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

Официальное название

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

Обзор

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).

Вмешательства

• Устройство Chitosan-based dressing
  Chitosan-based dressing for wound and scar treatment will be used (e.g. ChitoCare® medical Wound Healing Gel)
• Устройство Silver-based dressing
  Silver-based dressing (e.g. AQUACEL® Ag), followed by a cosmetic lotion (e.g.: Bepanthol® DERMA) will be used

Первичные конечные точки

• Wound Healing Time [Срок оценки: Up to 21 days]

Вторичные конечные точки (8)

• Wound Healing Rate [Срок оценки: 7, 14, and 21 days]
• Complete Wound Healing Rate [Срок оценки: 21 days]
• Scar Outcomes [Срок оценки: 1, 3, and 6 months]
• Cost-effectiveness [Срок оценки: 21 days]
• Professional Experience [Срок оценки: 0, 7, 14, and 21 days]
• Patient Experience [Срок оценки: 0, 7, 14 and 21 days, and 1, 3, and 6 months]
• Adverse Events [Срок оценки: up to 21 days]
• Rate of Infection [Срок оценки: up to 1 month]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Словения · 1 центр

• General Hospital Novo mesto — Novo Mesto

Идентификаторы

NCT: NCT06987981 · CHITAG-25-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