NOVAPAK nasal packing applied to nasal cavity for Shellfish Hypersensitivity

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
St. Joseph's Health Care, London, Canada
Shellfish Hypersensitivity+2 More
NOVAPAK nasal packing applied to nasal cavity - Device
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions

  • Shellfish Hypersensitivity
  • Epistaxis

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Shellfish Hypersensitivity

Study Objectives

5 Primary · 4 Secondary · Reporting Duration: Until one hour after the test.

Hour 48
Second stage - Novapak in the nasal cavity (48 h)
Second stage - Novapak in the nasal cavity (48 hours)
Hour 1
Change in Nasal congestion score - (1 hour)
Change in Nasal congestion score - (1h)
Hour 48
Change in Nasal congestion score - (48 h)
Change in Nasal congestion score - (48 hours)
Until one hour after the test
Second stage - Novapak in the nasal cavity (1 h)
Second stage - Novapak in the nasal cavity (1 hour)
Until one hour after the test.
First stage - Skin test

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Shellfish Hypersensitivity

Trial Design

1 Treatment Group

Study arm
1 of 1
Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: NOVAPAK nasal packing applied to nasal cavity · No Placebo Group · Phase 4

Study armExperimental Group · 2 Interventions: NOVAPAK nasal packing applied to forearm, NOVAPAK nasal packing applied to nasal cavity · Intervention Types: Device, Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: until one hour after the test.
Closest Location: St. Joseph's Health Care · London, Canada
Photo of ontario 1Photo of ontario 2Photo of ontario 3
2006First Recorded Clinical Trial
1 TrialsResearching Shellfish Hypersensitivity
37 CompletedClinical Trials

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor
607 Previous Clinical Trials
398,936 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a history of an allergic reaction to a food or other allergen.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References