transplant surgery

移植手术
  • 文章类型: Journal Article
    为了获得专业知识,Turkiye的移植外科医生接受严格的培训,包括医学院,residence,义务服务,和广泛的移植手术培训。尽管他们的学术和临床知识水平很高,移植手术的成功在很大程度上取决于文化能力。通过对安卡拉21名专门从事肾脏和肝脏移植的移植外科医生的半结构化访谈,这项研究揭示了健康文盲,文化,和民间传说创造了巨大的障碍。外科医生在忍受恶劣工作条件的同时应对这些挑战。这项研究强调了文化能力在移植手术中的关键作用,强调外科医生了解和解决患者不同文化需求的必要性。主要研究结果表明,外科医生必须在医学专业知识与文化敏感性之间取得平衡,以提供有效的护理。这项研究确定了四个主要的文化障碍:精神信任,家庭政治,健康文盲,和亚文化无能。有效的移植手术需要结合理论水平和文化意识,以满足患者的需求并改善手术效果。
    To achieve expertise, transplant surgeons in Turkiye undergo rigorous training, including medical school, residency, compulsory service, and extensive training in transplant surgery. Despite their high academic and clinical knowledge level, success in transplant surgery heavily depends on cultural competency. Through semi-structured interviews with 21 transplant surgeons specializing in kidney and liver transplants in Ankara, this study reveals how health illiteracy, culture, and folklore create significant barriers. Surgeons navigate these challenges while enduring harsh working conditions. This research highlights the critical role of cultural competency in transplant surgery, emphasizing the necessity for surgeons to understand and address the diverse cultural needs of their patients. Key findings indicate that surgeons must balance medical expertise with cultural sensitivity to deliver effective care. This study identifies four main cultural barriers: spiritual trust, family politics, health illiteracy, and subcultural incompetency. Effective transplant surgery requires a combination of theoretical proficiency and cultural awareness to meet a patient\'s needs and improve surgical outcomes.
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  • 文章类型: Journal Article
    背景:半月板切除术后的疼痛和残疾可能是一个严重的终身问题。治疗方案很少,尤其是年轻人。非手术管理(康复)是一种选择,但越来越多的外科医生正在为这些人进行半月板同种异体移植(MATs)。然而,这仍然是一个不常见的程序,MAT的可用性和使用在英国和国际上差异很大。目前尚不清楚哪种治疗方案是最有效和最具成本效益的。
    方法:半月板移植手术或优化康复试验是一项国际性的,多中心,随机对照试验。目的是比较MAT与个性化优化包装的临床和成本效益,进步,我们称之为个性化膝关节治疗(PKT)的康复。参与者将从英国各地的网站招募,澳大利亚,加拿大和比利时。计划的144名参与者在随机化后24个月(主要结果)提供至少90%的功效来检测膝关节损伤和骨关节炎结果评分(KOOS4)的10分差异。将从医疗保健系统和个人社会服务的角度进行前瞻性计划的经济评估。次要结果数据,包括健康效用,职业状况,体育参与,心理健康,进一步治疗,不良事件将在3,6,12,18和24个月收集。分析将在意向对待的基础上进行,并按照《综合报告标准试验声明》进行报告。
    背景:该试验于2022年8月19日获得伦敦-布卢姆斯伯里研究伦理委员会(22/LO/0327)和悉尼北部地方卫生区人类研究伦理委员会的批准,新南威尔士州,澳大利亚于2023年3月13日(2022/ETH01890)。试验结果将通过同行评审的出版物传播,在国际会议上的演讲,在摘要中,并酌情使用社交媒体。该方案符合推荐的标准方案项目:干预试验建议(SPIRIT)清单。
    背景:ISRCTN87336549。
    BACKGROUND: Pain and disability after meniscectomy can be a substantial lifelong problem. There are few treatment options, especially for young people. Non-surgical management (rehabilitation) is an option but increasingly surgeons are performing meniscal allograft transplants (MATs) for these individuals. However, this is still an uncommon procedure, and availability and usage of MAT vary widely both in the UK and internationally. It is not known which treatment option is the most effective and cost-effective.
