Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05343650
Study type Interventional
Source Lawson Health Research Institute
Contact Leigh J Sowerby, MD
Phone +15196466143
Email rhinologyclinic@sjhc.london.on.ca
Status Not yet recruiting
Phase Phase 4
Start date March 15, 2024
Completion date May 15, 2025

See also
  Status Clinical Trial Phase
Completed NCT05334017 - Xylometazoline and Cocaine for Nasal Vasoconstriction Phase 4
Not yet recruiting NCT04519463 - The Effect of Local Anesthesia With Lidocaine During Insertion and Removal of Nasal Packing Early Phase 1
Recruiting NCT01886768 - Double Versus Single Pledget Nasal Anesthesia for Transnasal Endoscopy N/A
Recruiting NCT00390663 - A Prospective Randomised Controlled Trial of Management of Recurrent Nosebleeds in Children Phase 4
Suspended NCT04054687 - Intranasal TXA for Anterior Epistaxis in the Emergency Department Phase 2
Completed NCT02285634 - The Effect of Intranasal Vasoconstrictor Medications on Hemodynamic Parameters: A Randomized Double-blind, Placebo-controlled Trial. N/A
Completed NCT01485224 - Efficacy of Thalidomide in the Treatment of Hereditary Hemorrhagic Telangiectasia Phase 2
Completed NCT00793117 - The Effect of Packing in Post Operative Management of FESS Phase 4
Recruiting NCT06259292 - Comprehensive HHT Outcomes Registry of the United States (CHORUS)
Recruiting NCT03850964 - Effects of Pazopanib on Hereditary Hemorrhagic Telangiectasia Related Epistaxis and Anemia (Paz) Phase 2/Phase 3
Recruiting NCT05281952 - Medico-economic Evaluation of Management Strategies for Severe Epistaxis N/A
Completed NCT03360045 - Comparing Effectiveness of Merocel and Packing With Tranexamic Acid in the Management of Anterior Epistaxis Phase 4
Completed NCT04279288 - The Roles of Hilotherapy in the Management of Epistaxis and Nasal Fractures N/A
Completed NCT03912051 - Assessment of Performance and Safety of an Asymmetric Balloon in the Treatment of Intranasal Bleeding Managed in an Emergency Setting N/A
Not yet recruiting NCT02677467 - Correlation Between Epistaxis and Cardiovascular Disease N/A
Completed NCT01314274 - Intranasal Submucosal Bevacizumab for Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT) Phase 2
Terminated NCT01051427 - Control of Epistaxis With Surgiflo N/A
Completed NCT00863356 - Trial of a Novel Chitosan Hemostatic Sealant in the Management of Complicated Epistaxis N/A
Recruiting NCT05269849 - Sirolimus for Nosebleeds in HHT Phase 2
Not yet recruiting NCT02963129 - Treatment of Nasal Staphylococcus Aureus Colonization in Patients With HHT Phase 3