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

NCT06987981 | Recruiting DMC

• 1 other identifier: CHITAG-25-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Chitosan-based dressing; Silver-based dressing

Outcome Measures

Primary Outcomes (1)

• Wound Healing Time

  To evaluate and compare the wound healing time, measured as the number of days required for complete healing of the study wound, between the treatment groups.

  Up to 21 days

Secondary Outcomes (8)

• Wound Healing Rate

  7, 14, and 21 days

• Complete Wound Healing Rate

  21 days

• Scar Outcomes

  1, 3, and 6 months

• Cost-effectiveness

  21 days

• Professional Experience

  0, 7, 14, and 21 days

Study Arms (2)

Chitosan group

ACTIVE COMPARATOR

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

Device: Chitosan-based dressing

Ag group

ACTIVE COMPARATOR

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

Device: Silver-based dressing

Interventions

Chitosan-based dressing DEVICE

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

Chitosan group

Silver-based dressing DEVICE

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

Ag group

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age between 6 months and 17 years old
• Having a first or second-degree superficial burn that does not require excision and grafting
• Patients with a burn of less than 20% of the total body surface area (TBSA)
• Admission within 72 hours of burn injury
• First line of therapy is Burnshield® Dressing for the first 48 hours
• Clean non-infected wound as diagnosed by the attending physician
• Informed consent of the patient or caregiver

You may not qualify if:

• Causes other than contact burn, flame or scald injuries (i.e., electrical, chemical or frostbite)
• Diabetes mellitus
• Significant cardiac, pulmonary, or renal insufficiency
• Severe hematologic disease, malignancy, hypo-immunity
• Wounds noted to be contaminated or infected
• Systemic inflammatory response syndrome (SIRS) or sepsis
• Moderate or severe respiratory tract or lungs burn injuries
• Previous treatment efforts such as previous debridement, silver sulfadiazine ointment or other topical agents (e.g.: oil, toothpaste, betadine, rivano)
• Being pregnant or breastfeeding
• Known sensitivity or allergy to one of the dressings or its components.

Sponsors & Collaborators

• Miloš Potkonjak: lead
• General Hospital of Novo mesto: collaborator

Study Sites (1)

General Hospital Novo mesto

Novo Mesto, 8000, Slovenia

RECRUITING

Study Officials

• Miloš Potkonjak, MD, surgeon

  General Hospital of Novo mesto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miloš Potkonjak, MD, surgeon

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, surgeon

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 23, 2025
• Study Start: July 21, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: September 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)