NOVAPAK Nasal Packing in Shellfish Allergic Patients

September 7, 2023 updated by: Lawson Health Research Institute

NOVAPAK Nasal Packing: Safety Study in Shellfish Allergic Patients

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N5A 4V2
        • St. Joseph's Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study arm

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
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.
Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First stage - Skin test
Time Frame: Until one hour after the 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)
Time Frame: Until one hour after the test
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)
Time Frame: 48 hours after the test.
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)
Time Frame: Baseline, 1 hour after the provocation challenge.

Change on the nasal congestion score 1 hour after the provocation challenge in the nose using NOVAPAK 0 =No congestion

  1. =Mild congestion
  2. =Moderate congestion
  3. =Severe congestion
Baseline, 1 hour after the provocation challenge.
Change in Nasal congestion score - (48 hours)
Time Frame: Baseline, 48 hours after the provocation challenge.

Change on the nasal congestion score 48 hours after the provocation challenge in the nose using NOVAPAK 0 =No congestion

  1. =Mild congestion
  2. =Moderate congestion
  3. =Severe congestion
Baseline, 48 hours after the provocation challenge.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2024

Primary Completion (Estimated)

December 24, 2024

Study Completion (Estimated)

May 15, 2025

Study Registration Dates

First Submitted

April 5, 2022

First Submitted That Met QC Criteria

April 21, 2022

First Posted (Actual)

April 25, 2022

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 7, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ReDA 12329

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Epistaxis

Clinical Trials on NOVAPAK nasal packing applied to forearm

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe