Pediatric BurnsNCT06971562
Silver in Partial Thickness Pediatric Burns
A study testing Aquacel AG and Aquacel in people with Pediatric Burns, run by IWK Health Centre at 1 site in Canada.
Trial summary
Most burns in children are due to scalds and with proper dressings will heal on their own without the need for surgery such as skin grafting. Many current burn dressings contain silver which is felt to reduce the risk of infection. Unfortunately, when applied to burns, silver causes pain and may actually slow healing. Read more about this study
- Who is it for?
- Ages Up to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Burns
- What is being tested?
- Aquacel AG and Aquacel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 3 May 2017to 10 May 2025
- 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 Up to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- <16 years old
- partial thickness thermal (scald, contact, fire) burns up to 25% TBSA on the trunk and extremities
- presenting < 72 hours after injury
Who cannot join
- mixed burn pattern (combination of partial and full thickness burn) or full thickness burns requiring surgery at either anatomic sites.
- isolated burns to perineum, hands, or feet allergy to silver
- concomitant injury (eg.fractures)
- inhalational injury
- chemical burn
- electrical burn
- unable to understand English or French
- have not had a silver-based wound dressing applied prior to presentation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Silver on Re-epithelialization, Infection and Hypertrophic Scarring of Partial Thickness Burns in Pediatric Patients: A Randomized Controlled Trial
Most burns in children are due to scalds and with proper dressings will heal on their own without the need for surgery such as skin grafting. Many current burn dressings contain silver which is felt to reduce the risk of infection. Unfortunately, when applied to burns, silver causes pain and may actually slow healing. The aim of this study is to compare the time it takes for less severe burns in children to heal when they are treated with two forms of the same dressing, one that contains silver and another that does not. In addition, we will check to see if there is a difference between dressings in terms of the risk of infection and the quality of the healed skin.
Read the detailed description
This randomized controlled single-blind trial will examine the effect of silver in dressings to healing of superficial partial thickness burns in a pediatric population. Briefly, patients under the age of 16 with <25% total body surface area (TBSA) superficial partial thickness burns not exclusively to the perineum, face, hands, or feet, no inhalational, chemical or electrical burns and no other concomitant injuries presenting to the plastic surgery service < 72 hours after injury will be eligible to receive a hydrocellulose dressing either without (Aquacel) or with silver (Aquacel AG) to their burns. Patients will be excluded if they have a documented allergy to silver. Demographic and clinical information (including mechanism of injury and area involved) will be collected after informed consent is obtained. Photographs and surface area of the burned area will be recorded using an app (LesionMeter, version 1.1). Using a computer generated block randomization sequence, patients will either have Aquacel or Aquacel AG applied to their burn by a burn nurse. Patients then follow-up in clinic 7-10 days later to assess the extent of re-epithelialization. As the Aquacel dressing separates from skin once it has re-epithelialized, the extent of non-healed burn will be assessed by the plastic surgeon blinded to the patient's treatment group by assessing the amount of dressing still adherent once it has been trimmed. Follow-up is then performed every two days after the initial dressing until the dressing has completely separated. Subsequent follow-up visits are then performed at 3 and 6 months after injury during which a Vancouver Scar Scale assessment is performed by an occupational therapist blinded to the treatment group of the patient. The primary outcome will be time-to-re-epithelialization in days, with secondary outcomes including rate of infection per treatment group and difference in mean Vancouver Scar Scale scores at 3- and 6-month follow-ups.
- Conditions
- Pediatric Burns
- Being tested
- Aquacel AG, Aquacel
- Keywords
- silver, burn dressing, re-epithelialization, scarring, infection
- Medical subject headings
- Cicatrix, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquacel AGDevice
Hydrocellulose wound dressing containing 1.2% cationic silver
AquacelDevice
Hydrocellulose wound dressing
| Study group | Role | What they receive |
|---|---|---|
| Aquacel | Active comparator | Aquacel hydrocellulose-based dressing applied to partial thickness burns Receives: Device: Aquacel |
| Aquacel AG | Active comparator | Aquacel AG is identical in base composition to Aquacel (ie a hydrocellulose-based wound dressing which adheres to the raw wound surface) but contains 1.2% cationic silver. Receives: Device: Aquacel AG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-to-re-epithelialization
Time (in days) for complete re-epithelialization of the burn to which the dressing was applied
Measured: 10-21 days
Secondary outcomes (2)
Rate of infection
Incidence of infection in each study arm
Measured: 3 months
Vancouver Scar Scale (VSS) score
Mean cumulative VSS score for each Arm.
