A Phase 4 interventional study of NOVAPAK nasal packing applied to forearm and NOVAPAK nasal packing applied to nasal cavity in Shellfish Hypersensitivity and Epistaxis, sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-11.
Sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Phase 4, Interventional, and Other
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.
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.
96 studies on the registry are indexed under Epistaxis; 22 are open to participants now.
This study's planned enrollment of 20 is below the median of 64 across 81 interventional studies indexed under Epistaxis.
Browse Epistaxis studies →London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's is the lead sponsor of 331 studies on the registry; 137 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Device: NOVAPAK nasal packing applied to nasal cavity
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.
A piece of Novapak material will be applied to the participant's nasal cavity at the level of the inferior turbinate for 15 minutes
First stage - Skin test
The occurrence of an Allergic reaction to Novapak packing in the anterior aspect of the patients' non-dominant arm will be tested.
Time frame: Until one hour after the test.
Second stage - Novapak in the nasal cavity (1 hour)
The occurrence of Allergic reaction to Novapak packing on the participant's nasal cavity at the level of the inferior turbinate.
Time frame: Until one hour after the test
Second stage - Novapak in the nasal cavity (48 hours)
The occurrence of Allergic reaction to Novapak packing on the participant's nasal cavity at the level of the inferior turbinate.
Time frame: 48 hours after the test.
Change in Nasal congestion score - (1 hour)
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
Time frame: Baseline, 1 hour after the provocation challenge.
Change in Nasal congestion score - (48 hours)
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
Time frame: Baseline, 48 hours after the provocation challenge.
Plan to share: No
Start is estimated for Mar 2024; primary completion for Dec 2024, 9 months later.
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This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's →