Prospective randomised controlled trial of Algisite™ M, Cuticerin™, and Sorbact® as donor site dressings in paediatric split-thickness skin grafts

Abstract

Background

This is a parallel three-arm prospective randomised controlled trial (RCT) comparing Algisite™ M, Cuticerin™, and Sorbact® as donor site dressings in paediatric split-thickness skin grafts (STSG). All three were in current use within the Pegg Leditschke Children’s Burn centre (PLCBC), the largest paediatric burns centre in Queensland, Australia. Our objective was to find the best performing dressing, following on from previous trials designed to rationalise dressings for the burn wound itself.

Methods

All children for STSG, with thigh donor sites, were considered for enrolment in the trial. Primary outcome measures were days to re-epithelialisation, and pain. Secondary measures were cost, itch, and scarring at 3 and 6 months. Patients and parents were blinded to group assignment. Blinding of assessors was possible with the dressing in situ, with partial blinding following first dressing change. Blinded photographic assessments of re-epithelialisation were used. Scar assessment was blinded. Covariates for analysis were sex, age, and graft thickness (as measured from a central biopsy).

Results

There were 101 patients randomised to the Algisite™ M (33), Cuticerin™ (32), and Sorbact® (36) arms between April 2015 and July 2016. All were analysed for time to re-epithelialisation. Pain scores were not available for all time points in all patients. There were no significant differences between the three arms regarding pain, or time to re-epithelialisation. There were no significant differences for the secondary outcomes of itch, scarring, or cost. Regression analyses demonstrated faster re-epithelialisation in younger patients and decreased donor site scarring at 3 and 6 months with thinner STSG. There were no adverse effects noted.

Conclusions

There are no data supporting a preference for one trial dressing over the others, in donor site wounds (DSW) in children. Thinner skin grafts lead to less donor site scarring in children. Younger patients have faster donor site wound healing.

Trial registration

Australia and New Zealand Clinical Trials Register (ACTRN12614000380695).

Royal Children’s Hospital Human Research Ethics Committee (HREC/14/QRCH/36).

University of Queensland Medical Research Ethics Committee (#2014000447).