Measured: 3 and 6 months post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start3 May 2017
- Primary completion10 May 2025 (estimated)
- Study completion10 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric BurnsStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- IWK Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Bezuhly, IWK Health Centre
- Investigators
- Michael Bezuhly, MD, MSc, SM, FRCSC, Principal investigator, IWK Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971562
- Sponsor's protocol ID
- 1022040
- Status last verified
- May 2025
- First submitted
- 6 May 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Silver on Re-epithelialization, Infection and Hypertrophic Scarring of Partial Thickness Burns in Pediatric Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06971562
- Acronym / sponsor ID
- 1022040
- Conditions
- Pediatric Burns
- Keywords
- silver, burn dressing, re-epithelialization, scarring, infection
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Study start
- 3 May 2017 (actual)
- Primary completion
- 10 May 2025 (estimated)
- Study completion
- 10 May 2025 (estimated)
- First posted
- 14 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.
Most burns in children are due to scalds and with proper dressings will heal on their own without the need for surgery such as skin grafting. Many current burn dressings contain silver which is felt to reduce the risk of infection. Unfortunately, when applied to burns, silver causes pain and may actually slow healing. The aim of this study is to compare the time it takes for less severe burns in children to heal when they are treated with two forms of the same dressing, one that contains silver and another that does not. In addition, we will check to see if there is a difference between dressings in terms of the risk of infection and the quality of the healed skin.
Detailed description
This randomized controlled single-blind trial will examine the effect of silver in dressings to healing of superficial partial thickness burns in a pediatric population. Briefly, patients under the age of 16 with <25% total body surface area (TBSA) superficial partial thickness burns not exclusively to the perineum, face, hands, or feet, no inhalational, chemical or electrical burns and no other concomitant injuries presenting to the plastic surgery service < 72 hours after injury will be eligible to receive a hydrocellulose dressing either without (Aquacel) or with silver (Aquacel AG) to their burns. Patients will be excluded if they have a documented allergy to silver. Demographic and clinical information (including mechanism of injury and area involved) will be collected after informed consent is obtained. Photographs and surface area of the burned area will be recorded using an app (LesionMeter, version 1.1). Using a computer generated block randomization sequence, patients will either have Aquacel or Aquacel AG applied to their burn by a burn nurse. Patients then follow-up in clinic 7-10 days later to assess the extent of re-epithelialization. As the Aquacel dressing separates from skin once it has re-epithelialized, the extent of non-healed burn will be assessed by the plastic surgeon blinded to the patient's treatment group by assessing the amount of dressing still adherent once it has been trimmed. Follow-up is then performed every two days after the initial dressing until the dressing has completely separated. Subsequent follow-up visits are then performed at 3 and 6 months after injury during which a Vancouver Scar Scale assessment is performed by an occupational therapist blinded to the treatment group of the patient. The primary outcome will be time-to-re-epithelialization in days, with secondary outcomes including rate of infection per treatment group and difference in mean Vancouver Scar Scale scores at 3- and 6-month follow-ups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aquacel | Active comparator | Device: AquacelAquacel hydrocellulose-based dressing applied to partial thickness burns |
| Aquacel AG | Active comparator | Device: Aquacel AGAquacel AG is identical in base composition to Aquacel (ie a hydrocellulose-based wound dressing which adheres to the raw wound surface) but contains 1.2% cationic silver. |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- <16 years old
- partial thickness thermal (scald, contact, fire) burns up to 25% TBSA on the trunk and extremities
- presenting < 72 hours after injury
Key exclusion criteria (8 listed)
- mixed burn pattern (combination of partial and full thickness burn) or full thickness burns requiring surgery at either anatomic sites.
- isolated burns to perineum, hands, or feet allergy to silver
- concomitant injury (eg.fractures)
- inhalational injury
- chemical burn
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 |
|---|---|---|
| Aquacel AGHydrocellulose wound dressing containing 1.2% cationic silver | Device | Aquacel AG |
| AquacelHydrocellulose wound dressing | Device | Aquacel |
Primary outcome
Time-to-re-epithelialization
Time frame: 10-21 days
Time (in days) for complete re-epithelialization of the burn to which the dressing was applied
2 secondary outcomes
Rate of infection
Time frame: 3 months
Vancouver Scar Scale (VSS) score
Time frame: 3 and 6 months post-injury
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 14 May 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Michael Bezuhly, MD, MSc, SM, FRCSC principal investigator
IWK Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquacel AG and Aquacel in people with Pediatric Burns, run by IWK Health Centre at 1 site in Canada.
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 3 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 14 May 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 Canada. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-to-re-epithelialization (time frame: 10-21 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 14 May 2025.