Actively Recruiting
A Randomized, Open Label, Two-arm Study Evaluating Burn Wound and Scar Healing Time in Children Using Chitosan-Based vs. Silver-Based Dressings
Led by Miloš Potkonjak · Updated on 2025-09-04
40
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
M
Miloš Potkonjak
Lead Sponsor
G
General Hospital of Novo mesto
Collaborating Sponsor
AI-Summary
What this Trial Is About
Burn injuries are a common form of trauma worldwide, causing significant health challenges, especially in children. This research compares two types of dressings used in treating superficial burns in children aged 6 months to 17 years: chitosan-based dressings and silver-based dressings. The study aims to evaluate their effects on wound healing time, scar formation, cost-effectiveness, and patient experience, using the POSAS (Patient and Observer Scar Assessment Scale) to assess scars. Participants will be randomly assigned to one of two groups. One group will receive treatment with a chitosan-based dressing designed to support wound and scar healing. The other group will use a silver-based dressing followed by a cosmetic lotion. Both treatments are applied after initial care with Burnshield® dressing during the first 48 hours. The study focuses on burns not requiring surgery, with less than 20% of the body surface area affected. During the study, participants will be monitored for up to 21 days to assess wound healing time and rate, with scar evaluation continuing at 1, 3, and 6 months. Researchers will collect data on cost-effectiveness, professional and patient experiences, adverse events, and infection rates. Assessments include clinical evaluation of the wound and scar healing progress to understand which dressing better supports recovery in pediatric burn patients.
CONDITIONS
Brief Title
Comparing How Burn Wounds and Scars Heal in Children Using Chitosan and Silver Dressings
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 6 months and 17 years old
- First or second-degree superficial burn not requiring excision and grafting
- Burn covers less than 20% of total body surface area
- Admission within 72 hours of burn injury
- Burnshield® Dressing used as first line therapy for the first 48 hours
- Clean, non-infected wound as confirmed by the attending physician
- Informed consent obtained from patient or caregiver
You will not qualify if you...
- Burn caused by electrical, chemical, or frostbite injuries
- Diabetes mellitus
- Significant heart, lung, or kidney insufficiency
- Severe blood disorders, cancer, or weakened immune system
- Wounds that are contaminated or infected
- Systemic inflammatory response syndrome (SIRS) or sepsis
- Moderate or severe burns to respiratory tract or lungs
- Previous treatments like debridement, silver sulfadiazine ointment, or other topical agents
- Pregnancy or breastfeeding
- Known allergy or sensitivity to study dressings or their components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 21 days
Participants receive either a chitosan-based dressing or a silver-based dressing followed by a cosmetic lotion to treat their burn wounds and scars.
Multiple visits during the treatment period up to 21 days
Duration - Up to 6 months
Participants are monitored for scar outcomes, patient experience, and rate of infection after treatment ends.
Visits at 1, 3, and 6 months after treatment
Trial Site Locations
Total: 1 location
1
General Hospital Novo mesto
Novo Mesto, Slovenia, 8000
Actively Recruiting
Research Team
M
Miloš Potkonjak, MD, surgeon
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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