None listed
Conditions
Brief summary
Abnormal donor site colour causes much distress to children and their families and remains a difficult problem for clinicians to treat. In children receiving a skin graft to treat a burn injury, the donor site is a source of pain, itch and at risk of scarring. The current the donor site dressings mainly enable faster wound healing. None of the dressings address the colour restoration in donor sites. The Regenerative Epithelial Suspension (RES™) prepared using the RECELL® Autologous Cell Harvesting (ACH) device has been in clinical use for over a decade. Once prepared a mixture of epithelial cells is applied to the wound. There are few studies that evaluate donor site wound management in children with RES™. Recently, in a study comparing RES™ with skin grafts (control group), wounds treated with RES™ had comparable healing, with significantly smaller donor site, less pain and better appearance relative to the control group. The RECELL® ACH device is easy to use, requires smaller donor skin sample, fewer dressing changes, lower pain scores and as such, may incur less cost in the overall burn wound treatment. Delayed wound healing is associated with higher scarring risk in children. Graft loss results in delayed healing. Current standard practice at the study site includes the topical application of ARTISS® (biological product that acts as an adhesive agent) onto the recipient site before skin graft. The fibrin facilitates adhesion of the sheet graft to the recipient site. The combination of RES™ with skin graft was reported as both effective and safe in adult studies. However, the effect of RES™ on the skin graft, recipient site graft takes and colour in children has not been assessed in the published literature. This study aims to evaluate the efficacy of a RES™ on donor site colour at 12 months after skin graft and recipient site graft take in children.
Interventions
The initial application of intervention will be under general anaesthesia by the burns surgical team using sterile technique.
ARM1:
Donor Site Intervention. The intended donor site will be marked to a maximum area of 320sqcm. Following sterile skin preparation, a donor skin biopsy will be harvested with a pneumatic dermatome(Zimmer Inc., Warsaw, IN, USA) at depth of 0.018cm(0.007in). Topical application of local aneasthesia (bupivacaine 0.25% with epinephrine 1:200,000 AstraZeneca Pty Ltd, N
The initial application of intervention will be under general anaesthesia by the burns surgical team using sterile technique. ARM1: Donor Site Intervention. The intended donor site will be marked to a maximum area of 320sqcm. Following sterile skin preparation, a donor skin biopsy will be harvested with a pneumatic dermatome(Zimmer Inc., Warsaw, IN, USA) at depth of 0.018cm(0.007in). Topical application of local aneasthesia (bupivacaine 0.25% with epinephrine 1:200,000 AstraZeneca Pty Ltd, North Ryde, NSW, Australia) , calculated at a maximum safe dose(2 to 2.5 mg/kg) will facilitate pain relief and haemostasis at the newly created donor site wound (DSW). A three step degradation process with the RECELL® Autologous Cell Harvesting (ACH) device transforms the skin biopsy in a Regenerative Epithelial Suspension (RES™) as per manufacturer specifications. The RES™ will the be applied by droplet or spray onto the donor site wound and covered with Cuticerin®, a low-adherent , impregnate dressing composed of smooth acetate fabric coated in a water repellant ointment containing petrolatum, paraffin and Eucerite®. The sequence of outer layers will be Allevyn® followed by Hypafix®. The first change of dressing will be a week post-skin graft . Thereafter Xeroform® will be applied to the DSW every 2-3 days until greater than 95% re-epithelialisation is confirmed by a burns clinician. Xeroform® is a non-adherent, petrolatum coated fine mesh gauze that contains 3% bismuth tribromophenate. Recipient Site Intervention: Skin graft recipient site will be marked to maximum of 400sqcm for evaluation. RES™ will then be topically applied to the recipient site followed by perforated, split-thickness skin sheet graft with or without ARTISS®, a fibrin sealant. The graft will be fixed to normal skin with or without Histoacryl® tissue glue. The sequence of secondary, outer dressings will be Mepitel® , Acticoat® , Hypafix® . Depending on the site of the skin graft negative pressure wound therapy may also be applied as per clinician assessment. Change of dressing schedule and application of Xeroform® is as described for the donor site wound. Intervention fidelity will be assessed using a questionnaire that evaluates each step of dressing application by an investigator aligned with the study..
Sponsors
Department of Industry , Innovation and Science
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
No minimum to 16 Years
Healthy volunteers
No
Inclusion criteria
1. Acute burn injury requiring a split thickness skin graft for which: a. The donor site for evaluation should not exceed 320 sqcm. b. The split-thickness skin graft recipient site for evaluation should not exceed 400 sqcm. 2. Child (and/or accompanying guardian) is willing and able to complete all follow-up evaluations required by the study protocol.
Exclusion criteria
Non-English-Speaking Background 2. Child in the care of the Department of Community Services 3. Full thickness skin graft 4. Hypersensitivity to trypsin or sodium lactate. 5. Previous adverse reaction to general anaesthesia.
Outcome results
None listed