NOVAPAK Nasal Packing in Shellfish Allergic Patients

Status Not yet recruiting

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

Clinical Trial Details

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

View Details

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	`NCT04279288` - The Roles of Hilotherapy in the Management of Epistaxis and Nasal Fractures	N/A
Completed	`NCT03360045` - Comparing Effectiveness of Merocel and Packing With Tranexamic Acid in the Management of Anterior Epistaxis	Phase 4
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

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.