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. 2018 Nov 27:6:33.
doi: 10.1186/s41038-018-0135-y. eCollection 2018.

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

Craig A McBride  1   2   3 , Roy M Kimble  1   2   3 , Kellie A Stockton  1   2
Affiliations

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

Craig A McBride et al. Burns Trauma. .

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).

Keywords: Alginate; Algisite™ M; Burns; Cuticerin™; Donor site wound; Paediatric; Sorbact®; Split-thickness skin graft.

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Conflict of interest statement

Craig A McBride FRACS is a Senior Staff Specialist Paediatric Surgeon with Children’s Health Queensland. He is a Senior Paediatric Burns Surgeon with the PLCBC. This RCT forms part of a research higher degree. Roy M Kimble MD, FRCS, FRACS is Professor of Paediatric Surgery and Director of Paediatric Surgery at Lady Cilento Children’s Hospital (Children’s Health Services Queensland). He is a Senior Paediatric Burns Surgeon with the PLCBC. Kellie Stockton PhD, BApp Sc (Physio), Post Grad Dip Physio (cardiothoracic) was Clinical Research Manager of the Centre for Children’s Burns and Trauma Research (CCBTR) at the time this study was being conducted. She is now the Director of Physiotherapy for Children’s Health Queensland.This trial was approved by the Royal Children’s Hospital Human Research Ethics Committee (HREC/14/QRCH/36) and the University of Queensland Medical Research Ethics Committee (#2014000447). All patients were entered after signed consent.Not applicable.None of the authors have any financial ties to Abigo Medical AB. None of the authors have received honoraria, travel, or accommodation from the company. None of the authors have undertaken speaking engagements at the request of the company. RMK and CAM have both accepted invitations, with attendant travel and accommodation, from Smith & Nephew to speak at meetings and conferences regarding the treatment of paediatric burns and the use of negative pressure wound therapy in children. RMK has provided medico-legal opinion for Smith & Nephew. Smith & Nephew had no involvement in the conduct of this trial. The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Consolidated Standards for Reporting Trials (CONSORT) diagram for Donor Site Wounds Trial. CONSORT diagram of patients enrolled, and numbers available for outcomes measured. STSG split-thickness skin graft, NRS numeric rating scale, FLACC face, legs, activity, cry, consolability scale, re-epi re-epithelialisation, mo months, POSAS patient observer scar assessment scale, USS ultrasound scan, obs observer, pt patient
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