Implementation of negative pressure for acute pediatric burns (INPREP): A stepped-wedge cluster randomized controlled trial protocol

Maleea D Holbert; Fiona Wood; Andrew J A Holland; Warwick Teague; Roy M Kimble; Dianne Crellin; Cody C Frear; Kristen Storey; Natalie Phillips; Yvonne Singer; Tanesha A Dimanopoulos; Lisa Martin; Leila Cuttle; Dimitrios Vagenas; Steven M McPhail; Pauline Calleja; Jed Duff; Alexandra De Young; Bronwyn R Griffin

doi:10.1371/journal.pone.0315278

Implementation of negative pressure for acute pediatric burns (INPREP): A stepped-wedge cluster randomized controlled trial protocol

PLoS One. 2024 Dec 10;19(12):e0315278. doi: 10.1371/journal.pone.0315278. eCollection 2024.

Authors

Maleea D Holbert^{1

2}, Fiona Wood^{3

4}, Andrew J A Holland^{5

6}, Warwick Teague^{7

8

9

10}, Roy M Kimble^{2

11}, Dianne Crellin^{8

9

12}, Cody C Frear^{2

11}, Kristen Storey^{1

2}, Natalie Phillips^{2

13}, Yvonne Singer¹, Tanesha A Dimanopoulos^{1

2}, Lisa Martin^{3

4}, Leila Cuttle¹⁴, Dimitrios Vagenas¹⁵, Steven M McPhail¹⁶, Pauline Calleja¹⁷, Jed Duff¹⁸, Alexandra De Young², Bronwyn R Griffin^{1

2}

Affiliations

¹ School of Nursing and Midwifery, Griffith University, Nathan Campus, South Brisbane, QLD, Australia.
² Children's Health Queensland Hospital and Health Service, South Brisbane, QLD, Australia.
³ Perth Children's Hospital, Nedlands, WA, Australia.
⁴ Burn Injury Research Unit, University of Western Australia, Crawley, WA, Australia.
⁵ The Burns Unit, The Children's Hospital at Westmead, Westmead, NSW, Australia.
⁶ Faculty of Medicine and Health, Sydney Medical School, The University of Sydney, Sydney, NSW, Australia.
⁷ Murdoch Children's Research Institute, Surgical Research, Parkville, VIC, Australia.
⁸ Burns Service, The Royal Children's Hospital Melbourne, Parkville, VIC, Australia.
⁹ Department of Paediatrics, The University of Melbourne, Parkville, VIC, Australia.
¹⁰ School of Public Health & Preventive Medicine, Monash University, Melbourne, VIC, Australia.
¹¹ Faculty of Medicine, University of Queensland, Herston, Brisbane, QLD, Australia.
¹² Department of Nursing, The University of Melbourne, Parkville, Victoria, Australia.
¹³ Child Health Research Centre, University of Queensland, South Brisbane, QLD, Australia.
¹⁴ Faculty of Health, School of Biomedical Sciences, Queensland University of Technology, Brisbane, Australia.
¹⁵ Faculty of Health, Research Methods Group, School of Public Health and Social Work, Queensland University of Technology, Brisbane, Australia.
¹⁶ Australian Centre for Health Services Innovation and Centre for Healthcare Transformation, School of Public Health and Social Work, Queensland University of Technology, Brisbane, Kelvin Grove, Australia.
¹⁷ College of Healthcare Sciences, James Cook University, Cairns, Australia.
¹⁸ Faculty of Health, Centre for Healthcare Transformation, Queensland University of Technology, Brisbane, Australia.

Abstract

Background: Acute application of adjunctive negative pressure wound therapy (NPWT) significantly improves time to re-epithelialization in pediatric burn patients. This adjunctive treatment has not yet been broadly or routinely adopted as a standard primary burns dressing strategy. The Implementation of Negative PRessurE for acute Pediatric burns (INPREP) trial will implement and evaluate the impact of adjunctive NPWT in parallel with co-designed implementation strategies and resources across four major pediatric hospitals.

Methods: We will conduct a multi-center, prospective, stepped-wedge cluster randomized controlled trial to implement adjunctive NPWT for acute pediatric burns. Participants will include pediatric burn patients presenting to one of four Australian tertiary pediatric hospitals for burn treatment. The intervention is adjunctive NPWT in parallel with co-designed and tailored implementation strategies and a suite of NPWT implementation resources, which form the INPREP toolkit. Using a hybrid type III design, this trial aims to evaluate the effectiveness of NPWT implementation in parallel with the INPREP toolkit using (i) implementation outcomes (e.g., adoption, appropriateness, acceptability, feasibility, and sustainability) and (ii) clinical outcomes (e.g., days to re-epithelialization, scar management requirements, skin grafting requirements). The primary outcome of this trial is treatment adoption-the proportion of eligible patients who receive NPWT.

Discussion: This manuscript outlines a protocol for a hybrid type III stepped-wedge cluster randomized controlled trial of adjunctive NPWT implementation in acute pediatric burn care. We anticipate that NPWT implementation in parallel with the INPREP toolkit will be generalizable to emergency departments and burn services across Australia, and evidence generated will inform pediatric burn care internationally.

Trial registration: Australian and New Zealand Clinical Trials Registry: ACTRN12622000166774. Registered 1 February 2022.

Copyright: © 2024 Holbert et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Publication types

Clinical Trial Protocol

MeSH terms

Adolescent
Australia
Burns* / therapy
Child
Child, Preschool
Female
Humans
Male
Multicenter Studies as Topic*
Negative-Pressure Wound Therapy* / methods
Prospective Studies
Randomized Controlled Trials as Topic*
Re-Epithelialization
Wound Healing

Grants and funding

National Health and Medical Research Council Partnership Projects [PRC2 Funding ID: 2006970] The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.