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Active, Not Recruiting

NCT Number: NCT06971562

Silver in Partial Thickness Pediatric Burns

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • <16 years old
  • partial thickness thermal (scald, contact, fire) burns up to 25% TBSA on the trunk and extremities
  • presenting < 72 hours after injury

Exclusion criteria

  • 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

Treatment and study plan

Aquacel Ag

Device

Hydrocellulose wound dressing containing 1.2% cationic silver

Aquacel

Device

Hydrocellulose wound dressing

Primary outcomes

  1. 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

Secondary outcomes

  1. Rate of infection

    Time frame: 3 months

    Incidence of infection in each study arm

  2. Vancouver Scar Scale (VSS) score

    Time frame: 3 and 6 months post-injury

    Mean cumulative VSS score for each Arm.

Sponsors and collaborators

Lead sponsor

IWK Health Centre

Other

Registry information

Official study title

Effect of Silver on Re-epithelialization, Infection and Hypertrophic Scarring of Partial Thickness Burns in Pediatric Patients: A Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
May 14, 2025
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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