Feasibility, Acceptability and Safety study of the PICO™ Device (Negative Pressure Wound Therapy) in Acute Paediatric Burns

Emma Lumsden¹, Roy Kimble^1,2,3, Kristen Storey¹, Catherine McMillan¹, Robert Ware², Bronwyn Griffin ^1,2,3,
¹Queensland Children’s Hospital, South Brisbane, Queensland, Australia
²Griffith University , Gold Coast, Queensland, Australia
³Center for Children’s Health Research, South Brisbane, Queensland , Australia

Abstract

Introduction: Negative Pressure Wound Therapy (NPWT) in acute burn care may decrease the time to re-epithelialisation by more than 20%. Despite this, the perceived burden of use; including therapeutic, physical and financial, have so far limited the use of NPWT in acute burn care. This might be minimised by utilising the small, ultra-portable, single-use NPWT device PICO™ as opposed to larger devices, which to date has never been studied in acute burn care. This research will therefore primarily assess the feasibility, acceptability and safety of PICO™ in paediatric burns. Secondary outcomes include time to re-epithelialisation, pain, itch, cost and scar formation.

Methods and analysis: This single site, prospective, pilot randomised control trial was conducted in an Australian quaternary paediatric burns centre. Participants will be aged ≤16-years, otherwise well and managed within 24-hours of sustaining a burn that fits beneath a PICO™ dressing. Thirty participants were randomised to one of three groups; group 1: Mepitel® and ACTICOAT™, group 2: Mepitel®, ACTICOAT™ and PICO™, group 3: Mepitel®, ACTICOAT™ Flex and PICO™. Patient outcomes were recorded at each dressing change to assess efficacy and safety outcomes until three months post burn wound re-epithelialisation. Surveys, randomisation and data storage were undertaken via online platforms and physical data storage collated at the Centre for Children’s Health Research, Brisbane, Australia. Analysis was done using Stata statistical software.

Results: The data for this study has just finished being collected and will be ready at the time of the conference.

Ethics: Ethics has been obtained from Queensland Health and Griffith Human Research Ethics committees including a site-specific approval.

Registration and Details: Registration is with the Australian and New Zealand Clinical Trials Registry (ACTRN12622000009718). A grant was provided by Smith & Nephew which partially funded the trial.

Biography

Dr Emma Lumsden is currently a Principal House Officer in general surgery at the Royal Brisbane and Women’s Hospital. She is completing her PhD with Griffith University under the supervision of Professor Roy Kimble, Professor Robert Ware and Associate Professor Bronwyn Griffin.