Comparing How Burn Wounds and Scars Heal in Children Using Chitosan and Silver Dressings (CHITAG)

Miloš Potkonjak

Status: Enrolling

Conditions: Burns Degree Second; Pediatric

Treatments: Device: Silver-based dressing; Device: Chitosan-based dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT06987981

CHITAG-25-01

Details and patient eligibility

About

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).

Enrollment: 40 estimated patients

Sex: All

Ages: 6 months to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Chitosan group

Active Comparator group

Description:

Chitosan group - using chitosan-based dressing for wound and scar treatment

Treatment:

Device: Chitosan-based dressing

Ag group

Active Comparator group

Description:

Ag group - using silver-based dressing, followed by a cosmetic lotion

Treatment:

Device: Silver-based dressing