    METHODS: The Meniscal Transplant surgery or Optimised Rehabilitation trial is an international, multicentre, randomised controlled trial. The aim is to compare the clinical and cost effectiveness of MAT versus an optimised package of individualised, progressive, rehabilitation that we have called personalised knee therapy (PKT).Participants will be recruited from sites across the UK, Australia, Canada and Belgium. The planned 144 participants provide at least 90% power to detect a 10-point difference in the Knee injury and Osteoarthritis Outcome Score (KOOS4) at 24-months post randomisation (primary outcome). A prospectively planned economic evaluation will be conducted from a healthcare system and personal social services perspective. Secondary outcome data including health utility, occupational status, sports participation, mental well-being, further treatment, and adverse events will be collected at 3, 6, 12, 18, and 24 months. Analysis will be on an intention-to-treat basis and reported in-line with the Consolidated Standards of Reporting Trials statement.
    BACKGROUND: The trial was approved by the London-Bloomsbury Research Ethics Committee on 19 August 2022 (22/LO/0327) and Northern Sydney Local Health District Human Research Ethics Committee, NSW, Australia on the 13 March 2023 (2022/ETH01890).Trial results will be disseminated via peer-reviewed publications, presentations at international conferences, in lay summaries and using social media as appropriate.This protocol adheres to the recommended Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist.
    BACKGROUND: ISRCTN87336549.
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  • 文章类型: Journal Article
    加拿大的土著人民面临着影响实体器官移植的医疗保健不平等。土著患者在肝移植过程中的经验,以及移植专业人员如何看待土著人民面临的挑战,没有被研究过。通过远程医疗对不列颠哥伦比亚省的土著肝移植患者(n=7)和移植护理提供者(n=6)进行了13次半结构化定性访谈,2021年4月至2022年5月之间的加拿大。确定了为临床方法和移植护理计划提供信息的主题,并由土著健康专家进行了验证。在患者参与者中:移植发生在1992年至2020年之间;所有人都是女性;采访时的平均年龄为60岁。在移植护理提供者的参与者中:角色包括护理,社会工作,和手术;83%为女性;接受移植治疗的中位年数为10年。确定了三个广泛的主题:土著优势和资源,系统性和结构性障碍,和不一致的护理和文化安全的卫生专业影响土著患者在肝移植期间的护理。这项研究有助于深入了解肝脏移植过程中的系统性障碍和土著韧性。需要拆除早期与护理挂钩的结构性障碍,以及为移植临床医生提供有关土著历史的培训,文化协议,强烈建议文化安全。
    Indigenous Peoples in Canada face healthcare inequities impacting access to solid organ transplantation. The experiences of Indigenous patients during the liver transplant process, and how transplant professionals perceive challenges faced by Indigenous Peoples, has not been studied. Thirteen semi-structured qualitative interviews were conducted via telehealth with Indigenous liver transplant patients (n = 7) and transplant care providers (n = 6) across British Columbia, Canada between April 2021-May 2022. Themes were identified to inform clinical approaches and transplant care planning and validated by Indigenous health experts. Among patient participants: transplants occurred between 1992-2020; all were women; and the mean age at the time of interview was 60 years. Among transplant care provider participants: roles included nursing, social work, and surgery; 83% were women; and the median number of years in transplant care was ten. Three broad themes were identified: Indigenous strengths and resources, systemic and structural barriers, and inconsistent care and cultural safety across health professions impact Indigenous patient care during liver transplantation. This study contributes insights into systemic barriers and Indigenous resilience in the liver transplant journey. Dismantling structural barriers to early linkage to care is needed, and training for transplant clinicians on Indigenous histories, cultural protocols, and cultural safety is strongly recommended.
