Status:
UNKNOWN
NOVAPAK Nasal Packing in Shellfish Allergic Patients
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions:
Shellfish Hypersensitivity
Epistaxis
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
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 antibacteria...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 15 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05343650
Start Date
March 15 2024
End Date
May 15 2025
Last Update
September 11 2023
Active Locations (1)
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1
St. Joseph's Health Care
London, Ontario, Canada, N5A 4V2