Lumsden Emma, Kimble Roy, McMillan Catherine, Storey Kristen, Ware Robert S, Griffin Bronwyn
Faculty of Health, Griffith University, Gold Coast Campus, Parklands Dr, Southport, QLD, 4222, Australia.
Queensland Children's Hospital, Stanley St., South Brisbane, QLD, 4101, Australia.
Pilot Feasibility Stud. 2023 May 26;9(1):90. doi: 10.1186/s40814-023-01308-z.
The goal of paediatric hand and foot burn management is hypertrophic scar and/or contracture prevention. The risk of scar formation may be minimised by integrating negative pressure wound therapy (NPWT) as an acute care adjunct as it decreases the time to re-epithelialisation. NPWT has known associated therapeutic burden; however, this burden is hypothesised to be outweighed by an increased likelihood of hypertrophic scar prevention. This study will assess the feasibility, acceptability and safety of NPWT in paediatric hand and foot burns with secondary outcomes of time to re-epithelialisation, pain, itch, cost and scar formation.
This is a single-site, pilot randomised control trial. Participants must be aged ≤ 16 years, otherwise well and managed within 24 h of sustaining either a hand or foot burn. Thirty participants will be randomised to either standard care (Mepitel®-a silicone wound interface contact dressing-and ACTICOAT™-a nanocrystalline silver-impregnated dressing) or standard care plus NPWT. Patients will be reviewed until 3 months post-burn wound re-epithelialisation, with measurements taken at dressing changes to assess primary and secondary outcomes. Surveys, randomisation and data storage will be done via online platforms and physical data storage collated at the Centre for Children's Health Research, Brisbane, Australia. Analysis will be performed using the Stata statistical software.
Queensland Health and Griffith University Human Research ethics approval including a site-specific assessment was obtained. The findings of this study will be disseminated through clinical meetings, conference presentations and peer reviewed journals.
Registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12622000044729, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=381890&isReview=true , registered 17/01/2022).
小儿手足烧伤管理的目标是预防瘢痕增生和/或挛缩。通过将负压伤口治疗（NPWT）作为急性护理辅助手段，可以将瘢痕形成的风险降至最低，因为它可以缩短上皮再形成的时间。NPWT已知存在相关的治疗负担；然而，据推测，这种负担会被预防瘢痕增生可能性的增加所抵消。本研究将评估NPWT在小儿手足烧伤中的可行性、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、成本和瘢痕形成。
这是一项单中心的试点随机对照试验。参与者年龄必须≤16岁，身体健康，且在手部或足部烧伤后24小时内接受治疗。30名参与者将被随机分为标准护理组（美皮康®——一种硅胶伤口界面接触敷料——和爱康肤银™——一种含纳米晶银的敷料）或标准护理加NPWT组。患者将接受随访，直至烧伤创面上皮再形成后3个月，在换药时进行测量，以评估主要和次要结果。调查、随机分组和数据存储将通过在线平台进行，实体数据存储在澳大利亚布里斯班儿童健康研究中心进行整理。分析将使用Stata统计软件进行。
已获得昆士兰卫生和格里菲斯大学人类研究伦理批准，包括特定地点评估。本研究的结果将通过临床会议、会议报告和同行评审期刊进行传播。
已在澳大利亚和新西兰临床试验注册中心注册（ACTRN12622000044729，https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=381890&isReview=true ，于2022年1月17日注册）。
