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PICO 装置(负压伤口治疗)治疗急性儿科烧伤的可行性、可接受性和安全性研究方案。

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

机构信息

Faculty of Health, Griffith University, Southport, Queensland, Australia

Burns Department, Queensland Children's Hospital, South Brisbane, Queensland, Australia.

出版信息

BMJ Open. 2023 May 3;13(5):e068499. doi: 10.1136/bmjopen-2022-068499.


DOI:10.1136/bmjopen-2022-068499
PMID:37137557
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10163492/
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.

摘要

引言:负压伤口治疗(NPWT)在急性烧伤护理中可使上皮再形成时间缩短超过 20%。尽管如此,由于使用的负担,包括治疗、身体和经济方面,NPWT 在急性烧伤护理中的应用受到限制。使用小的、超便携、一次性 NPWT 设备 PICO 而非更大的设备可能会最小化这种限制,迄今为止,这在急性烧伤护理中从未被研究过。因此,这项研究将主要评估 PICO 在儿科烧伤中的可行性、可接受性和安全性。次要结果包括上皮再形成时间、疼痛、瘙痒、成本和疤痕形成。

方法和分析:本方案详细介绍了临床试验方法,且为预结果。这是一项在澳大利亚四级儿科烧伤中心进行的单站点、前瞻性、初步随机对照试验。参与者必须年龄≤16 岁,身体状况良好,且在发生烧伤后 24 小时内得到管理,烧伤面积适合 PICO 敷料覆盖。30 名参与者将随机分为三组:A 组:Mepitel 和 ACTICOAT、B 组:Mepitel、ACTICOAT 和 PICO、C 组:Mepitel、ACTICOAT Flex 和 PICO。将在每次换药时记录患者的结局,以评估疗效和安全性结局,直至烧伤后 3 个月上皮再形成。调查、随机分组和数据存储将通过在线平台进行,而物理数据将在澳大利亚布里斯班的儿童健康研究中心进行整理。分析将使用 StataSE 17.0 统计软件进行。

伦理和传播:昆士兰州卫生署和格里菲斯人类研究伦理委员会已获得伦理批准,包括特定地点的批准。这些数据将通过临床会议、会议演讲和同行评议期刊进行传播。

试验注册号:ACTRN12622000009718。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3137/10163492/c9aa1dc09866/bmjopen-2022-068499f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3137/10163492/c9aa1dc09866/bmjopen-2022-068499f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3137/10163492/c9aa1dc09866/bmjopen-2022-068499f01.jpg

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引用本文的文献

[1]
Pediatric Burn Treatment with Non-Thermal Atmospheric Plasma and Epifast: Clinical Results.

Eur Burn J. 2025-4-14

本文引用的文献

[1]
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

[2]
Effectiveness of a hydrogel dressing as an analgesic adjunct to first aid for the treatment of acute paediatric burn injuries: a prospective randomised controlled trial.

BMJ Open. 2021-1-5

[3]
Randomized clinical trial of negative pressure wound therapy as an adjunctive treatment for small-area thermal burns in children.

Br J Surg. 2020-12

[4]
Comparative effectiveness of Biobrane®, RECELL® Autologous skin Cell suspension and Silver dressings in partial thickness paediatric burns: BRACS randomised trial protocol.

Burns Trauma. 2019-10-31

[5]
A comparison study of methods for estimation of a burn surface area: Lund and Browder, e-burn and Mersey Burns.

Burns. 2019-9-24

[6]
The Brisbane Burn Scar Impact Profile (child and young person version) for measuring health-related quality of life in children with burn scars: A longitudinal cohort study of reliability, validity and responsiveness.

Burns. 2019-8-3

[7]
Ultraportable Devices for Negative Pressure Wound Therapy: First Comparative Analysis.

J Invest Surg. 2021-3

[8]
Implementation science: What is it and why should I care?

Psychiatry Res. 2019-4-23

[9]
Prospective randomised controlled trial of Algisite™ M, Cuticerin™, and Sorbact® as donor site dressings in paediatric split-thickness skin grafts.

Burns Trauma. 2018-11-27

[10]
Agreement Between Parent Proxy Report and Child Self-Report of Pain Intensity and Health-Related Quality of Life After Surgery.

Acad Pediatr. 2017-12-8

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