NOVAPAK for Shellfish Allergy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a nasal packing material called NOVAPAK to determine its safety for individuals with shellfish allergies. Currently, NOVAPAK aids healing and stops bleeding in nasal surgeries. The study aims to ensure it does not trigger allergic reactions in those with shellfish allergies. Participants must have a confirmed shellfish allergy from past reactions or tests. As a Phase 4 trial, NOVAPAK is already FDA-approved and proven effective, and this research seeks to understand its benefits for more patients.
Will I have to stop taking my current medications?
If you are taking antihistamine medications or prednisone, you will need to stop them to participate in the trial. The protocol does not specify other medications, but you should discuss your current medications with the trial team.
What is the safety track record for NOVAPAK Nasal Packing?
Research has shown that NOVAPAK, a nasal packing material derived from a substance found in shellfish, has been used safely in various situations. Notably, similar materials have not caused allergic reactions in people with shellfish allergies during emergencies, such as in military settings. This suggests that NOVAPAK might be safe for individuals with shellfish allergies. However, the manufacturer advises caution because allergic reactions remain possible. This study aims to confirm its safety for these individuals. Overall, existing evidence suggests that NOVAPAK is unlikely to cause allergic reactions, but this study will provide more definitive answers.12345
Why are researchers enthusiastic about this study treatment?
Unlike most treatments for shellfish allergies, which often involve strict avoidance and emergency epinephrine for allergic reactions, NOVAPAK offers a new approach through a unique delivery method. This treatment involves applying a specialized nasal packing material that could potentially desensitize the body to shellfish allergens. Researchers are excited because NOVAPAK is designed to be a localized treatment, reducing the risk of systemic side effects and potentially offering a more convenient and non-invasive option for managing shellfish allergies. The novel application technique and targeted approach of NOVAPAK could represent a significant step forward in allergy treatment.
What evidence suggests that NOVAPAK Nasal Packing is safe for patients with shellfish allergy?
Research shows that NOVAPAK, a material used in nasal surgeries, is generally safe and effective. It aids healing, reduces bleeding, and fights bacteria. Although made from chitosan, a substance found in shellfish, it lacks the proteins that typically cause allergic reactions. In emergencies, chitosan bandages have been safely used on people with shellfish allergies without causing reactions. This suggests that NOVAPAK is unlikely to trigger allergies in those with shellfish allergies. The trial will specifically test NOVAPAK's safety for individuals with shellfish allergies to further confirm its safety for these individuals.12367
Are You a Good Fit for This Trial?
This trial is for adults aged 18-60 with a confirmed shellfish allergy. Candidates must have had a previous allergic reaction to shellfish or convincing clinical history and testing. People taking beta-blockers, those with severe lung, heart, or cerebrovascular diseases, pregnant individuals, and patients who can't stop antihistamines or prednisone are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Stage 1: Skin Test
Participants undergo a skin prick test and IgE analysis for shellfish allergy. Novapak is applied to the skin for 30 minutes, followed by 1-hour monitoring for allergic reactions.
Stage 2: Nasal Application
If no allergic symptoms are observed in Stage 1, Novapak is applied to the nasal cavity for 15 minutes, followed by 1-hour monitoring for allergic reactions.
Follow-up
Participants are monitored for allergic reactions and changes in nasal congestion score 48 hours after the nasal application.
What Are the Treatments Tested in This Trial?
Interventions
- NOVAPAK Nasal Packing
Trial Overview
The study tests the safety of NOVAPAK nasal packing in people allergic to shellfish. NOVAPAK will be applied both on the forearm and inside the nasal cavity to see if it's safe for use after nosebleeds or surgery despite its shellfish-derived materials.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
London Health Sciences Centre OR Lawson Research Institute of St. Joseph's
Lead Sponsor
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
Lead Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead Sponsor
Lawson Health Research Institute
Lead Sponsor
Citations
NOVAPAK Nasal Packing in Shellfish Allergic Patients
Since Novapak contains purified chitosan, the investigators hypothesizes that no allergic reactions will be demonstrated. Arms & Interventions. Arms.
Novapak Prospective Observational ...
This study is being conducted to support the safety and treatment effectiveness profile of the Medtronic. Novapak Nasal Sinus Packing and Stent ...
Novapak Prospective Observational Clinical Trial
The primary objective is to assess the safety of the Novapak Nasal Sinus Packing and Stent device used as indicated post-operatively in patients ...
4.
aging.networkofcare.org
aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05343650?keyword=%22Epistaxis%22NOVAPAK Nasal Packing in Shellfish Allergic Patients
This is a prospective interventional study to assess whether the tested product triggers an allergic reaction in patients with known-shellfish allergies.
Novapak™ Nasal Sinus Packing and Stent
Novapak™ nasal sinus packing and stent contains chitosan from shellfish and should not be used in patients with known allergic responses to shellfish. For ...
6.
centerwatch.com
centerwatch.com/clinical-trials/listings/NCT05747014/novapak-prospective-observational-clinical-trialNovapak Prospective Observational Clinical Trial
The primary objective is to assess the safety of the Novapak Nasal Sinus Packing and Stent device used as indicated post-operatively in patients ...
7.
aging.networkofcare.org
aging.networkofcare.org/riverside/CommunityResources/ClinicalTrials/Detail/NCT05343650?keyword=%22Epistaxis%22NOVAPAK Nasal Packing in Shellfish Allergic Patients
This is a prospective interventional study to assess whether the tested product triggers an allergic reaction in patients with known-shellfish allergies.
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