Comparing How Burn Wounds and Scars Heal in Children Using Chitosan and Silver Dressings (NCT06987981) | Clinical Trial Compass
RecruitingNot Applicable
Comparing How Burn Wounds and Scars Heal in Children Using Chitosan and Silver Dressings
Slovenia40 participantsStarted 2025-07-21
Plain-language 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).
Who can participate
Age range6 Months – 17 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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)