A multi centric, Open label, double arm, randomized, comparative clinical study to evaluate safety and tolerability of VELNEZ® with Gelatin based space occupying dressing after middle ear surgery.
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- • Incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs) within 60 days post-surgery.
研究概览
简要总结
Middle ear surgeries—such as stapedotomy, tympanoplasty, and myringotomy—require careful postoperative management to ensure optimal healing and restoration of auditory function. Maintaining a clean, dry, and microbe-free ear canal is essential, as moisture and irritants can hinder recovery. Traditional postoperative dressings often adhere strongly to the wound bed, which may cause reactive bleeding and increase the risk of infection during removal.
To overcome these limitations, the VELNEZ® space-occupying dressing pack has been introduced as an innovative alternative. VELNEZ® is a biodegradable composite that naturally disintegrates within a few days of placement, eliminating the need for painful or traumatic removal. Its design supports reduced fibrosis, enhanced healing, and improved clotting, contributing to smoother postoperative outcomes in middle ear surgeries.
In contrast, gelatin-based dressings are sterile, compressed, porcine-derived absorbable sponges used primarily as hemostatic agents. They effectively control capillary, venous, and arteriolar bleeding when conventional methods are insufficient. These dressings are water-insoluble, pliable, and easily cut without fraying. Their high absorbency allows them to take up several times their weight in blood, promoting clot formation and gradual absorption within tissue without significant tissue reaction.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female participants in the age group of 18 to 65 years.
- •(Both Included).
- •Participant is confirmed diagnosis of inactive Chronic Suppurative Otitis Media (CSOM) (no ear discharge for at least 2 months).
- •Participant for the use of ear dressing pack (either VELNEZ® or Gelatin based dressing) in routine clinical practice after a planned otologic surgery for middle ear.
- •Participant who can provide informed consent form in writing or through his LAR.
- •Participants who are able and willing to comply with all study procedures and allow their study data to be collected at pre-defined follow-up period/ time and used for study objectives.
排除标准
- •Participants who are unable to be treated with either VELNEZ® or Gelatin based dressing in routine clinical practice after a planned middle ear surgery.
- •Participant who cannot provide written informed consent for data collection.
- •Participant who will unwilling or unable to comply with the postoperative visits necessary for data collection.
- •Participant with a sign of active infection at the site of surgery [Presence of active middle ear infection or otorrhea (ear discharge).]
- •Participant having history of previous ear surgery on the same ear planned for the study procedure.
- •Participant with uncontrolled cholesteatoma, malignant otologic tumors, complications of chronic ear disease.
- •Participation in another interventional clinical trial within 30 days prior to screening or during the study period.
- •Pregnant and nursing women.
- •Participant with uncontrolled hypertension.
- •Participants who have a history of allergy (Hypersensitive) reactions with any of the ingredients of the device (VELNEZ® / Gelatin based dressing) i.e., Chitosan, Gelatin and Psyllium husk etc.
- •Participant with bleeding disorders or is on anticoagulants or antiplatelet medications (e.g., warfarin, clopidogrel, NOACs).
- •Any medical condition that, in the opinion of the investigator, would make the participant unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study) or Presence of severe systemic illness like cardiovascular disease, liver dysfunction or psychiatric illness.
- •Participant with history of postoperative recurrent infections and participants with bleeding diathesis.
- •Participant testing positive for serological markers indicating systemic infection (e.g., HIV, hepatitis B/C).
- •Participant with medical conditions known to impair healing, including:.
结局指标
主要结局
• Incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs) within 60 days post-surgery.
时间窗: 60 ± 5 Days post surgery.
• Time to complete degradation of the dressing, assessed via tympanometry
时间窗: 60 ± 5 Days post surgery.
次要结局
- • Percentage of participants with successful graft uptake (complete tympanic membrane closure) at day 10, 20, 30, 45 and 60 days.(• Observation of non-adhesion properties of the ear dressing in the ear mucosa accessed through the outer ear side.)
研究者
Dr Akhil Pratap Singh
S.N Medical College, Agra