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NCT Number: NCT06987981

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

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).

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Key information

Age range

6 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Hospital Novo mesto

Novo Mesto, 8000, Slovenia

Location status: Recruiting

Location contact

Ljubinka Počrvina, Head of project-research and quality office

CONTACT

[email protected]

+386 7 391 61 00

Miloš Potkonjak, MD, surgeon

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Chitosan-based dressing

Device

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

Silver-based dressing

Device

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

Primary outcomes

  1. Wound Healing Time

    Time frame: Up to 21 days

    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.

Secondary outcomes

  1. Wound Healing Rate

    Time frame: 7, 14, and 21 days

    To evaluate and compare the wound healing rate, calculated as the ratio of the healed wound area to the initial wound area, at 7, 14, and 21 days of treatment

  2. Complete Wound Healing Rate

    Time frame: 21 days

    To assess and compare the percentage of patients achieving complete wound healing within 21 days of treatment

  3. Scar Outcomes

    Time frame: 1, 3, and 6 months

    To evaluate and compare scar outcomes of treated burn wounds using a validated scar assessment tool Patient and Observer Scar Assessment Scale (POSAS) at 1 month, 3 months, and 6 months after injury. POSAS measures subjective assessment on a 1-10 scale from normal skin to worst scar imaginable across 6 metrics (surface area, vascularity, pigmentation, thickness, pliability and relief). The lowest sum score, reflecting normal skin, is 6 and the highest score, reflecting the worst imaginable scar, is 60.

  4. Cost-effectiveness

    Time frame: 21 days

    To assess the cost-effectiveness of the treatment (e.g.: number of dressing changes required, number of hospital visits, costs of additional therapies related to wound healing (e.g., pain relievers)), at 21 days of treatment.

  5. Professional Experience

    Time frame: 0, 7, 14, and 21 days

    Medical staff will complete a survey consisting of 4 items evaluating their experience with the selected therapy. The survey includes questions addressing the complexity of the wound care therapy-such as its application, removal, and time requirements-as well as overall satisfaction. Responses will be collected using a combination of Yes/No/Not sure options and a Visual Analogue Scale (VAS), where 0 indicates "Not at all" and 5 indicates "Very much."

  6. Patient Experience

    Time frame: 0, 7, 14 and 21 days, and 1, 3, and 6 months

    Patients will complete a survey consisting of 4 to 7 items evaluating their experience with the burn wound or scar treatment procedure. The survey includes questions related to patient satisfaction, which are a combination of Yes/No/Not sure responses and a visual analogue scale (VAS), where 0 represents "Not at all" and 5 represents "Very much." Additionally, questions addressing the patient's response to treatment use face scale items scored from 0 to 10, assessing symptoms such as pain, heat, itching, and irritation. A score of 0 corresponds to "Not at all," while a score of 10 indicates "Very much," with higher scores reflecting greater intensity of the respective symptom.

  7. Adverse Events

    Time frame: up to 21 days

    To assess the proportion of patients who experience adverse events associated with the dressing, from the time of admission up to 21 days of treatment.

  8. Rate of Infection

    Time frame: up to 1 month

    To evaluate the rate of infection in burn wounds, defined as the number of infected wounds divided by the total number of burn wounds, assessed at each study visit up to 1 month of treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Miloš Potkonjak, MD, surgeon

CONTACT

[email protected]

+386 7 391 61 00

Sponsors and collaborators

Lead sponsor

Miloš Potkonjak

Other

Collaborators

  • General Hospital of Novo mesto

Registry information

Official study title

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

Acronym: CHITAG

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 23, 2025
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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