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How Should Clinical Wound Care and Management Translate to Effective Engineering Standard Testing Requirements from Foam Dressings? Mapping the Existing Gaps and Needs. 临床伤口护理和管理应如何转化为泡沫敷料的有效工程标准测试要求?映射现有差距和需求。
IF 4.9 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-01-01 Epub Date: 2022-04-05 DOI: 10.1089/wound.2021.0173
Amit Gefen, Paulo Alves, Dimitri Beeckman, Breda Cullen, José Luis Lázaro-Martínez, Hadar Lev-Tov, Bijan Najafi, Nick Santamaria, Andrew Sharpe, Terry Swanson, Kevin Woo

Significance: Wounds of all types remain one of the most important, expensive, and common medical problems, for example, up to approximately two-thirds of the work time of community nurses is spent on wound management. Many wounds are treated by means of dressings. The materials used in a dressing, their microarchitecture, and how they are composed and constructed form the basis for the laboratory and clinical performances of any advanced dressing. Recent Advances: The established structure/function principle in material science is reviewed and analyzed in this article in the context of wound dressings. This principle states that the microstructure determines the physical, mechanical, and fluid transport and handling properties, all of which are critically important for, and relevant to the, adequate performances of wound dressings. Critical Issues: According to the above principle, once the clinical requirements for wound care and management are defined for a given wound type and etiology, it should be theoretically possible to translate clinically relevant characteristics of dressings into physical test designs resulting specific metrics of materials, mechanical, and fluid transport and handling properties, all of which should be determined to meet the clinical objectives and be measurable through standardized bench testing. Future Directions: This multidisciplinary review article, written by an International Wound Dressing Technology Expert Panel, discusses the translation of clinical wound care and management into effective, basic engineering standard testing requirements from wound dressings with respect to material types, microarchitecture, and properties, to achieve the desirable performance in supporting healing and improving the quality of life of patients.

意义:所有类型的伤口仍然是最重要、最昂贵和最常见的医疗问题之一,例如,社区护士大约三分之二的工作时间用于伤口管理。许多伤口是用敷料治疗的。敷料中使用的材料、其微结构以及它们的组成和构造方式构成了任何先进敷料的实验室和临床性能的基础。最新进展:本文从创伤敷料的角度对材料科学中已确立的结构/功能原理进行了回顾和分析。该原理指出,微观结构决定了物理、机械和流体的传输和处理特性,所有这些特性对于伤口敷料的充分性能至关重要,并与之相关。关键问题:根据上述原则,一旦为给定的伤口类型和病因定义了伤口护理和管理的临床要求,理论上就有可能将敷料的临床相关特征转化为物理测试设计,从而产生材料、机械和流体运输和处理性能的具体指标,所有这些都应该确定为满足临床目标,并通过标准化的台架测试进行测量。未来方向:这篇由国际伤口敷料技术专家小组撰写的多学科综述文章讨论了将临床伤口护理和管理转化为伤口敷料在材料类型、微结构和性能方面的有效、基本的工程标准测试要求,以在支持愈合和提高患者的生活质量方面实现期望的性能。
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引用次数: 11
Reliability of an AI-Powered Application Across Different Mobile Devices for Assessment of Chronic Wounds. 人工智能驱动的应用程序在不同移动设备上评估慢性创伤的可靠性。
IF 5.8 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-01-01 Epub Date: 2023-03-28 DOI: 10.1089/wound.2022.0095
Mark Swerdlow, Jessica Lo, David G Armstrong