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  • 文章类型: Case Reports
    肝脏间叶性错构瘤(MHL)很少见。已描述不到50例成人病例。由于它们的潜在变性或复发,必须进行完整的手术切除。我们描述了一个26岁的患者,有明显的实性病变,移位的腹部器官。经皮穿刺活检提示诊断为MHL。进行了无1段的右半肝切除术;术后过程顺利。肿瘤的间充质成分对结蛋白和平滑肌肌动蛋白具有反应性。证实了低增殖指数(MIB1)。遗传咨询:DICER1和CDKN1C基因测序分析为阴性,染色体11p15区DNA甲基化剖析正常。42个月后,没有复发。总之,临床医生在鉴别诊断中应考虑MHL。尺寸和激进性的需要强加了主要的肝切除或肝移植,应在转诊中心进行。
    Mesenchymal hamartoma of the liver (MHL) is rare. Less than 50 adult cases have been described. Due to their potential degeneration or recurrence, a complete surgical resection must be performed. We describe a case of a 26-year-old with a palpable solid lesion, which displaced abdominal organs. Percutaneous needle biopsies suggested the diagnosis of MHL. A right hemi-hepatectomy without segment 1 was performed; the post-operative course was uneventful. The mesenchymal component of the tumour was reactive to desmin and smooth muscle actin. Low proliferation index was confirmed (MIB1). Genetic counselling: the sequencing analysis of DICER1 and CDKN1C gene was negative, DNA methylation analysis on the chromosome 11p15 region was normal. After 42 months, there was no recurrence. In conclusion, clinicians should consider MHL in the differential diagnosis. The dimension and the need of radicality impose major liver resections or liver transplantations, which should be performed in referral centres.
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  • 文章类型: Journal Article
    背景:肺移植是治疗终末期肺病的金标准,对于在最佳医疗管理失败后满足严格接受标准的一小部分患者。身体虚弱在肺移植候选人中普遍存在,并且在等待名单和术后都与较差的结果有关。运动已被证明有利于优化肺移植候选人的运动能力和生活质量,但它对身体虚弱的影响是未知的。这篇综述旨在评估运动干预措施在改善等待肺移植的成年人的身体虚弱方面的有效性。
    方法:该方案在PROSPERO数据库中进行了前瞻性注册。我们将搜索四个数据库和试验注册表,以确定进行运动干预和评估与身体虚弱有关的结果的成人肺移植候选人的主要研究。研究必须包括至少10名参与者。文章筛选将由两名研究人员在每个阶段独立进行。提取将由一名审阅者执行,并由一秒钟检查。研究中的偏倚风险将由两名独立的评审员使用适合每个研究的研究设计的工具进行评估;我们将使用Cochrane偏差风险2或ROBINS-I。在审查过程的每个阶段,差异将通过与第三审核员达成共识或协商来解决。如果可能和适当的话,将进行虚弱结局的荟萃分析,以及预先指定的亚组和敏感性分析。在我们无法进行荟萃分析的地方,我们将在没有荟萃分析指导的情况下进行叙事综合。审查将使用系统审查和荟萃分析清单的首选报告项目进行报告。
    背景:由于本研究的性质,没有预测到伦理问题。传播将通过会议摘要进行,专业网络,同行评审的期刊和患者支持小组。
    CRD42022363730。
    BACKGROUND: Lung transplantation is the gold-standard treatment for end-stage lung disease for a small group of patients meeting strict acceptance criteria after optimal medical management has failed. Physical frailty is prevalent in lung transplant candidates and has been linked to worse outcomes both on the waiting list and postoperatively. Exercise has been proven to be beneficial in optimising exercise capacity and quality of life in lung transplant candidates, but its impact on physical frailty is unknown. This review aims to assess the effectiveness of exercise interventions in modifying physical frailty for adults awaiting lung transplantation.
