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

<h4>Background</h4>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....

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Main Authors: 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
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2024-01-01
Series:PLoS ONE
Online Access:https://doi.org/10.1371/journal.pone.0315278
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author 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
author_facet 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
author_sort Maleea D Holbert
collection DOAJ
description <h4>Background</h4>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.<h4>Methods</h4>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.<h4>Discussion</h4>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.<h4>Trial registration</h4>Australian and New Zealand Clinical Trials Registry: ACTRN12622000166774. Registered 1 February 2022.
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spelling doaj-art-3214f65c66bc4cb59a3e768b0a7b9fdd2025-08-20T02:39:15ZengPublic Library of Science (PLoS)PLoS ONE1932-62032024-01-011912e031527810.1371/journal.pone.0315278Implementation of negative pressure for acute pediatric burns (INPREP): A stepped-wedge cluster randomized controlled trial protocol.Maleea D HolbertFiona WoodAndrew J A HollandWarwick TeagueRoy M KimbleDianne CrellinCody C FrearKristen StoreyNatalie PhillipsYvonne SingerTanesha A DimanopoulosLisa MartinLeila CuttleDimitrios VagenasSteven M McPhailPauline CallejaJed DuffAlexandra De YoungBronwyn R Griffin<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Discussion</h4>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.<h4>Trial registration</h4>Australian and New Zealand Clinical Trials Registry: ACTRN12622000166774. Registered 1 February 2022.https://doi.org/10.1371/journal.pone.0315278
spellingShingle 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
Implementation of negative pressure for acute pediatric burns (INPREP): A stepped-wedge cluster randomized controlled trial protocol.
PLoS ONE
title Implementation of negative pressure for acute pediatric burns (INPREP): A stepped-wedge cluster randomized controlled trial protocol.
title_full Implementation of negative pressure for acute pediatric burns (INPREP): A stepped-wedge cluster randomized controlled trial protocol.
title_fullStr Implementation of negative pressure for acute pediatric burns (INPREP): A stepped-wedge cluster randomized controlled trial protocol.
title_full_unstemmed Implementation of negative pressure for acute pediatric burns (INPREP): A stepped-wedge cluster randomized controlled trial protocol.
title_short Implementation of negative pressure for acute pediatric burns (INPREP): A stepped-wedge cluster randomized controlled trial protocol.
title_sort implementation of negative pressure for acute pediatric burns inprep a stepped wedge cluster randomized controlled trial protocol
url https://doi.org/10.1371/journal.pone.0315278
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