Comparing chitosan and silver dressings for healing children's superficial burns

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

This trial will try chitosan-based dressings versus silver-based dressings to see which helps children 6 months to 17 years with superficial second-degree burns heal with less scarring.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 6 Months to 17 Years
• Sex: All
• Sponsor: General Hospital of Novo mesto (other)
• Locations: 1 site (Novo Mesto)
• Trial ID: NCT06987981 on ClinicalTrials.gov

What this trial studies

This interventional study enrolls pediatric patients with first- or superficial second-degree burns covering under 20% total body surface area who present within 72 hours of injury. After an initial 48 hours with Burnshield® dressing, participants receive either a chitosan-based hydrogel dressing or a silver-based dressing applied and monitored by the clinical team. Outcomes focus on wound healing dynamics and scar formation, with regular follow-up visits to document closure, infection status, and scar appearance. The trial compares the two dressing types to determine whether the newer chitosan option offers equal or improved healing and scarring outcomes compared with standard silver dressings.

Who should consider this trial

Good fit: Children aged 6 months to 17 years with a clean, non-infected first- or superficial second-degree burn involving less than 20% TBSA and admitted within 72 hours are ideal candidates.

Not a fit: Children with deep (third-degree) burns, burns over 20% TBSA, infected or contaminated wounds, electrical/chemical/frostbite injuries, or significant comorbidities like diabetes or immunosuppression are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, chitosan dressings could offer faster healing and reduced scarring in children with superficial burns using a naturally biocompatible material.

How similar studies have performed: Silver-based dressings are widely used and supported by clinical experience, while chitosan materials have shown promising antibacterial and regenerative effects in preclinical studies and limited clinical reports but remain less extensively tested in pediatric burn scarring.

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.

Where this trial is running

Novo Mesto

• General Hospital Novo mesto — Novo Mesto, Slovenia (RECRUITING)

Study contacts

• Principal investigator: Miloš Potkonjak, MD, surgeon — General Hospital of Novo mesto
• Study coordinator: Miloš Potkonjak, MD, surgeon

Conditions: Burns Degree Second, Pediatric, Chitosan-based dressing, Silver-based dressing