    METHODS: This protocol was prospectively registered on the PROSPERO database. We will search four databases plus trial registries to identify primary studies of adult candidates for lung transplantation undertaking exercise interventions and assessing outcomes pertaining to physical frailty. Studies must include at least 10 participants. Article screening will be performed by two researchers independently at each stage. Extraction will be performed by one reviewer and checked by a second. The risk of bias in studies will be assessed by two independent reviewers using tools appropriate for the research design of each study; where appropriate, we will use Cochrane Risk of Bias 2 or ROBINS-I. At each stage of the review process, discrepancies will be resolved through a consensus or consultation with a third reviewer. Meta-analyses of frailty outcomes will be performed if possible and appropriate as will prespecified subgroup and sensitivity analyses. Where we are unable to perform meta-analysis, we will conduct narrative synthesis following Synthesis without Meta-analysis guidance. The review will be reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist.
    BACKGROUND: No ethical issues are predicted due to the nature of this study. Dissemination will occur via conference abstracts, professional networks, peer-reviewed journals and patient support groups.
    UNASSIGNED: CRD42022363730.
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  • 文章类型: Journal Article
    背景:2014年肾脏分配系统(KAS)修订版旨在提高器官分配的公平性并改善患者预后。这项研究评估了KAS修订对美国肾移植人口统计学和结果的影响。
    方法:从1998年到2022年,我们利用器官采购和移植网络/移植接受者科学注册(OPTN/SRTR)数据库进行了一项回顾性研究。我们比较了接受者和捐赠者的特征,以及KAS修订前后的结果(移植物衰竭和受体生存率)。
    结果:Post-KAS,受助人年龄明显较大(53vs48,P<.001),医疗补助受益人增加(7.3%vs5.5%,P<.001)。尽管移植物存活率增加,HR=.91(95%CI0.80-.92,P<.001),受体总生存率下降,HR=1.06(95%CI1.04-1.09,P<.001)。KAS修订导致接受者和捐助者之间的种族多样性增加,加强器官分配的公平性。然而,跨种族群体的移植失败率和受体生存率存在差异。
    结论:2014年肾脏分配系统修订导致了肾移植领域的重要变化。虽然在器官分配中增加种族平等方面取得了进展,需要进一步完善以解决持续的差距。认识到不断变化的患者状况和社会经济因素对于制定未来的政策修改至关重要。
    BACKGROUND: The 2014 Kidney Allocation System (KAS) revision aimed to enhance equity in organ allocation and improve patient outcomes. This study assesses the impacts of the KAS revision on renal transplantation demographics and outcomes in the United States.
    METHODS: We conducted a retrospective study utilizing the Organ Procurement and Transplantation Network/Scientific Registry of Transplant Recipients (OPTN/SRTR) database from 1998 to 2022. We compared recipient and donor characteristics, and outcomes (graft failure and recipient survival) pre- and post-KAS revision.
    RESULTS: Post-KAS, recipients were significantly older (53 vs 48, P < .001) with an increase in Medicaid beneficiaries (7.3% vs 5.5%, P < .001). Despite increased graft survival, HR = .91 (95% CI 0.80-.92, P < .001), overall recipient survival decreased, HR = 1.06 (95% CI 1.04-1.09, P < .001). KAS revision led to greater racial diversity among recipients and donors, enhancing equity in organ allocation. However, disparities persist in graft failure rates and recipient survival across racial groups.
    CONCLUSIONS: The 2014 Kidney Allocation System revision has led to important changes in the renal transplantation landscape. While progress has been made towards increasing racial equity in organ allocation, further refinements are needed to address ongoing disparities. Recognizing the changing patient profiles and socio-economic factors will be crucial in shaping future policy modifications.
