An open-labelled, Prospective, three arm, single center, randomized clinical study to compare patient satisfaction and clinical outcome associated with available nasal packs in nasal surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To assess and compare the efficacy of the nasal packs (VELNEZ, Merocel, or Rapid Rhino) in ceasing reactive bleeding and achieving secondary bleeding control in post-operative nasal surgery patients. This will be evaluated based on the duration and extent of bleeding cessation observed with each nasal pack.
研究概览
简要总结
The use of nasal dressings is a critical component in the management of various nasal conditions, providing support, hemostasis, and localized treatment. Careful consideration of the type and duration of packing, along with monitoring for complications, is essential for optimal patient outcomes.
This is an investigator-initiated trial here, all subjects planned for nasal surgery and requiring nasal packing post-surgery will be enrolled after taking their permission to participate in the study and after obtaining their written consent. Each participant will be assigned a treatment (Merocel, Rapid Rhino, or Velnez)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Subject eligible for the use of a nasal pack (either VELNEZ, Merocel or Rapid Rhino) in routine clinical practice after a planned nasal surgery.
- •Male and female in the age group of 18 to 70 years.
- •(Both Included)
- •Subjects who can provide informed consent form in writing.
- •Subjects who allow their study data to be collected at pre-defined follow-up period.
排除标准
- •Subject who are unable to be treated with the other than VELNEZ, Merocel or Rapid Rhino nasal pack in routine clinical practice after a planned nasal surgery.
- •Subject unwilling or unable to comply with the postoperative visits necessary for data collection.
- •Subject with an active infection at the surgery site.
- •Subject with a history of asthma.
- •Subject who are on aspirin or anti-platelet drugs therapy.
- •Hypertensive subjects.
- •Subjects who have a history of allergy (Hypersensitive) reactions with any of the ingredients of the nasal pack.
- •Subject with bleeding disorders.
- •Any medical condition that, in the opinion of the investigator, would make the subject unsuitable for inclusion (e.g., a chronic, relapsing or hereditary disease that may interfere with the outcome of the study).
结局指标
主要结局
To assess and compare the efficacy of the nasal packs (VELNEZ, Merocel, or Rapid Rhino) in ceasing reactive bleeding and achieving secondary bleeding control in post-operative nasal surgery patients. This will be evaluated based on the duration and extent of bleeding cessation observed with each nasal pack.
时间窗: 3 weeks
The assessment of synechiae formation among the various nasal pack groups. The presence and extent of adhesions between the nasal mucosa and other structures will be evaluated to determine the incidence of synechiae formation.
时间窗: 3 weeks
The assessment of safety based on adverse events reported with the application of the nasal packs used. Any adverse reactions, complications, or adverse events related to the use of nasal packs will be documented and compared between the different nasal pack groups.
时间窗: 3 weeks
次要结局
- Patient-reported discomfort associated with the use of nasal packs post-surgery is an important endpoint. This will include assessing discomfort caused by the presence of the nasal pack, discomfort during its removal (including pressure and pain), and overall discomfort experienced by patients during the post-operative period.(Evaluation of bleeding through the nose following the removal of nasal packs will provide insights into the effectiveness of hemostasis and bleeding control achieved by each nasal pack type.)
研究者
Dr Akhil Partap Singh
Department of ENT