Status:
RECRUITING
Comparing How Burn Wounds and Scars Heal in Children Using Chitosan and Silver Dressings
Lead Sponsor:
Miloš Potkonjak
Collaborating Sponsors:
General Hospital of Novo mesto
Conditions:
Burns Degree Second
Pediatric
Eligibility:
All Genders
6-17 years
Phase:
NA
Brief Summary
Burns are among the most common types of trauma worldwide, ranking fourth after traffic accidents, falls, and violence, and account for an estimated 265,000 deaths annually (WHO). Most burn injuries r...
Eligibility Criteria
Inclusion
- Age between 6 months and 17 years old
- Having a first or second-degree superficial burn that does not require excision and grafting
- Patients with a burn of less than 20% of the total body surface area (TBSA)
- Admission within 72 hours of burn injury
- First line of therapy is Burnshield® Dressing for the first 48 hours
- Clean non-infected wound as diagnosed by the attending physician
- Informed consent of the patient or caregiver
Exclusion
- Causes other than contact burn, flame or scald injuries (i.e., electrical, chemical or frostbite)
- Diabetes mellitus
- Significant cardiac, pulmonary, or renal insufficiency
- Severe hematologic disease, malignancy, hypo-immunity
- Wounds noted to be contaminated or infected
- Systemic inflammatory response syndrome (SIRS) or sepsis
- Moderate or severe respiratory tract or lungs burn injuries
- Previous treatment efforts such as previous debridement, silver sulfadiazine ointment or other topical agents (e.g.: oil, toothpaste, betadine, rivano)
- Being pregnant or breastfeeding
- Known sensitivity or allergy to one of the dressings or its components.
Key Trial Info
Start Date :
July 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06987981
Start Date
July 21 2025
End Date
September 30 2027
Last Update
September 4 2025
Active Locations (1)
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1
General Hospital Novo mesto
Novo Mesto, Slovenia, 8000