The efficacy of CUTICERIN® with or without a Regenerative Epithelial Suspension (RES™), on donor site pigmentation in children: The DRESSing Trial Protocol

Dr Anjana Bairagi1, Dr Bronwyn  Griffin1,2,3, Dr Zephanie Tyack1,4,5, Prof Steven McPhail4,5, Dr Dimitrios Vagenas6, Dr  Craig  McBride1,2,7, Prof  Roy  Kimble1,2,3,7

1Cenre For Children’s Burns & Trauma Research, South Brisbane, Brisbane, Australia, 2Pegg Leditschke Children’s Burns Centre, Queensland Children’s Hospital, Brisbane, Australia, 3School of Nursing & Institute of Health and Biomedical Innovation (IHBI), Queensland University of Technology, Brisbane, Australia, 4School of Public Health and Social Work & Institute of Health and  Biomedical Innovation, Queensland University of Technology, Brisbane, Australia, 5Centre for Functioning and Health Research, Metro South Health, Brisbane, Australia, 6Research Methods Group & Institute of Health and Biomedical Innovation IHBI, Queensland University of Technology, Brisbane, Australia, 7Faculty of Medicine, University of Queensland, Brisbane, Australia

Abstract:

Introduction:

Paediatric donor site wound (DSW) dyspigmentation is a common complication of a split thickness skin graft (SSG).  The constant visible reminder of the preceding traumatic injury is responsible for a child’s continued distress and remains a challenge for clinicians to treat.  The Regenerative Epithelial Suspension (RES™) prepared with the RECELL® Autologous Cell Harvesting Device, contains the fundamental cell components for human melanogenesis.  Whilst, RES™ has demonstrated improved pigmentation for patients with post burn leukoderma and vitiligo, the effectiveness of RES™ in paediatric DSW is poorly understood. The DRESSing trial aims to evaluate the efficacy of RES™ for managing pigmentation of childhood DSW.

Method:

A two-arm, parallel group, and single-centre randomised trial will be conducted. Eligible children (age < 16 years, n=40) requiring a SSG after an acute partial thickness burn will be randomised to either CUTICERIN® with or without RES™. Using DSW pigmentation at 12 months post-date of injury, a 5% significance level and power of 80%, a sample size of 20 patients per group will be required. Secondary outcomes (donor site re-epithelialisation time, pain, itch, scar severity, health-related quality of life, treatment satisfaction, dressing application ease and healthcare resource utilisation) will be assessed at 3, 6 and 12 months post- date of injury . There are no results, as this is a protocol.

Conclusion:

Paediatric DSW dyspigmentation affects the quality of life for burn survivors, especially children. This trial will add to the body of evidence regarding the efficacy of cell-based therapies in acute burns for managing pigmentation


Biography:

Dr Anjana Bairagi is a paediatric surgeon undertaking a PhD with the  Centre of Children’s Burns & Trauma Research Group. Her research is evaluating non-cultured autologous skin cell suspensions in the management of partial thickness burn injuries in children.

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