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.

About ANZBA

ANZBA is a not for profit organisation and the peak body for health professionals responsible for the care of the burn injured in Australia and New Zealand. ANZBA encourages higher standards of care through education, performance monitoring and research.

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