CTRI/2019/12/022330招募中3 期
An Open Label, Prospective, Multi-Centric, Pivotal Clinical Investigation to Evaluate the Efficacy, Safety and Tolerability of Twak-M Skin Regeneration Scaffold on Adult Subjects with Second Degree Burns in Comparison with Bovine Collagen Dressing.
Polyskin Life Sciences India Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Adults above the age of 21-65 years (both ages and sexes inclusive) with with second degree burns (flame or
- •scald burns; partial-thickness second-degree burns).
- •2. Partial thickness burns between 4% and 40% Total Body Surface Area (TBSA).
- •3. Subject with ABSI score of 2 -7 at the time of screening (both scores inclusive).
- •4. Subject with burn wound of a minimum of 2 x 6 inches.
- •5. Subject/LAR who is willing to give informed consent for participation, able to comprehend and understand
- •the responsibilities during treatment period and follow up period.
- •6. Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
排除标准
- •1. Subjects with known hypersensitivity to the investigational product or its constituents.
- •2. Subjects with pulmonary burns/inhalation injuries, chemical or electrical burns inclusive of lighting burns.
- •3. Subjects with immunucompromised state complications that may hinder normal wound healing.
- •4. Subjects with psoriasis, or other dermatological conditions close to or on the site of the burn wound,
- •considered for this study.
- •5. Subjects with skin cancer.
- •6. Subject with serious dermatological infection in past three months requiring systemic therapy.
- •7. Subjects with facial melasma, lesions and other types of skin damage that is not psoriasis.
- •8. History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection.
- •9. History of opportunistic infections (e.g., systemic fungal infections, parasites).
- •10. History/diagnosis of diabetes mellitus.
- •11. Any underlying uncontrolled medical illness including hypertension, liver disease or history of alcoholism,
- •HIV, hepatitis, severe cardiovascular, pulmonary, (especially COPD where steroid treatment is required),
- •cerebral, hematologic, neurological or psychiatric disease or any other serious medical illness.
- •12. A known history or present condition of allergic response to any cosmetic products.
- •13. Females who are pregnant or lactating or planning to become pregnant during the study period.
- •14. Subjects, who in the opinion of the Investigator or the Medical Experts are not eligible for enrollment in the study
研究者
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