Loading clinical trials...

Comparing How Burn Wounds and Scars Heal in Children Using Chitosan and Silver Dressings | Clinical Trials | Clareo Health

RECRUITINGNA

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

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

NCT06987981•Miloš Potkonjak

View on ClinicalTrials.gov

Summary

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).

Eligibility

Age

0 - 17 years

Sex

ALL

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.

Locations (1)

General Hospital Novo mesto

Novo Mesto, Slovenia

Key Dates

Start Date

July 21, 2025

Primary Completion Date

April 30, 2027

Completion Date

September 30, 2027

Last Updated

September 4, 2025

Enrollment

ESTIMATED participants

Conditions

Burns Degree SecondPediatric

Interventions

Chitosan-based dressing

DEVICE

Silver-based dressing

DEVICE

Contacts

Miloš Potkonjak, MD, surgeon

CONTACT

+386 7 391 61 00 milos.potkonjak@sb-nm.si

Transcutaneous pO₂ Monitoring in PICU

NCT07478380

Pediatric Critical Illness

View study

RECRUITINGPHASE1

Haploidentical Hematopoietic Stem Cell Transplantation With Ex Vivo TCR Alpha/Beta and CD19 Depletion in Pediatric Hematologic Malignancies

NCT05011422

Pediatric Hematologic Malignancies

View study

RECRUITINGPHASE2/PHASE3

Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS

NCT05267821

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Transcutaneous pO₂ Monitoring in PICU

Haploidentical Hematopoietic Stem Cell Transplantation With Ex Vivo TCR Alpha/Beta and CD19 Depletion in Pediatric Hematologic Malignancies

Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS

Transversalis Fascia Plane Versus Transversus Abdominis Plane Block for Postoperative Analgesia in Children

COPM-Based Goal Setting Strategies in the PICU

CD45RA-depleted CD19-CAR T Cell Consolidation After TCRαβ+/CD19 B Cell-depleted Haploidentical Hematopoietic Cell Transplantation for Relapsed/Refractory CD19+ ALL and Lymphoma