NOVAPAK Nasal Packing in Shellfish Allergic Patients

Launched by LONDON HEALTH SCIENCES CENTRE RESEARCH INSTITUTE OR LAWSON RESEARCH INSTITUTE OF ST. JOSEPH'S · Apr 21, 2022

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ClinConnect Summary

The NOVAPAK trial is studying a special type of nasal packing called NOVAPAK, which is made from materials found in shellfish. This packing is often used after nose surgery or to stop nosebleeds, as it helps with healing and reduces bleeding. Although NOVAPAK doesn’t have the proteins that usually cause allergic reactions in people with shellfish allergies, the manufacturer suggests that those with known allergies should be cautious. The goal of this study is to see if NOVAPAK can be safely used in people who are allergic to shellfish, which could improve care and treatment for these patients.

To participate in the trial, you need to be an adult between 18 and 60 years old and have a confirmed history of shellfish allergy. This means you should have experienced an allergic reaction to shellfish in the past, either through a direct test or a doctor's assessment. Those with certain serious health conditions, like severe lung or heart disease, or who are pregnant, won't be eligible to join. If you take certain medications or have had severe allergic reactions in the past, you may also be excluded. If you qualify and choose to participate, you'll be helping researchers learn more about the safety of NOVAPAK for people with shellfish allergies.

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ALL

Eligibility criteria

• 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