Burns Degree SecondCHITAGNCT06987981
Comparing How Burn Wounds and Scars Heal in Children Using Chitosan and Silver Dressings
A study testing Chitosan-based dressing and Silver-based dressing in people with Burns Degree Second and Pediatric, run by Miloš Potkonjak at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Burns Degree Second, Pediatric
- What is being tested?
- Chitosan-based dressing and Silver-based dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSlovenia
- Study dates
- 21 Jul 2025to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site, 1 recruiting
- Recruiting
General Hospital Novo mesto
Novo Mesto, 8000
Ljubinka Počrvina, Head of project-research and quality office, +386 7 391 61 00, ljubinka.pocrvina@sb-nm.si
Miloš Potkonjak, MD, surgeon
About this study
Official 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
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
- Being tested
- Chitosan-based dressing, Silver-based dressing
- Keywords
- Chitosan-based dressing, Silver-based dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chitosan-based dressingDevice
Chitosan-based dressing for wound and scar treatment will be used (e.g. ChitoCare® medical Wound Healing Gel)
Silver-based dressingDevice
Silver-based dressing (e.g. AQUACEL® Ag), followed by a cosmetic lotion (e.g.: Bepanthol® DERMA) will be used
| Study group | Role | What they receive |
|---|---|---|
| Chitosan group | Active comparator | Chitosan group - using chitosan-based dressing for wound and scar treatment Receives: Device: Chitosan-based dressing |
| Ag group | Active comparator | Ag group - using silver-based dressing, followed by a cosmetic lotion Receives: Device: Silver-based dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 21 days
Secondary outcomes (8)
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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."
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start21 Jul 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burns Degree SecondStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Miloš Potkonjak
- Sponsor type
- University, hospital or other
- Collaborators
- General Hospital of Novo mesto
- Responsible party
- Sponsor-investigator, Miloš Potkonjak, General Hospital of Novo mesto
- Investigators
- Miloš Potkonjak, MD, surgeon, Principal investigator, General Hospital of Novo mesto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987981
- Sponsor's protocol ID
- CHITAG-25-01
- Acronym
- CHITAG
- Status last verified
- May 2025
- First submitted
- 9 May 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As an Institution operating under the jurisdiction of the European Union, we are subject to the General Data Protection Regulation (GDPR), which imposes strict requirements on the processing and sharing of personal data, including health-related information. IPD from clinical trials is considered sensitive personal data under GDPR. Even when data is anonymized or pseudonymized, sharing IPD with third parties-especially outside the EU-requires careful assessment of data protection safeguards, appropriate legal basis, and in some cases, additional participant consent. Unless all conditions for lawful data transfer and processing are met, including compliance with GDPR Articles 44-50 concerning international data transfers, we are not permitted to share IPD. For this reason, and in order to ensure full compliance with EU data protection regulations and to protect the privacy and rights of our study participants, we are currently unable to share individual-level clinical trial data.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06987981
- Acronym / sponsor ID
- CHITAG / CHITAG-25-01
- Conditions
- Burns Degree Second, Pediatric
- Keywords
- Chitosan-based dressing, Silver-based dressing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Miloš PotkonjakUniversity, hospital or other
- Collaborators
- General Hospital of Novo mesto
- Study start
- 21 Jul 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 23 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chitosan group | Active comparator | Device: Chitosan-based dressingChitosan group - using chitosan-based dressing for wound and scar treatment |
| Ag group | Active comparator | Device: Silver-based dressingAg group - using silver-based dressing, followed by a cosmetic lotion |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chitosan-based dressingChitosan-based dressing for wound and scar treatment will be used (e.g. ChitoCare® medical Wound Healing Gel) | Device | Chitosan group |
| Silver-based dressingSilver-based dressing (e.g. AQUACEL® Ag), followed by a cosmetic lotion (e.g.: Bepanthol® DERMA) will be used | Device | Ag group |
Primary outcome
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.
8 secondary outcomes
Wound Healing Rate
Time frame: 7, 14, and 21 days
Complete Wound Healing Rate
Time frame: 21 days
Scar Outcomes
Time frame: 1, 3, and 6 months
Cost-effectiveness
Time frame: 21 days
Professional Experience
Time frame: 0, 7, 14, and 21 days
Patient Experience
Time frame: 0, 7, 14 and 21 days, and 1, 3, and 6 months
Adverse Events
Time frame: up to 21 days
Rate of Infection
Time frame: up to 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No. As an Institution operating under the jurisdiction of the European Union, we are subject to the General Data Protection Regulation (GDPR), which imposes strict requirements on the processing and sharing of personal data, including health-related information. IPD from clinical trials is considered sensitive personal data under GDPR. Even when data is anonymized or pseudonymized, sharing IPD with third parties-especially outside the EU-requires careful assessment of data protection safeguards, appropriate legal basis, and in some cases, additional participant consent. Unless all conditions for lawful data transfer and processing are met, including compliance with GDPR Articles 44-50 concerning international data transfers, we are not permitted to share IPD. For this reason, and in order to ensure full compliance with EU data protection regulations and to protect the privacy and rights of our study participants, we are currently unable to share individual-level clinical trial data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Miloš Potkonjak, MD, surgeon principal investigator
General Hospital of Novo mesto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chitosan-based dressing and Silver-based dressing in people with Burns Degree Second and Pediatric, run by Miloš Potkonjak at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miloš Potkonjak, MD, surgeon (+386 7 391 61 00, milos.potkonjak@sb-nm.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Healing Time (time frame: Up to 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.