Clinical trial NCT06987981: Comparing How Burn Wounds and Scars Heal in Children Using Chitosan and Silver Dressings
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Burns Degree Second
Pediatric
Keywords: Chitosan-based dressing
Silver-based dressing
Lead sponsor: General Hospital of Novo mesto
Sponsor class: OTHER
Collaborators: name: General Hospital of Novo mesto
First posted: 2025-05-23
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 criteria: Inclusion Criteria:

1. Age between 6 months and 17 years old
2. Having a first or second-degree superficial burn that does not require excision and grafting
3. Patients with a burn of less than 20% of the total body surface area (TBSA)
4. Admission within 72 hours of burn injury
5. First line of therapy is Burnshield® Dressing for the first 48 hours
6. Clean non-infected wound as diagnosed by the attending physician
7. Informed consent of the patient or caregiver

Exclusion Criteria:

1. Causes other than contact burn, flame or scald injuries (i.e., electrical, chemical or frostbite)
2. Diabetes mellitus
3. Significant cardiac, pulmonary, or renal insufficiency
4. Severe hematologic disease, malignancy, hypo-immunity
5. Wounds noted to be contaminated or infected
6. Systemic inflammatory response syndrome (SIRS) or sepsis
7. Moderate or severe respiratory tract or lungs burn injuries
8. Previous treatment efforts such as previous debridement, silver sulfadiazine ointment or other topical agents (e.g.: oil, toothpaste, betadine, rivano)
9. Being pregnant or breastfeeding
10. Known sensitivity or allergy to one of the dressings or its components.

Primary outcomes:
measure: Wound Healing Time
timeFrame: Up to 21 days
Secondary outcomes:
measure: Wound Healing Rate
timeFrame: 7, 14, and 21 days
measure: Complete Wound Healing Rate
timeFrame: 21 days
measure: Scar Outcomes
timeFrame: 1, 3, and 6 months
measure: Cost-effectiveness
timeFrame: 21 days
measure: Professional Experience
timeFrame: 0, 7, 14, and 21 days
measure: Patient Experience
timeFrame: 0, 7, 14 and 21 days, and 1, 3, and 6 months
measure: Adverse Events
timeFrame: up to 21 days
measure: Rate of Infection
timeFrame: up to 1 month
Other outcomes:
Locations:
city: Novo mesto
country: Slovenia
facility: General Hospital Novo mesto
Study officials:
affiliation: General Hospital of Novo mesto
name: Miloš Potkonjak, MD, surgeon
role: PRINCIPAL_INVESTIGATOR
References: