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Safety and efficacy assessment of Polyurethane film for healing superficial second-degree burns

Phase 1
Recruiting
Conditions
Burn of superficial second-degree.
Burn of second degree, body region unspecified
T30.2
Registration Number
IRCT20210414050966N1
Lead Sponsor
Avicenna Center of Excellence
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
10
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

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Inflammation. Timepoint: Daily. Method of measurement: Based on the physician's observation.;Itching and burning. Timepoint: Daily. Method of measurement: According to the VAS criteria.
Secondary Outcome Measures
NameTimeMethod
Healing time. Timepoint: Daily. Method of measurement: Based on the physician's observation.;Amount of pain. Timepoint: Daily. Method of measurement: According to the VAS criteria.;Color of burn wound. Timepoint: Daily. Method of measurement: Based on the physician's observation.;Amount of exudate. Timepoint: Daily. Method of measurement: Based on the physician's observation.
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