None listed
Conditions
Brief summary
Managing scarring remains a significant challenge despite global reductions in burn incidence and severity of burn scars over the last 30 years. Ablative fractional CO2 laser therapy and medical needling are potentially revolutionary and minimally invasive interventions to treat severe burns scars. Laser and needling produce microscopic holes in scar tissue and this process is thought to assist scar tissue remodelling. Needling may have some advantages over laser in terms of feasibility. As there has been minimal investigation of laser and medical needling in children with severe burn scars, there is an urgent need to conduct a rigorous trial within this population. A randomised controlled trial will be conducted at a specialist children’s hospital with a sample of children with severe burn scars. Children will be randomised to one of two intervention groups: ablative fractional CO2 laser therapy or medical needling. The primary outcome of this trial will be ultrasound-assessed scar thickness post-intervention.
Interventions
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
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.
Sponsors
The University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
Participants will be 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. • Able to attend the study sites for treatment and follow-up.
Exclusion criteria
Participants will not be included if they have: • Previously received laser therapy or medical needling as part of treatment for their burn scars • Hypersensitivity to light/laser treatments as laser therapy would be contraindicated; • Co-morbid skin disorders (i.e., current eczema, dermatitis, skin cancer) as these could confound wound healing and scarring post-intervention.
Outcome results
None listed