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Randomised controlled trial of donor site dressings in paediatric split skin grafts

Randomised controlled trial comparing three different donor site dressings (Sorbact, Cuticerin, Algisite) in paediatric patients undergoing split skin grafting for burn injury in terms of time to re-epithelialisation, pain and itch while dressing on, ease of application, care, and removal, cosmetic appearance of donor site and cost

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000380695
Enrollment
101
Registered
2014-04-08
Start date
2014-04-17
Completion date
2016-07-15
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Paediatric split skin grafts leave a donor site, requiring a dressing. The optimum dressing for this site is the subject of much discussion and debate amongst burns clinicians. In our unit there are currently three dressings in regular use. We therefore have equipoise to undertake a randomised controlled trial in an effort to determine which is the best of the three. Outcome measures we will be examining relate to both patients and staff. These outcomes include pain and itch while the dressing is on ease of application, care, and removal time to reepithelialisation cost cosmetic appearance of the donor site There are a number of such trials in the literature. None of them have directly compared our three dressings (algisite, cuticerin, sorbact). Few of the trials in the literature have looked at children, so the answer is not already in the literature. By using real world controls we hope to find the optimum dressing in our environment. This will become our new preferred dressing, and will naturally then become the new control against which we will measure the performance of newer products that will inevitably come onto the market in subsequent years. Patients will be randomised to one or more of the three arms of the study, without them or the assessing staff being aware of the contact dressing. We will then measure outcomes with the above aims in mind; using previously validated scoring systems examining the responses of parents, patients and staff members. We will use both qualitative and quantitative assessment methods.

Interventions

Three different donor site dressings - Cuticerin. A smooth acetate gauze dressing impregnated with a water repellant petrolatum ointment - Sorbact. A hydrogel applied to a mesh dressing designed to absorb bacteria onto itself from the wound bed by hydrophobic reaction - Algisite. This is a calcium alginate dressing, the most common dressing used on donor sites in this region All dressings come in premade peel packs, and can be simply applied in theatre directly to the wound bed. This will then

Three different donor site dressings - Cuticerin. A smooth acetate gauze dressing impregnated with a water repellant petrolatum ointment - Sorbact. A hydrogel applied to a mesh dressing designed to absorb bacteria onto itself from the wound bed by hydrophobic reaction - Algisite. This is a calcium alginate dressing, the most common dressing used on donor sites in this region All dressings come in premade peel packs, and can be simply applied in theatre directly to the wound bed. This will then be covered with an absorbent second layer dressing (allevyn) and tape (hypafix). Dressings will be removed at seven days to assess the wound, then reapplied if necessary every seven days until full re-epithelialisation

Sponsors

Stuart Pegg Paediatric Burns Centre
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 14 Years
Healthy volunteers
No

Inclusion criteria

Patients of the Stuart Pegg Paediatric Burns Centre (SPPBC) undergoing split skin grafting for burns

Exclusion criteria

Aged >15 years of age Non-English speaking Cognitive impairment Current involvement with Department Communities (Child Safety)

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 18, 2026