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  • 文章类型: Journal Article
    在巨大损失时经常经历的手术遗憾可能会导致外科医生反思他们的实践和术中决策。不可避免的是,在外科行业,在训练和实践中,外科医生的决定会受到质疑,同行,可能还有病人。这里,我们探讨了一例活体捐肾的案例,其中外科医生选择停止手术以偶然发现。最终,这违背了病人的意愿,也违背了外科医生和病人的道德风险和遗憾。本文从一个利他主义捐献者病例的镜头和外科医生的不作为中探讨了手术遗憾,讨论手术决策的伦理和外科医生在术中和术后的观点。
    Surgical regret often experienced at times of a great loss may cause a surgeon to reflect on their practice and intraoperative decision-making. It is inevitable that in the surgical profession, both in training and practice, a surgeon\'s decisions will be questioned by themselves, peers, and possibly patients. Here, we explore a case of living donor kidney donation in which the surgeon chooses to discontinue the operation for an incidental finding. Ultimately, this is against the patient\'s wishes and a decision over which both the surgeon and patient experience moral hazard and regret. This article explores surgical regret from the lens of an altruistic donor case and a surgeon\'s inaction, discussing the ethics of the operative decision-making and surgeon\'s viewpoint intra- and post-operatively.
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  • 文章类型: Journal Article
    目的:在实体器官移植(SOT)受者中,不坚持免疫抑制剂的药物治疗会威胁同种异体移植的存活和功能维持。这项研究旨在调查中国SOT接受者在COVID-19重新开放期间免疫抑制剂药物不依从性的患病率和相关因素。
    方法:横断面研究。
    方法:中南.
    方法:接受SOT伴功能性移植物的成年患者。
    方法:测量体力活动的社会人口统计学问卷和量表,使用抑郁症和药物治疗不依从性来收集数据.进行Logistic回归分析以确定与药物治疗不依从性相关的因素。使用SPSSPROCESS宏4.3软件进行了调解和适度调解分析,以检查大流行重新开放期间影响药物行为的潜在机制。
    结果:本研究共招募了1121名参与者,药物不依从的发生率为36.3%。收件人是男人,月收入较高,独自生活,接受移植至少3年,接受过COVID-19疫苗接种和经历过抑郁症状的患者出现不依从的风险增加。相反,那些从事高强度体力活动的人表现出降低的风险。体力活动与药物治疗不依从性呈负相关(r=-0.124,p<0.001),抑郁完全介导了这种关系(B=-0.014,95%CI:-0.032至-0.003)。COVID-19疫苗接种显著缓解了体力活动与抑郁之间的关系(B=-0.303,95%CI:-0.515至-0.090)。
    结论:本研究调查了在中国COVID-19重新开放期间,SOT接受者的药物不依从性患病率,其相关因素和潜在机制。抑郁症完全介导了体力活动和药物治疗不依从性之间的联系,COVID-19疫苗可缓解体力活动与抑郁之间的关系。这些发现为应对公共卫生紧急情况时管理药物行为提供了一些见解。然而,在恢复正常生活后,应跟踪调节调解模型中显示的关系,并应探索其他潜在关系,以深入了解药物非依从行为.
    OBJECTIVE: Medication non-adherence to immunosuppressants threatens allograft survival and function maintenance among solid organ transplant (SOT) recipients. This study aimed to investigate the prevalence of immunosuppressant medication non-adherence and associated factors during the COVID-19 reopening period among Chinese SOT recipients.
    METHODS: Cross-sectional study.
    METHODS: South-central China.
    METHODS: Adult patients who received SOT with functioning graft.
    METHODS: Sociodemographic questionnaire and scales to measure physical activity, depression and medication non-adherence were used to collect data. Logistic regression analysis was conducted to identify factors associated with medication non-adherence. Mediation and moderated mediation analyses were performed to examine the potential mechanisms influencing medication behaviour during the pandemic reopening period using SPSS PROCESS macro 4.3 software.
