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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: milos.potkonjak@sb-nm.si
• Phone: +386 7 391 61 00

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.