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

NCT ID: NCT06987981

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-21
• Study Completion Date: 2027-09-30

Brief 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).

Conditions

Burns Degree Second; Pediatric

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chitosan group

Chitosan group - using chitosan-based dressing for wound and scar treatment

Group Type: ACTIVE_COMPARATOR

Chitosan-based dressing

Intervention Type: DEVICE

Chitosan-based dressing for wound and scar treatment will be used (e.g. ChitoCare® medical Wound Healing Gel)

Ag group

Ag group - using silver-based dressing, followed by a cosmetic lotion

Group Type: ACTIVE_COMPARATOR

Silver-based dressing

Intervention Type: DEVICE

Silver-based dressing (e.g. AQUACEL® Ag), followed by a cosmetic lotion (e.g.: Bepanthol® DERMA) will be used

Interventions

Chitosan-based dressing

Chitosan-based dressing for wound and scar treatment will be used (e.g. ChitoCare® medical Wound Healing Gel)

Intervention Type: DEVICE

Silver-based dressing

Silver-based dressing (e.g. AQUACEL® Ag), followed by a cosmetic lotion (e.g.: Bepanthol® DERMA) will be used

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

General Hospital of Novo mesto

OTHER

Sponsor Role: collaborator

Miloš Potkonjak

OTHER

Sponsor Role: lead

Responsible Party

Miloš Potkonjak

MD, surgeon

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Miloš Potkonjak, MD, surgeon

Role: PRINCIPAL_INVESTIGATOR

General Hospital of Novo mesto

Locations

General Hospital Novo mesto

Novo Mesto, , Slovenia

Site Status: RECRUITING

Countries

Slovenia

Central Contacts

Miloš Potkonjak, MD, surgeon

Role: CONTACT

milos.potkonjak@sb-nm.si

+386 7 391 61 00

Facility Contacts

Ljubinka Počrvina, Head of project-research and quality office

Role: primary

ljubinka.pocrvina@sb-nm.si

+386 7 391 61 00

Other Identifiers

CHITAG-25-01

Identifier Type: -

Identifier Source: org_study_id