Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2025-12-30 @ 5:09 AM
Study NCT ID:
NCT05343650
Status:
UNKNOWN
Last Update Posted:
2023-09-11
First Post:
2022-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NOVAPAK Nasal Packing in Shellfish Allergic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067208', 'term': 'Shellfish Hypersensitivity'}, {'id': 'D004844', 'term': 'Epistaxis'}], 'ancestors': [{'id': 'D005512', 'term': 'Food Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'prospective interventional study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2025-05-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-07', 'studyFirstSubmitDate': '2022-04-05', 'studyFirstSubmitQcDate': '2022-04-21', 'lastUpdatePostDateStruct': {'date': '2023-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'First stage - Skin test', 'timeFrame': 'Until one hour after the test.', 'description': "The occurrence of an Allergic reaction to Novapak packing in the anterior aspect of the patients' non-dominant arm will be tested."}, {'measure': 'Second stage - Novapak in the nasal cavity (1 hour)', 'timeFrame': 'Until one hour after the test', 'description': "The occurrence of Allergic reaction to Novapak packing on the participant's nasal cavity at the level of the inferior turbinate."}, {'measure': 'Second stage - Novapak in the nasal cavity (48 hours)', 'timeFrame': '48 hours after the test.', 'description': "The occurrence of Allergic reaction to Novapak packing on the participant's nasal cavity at the level of the inferior turbinate."}], 'secondaryOutcomes': [{'measure': 'Change in Nasal congestion score - (1 hour)', 'timeFrame': 'Baseline, 1 hour after the provocation challenge.', 'description': 'Change on the nasal congestion score 1 hour after the provocation challenge in the nose using NOVAPAK 0 =No congestion\n\n1. =Mild congestion\n2. =Moderate congestion\n3. =Severe congestion'}, {'measure': 'Change in Nasal congestion score - (48 hours)', 'timeFrame': 'Baseline, 48 hours after the provocation challenge.', 'description': 'Change on the nasal congestion score 48 hours after the provocation challenge in the nose using NOVAPAK 0 =No congestion\n\n1. =Mild congestion\n2. =Moderate congestion\n3. =Severe congestion'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nasal bleedings', 'Post-surgical healing', 'chitosan-based films'], 'conditions': ['Shellfish Hypersensitivity', 'Epistaxis']}, 'referencesModule': {'references': [{'pmid': '16532368', 'type': 'BACKGROUND', 'citation': 'Kurita K. Chitin and chitosan: functional biopolymers from marine crustaceans. Mar Biotechnol (NY). 2006 May-Jun;8(3):203-26. doi: 10.1007/s10126-005-0097-5. Epub 2006 Mar 17.'}, {'pmid': '12615058', 'type': 'BACKGROUND', 'citation': 'Chou TC, Fu E, Wu CJ, Yeh JH. Chitosan enhances platelet adhesion and aggregation. Biochem Biophys Res Commun. 2003 Mar 14;302(3):480-3. doi: 10.1016/s0006-291x(03)00173-6.'}, {'pmid': '8978649', 'type': 'BACKGROUND', 'citation': 'Rao SB, Sharma CP. Use of chitosan as a biomaterial: studies on its safety and hemostatic potential. J Biomed Mater Res. 1997 Jan;34(1):21-8. doi: 10.1002/(sici)1097-4636(199701)34:13.0.co;2-p.'}, {'pmid': '31558059', 'type': 'BACKGROUND', 'citation': 'Winebrake JP, Mahrous A, Kacker A, Tabaee A, Levinger JI, Pearlman AN, Stewart MG, Lelli GJ Jr. Postoperative Bioresorbable Chitosan-Based Dressing for Endoscopic Middle Meatal Dacryocystorhinostomy With Balloon Dilation. Ear Nose Throat J. 2021 Jul;100(6):425-429. doi: 10.1177/0145561319866822. Epub 2019 Sep 26.'}, {'pmid': '28456847', 'type': 'BACKGROUND', 'citation': 'Zhou JC, Zhang JJ, Zhang W, Ke ZY, Zhang B. Efficacy of chitosan dressing on endoscopic sinus surgery: a systematic review and meta-analysis. Eur Arch Otorhinolaryngol. 2017 Sep;274(9):3269-3274. doi: 10.1007/s00405-017-4584-x. Epub 2017 Apr 29.'}, {'pmid': '22925096', 'type': 'BACKGROUND', 'citation': 'Kourelis K, Shikani AH. Effectiveness of chitosan-based packing in 35 patients with recalcitrant epistaxis in the context of coagulopathy. Clin Otolaryngol. 