ACTRN12621000288820.

Study name	A randomised controlled trial of ablative fractional CO2 laser and medical needling in children with burn scars
Methods	Randomised controlled trial: stratified allocation will be used in the study with scar thickness of the treatment site (< 2 mm, greater than or equal to 2 mm) as the unit of stratification. Randomisation will be at the level of the individual in random blocks.
Participants	Both males and females aged 18 years or younger at the time of recruitment and have: hypertrophic burn scarring of any size at 6‐months or more post‐burn with functional and/or cosmetic implications determined by patient‐report on the Brisbane Burn Scar Impact Profile
Interventions	Intervention arm 1 ‐ Ablative fractional CO2 laser therapy plus 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 1 of 3 depth settings (1 to 2 mm, 60 to 70mj – shallow skin lesion, 2 to 3 mm, 70 to 120mj – medium skin lesion, > 3mm, 120 to 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, 250 Hz, 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 fact sheet 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 plus 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 fact sheet 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‐epithelialization post needling as appropriate.
Outcomes	Scar thickness measured using high frequency ultrasound. Scar pigmentation measured using the DSM‐II ColorMeter L* parameter. Scar pigmentation measured using the DSM‐II Colormeter melanin parameter. Burn‐scar specific, health‐related quality of life (child itch severity). Brisbane Burn Scar Impact Profile itch items. Reported by parent proxies or children aged 8 years or older. Burn‐scar specific, health‐related quality of life (child pain severity). Brisbane Burn Scar Impact Profile pain items. Reported by parent proxies or children aged 8 years or older. Burn‐scar specific, health‐related quality of life (perceived scar tightness). Brisbane Burn Scar Impact Profile scar tightness items. Reported by parent proxies or children aged 8 years or older. Burn‐scar specific, health‐related quality of life (child appearance). Brisbane Burn Scar Impact Profile appearance subscale. Reported by parent proxies or children aged 8 years or older. Burn‐scar specific, health‐related quality of life (child daily living). Brisbane Burn Scar Impact Profile daily living subscale. Reported by parent proxies or children aged 8 years or older. Generic health‐related quality of life: CHU‐9D utility measure. Reported by parent proxies or children aged 8 years or older. School functioning: PEDS‐QL school functioning subscale. Reported by children aged 8 years or older. Days missed from school or daycare: a single question for the number of days missed from school or daycare reported by parent proxies or children aged 8 years or older. Days missed from employment: a single question for number of days missed from employment self‐reported by a caregiver. Satisfaction with scar response to treatment measured using a 0 to 10 numeric rating scale. Data will be gathered from patients aged 8 years and older and all parents/caregivers. Adverse effects to the laser intervention may include redness, changes in pigmentation (hyperpigmentation or hypopigmentation), a hypersensitive scar, blistering and irritation around hair follicles, infection, scarring, swelling and bruising for 7 to 10 days after the procedure. This outcome will be measured by participant/proxy self‐report using a study‐specific questionnaire. Adverse effects to the medical needling intervention may include swelling, tingling, and redness for a day or more. Burn‐scar specific, health‐related quality of life (child friendships and social interaction). Brisbane Burn Scar Impact Profile friendships and social interaction subscale. Reported by parent proxies or children aged 8 years or older. Burn‐scar specific, health‐related quality of life (child mobility). Brisbane Burn Scar Impact Profile mobility subscale. Reported by parent proxies or children aged 8 years or older. Burn scar specific health‐related quality of life (child overall impact) ‐ Brisbane Burn Scar Impact Profile overall impact subscale. Burn scar specific health‐related quality of life (child emotional reactions) ‐ Brisbane Burn Scar Impact Profile emotional reactions subscale. Burn scar specific health‐related quality of life (child physical symptoms) ‐ Brisbane Burn Scar Impact Profile physical symptoms subscale.
Starting date	Not reported
Contact information	Dr Zephanie Tyack The University of Queensland 62 Graham St. South Brisbane QLD 4101 Australia +61 7 3069 7343 z.tyack@uq.edu.au
Notes