Ablative, fractional CO2 laser and medical needling to enhance burn scarring in children: A pilot randomised trial

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 DEEP FX, SCAAR FX setting; ARTG no. 182239. The dosage applied by the laser intervention will be 120-130mJ, 1% density, square size 10, 250Hz, 1 pass with minimal overlapping. 120MJ will be the dose applied to scarred skin without contractures or tightness and 130MJ will be the dose applied to areas with contractures or tightness. The dose applied and areas these doses were applied will be recorded as part of a fidelity checklist. Blood and extradite may also aid in the healing process thus will not be removed during the theatre session. Delivered individually in 3 sessions, each 1-month apart at 2-months post-burn, 4-months post-burn and 6-months post-burn. The site will be covered with a Sorbact dressing immediately post-intervention until removal approximately 24 hours later and following that paraffin 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 factsheet will be provided to the caregivers of participants with post-procedural information regarding ongoing treatment, aftercare of the treatment site, potential adverse effects, and staff contact details. Standard care is as per the standard care group 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. 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). For sites such as small fingers and curved sites where the roller is difficult to apply, a dermapen will be used for the needling. Blood and extradite may also aid in the healing process thus will not be removed during the theatre session. Delivered individually in 3 sessions, each 2-months apart at 2-months post-burn, 4-months post-burn and 6-months post-burn. The site will be covered with a Sorbact dressing immediately post-intervention until removal approximately 24 hours later and following that paraffin 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. Standard care is as per the standard care group with the exception of the medical needling intervention which will not be delivered to this group from 6-months to 12-months post-burn (the study endpoint). with the exception of brief cessation of standard care interventions post-operatively. In addition there will be a short period of cessation of standard care interventions post-operatively. Silicone and pressure garment therapy will be recommenced after re-epithelialisation post needling. A factsheet will be provided to the caregivers of participants with post-procedural information regarding ongoing treatment, aftercare of the treatment site, potential adverse effects, and staff contact details. The medical needling or ablative fractional CO2 laser component of intervention arm 1 and intervention arm 2 will be delivered in an operating theatre in a major metropolitan children's hospital. Intervention arm 3 - standard care: Standard care may include pressure garments, silicone products, skin or scar massage, exercises, moisturisers, education regarding sun protection, medical needling (as per intervention arm 2 but from 6-months post-burn). The dose and type of interventions provided is determined by treating health professionals. One or more of these interventions may be provided. The medical needling component of the intervention is delivered in an operating theatre in a major metropolitan children's hospital.