IRCT20210414050966N1
Recruiting
Phase 1
Safety and efficacy assessment of Polyurethane film for healing superficial second-degree (partial thickness) burns: Phase 1 clinical trial
Avicenna Center of Excellence0 sites10 target enrollmentTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Avicenna Center of Excellence
- Enrollment
- 10
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Female or male between 18 and 60 years old
- •Second\-degree burn that are expected to heal in two to three weeks.
- •Burns have been caused by contact with a heat source or hot liquids.
- •Total body surface area in burns (TBSA) between10% \- 25% based on Lund and Browder chart
- •Burned within the first 72 hours.
- •No signs of infection in the wound
Exclusion Criteria
- •Presence of Underlying Medical Conditions such as dermatosis, allergy, cancer, renal failure, anemia, diabetes, cardiovascular disease, malignancy, immunodeficiency
- •Injury to burn wounds during care
- •Subjects with systemic infections receiving antibiotic treatment
- •Need to consumption immunosuppressive drugs?, Corticosteroids, chemotherapy, and radiation therapy during the experiment
- •Subjects declined participation and no referral to the hospital for continuing the treatment
- •Pregnancy, breastfeeding, and presence of trauma
Outcomes
Primary Outcomes
Not specified
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