CTRI/2023/11/060389已完成Unknown
A Prospective, Non-Comparative, Open-label, Single-arm Clinical Study to Evaluate the efficacy of SCARXGEN in the management of post-surgical scars
Regenxgen Biosolutions Private Limited1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年12月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1. Improvement in scar appearance
研究概览
简要总结
| Silicone Gel Sheet (Brand Name: Scarxgen) is soft, clear, transparent, conformable, re-usable self-adhesive sheet made of medical grade silicone, adhered on release liner. Silicone Gel Sheet is supplied non-sterile in medical grade peel open pouches. The product can be cut to size depending on the size of the scar. Silicone Gel Sheet is biocompatible as per applicable ISO 10993 standards. Scarxgen is indicated for use in prevention and/or management of old and newly formed, red and raised scars (Hypertrophic Scars/Keloids). Scarxgen’s ability to provide semi-occlusion and modulate water vapour transmission to enable hydration to the scar is its key novel feature. Scarxgen offers gentle adhesion to healthy skin, thereby enabling painless and atraumatic removal. Scarxgen is a CE certified Medical Device as per European Medical Device Regulations - EU MDR 2017/745. |
This Clinical Study is aimed at measuring the efficacy of Scarxgen on post-surgical scars with focused on scars developing Post-Orthopedic, Post- Gynecological, Post- General Surgery and Post- Cardio-thoracic surgeries
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 3.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Both Male and female patients aged above 3 years
- •Patients with post-surgical linear hypertrophic scars and/or keloids with Age of Hypertrophic Scars and/keloids between 2 months to 2 years and Size of Scar: Less than 30cm in length (Length < 30cm)
- •Patients who can understand and follow specific instructions of the hospital as far as application, removal, storage, and re-application of the study product in a systematic manner
- •Patients or patients with parents/guardians who can and are willing to provide written informed consent
- •Patient who understands and is willing to participate in the clinical study and can comply with scheduled visits as per the protocol and follow-up study procedures.
排除标准
- •1.Patient with signs of wound dehiscence, wound infection, open wounds in the post-operative area at the time of first application
- •Patient who has received any type of hypertrophic scar or keloid treatment within 4 weeks prior to start of the current study or planning to undergo another parallel treatment for hypertrophic scars or keloids
- •Patients having history of developing genetic keloids
- •Patients with history of collagen vascular disease, connective tissue disease (cutis laxica), systemic psoriasis, lupus or scleroderma
- •Patient with known allergy/ hypersensitivity to medical tapes, or adhesives, silicone gel sheet or any of the individual polysiloxane based products
- •Patients with pitted or depressed scars as per clinical assessment
- •Patients having dermatological conditions (For example: Psoriasis, Eczema etc.)
- •Presence of any condition(s) that seriously compromises the patient’s ability to complete this study or has a known history of poor adherence with medical treatment.
结局指标
主要结局
1. Improvement in scar appearance
时间窗: Screening Period plus 24 weeks of treatment period assessed at Baseline Visit and follow up visits on Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180
2. Effective reduction in total scar size
时间窗: Screening Period plus 24 weeks of treatment period assessed at Baseline Visit and follow up visits on Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180
次要结局
- Adverse Event Monitoring(24 weeks of Study Period)
研究者
Dr Athira Gopinathan
SRM Medical College Hospital & Research Centre
研究点 (1)
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