NOVAPAK Nasal Packing: Safety Study in Shellfish Allergic Patients
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- First stage - Skin test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18-60
- •Positive history of shellfish allergy
- •Confirmation of allergy via previous reaction during oral challenge or convincing clinical history and testing.
排除标准
- •Severe lung diseases: severe asthma, obstructive lung disease
- •Severe cardiovascular disease: history of congestive heart failure, myocardial infarction, valvulopathy, or unstable tachy-or-bradyarrhythmia.
- •Severe cerebrovascular disease: history of stroke or severe carotid stenosis.
- •Presence of beta-blocker mediations.
- •Patients unable to discontinue antihistamine medications or prednisone.
- •Patients with severe or refractory anaphylaxis during prior oral challenge to shellfish, or those with documented systemic mastocytosis.
- •Pregnancy
结局指标
主要结局
First stage - Skin test
时间窗: Until one hour after the test.
The occurrence of an Allergic reaction to Novapak packing in the anterior aspect of the patients' non-dominant arm will be tested.
Second stage - Novapak in the nasal cavity (48 hours)
时间窗: 48 hours after the test.
The occurrence of Allergic reaction to Novapak packing on the participant's nasal cavity at the level of the inferior turbinate.
Second stage - Novapak in the nasal cavity (1 hour)
时间窗: Until one hour after the test
The occurrence of Allergic reaction to Novapak packing on the participant's nasal cavity at the level of the inferior turbinate.
次要结局
- Change in Nasal congestion score - (48 hours)(Baseline, 48 hours after the provocation challenge.)
- Change in Nasal congestion score - (1 hour)(Baseline, 1 hour after the provocation challenge.)