NOVAPAK Nasal Packing in Shellfish Allergic Patients

NCT05343650 | Unknown Phase 4

• 1 other identifier: ReDA 12329
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Shellfish Hypersensitivity; Epistaxis

Keywords

nasal bleedings; Post-surgical healing; chitosan-based films

Outcome Measures

Primary Outcomes (3)

• First stage - Skin test

  The occurrence of an Allergic reaction to Novapak packing in the anterior aspect of the patients' non-dominant arm will be tested.

  Until one hour after the test.

• Second stage - Novapak in the nasal cavity (1 hour)

  The occurrence of Allergic reaction to Novapak packing on the participant's nasal cavity at the level of the inferior turbinate.

  Until one hour after the test

• Second stage - Novapak in the nasal cavity (48 hours)

  The occurrence of Allergic reaction to Novapak packing on the participant's nasal cavity at the level of the inferior turbinate.

  48 hours after the test.

Secondary Outcomes (2)

• Change in Nasal congestion score - (1 hour)

  Baseline, 1 hour after the provocation challenge.

• Change in Nasal congestion score - (48 hours)

  Baseline, 48 hours after the provocation challenge.

Study Arms (1)

Study arm

EXPERIMENTAL

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. Stage 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.

Device: NOVAPAK nasal packing applied to forearm; Device: NOVAPAK nasal packing applied to nasal cavity

Interventions

NOVAPAK nasal packing applied to forearm DEVICE

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.

Study arm

NOVAPAK nasal packing applied to nasal cavity DEVICE

A piece of Novapak material will be applied to the participant's nasal cavity at the level of the inferior turbinate for 15 minutes

Study arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 18-60
• Positive history of shellfish allergy
• Confirmation of allergy via previous reaction during oral challenge or convincing clinical history and testing.

You may not qualify if:

• Severe lung diseases: severe asthma, obstructive lung disease
• Severe cardiovascular disease: history of congestive heart failure, myocardial infarction, valvulopathy, or unstable tachy-or-bradyarrhythmia.
• Severe cerebrovascular disease: history of stroke or severe carotid stenosis.
• Presence of beta-blocker mediations.
• Patients unable to discontinue antihistamine medications or prednisone.
• Patients with severe or refractory anaphylaxis during prior oral challenge to shellfish, or those with documented systemic mastocytosis.
• Pregnancy

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

St. Joseph's Health Care

London, Ontario, N5A 4V2, Canada

Location

Related Publications (14)

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  PMID: 16532368 BACKGROUND

• 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: 12615058 BACKGROUND

• 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: 8978649 BACKGROUND

• 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: 31558059 BACKGROUND

• 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: 28456847 BACKGROUND

• 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: 22925096 BACKGROUND

• 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.

  PMID: 20109331 BACKGROUND

• HemCon® Bandage PRO - Tricol Biomedical [Internet]. [cited 2021 Dec 28]. Available from: https://tricolbiomedical.com/product/hemcon-bandage-pro/

  BACKGROUND

• 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: 22128651 BACKGROUND

• 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: 27009439 BACKGROUND

• 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: 15241360 BACKGROUND

• 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: 27613460 BACKGROUND

• 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: 23575656 BACKGROUND

• 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.

  PMID: 34489219 BACKGROUND

MeSH Terms

Conditions

Shellfish Hypersensitivity; Epistaxis

Condition Hierarchy (Ancestors)

Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Central Study Contacts

Leigh J Sowerby, MD

CONTACT

+15196466143; rhinologyclinic@sjhc.london.on.ca

Taciano Rocha, Ph.D.

CONTACT

+15196466100; taciano.rocha@sjhc.london.on.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective interventional study

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 25, 2022
• Study Start: March 15, 2024
• Primary Completion: December 24, 2024
• Study Completion: May 15, 2025
• Last Updated: September 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)