Effectiveness of topical silicone gel and pressure garment therapy for burn scar prevention and management in children: a randomized controlled trial.

Participants and treating clinicians could not be blinded because the interventions were visible, although scar thickness was measured by a blinded assessor and primary outcomes were analysed by a blinded analyst. Six children withdrew immediately after randomization, and attrition was higher in the combined group at six months, so missing data may affect the combined treatment comparison. The trial excluded isolated facial, ear, or genital burns, and included very few children with Fitzpatrick skin type VI (black skin) or scar reconstruction surgery, so results may not apply to those groups. Only selected scar sites were assessed, so the findings may not represent the whole scar. The study compared three active scar interventions with each other, not against no scar intervention. Adherence was lower in the combined group, so outcome differences may partly reflect how often the treatments were actually used. The observed scar-thickness difference was below the ultrasound device's smallest detectable change, and no clinically important difference threshold was established.

Stratpharma, which makes the silicone gel used in the trial, provided a research grant to The University of Queensland and funded open-access publication. The authors declared that Stratpharma had no part in the final study design, data collection, or analysis, and that investigators had no financial interest in Strataderm or Stratpharma.

Do not conclude that combining silicone gel and pressure garment improves burn scars in children. At six months, itch was similar across groups, and combined treatment had greater ultrasound scar thickness than silicone alone.