Protocol for a feasibility, acceptability and safety study of the PICO device (negative pressure wound therapy) in acute paediatric burns

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 limited the use of NPWT in acute burn care. This might be minimised by using the small, ultraportable, 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 protocol details a clinical trial methodology and is pre-results. This single site, prospective, pilot randomised controlled trial will be conducted in an Australian quaternary paediatric burns centre. Participants must be aged ≤16 years, otherwise well and managed within 24 hours of sustaining a burn that fits beneath a PICO dressing. Thirty participants will be randomised to one of three groups: group A: Mepitel and ACTICOAT, group B: Mepitel, ACTICOAT and PICO and group C: Mepitel, ACTICOAT Flex and PICO. Patient outcomes will be recorded at each dressing change to assess efficacy and safety outcomes until 3 months postburn wound re-epithelialisation. Surveys, randomisation and data storage will be undertaken via online platforms and physical data storage collated at the Centre for Children's Health Research, Brisbane, Australia. Analysis will be done by using StataSE 17.0 statistical software.

Ethics and dissemination: Ethics has been obtained from Queensland Health and Griffith Human Research Ethics committees including a site-specific approval. These data will be disseminated via clinical meetings, conference presentations and peer-reviewed journals.

Trial registration number: ACTRN12622000009718.

Keywords: clinical trials; paediatric surgery; qualitative research; statistics & research methods; surgery; wound management.

Figure 1

Participant timeline—schedule of enrolment and data collection. BBSIP, Brisbane Burns Scar Impact Profile; DC, dressing change, POH, point of healing; TBSA, total body surface area.