IWK Health Centre
Halifax, Nova Scotia, B3K 6R8, Canada
NCT Number: NCT06971562
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.
This study is active but is not currently recruiting participants.
Up to 16 year
All sexes
Interventional
Not applicable
Halifax, Nova Scotia, B3K 6R8, Canada
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Hydrocellulose wound dressing containing 1.2% cationic silver
Hydrocellulose wound dressing
Time frame: 10-21 days
Time (in days) for complete re-epithelialization of the burn to which the dressing was applied
Time frame: 3 months
Incidence of infection in each study arm
Time frame: 3 and 6 months post-injury
Mean cumulative VSS score for each Arm.
IWK Health Centre
Other
Effect of Silver on Re-epithelialization, Infection and Hypertrophic Scarring of Partial Thickness Burns in Pediatric Patients: A Randomized Controlled Trial
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