2012 Aug;37(4):309-13. doi: 10.1111/j.1749-4486.2012.02488.x. No abstract available.'}, {'pmid': '20109331', 'type': 'BACKGROUND', 'citation': 'Valentine R, Athanasiadis T, Moratti S, Hanton L, Robinson S, Wormald PJ. The efficacy of a novel chitosan gel on hemostasis and wound healing after endoscopic sinus surgery. Am J Rhinol Allergy. 2010 Jan-Feb;24(1):70-5. doi: 10.2500/ajra.2010.24.3422.'}, {'type': 'BACKGROUND', 'citation': 'HemCon® Bandage PRO - Tricol Biomedical [Internet]. [cited 2021 Dec 28]. Available from: https://tricolbiomedical.com/product/hemcon-bandage-pro/'}, {'pmid': '22128651', 'type': 'BACKGROUND', 'citation': 'Waibel KH, Haney B, Moore M, Whisman B, Gomez R. Safety of chitosan bandages in shellfish allergic patients. Mil Med. 2011 Oct;176(10):1153-6. doi: 10.7205/milmed-d-11-00150.'}, {'pmid': '27009439', 'type': 'BACKGROUND', 'citation': 'Amaral L, Silva D, Couto M, Nunes C, Rocha SM, Coimbra MA, Coimbra A, Moreira A. Safety of chitosan processed wine in shrimp allergic patients. Ann Allergy Asthma Immunol. 2016 May;116(5):462-3. doi: 10.1016/j.anai.2016.02.004. Epub 2016 Mar 19. No abstract available.'}, {'pmid': '15241360', 'type': 'BACKGROUND', 'citation': 'Sicherer SH, Munoz-Furlong A, Sampson HA. Prevalence of seafood allergy in the United States determined by a random telephone survey. J Allergy Clin Immunol. 2004 Jul;114(1):159-65. doi: 10.1016/j.jaci.2004.04.018.'}, {'pmid': '27613460', 'type': 'BACKGROUND', 'citation': 'Moonesinghe H, Mackenzie H, Venter C, Kilburn S, Turner P, Weir K, Dean T. Prevalence of fish and shellfish allergy: A systematic review. Ann Allergy Asthma Immunol. 2016 Sep;117(3):264-272.e4. doi: 10.1016/j.anai.2016.07.015.'}, {'pmid': '23575656', 'type': 'BACKGROUND', 'citation': 'Lopata AL, Jeebhay MF. Airborne seafood allergens as a cause of occupational allergy and asthma. Curr Allergy Asthma Rep. 2013 Jun;13(3):288-97. doi: 10.1007/s11882-013-0347-y.'}, {'pmid': '34489219', 'type': 'BACKGROUND', 'citation': 'Gelis S, Rueda M, Pascal M, Fernandez-Caldas E, Fernandez EA, Araujo-Sanchez G, Bartra J, Valero A. Usefulness of the Nasal Allergen Provocation Test in the Diagnosis of Shellfish Allergy. J Investig Allergol Clin Immunol. 2022 Dec 15;32(6):460-470. doi: 10.18176/jiaci.0736. Epub 2022 Sep 7.'}]}, 'descriptionModule': {'briefSummary': 'NOVAPAK is a sponge-like material made from materials found in shellfish. It is commonly used after nasal surgery or in nasal bleeding, as it promotes healing, decreases bleeding, and has antibacterial properties. Although NOVOPAK does not contain proteins or compounds known to be responsible for allergic reactions in people with a known allergy to shellfish, out of an abundance of caution, the manufacturer (Medtronic) has recommended avoidance in those with known shellfish allergy. There have been no reported allergic reactions in patients with shellfish allergy who were given chitosan bandages in emergencies (e.g. military applications). The study aims to investigate the safety of its use in patients with known shellfish allergy to improve healthcare quality and patient care support.', 'detailedDescription': "This is a prospective interventional study to assess whether the tested product triggers an allergic reaction in patients with known-shellfish allergies.\n\nThe primary objective is to assess the safety of Novapak, a chitosan-containing nasal packing material, in patients with known shellfish allergy.