A randomised controlled trial of ablative fractional CO2 laser and medical needling in children with burn scars

Intervention arm 1 - Ablative fractional CO2 laser therapy + standard care: Ablative fractional CO2 laser therapy will be delivered by a surgeon to each participant under a general anaesthetic using a Lumenis Ablative Fractional CO2 laser with SCAAR FX setting; ARTG no. 182239. The dosage applied by the laser intervention will be delivered at one of three depth settings (1-2mm, 60-70mj – shallow skin lesion, 2-3mm, 70-120mj – medium skin lesion, >3mm, 120-150mj – deep skin lesion), which will be determined by ultrasound measurement of scar thickness pre-operatively; and with a standard device setting of 1% density, square size 10, 250Hz, 1 pass with minimal overlapping. The dose applied and areas these doses were applied will be recorded as part of a fidelity checklist. Delivered individually over 1 session at 6 months or more post-burn. Following the intervention any blood and/or exudate will be cleaned, the site will be covered with a Sorbact dressing immediately post-intervention for 24 hours and following that QV intensive moisturising cream will be applied as many times a day as needed to prevent dryness of the skin site. The duration of the intervention will vary for each participant and will be determined by the treating surgeon but will usually be for no longer than 1 hour under general anaesthetic. A hospital-specific factsheet will be provided to the caregivers of participants with post-procedural information (e.g. ongoing treatment, aftercare of the treatment site). Standard care (see below) will continue with the exception of brief cessation of standard care interventions post-operatively. Silicone and pressure garment therapy will be recommenced after re-epithelialisation post laser intervention where appropriate. Intervention arm 2 - Medical needling + standard care: Medical needling will be delivered mechanically by a surgeon to each patient under a general anaesthetic using 3mm needles attached to a roller (Environ Roll-CIT 3mm). The dose applied and areas these doses were applied will be recorded as part of a fidelity checklist. Delivered individually in 1 session at 6-months or more post-burn. Following the intervention any blood and/or exudate will be cleaned, the site will be covered with a Sorbact dressing immediately post-intervention for 24 hours and following that QV intensive moisturising cream will be applied as many times a day as needed to prevent dryness of the skin site. The duration of the intervention will vary for each participant and will be determined by the treating surgeon but will usually be for no longer than 1 hour under general anaesthetic. A hospital-specific factsheet will be provided to the caregivers of participants with post-procedural information (e.g. ongoing treatment, aftercare of the treatment site). Standard care (see below) will continue with the exception of brief cessation of standard care interventions post-operatively. Silicone and pressure garment therapy will be recommenced after re-epithelialisation post needling as appropriate. NB: Standard care may include pressure garments, silicone products, skin or scar massage, exercises, moisturisers, education regarding sun protection. The dose and type of interventions provided is determined by treating health professionals. One or more of these interventions may be provided.