    RESULTS: A total of 1121 participants were recruited and the prevalence of medication non-adherence was 36.3% in this study. Recipients who were men, had a higher monthly income, lived alone, had received transplantation for a minimum of 3 years, had received COVID-19 vaccination and experienced depressive symptoms exhibited an increased risk of non-adherence. Contrarily, those who engaged in high-intensity physical activity exhibited a decreased risk. Physical activity was negatively associated with medication non-adherence (r=-0.124, p<0.001) with depression fully mediating this relationship (B=-0.014, 95% CI: -0.032 to -0.003). COVID-19 vaccination significantly moderated the relationship between physical activity and depression (B=-0.303, 95% CI: -0.515 to -0.090).
    CONCLUSIONS: This study investigated the prevalence of medication non-adherence among SOT recipients during the COVID-19 reopening period in China, its associated factors and a potential mechanism. Depression fully mediated the association between physical activity and medication non-adherence, and COVID-19 vaccination moderated the relationship between physical activity and depression. These findings provide some insights for managing medication behaviour when confronting public health emergencies. However, relationships displayed in the moderated mediation model should be tracked after returning to normal life and other potential relationships should be explored to deeply understand medication non-adherent behaviour.
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  • 文章类型: Clinical Trial Protocol
    背景:肺移植(LTx)旨在提高终末期肺部疾病患者的生存率和生活质量。静脉动脉体外膜氧合(VA-ECMO)被用作LTx的术中支持,尽管它的启动没有确切的指导方针。我们旨在评估需要双侧LTx的阻塞性或限制性肺病患者围手术期开始VA-ECMO的两种策略。在控制“按需”臂中,高血液动力学和呼吸需求将决定VA-ECMO的启动;在实验性的“系统”手臂中,VA-ECMO将先发制人。我们假设“系统”策略将增加第28天的无通气天数。
    方法:我们设计了一项平行组的多中心随机对照试验。患有阻塞性或限制性肺病的成人患者,需要双侧LTx,在LTx之前没有正式的先发制人的VA-ECMO,将包括在内。术前肺动脉高压伴血流动力学塌陷的患者,ECMO作为移植的桥梁,严重的低氧血症或高碳酸血症将被二次排除。在系统组中,VA-ECMO将在第一次肺动脉交叉钳夹术之前进行系统植入。在按需小组中,如果血液动力学或呼吸指标符合预先计划的标准,则将在术中植入VA-ECMO。不包括在内,次要排除和VA-ECMO起始标准通过Delphi程序在研究者中进行验证.ECMO和机械通气的术后撤机将根据最佳实践指南进行管理。将在意向治疗人群中比较两组之间在28天(主要终点)的无呼吸机天数。次要终点包括器官衰竭的发生,第28天,第90天和第1年的生命状态,和不良事件。
    背景:赞助商是巴黎援助委员会。ECMOToP协议第2.1版已由法国人权保护委员会批准。结果将发表在国际同行评审的医学期刊上。
    背景:NCT05664204。
    BACKGROUND: Lung transplantation (LTx) aims at improving survival and quality of life for patients with end-stage lung diseases. Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is used as intraoperative support for LTx, despite no precise guidelines for its initiation. We aim to evaluate two strategies of VA-ECMO initiation in the perioperative period in patients with obstructive or restrictive lung disease requiring bilateral LTx. In the control \'on-demand\' arm, high haemodynamic and respiratory needs will dictate VA-ECMO initiation; in the experimental \'systematic\' arm, VA-ECMO will be pre-emptively initiated. We hypothesise a \'systematic\' strategy will increase the number of ventilatory-free days at day 28.
