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

作者信息

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

机构信息

School of Nursing and Midwifery, Griffith University, Nathan Campus, South Brisbane, QLD, Australia.

Children's Health Queensland Hospital and Health Service, South Brisbane, QLD, Australia.

出版信息

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


DOI:10.1371/journal.pone.0315278
PMID:39656723
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11630585/
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.

摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a23/11630585/cb36a1929daf/pone.0315278.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a23/11630585/38f72514f864/pone.0315278.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a23/11630585/cb36a1929daf/pone.0315278.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a23/11630585/38f72514f864/pone.0315278.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a23/11630585/cb36a1929daf/pone.0315278.g002.jpg

相似文献

[1]
Implementation of negative pressure for acute pediatric burns (INPREP): A stepped-wedge cluster randomized controlled trial protocol.

PLoS One. 2024-12-10

[2]
Barriers and co-designed strategies for the implementation of negative pressure wound therapy in acute pediatric burn care in Australia: A mixed method study.

J Pediatr Nurs. 2024

[3]
Study of negative pressure wound therapy as an adjunct treatment for acute burns in children (SONATA in C): protocol for a randomised controlled trial.

Trials. 2019-2-13

[4]
Randomized clinical trial of negative pressure wound therapy as an adjunctive treatment for small-area thermal burns in children.

Br J Surg. 2020-12

[5]
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Trials. 2016-4-29

[6]
Cost-effectiveness of adjunctive negative pressure wound therapy in paediatric burn care: evidence from the SONATA in C randomised controlled trial.

Sci Rep. 2021-8-17

[7]
Negative pressure wound therapy in burns: a prospective, randomized-controlled trial.

Burns. 2024-9

[8]
Protocol for a feasibility, acceptability and safety study of the PICO device (negative pressure wound therapy) in acute paediatric burns.

BMJ Open. 2023-5-3

[9]
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Trials. 2022-7-19

[10]
Play and heal: randomized controlled trial of Ditto™ intervention efficacy on improving re-epithelialization in pediatric burns.

Burns. 2014-3

本文引用的文献

[1]
Barriers and co-designed strategies for the implementation of negative pressure wound therapy in acute pediatric burn care in Australia: A mixed method study.

J Pediatr Nurs. 2024

[2]
The feasibility of negative pressure wound therapy versus standard dressings in paediatric hand and foot burns protocol: a pilot, single-centre, randomised control trial.

Pilot Feasibility Stud. 2023-5-26

[3]
Reflections on 10 years of effectiveness-implementation hybrid studies.

Front Health Serv. 2022-12-8

[4]
Local burn wound environment versus systemic response: Comparison of proteins and metabolites.

Wound Repair Regen. 2022-9

[5]
Systemic long-term metabolic effects of acute non-severe paediatric burn injury.

Sci Rep. 2022-7-29

[6]
Negative pressure therapy in abdominal wall surgery.

Cir Esp (Engl Ed). 2022-8

[7]
Physical, Psychological, and Social Outcomes in Pediatric Burn Survivors Ages 5 to 18 Years: A Systematic Review.

J Burn Care Res. 2022-3-23

[8]
Circular RNA expression profiles following negative pressure wound therapy in burn wounds with experimental infection.

Bioengineered. 2022-2

[9]
Clinical Application of Vacuum Sealing Drainage for the Treatment of Deep Burn Wounds.

Am Surg. 2023-4

[10]
Cost-effectiveness of adjunctive negative pressure wound therapy in paediatric burn care: evidence from the SONATA in C randomised controlled trial.

Sci Rep. 2021-8-17

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