Comparing How Burn Wounds and Scars Heal in Children Using Chitosan and Silver Dressings
A Randomized, Open Label, Two-arm Study: Evaluation of Burn Wound and Scar Healing Time in Paediatric Burn Patients Using Chitosan-Based vs. Silver-Based Dressings
Miloš Potkonjak
40 participants
Jul 21, 2025
INTERVENTIONAL
Conditions
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 result from heat exposure, though other causes include friction, chemicals, and electricity. Effective burn treatment aims to promote wound healing by supporting tissue regeneration and maintaining optimal conditions such as moisture, oxygenation, and low bacterial load. In Slovenia and across Europe, silver-based dressings are commonly used for burn care. While they are known to support wound healing, their effectiveness in reducing scar formation remains unclear. Chitosan-based hydrogels, by contrast, offer promising benefits due to their natural biocompatibility, antibacterial action, and support for tissue repair, though clinical data are still limited. This study aims to compare the effectiveness of chitosan-based and silver-based dressings in burn wound healing, focusing on healing time, scar formation, cost-efficiency, and patient experience. Scar outcomes will be assessed using the validated POSAS (Patient and Observer Scar Assessment Scale).
Eligibility
Inclusion Criteria7
- 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 Criteria10
- 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.
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Interventions
Chitosan-based dressing for wound and scar treatment will be used (e.g. ChitoCare® medical Wound Healing Gel)
Silver-based dressing (e.g. AQUACEL® Ag), followed by a cosmetic lotion (e.g.: Bepanthol® DERMA) will be used
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06987981