CTRI/2021/04/032491已完成4 期
A Multi-Center, Prospective, Open label, Single Arm Post Market Surveillance Study toEvaluate the Safety & Efficacy of Silicone Gel Sheet for Scar Management (LysilTM,UrgoScarTM Sheet, Eusil®) in patients with fresh raised hypertrophic or keloid scars - EP-SGS-003_19
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 105
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1. Patients who can understand, follow the specific instructions off the clinic as far as the application, removal, storage and re-application of the study product is concerned in a systematic
- •2.Patient who can and willing to provide written Informed Consent
- •3. Patients with freshly re-epithelialized raised hypertrophic or keloid scars originated after normal wound healing and aged NOT more than 2 months and /or with freshly healed surgical
- •incision wounds resulting in raised hypertrophic or keloid scars aged NOT more than 2 months.
- •4. Patients with hypertrophic or keloid scars of size 13 cm or below in length and 8 cm or below in width (to fit the study product dimension of 15x10 cm)
- •5. Patient who has not taken treatment for hypertrophic or keloid scars from past 4 weeks from the day of screening.
- •6. Patient with hypertrophic or keloid scars on those anatomical areas which are clinically feasible for the application of Silicone Gel Sheet for scar management as per the evaluation of the investigator.
- •7. Patient understands and is willing to participate in the clinical study and can comply with scheduled visits as per the protocol and the follow-up with study procedures.
排除标准
- •1.Patient with known allergy/hypersensitivity to silicone gel sheet or any of the individual polysiloxane components of Silicone Gel Sheet for scar management (Test device).
- •2. Patient having any medical or social condition that would, in the opinion of the investigator, place the subject at an unacceptable risk or render the subject unable to meet the requirements of the protocol.
- •3. Patient with hypertrophic or keloid scars older than 2 months from re-epithelialization (wound closure) as evaluated by the investigator.
- •4. Patients with hypertrophic or keloid scars longer than 13 cm in and wider than 8 cm (to fit the study product dimension of 15x10 cm).
- •5. Patient with body impressions that may appear like hypertrophic or keloid scars but actually do no not fall in those categories as per clinical assessment.
- •6. Patient with pitted and depressed scars as per clinical assessment.
- •7. Patient with Acute Respiratory Syndrome Coronavirus (SARSCoV)-2 infection confirmed by any confirmatory tests
- •8. Patient has participated in another clinical study involvinganother investigational agent within 4 weeks of the start of this trial or is planning participation in another clinical trial during the current study duration.
- •9. Patient with hypertrophic or keloid scars where it is difficult to
- •apply the study product owing to the anatomical contours rendering it difficult for continuous maintenance of the study product.
- •10. Patient who have received hypertrophic or keloid scar treatment within 4 weeks of the first day of study treatment or planning to undergo another parallel treatment for hypertrophic or keloid scars.
- •11. Presence of any condition(s) which seriously compromises the patientâ??s ability to complete this study or has a known history of poor adherence with medical treatment.
研究者
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