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

Safety and efficacy assessment of Polyurethane film for healing superficial second-degree (partial thickness) burns: Phase 1 clinical trial

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210414050966N1
Enrollment
10
Registered
2021-09-09
Start date
2021-10-23
Completion date
Unknown
Last updated
2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burn of superficial second-degree. Burn of second degree, body region unspecified

Interventions

For patients with second-degree burn, at first blisters and dead tissue are removed and the wound area is washed with a disinfectant solution (such as hexisept (chlorhexidine), actiniscept, or 0.5% so

Sponsors

Avicenna Center of Excellence
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSayed Mohammad Razavi

Esfahan University of Medical Sciences

razavi@dnt.mui.ac.ir+98 31 3792 5579

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026