c placed for 2 minutes between the raw surfaces after synechiolysis with surgical blade no.15', 'armGroupLabels': ['Mitomycin C']}, {'name': 'Teflon nasal septal splint', 'type': 'DEVICE', 'otherNames': ['Teflon splint, nasal septal splint, internal nasal splint'], 'description': 'Teflon internal nasal septal splint placed between the raw surfaces and secured at the anterior end of septum with catgut 3-0 sutures, following synechiolysis with surgical blade no.15. Splint removed at the end of one week', 'armGroupLabels': ['Teflon septal splint']}]}, 'contactsLocationsModule': {'locations': [{'zip': '580022', 'city': 'Hubli', 'state': 'Karnataka', 'country': 'India', 'facility': 'Karnataka Institute of Medical Sciences', 'geoPoint': {'lat': 17.58662, 'lon': 76.51148}}], 'overallOfficials': [{'name': 'VIKRAM K BHAT, MS(ENT), DNB', 'role': 'STUDY_CHAIR', 'affiliation': 'Karnataka Institute of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karnataka Institute of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr SRINISH G', 'oldOrganization': 'KARNATAKA INSTITUTE OF MEDICAL SCIENCES'}}}}