A single centric, Open label, single arm, post marketing clinical follow-up (PMCF) study to evaluate safety and tolerability of VELNEZ- A space occupying dressing after ear surgery.
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Incidence of adverse events reported that directly attributes to the use of VELNEZ as an ear dressing.
研究概览
简要总结
VELNEZ is an ear dressing that is biodegradable and is designed to disintegrate within a few days of application. This feature eliminates the need for painful dressing removal procedures associated with traditional packs. Furthermore, VELNEZ aids in reducing fibrosis and also promotes healing and clotting, thereby facilitating a smoother recovery process for patients undergoing middle ear surgeries.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subject for the use of VELNEZ as a dressing pack in a routine clinical practice after a planned otologic surgery.
- •(Tympanoplasty or Myringoplasty or any other middle ear surgeries) 2.Male and female in the age group of 18 to 60 years.
- •(Both Included) 3.Subjects who can provide informed consent form in writing or through his LAR.
- •4.Subjects who allow their study data to be collected at pre-defined follow-up period/ time and used for study objectives.
排除标准
- •1.Subject who are unable to be treated with the VELNEZ as a dressing packing in routine clinical practice after a planned surgery.
- •2.Subject who cannot provide written informed consent for data collection.
- •3.Subject unwilling or unable to comply with the postoperative visits necessary for data collection.
- •4.Subject with a sign of active infection at the site of surgery.
- •5.Subject with uncontrolled cholesteatoma, malignant tumors, complications of chronic ear disease.
- •6.Subject who are on aspirin or anti-platelet drugs therapy.
- •7.Pregnant and nursing women.
- •8.Subject with uncontrolled hypertensive subjects.
- •9.Subjects who have a history of allergy (Hypersensitive) reactions with any of the ingredients of the device (VELNEZ) i.e., Chitosan, Gelatin and Psyllium husk etc.
- •10.Subject with bleeding disorders.
- •11.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).
- •12.Subject with history of postoperative recurrent infections and subjects with bleeding diathesis.
- •13.Subject found to be positive in serology.
- •14.Subject on immunosuppressive drugs.
结局指标
主要结局
Incidence of adverse events reported that directly attributes to the use of VELNEZ as an ear dressing.
时间窗: Up-yo 65 days post dressing
Incidence of post-operative primary and secondary bleeding during the conduct of the study.
时间窗: Up-yo 65 days post dressing
Proportion of study participants achieving degradation of the VELNEZ dressing within 28 days post-application.
时间窗: Up-yo 65 days post dressing
Proportion of study participants achieving degradation of the VELNEZ dressing within 60 days post-application.
时间窗: Up-yo 65 days post dressing
次要结局
- Incidence of moderate to severe pain reported by study participants by visit 11/end of study visit.(Occurrence of signs of infection at the site of VELNEZ application among study participants.)
研究者
Dr Ashish Chandra Agarwal
Dr Ram Manohar Lohia Institute of Medical Sciences