Published in:
Open Access 01-12-2015 | Study protocol
Three donor site dressings in pediatric split-thickness skin grafts: study protocol for a randomised controlled trial
Published in: Trials | Issue 1/2015
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Background
For children requiring split-thickness skin grafting for burn injury, the optimum donor site dressing is an ongoing subject of debate. The most common dressings in use, both regionally and worldwide, are calcium alginates. We will compare an alginate with two other dressings, all of which are in current use in the Pegg Leditschke Paediatric Burns Centre (PLPBC), to determine which dressing performs the best.
Methods/Design
This is a randomised, prospective single center parallel three-arm trial comparing three donor site wound (DSW) dressings: Algisite™ M, a calcium alginate dressing; Cuticerin™, a smooth acetate gauze impregnated with water-repellent ointment (petrolatum, paraffin and Eucerite®) and Sorbact®, a gauze mesh coated with a dialkylcarbamoyl chloride (DACC) and amorphous hydrogel.
Primary outcomes are days to complete DSW healing, and pain. Previously validated measures will be used for all outcomes. Secondary outcomes are: itch; scar appearance at three, six and 12 months; ease of dressing application and removal and dressing costs and utility. Results will be analysed on an intention-to-treat basis. Donor site thickness will be measured with a small biopsy from the center of the graft, to document the depth of the DSW across the groups.
Discussion
This study will provide comprehensive short- and long-term data on DSW dressings in pediatric split-thickness skin grafting. The best-performing dressing will become the preferred dressing for the PLPBC. We will provide rigorous data against which other dressings can be compared in future, recognising that alginates are the most common DSW dressing currently in use. Our study design replicates a real-world scenario in order to identify clinically significant differences between the three dressings.
Trial registration
This trial was prospectively registered on 8 April 2014 with the Australia and New Zealand Clinical Trials Register (identifier: ACTRN12614000380695).