Health Condition 1: T313- Burns involving 30-39% of body surface
Conditions
Interventions
Intervention1: Twak M Skin Regeneration Scaffold.: Intra Individual study. All subjects will be treated with Test IMD and Comparator on different part of their burn wounds for the treatment duration o
Sponsors
Polyskin Life Sciences India Pvt Ltd
Aurous HealthCare Research and Development India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Modified Photographic Wound Assessment Tool: Total score of â?¤12 by end of study.Timepoint: 1. Modified Photographic Wound Assessment Tool: Day 1, Day 10, Day 20, Day 30, Day 60, Day 90. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain Scale : Reduction of â?¥3 scores 2. POSAS Observer : Total score of â?¤30 3. POSAS Patient : Total score of â?¤35 4. Total Score of POSAS : Total score of â?¤65 5. Dermatology Life Quality of Index: Total Score of â?¤ 6 - 10Timepoint: 1. Pain Scal : Day 1, Day 10, Day 20, Day 30, Day 60, Day 90. 2. POSAS Observer, 3. POSAS Patient, 4. Total Score of POSAS.5. Dermatology Life Quality of Index : Day 10, Day 20, Day 30, Day 60, Day 90. | — |
Countries
India
Contacts
Public ContactDr VT Sriraam
Aurous HealthCare Research and Development India Pvt Ltd
Outcome results
None listed