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Management of paediatric donor sites of split-thickness skin grafts with Suprathel: a randomised control trial

Management of paediatric donor sites of split-thickness skin grafts with Suprathel: a randomised control trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000267954
Acronym
N/A
Enrollment
48
Registered
2020-02-28
Start date
2020-03-28
Completion date
2021-03-28
Last updated
2020-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Split-thickness skin grafts are routinely used to manage burns that are unlikely to heal with dressings alone. The skin graft is taken from a donor site, for example the thigh, creating a donor site wound. Treatment of this donor site wound has an impact on the total recovery and rehabilitation of the patient. Multiple dressings have been investigated for the management of the donor site wounds, including biobrane, calcium alginate, acetate guaze and gauze mesh. However, despite previous research the optimum dressing for donor site wounds remains unclear. Suprathel is an artificial substitute skin dressing that is commonly used on burns and graft site wounds. The paediatric surgeons at The Townsville Hospital have observed that Suprathel also has positive results when used on the donor site wound. Therefore, we propose to investigate the management of paediatric donor site wounds of split-thickness skin grafts with Suprathel in a randomised controlled study. We plan to compare the use of Suprathel with jelonet, a commonly used dressing on the donor site. Participants: Children 16 years or under requiring a clinically indicated split thickness skin graft Expected outcomes: Identifying whether Suprathel is superior to a commonly used dressing on paediatric donor sites.

Interventions

Two dressings used on donor site wounds in children will be compared in this randomised control trial: Suprathel (covered with Atruman + melolin + hypafix) and Jelonet (covered with melolin + hypafix). 1. Suprathel - Composed of a synthetic copolymer of polylactide trimethylene carbonate and e-caprolactone and is considered a temporary artificial skin substitute - Applied intra-operatively (by surgeon) after skin graft is taken, covered with Atruman + melolin + hypafix. Dressing gradually peels

Two dressings used on donor site wounds in children will be compared in this randomised control trial: Suprathel (covered with Atruman + melolin + hypafix) and Jelonet (covered with melolin + hypafix). 1. Suprathel - Composed of a synthetic copolymer of polylactide trimethylene carbonate and e-caprolactone and is considered a temporary artificial skin substitute - Applied intra-operatively (by surgeon) after skin graft is taken, covered with Atruman + melolin + hypafix. Dressing gradually peels off when skin underneath is healed. Reviewed day 5 by nursing staff/occupational therapist, if not healed protective dressing layer re-applied (Atruman + melolin + hypafix). Re-inspected day 10. This is repeated every 5 days until healed. - Monitored by nursing + parent sheet that contains: pain/distress score for dressing change 2. Jelonet - Parrafin based guaze dressing - Applied intra-operatively by surgeon, covered with melolin +hypafix - Same principles as above, however, dressing is completely removed at each 5d review (by nursing staff) and re-applied if not healed

Sponsors

The Townsville hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
0 to 16 Years
Healthy volunteers
No

Inclusion criteria

All patients aged 16 years and younger requiring a clinically indicated split thickness skin graft at our hospital will be invited to participate. Eligibility will be determined by the child’s primary surgeon or an investigator.

Exclusion criteria

Exclusion criteria will include non-english speaking parents or caregivers; children under the care of the Department of Child Safety and children with a cognitive impairment.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026