Comparing How Burn Wounds and Scars Heal in Children Using Chitosan and Silver Dressings
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Chitosan-based dressing, Silver-based dressing.
- Who it may be relevant to
- Registry conditions: Burns Degree Second, Pediatric. Basic parameters: 6 months — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Slovenia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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).
Interventions
- Device Chitosan-based dressing
Chitosan-based dressing for wound and scar treatment will be used (e.g. ChitoCare® medical Wound Healing Gel) - Device Silver-based dressing
Silver-based dressing (e.g. AQUACEL® Ag), followed by a cosmetic lotion (e.g.: Bepanthol® DERMA) will be used
Primary outcome measures
- Wound Healing Time [Time frame: Up to 21 days]
Secondary outcome measures (8)
- Wound Healing Rate [Time frame: 7, 14, and 21 days]
- Complete Wound Healing Rate [Time frame: 21 days]
- Scar Outcomes [Time frame: 1, 3, and 6 months]
- Cost-effectiveness [Time frame: 21 days]
- Professional Experience [Time frame: 0, 7, 14, and 21 days]
- Patient Experience [Time frame: 0, 7, 14 and 21 days, and 1, 3, and 6 months]
- Adverse Events [Time frame: up to 21 days]
- Rate of Infection [Time frame: up to 1 month]
Eligibility criteria
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)
- Being pregnant or breastfeeding
- Known sensitivity or allergy to one of the dressings or its components.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Slovenia · 1 center
- General Hospital Novo mesto — Novo Mesto
Identifiers
NCT: NCT06987981 · CHITAG-25-01