    METHODS: We designed a multicentre randomised controlled trial in parallel groups. Adult patients with obstructive or restrictive lung disease requiring bilateral LTx, without a formal indication for pre-emptive VA-ECMO before LTx, will be included. Patients with preoperative pulmonary hypertension with haemodynamic collapse, ECMO as a bridge to transplantation, severe hypoxaemia or hypercarbia will be secondarily excluded. In the systematic group, VA-ECMO will be systematically implanted before the first pulmonary artery cross-clamp. In the on-demand group, VA-ECMO will be implanted intraoperatively if haemodynamic or respiratory indices meet preplanned criteria. Non-inclusion, secondary exclusion and VA-ECMO initiation criteria were validated by a Delphi process among investigators. Postoperative weaning of ECMO and mechanical ventilation will be managed according to best practice guidelines. The number of ventilator-free days at 28 days (primary endpoint) will be compared between the two groups in the intention-to-treat population. Secondary endpoints encompass organ failure occurrence, day 28, day 90 and year 1 vital status, and adverse events.
    BACKGROUND: The sponsor is the Assistance Publique-Hôpitaux de Paris. The ECMOToP protocol version 2.1 was approved by Comité de Protection des Personnes Ile de France VIII. Results will be published in international peer-reviewed medical journals.
    BACKGROUND: NCT05664204.
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  • 文章类型: Clinical Trial Protocol
    背景:儿科供体部位的伤口通常因皮肤移植后的色素沉着不良而复杂化。这些容易识别的疤痕可能永远不会恢复正常的色素沉着。再生表皮混悬液(RES)已被证明可以改善白癜风患者的色素沉着,以及烧伤后的成年患者。关于RES对处理儿童供体部位疤痕的功效知之甚少。
    方法:将对40名儿童进行随机对照试验,将其分为两组(RES或无RES)标准敷料应用于供体部位伤口。所有需要分裂厚度皮肤移植的16岁或更小的儿童都将接受资格筛选。主要结果是植皮后12个月的供体部位瘢痕色素沉着。次要结果包括再上皮化时间,疼痛,痒,敷料应用容易,治疗满意度,瘢痕厚度和健康相关生活质量。皮肤移植后7天开始,敷料将每3-5天更换一次,直至供体部位≥95%的上皮再形成.将在每次换药和皮肤移植后3、6和12个月收集数据。
    背景:研究中心人类研究伦理委员会(HREC)(HREC/18/QCHQ/45807)于2019年2月11日确认了伦理批准。研究结果将发表在同行评审的期刊上,并在国家和国际会议上发表。这项研究在澳大利亚新西兰临床试验注册中心(可在https://anzctr.org获得。au/ACTRN12620000227998。aspx)。
    背景:澳大利亚新西兰临床试验注册中心[可在https://anzctr.org获得。au/ACTRN12620000227998。aspx].
    BACKGROUND: Paediatric donor site wounds are often complicated by dyspigmentation following a split-thickness skin graft. These easily identifiable scars can potentially never return to normal pigmentation. A Regenerative Epidermal Suspension (RES) has been shown to improve pigmentation in patients with vitiligo, and in adult patients following a burn injury. Very little is known regarding the efficacy of RES for the management of donor site scars in children.
    METHODS: A pilot randomised controlled trial of 40 children allocated to two groups (RES or no RES) standard dressing applied to donor site wounds will be conducted. All children aged 16 years or younger requiring a split thickness skin graft will be screened for eligibility. The primary outcome is donor site scar pigmentation 12 months after skin grafting. Secondary outcomes include re-epithelialisation time, pain, itch, dressing application ease, treatment satisfaction, scar thickness and health-related quality of life. Commencing 7 days after the skin graft, the dressing will be changed every 3-5 days until the donor site is ≥ 95% re-epithelialised. Data will be collected at each dressing change and 3, 6 and 12 months post skin graft.
    BACKGROUND: Ethics approval was confirmed on 11 February 2019 by the study site Human Research Ethics Committee (HREC) (HREC/18/QCHQ/45807). Study findings will be published in peer-reviewed journals and presented at national and international conferences. This study was prospectively registered on the Australian New Zealand Clinical Trials Registry (available at https://anzctr.org.au/ACTRN12620000227998.aspx).
    BACKGROUND: Australian New Zealand Clinical Trials Registry [Available at https://anzctr.org.au/ACTRN12620000227998.aspx].
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