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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Chitosan-based dressing for wound and scar treatment will be used (e.g. ChitoCare® medical Wound Healing Gel)
Silver-based dressing (e.g. AQUACEL® Ag), followed by a cosmetic lotion (e.g.: Bepanthol® DERMA) will be used
General Hospital Novo mesto
Novo Mesto, Slovenia
RECRUITINGWound 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.
Time frame: Up to 21 days
Wound Healing Rate
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
Time frame: 7, 14, and 21 days
Complete Wound Healing Rate
To assess and compare the percentage of patients achieving complete wound healing within 21 days of treatment
Time frame: 21 days
Scar Outcomes
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.
Time frame: 1, 3, and 6 months
Cost-effectiveness
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.
Time frame: 21 days
Professional Experience
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."
Time frame: 0, 7, 14, and 21 days
Patient Experience
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.
Time frame: 0, 7, 14 and 21 days, and 1, 3, and 6 months
Adverse Events
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.
Time frame: up to 21 days
Rate of Infection
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.
Time frame: up to 1 month
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