\n\nThe study will be conducted in two phases. First, participants will undergo an allergy test - Skin prick test (SPT) to crab, lobster, shrimp, oyster, clam, scallop, squid, and octopus -, and antibody levels analysis. Second, in a controlled setting (i.e., in a hospital clinic that includes a resuscitation cart and doctors monitoring - allergist and otolaryngologist), Novapak packing will be applied to the patient's skin for 30 minutes (on the anterior aspect of the patients' non-dominant arm). Then, provided that no allergic symptoms are observed in stage 1, the patient's nose will be anesthetized with topical lidocaine, and a piece of Novapak material will be applied to the participant's nasal cavity at the level of the inferior turbinate for 15 minutes. After removal, the participant will be monitored in the clinic for an hour. Any allergic reaction will be documented, including increased nasal congestion, rhinorrhea, or pruritis.\n\nSince Novapak contains purified chitosan, the investigators hypothesizes that no allergic reactions will be demonstrated."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18-60\n* Positive history of shellfish allergy\n* Confirmation of allergy via previous reaction during oral challenge or convincing clinical history and testing.\n\nExclusion Criteria:\n\n* Severe lung diseases: severe asthma, obstructive lung disease\n* Severe cardiovascular disease: history of congestive heart failure, myocardial infarction, valvulopathy, or unstable tachy-or-bradyarrhythmia.\n* Severe cerebrovascular disease: history of stroke or severe carotid stenosis.\n* Presence of beta-blocker mediations.\n* Patients unable to discontinue antihistamine medications or prednisone.\n* Patients with severe or refractory anaphylaxis during prior oral challenge to shellfish, or those with documented systemic mastocytosis.\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT05343650', 'briefTitle': 'NOVAPAK Nasal Packing in Shellfish Allergic Patients', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'NOVAPAK Nasal Packing: Safety Study in Shellfish Allergic Patients', 'orgStudyIdInfo': {'id': 'ReDA 12329'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study arm', 'description': "Stage 1 After shellfish allergy is confirmed through the skin prick test and IgE analysis, Novapak packing will be applied to the patient's skin for 30 minutes on the anterior aspect of the patients' non-dominant arm. In case of pre-existing wounds, it will be applied to the other forearm. Participants will then be monitored for 1 hour, and any- reaction will be documented. In case of any symptoms of an allergic reaction, their study participation will be terminated.\n\nStage 2 If no allergic symptoms are observed in stage 1, the patient's nose will be anesthetized with topical lidocaine. A piece of Novapak material will be applied to the participant's nasal cavity at the level of the inferior turbinate for 15 minutes. After removal, the participant will be monitored in the clinic for an hour. Any allergic reaction will be documented, including increased nasal congestion, rhinorrhea, or pruritis.", 'interventionNames': ['Device: NOVAPAK nasal packing applied to forearm', 'Device: NOVAPAK nasal packing applied to nasal cavity']}], 'interventions': [{'name': 'NOVAPAK nasal packing applied to forearm', 'type': 'DEVICE', 'description': "Novapak packing will be applied to the patient's skin for 30 minutes on the anterior aspect of the patients' non-dominant arm. In case of pre-existing wounds, it will be applied to the other forearm.", 'armGroupLabels': ['Study arm']}, {'name': 'NOVAPAK nasal packing applied to nasal cavity', 'type': 'DEVICE', 'description': "A piece of Novapak material will be applied to the participant's nasal cavity at the level of the inferior turbinate for 15 minutes", 'armGroupLabels': ['Study arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N5A 4V2', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Joseph's Health Care", 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'centralContacts': [{'name': 'Leigh J Sowerby, MD', 'role': 'CONTACT', 'email': 'rhinologyclinic@sjhc.london.on.ca', 'phone': '+15196466143'}, {'name': 'Taciano Rocha, Ph.D.', 'role': 'CONTACT', 'email': 'taciano.rocha@sjhc.london.on.ca', 'phone': '+15196466100', 'phoneExt': '61125'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}