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NOVAPAK Nasal Packing in Shellfish Allergic Patients

NCT05343650 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-09-11

No results posted yet for this study

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 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.

Conditions

Interventions

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

Sponsors & Collaborators

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-15
Primary Completion
2024-12-24
Completion
2025-05-15

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05343650 on ClinicalTrials.gov