Clinical Study on Twak M Skin Scaffold to Treat Burn Wounds
- Conditions
- Health Condition 1: T313- Burns involving 30-39% of body surface
- Registration Number
- CTRI/2019/12/022330
- Lead Sponsor
- Polyskin Life Sciences India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method