NOVAPAK Nasal Packing in Shellfish Allergic Patients

Epistaxis Clinical Trial

Official title:

NOVAPAK Nasal Packing: Safety Study in Shellfish Allergic Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05343650
• Other study ID #: ReDA 12329
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 15, 2024
• Est. completion date: May 15, 2025

Study information

• Verified date: September 2023
• Source: Lawson Health Research Institute
• Contact: Leigh J Sowerby, MD
• Phone: +15196466143
• Email: rhinologyclinic[@]sjhc.london.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a prospective interventional study to assess whether the tested product triggers an allergic reaction in patients with known-shellfish allergies.

The primary objective is to assess the safety of Novapak, a chitosan-containing nasal packing material, in patients with known shellfish allergy.

The 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.

Since Novapak contains purified chitosan, the investigators hypothesizes that no allergic reactions will be demonstrated.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: May 15, 2025
• Est. primary completion date: December 24, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Adults aged 18-60

• Positive history of shellfish allergy

• Confirmation of allergy via previous reaction during oral challenge or convincing clinical history and testing.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Epistaxis
• Hypersensitivity

Intervention

Device:
• NOVAPAK nasal packing applied to forearm
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.
• NOVAPAK nasal packing applied to nasal cavity
A piece of Novapak material will be applied to the participant's nasal cavity at the level of the inferior turbinate for 15 minutes

Locations

Country	Name	City	State
Canada	St. Joseph's Health Care	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (14)

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. — View 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. — View 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. — View Citation

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

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Primary	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	Change in Nasal congestion score - (1 hour)	Change on the nasal congestion score 1 hour after the provocation challenge in the nose using NOVAPAK 0 =No congestion; =Mild congestion; =Moderate congestion; =Severe congestion	Baseline, 1 hour after the provocation challenge.
Secondary	Change in Nasal congestion score - (48 hours)	Change on the nasal congestion score 48 hours after the provocation challenge in the nose using NOVAPAK 0 =No congestion; =Mild congestion; =Moderate congestion; =Severe congestion	Baseline, 48 hours after the provocation challenge.