儿童急性烧伤负压治疗（INPREP）：一项阶梯楔形整群随机对照试验方案
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.
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.
背景
急性烧伤时应用辅助性负压伤口治疗（NPWT）可显著缩短小儿烧伤患者的创面再上皮化时间。然而，这种辅助治疗尚未被广泛或常规地用作标准的主要烧伤敷料策略。急性小儿烧伤负压治疗实施（INPREP）试验将在四家主要儿科医院实施并评估辅助性NPWT的影响，并同时采用共同设计的实施策略和资源。
方法
我们将进行一项多中心、前瞻性、阶梯式楔形整群随机对照试验，以对急性小儿烧伤应用辅助性NPWT。参与者将包括到澳大利亚四家三级儿科医院之一接受烧伤治疗的小儿烧伤患者。干预措施为辅助性NPWT，并同时采用共同设计和量身定制的实施策略以及一套NPWT实施资源，这些构成了INPREP工具包。采用混合型III设计，本试验旨在通过以下方面评估NPWT与INPREP工具包并行实施的有效性：（i）实施结果（如采用率、适宜性、可接受性、可行性和可持续性）；（ii）临床结果（如创面再上皮化天数、瘢痕管理需求、皮肤移植需求）。本试验的主要结果是治疗采用率，即接受NPWT的符合条件患者的比例。
讨论
本手稿概述了一项关于在急性小儿烧伤护理中实施辅助性NPWT的混合型III阶梯式楔形整群随机对照试验的方案。我们预计，与INPREP工具包并行实施NPWT将适用于澳大利亚各地的急诊科和烧伤服务部门，所产生的证据将为国际小儿烧伤护理提供参考。
试验注册
澳大利亚和新西兰临床试验注册中心：ACTRN12622000166774。2022年2月1日注册。
Zotero 插件