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Search / Trial NCT06987981

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

Launched by MILOŠ POTKONJAK · May 16, 2025

Trial Information

Current as of July 22, 2025

Not yet recruiting

Keywords

Chitosan Based Dressing Silver Based Dressing

ClinConnect Summary

This clinical trial is looking at how well two different types of dressings help heal burn wounds in children. The dressings being compared are chitosan-based dressings, which come from a natural substance and may help with healing and fighting infection, and silver-based dressings, which are commonly used in burn care. The study will measure how quickly wounds heal, how much scarring occurs, the cost of treatment, and how the children and their families feel about their care.

To participate, children must be between 6 months and 17 years old and have a first or second-degree burn that is not too severe (meaning it doesn't cover more than 20% of their body). They should be admitted to the hospital within 72 hours of getting the burn and have a clean, non-infected wound. If eligible, participants will receive one of the dressings for their burn and will be monitored throughout the healing process. It’s important to note that children with certain health conditions or previous treatments may not be able to join the study.

Gender

ALL

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.

About Miloš Potkonjak

Miloš Potkonjak is a dedicated clinical trial sponsor with a strong commitment to advancing medical research and improving patient outcomes. With extensive experience in the design and management of clinical studies, Potkonjak focuses on innovative therapeutic approaches across various therapeutic areas. His organization emphasizes rigorous ethical standards, robust methodologies, and collaboration with healthcare professionals and regulatory bodies to ensure the highest quality of research. By fostering a patient-centered approach, Potkonjak aims to contribute to the development of effective treatments and enhance the overall landscape of clinical research.

Locations

Novo Mesto, , Slovenia

Patients applied

0 patients applied

Trial Officials

Miloš Potkonjak, MD, surgeon

Principal Investigator

General Hospital of Novo mesto

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported