NOVAPAK Nasal Packing in Shellfish Allergic Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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NOVAPAK Nasal Packing: Safety Study in Shellfish Allergic Patients

Conditions
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Shellfish Hypersensitivity, Epistaxis

Intervention / Treatment
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* Device: NOVAPAK nasal packing applied to forearm
* Device: NOVAPAK nasal packing applied to nasal cavity


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: prospective interventional study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study arm<br>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<br>* 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.<br>Device: NOVAPAK nasal packing applied to nasal cavity<br>* A piece of Novapak material will be applied to the participant's nasal cavity at the level of the inferior turbinate for 15 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nasal bleedings, Post-surgical healing, chitosan-based films