Silver in Partial Thickness Pediatric Burns
Effect of Silver on Re-epithelialization, Infection and Hypertrophic Scarring of Partial Thickness Burns in Pediatric Patients: A Randomized Controlled Trial
1 other identifier
interventional
80
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 3, 2017
CompletedFirst Submitted
Initial submission to the registry
May 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 10, 2025
CompletedFirst Posted
Study publicly available on registry
May 14, 2025
CompletedMay 14, 2025
May 1, 2025
8 years
May 6, 2025
May 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time-to-re-epithelialization
Time (in days) for complete re-epithelialization of the burn to which the dressing was applied
10-21 days
Secondary Outcomes (2)
Rate of infection
3 months
Vancouver Scar Scale (VSS) score
3 and 6 months post-injury
Study Arms (2)
Aquacel
ACTIVE COMPARATORAquacel hydrocellulose-based dressing applied to partial thickness burns
Aquacel AG
ACTIVE COMPARATORAquacel 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.
Interventions
Eligibility Criteria
You may qualify if:
- \<16 years old
- partial thickness thermal (scald, contact, fire) burns up to 25% TBSA on the trunk and extremities
- presenting \< 72 hours after injury
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Bezuhly, MD, MSc, SM, FRCSC
IWK Health Centre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 6, 2025
First Posted
May 14, 2025
Study Start
May 3, 2017
Primary Completion
May 10, 2025
Study Completion
May 10, 2025
Last Updated
May 14, 2025
Record last verified: 2025-05