Objective: Evaluate the inter- and intrarater reliability of a wound assessment tool in iPhone 12 and 13 mini modalities against a validated iPad mini/Structure Sensor configuration. Approach: We assessed a wound measurement application (eKare inSight®) for result consistency in patients presenting with wounds. Assessments were analyzed using a two-way analysis of variance. Intraclass correlation coefficient (ICC) was computed for intrarater (ICC1,1) and inter-rater (ICC2,1) analysis using a two-way random effects model. Paired t-test assessed the statistical difference between measurement methods. Results: Forty-two lesions were analyzed with surface areas ranging from 0.2 to 23 cm2 (average 4.33 ± 5.44 cm2). A high level of reliability was observed for repeat wound area measurements by the same examiner (ICC1,1 = 0.997) and between examiners with iPhone 13 mini (ICC2,1 = 0.998). There was no significant difference between iPhone 12 and iPad mini/Structure Sensor (p = 0.78) or between iPhone 13 mini and iPhone 12 (p = 0.22). Minimal difference existed between iPhone 13 mini and iPad mini/Structure Sensor (p = 0.049, Cohen's d = 0.01). Innovation: Increased pervasiveness of smartphones in clinical care, coupled with advances in smartphone imaging and machine learning, allows for a potential solution to the problem of fast and accurate wound measurements. The application investigated produces wound measurement results quickly and with demonstrated accuracy. It does not require a calibration sticker or reference marker and allows for automatic wound boundary delineation. Conclusion: The results of this study suggest that a digital planimetry mobile application may offer high levels of reliability across devices and users.

目的:根据经验证的iPad mini/Structure Sensor配置,评估iPhone 12和13 mini模式下伤口评估工具的评分者间和评分者内可靠性。方法:我们评估了伤口测量应用程序(eKare-inSight®)在出现伤口的患者中的结果一致性。评估采用双向方差分析法进行分析。使用双向随机效应模型计算评分者内(ICC1,1)和评分者间(ICC2,1)分析的组内相关系数(ICC)。配对t检验评估了测量方法之间的统计学差异。结果:分析了42个病变,表面积从0.2到23 cm2(平均4.33 ± 5.44 cm2)。同一检查者重复测量伤口面积的可靠性较高(ICC1,1 = 0.997)以及使用iPhone 13 mini(ICC2,1 = 0.998)。iPhone 12和iPad mini/Structure传感器之间没有显著差异(p = 0.78)或介于iPhone 13 mini和iPhone 12之间(p = 0.22)。iPhone 13 mini和iPad mini/结构传感器之间存在最小差异(p = 0.049,科恩d = 0.01)。创新:智能手机在临床护理中的普及率提高,加上智能手机成像和机器学习的进步,为快速准确的伤口测量问题提供了潜在的解决方案。所研究的应用程序可以快速、准确地产生伤口测量结果。它不需要校准标签或参考标记,并允许自动划定伤口边界。结论:这项研究的结果表明,数字面积测量移动应用程序可以在设备和用户之间提供高水平的可靠性。
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引用次数: 0
Acknowledgment of Reviewers 2023 鸣谢 2023 年审稿人
IF 4.9 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-01-01 DOI: 10.1089/wound.2023.29004.ack
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引用次数: 0
SLEEP, FATIGUE, AND INFLAMMATORY BIOMARKERS IN OLDER ADULTS WITH CHRONIC VENOUS LEG ULCERS (CVLUS) RECEIVING INTENSIVE OUTPATIENT WOUND CARE 接受门诊伤口强化护理的慢性静脉性腿部溃疡(CVLUS)老年人的睡眠、疲劳和炎症生物标志物
IF 4.9 3区 医学 Q1 DERMATOLOGY Pub Date : 2023-12-07 DOI: 10.1089/wound.2023.0124
S. Winders, Debra Lyon, Debra Lynch Kelly, Michael Weaver, Fan Yi, Magali Rezende de Carvalho, Joyce Stechmiller
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引用次数: 0
Automated electrical stimulation therapy accelerates re-epithelialization in a 3D in vitro human skin wound model 自动电刺激疗法加速了三维体外人体皮肤伤口模型的再上皮化
IF 4.9 3区 医学 Q1 DERMATOLOGY Pub Date : 2023-12-07 DOI: 10.1089/wound.2023.0018
Lay Keng Priscilla Lim, Yamini Balakrishnan, Gracia Goh, K. Tham, Yi Zhen Ng, D. Lunny, David Leavesley, Carine Bonnard
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引用次数: 0
Human Wound and Its Burden: Updated 2022 Compendium of Estimates. 人类创伤及其负担:2022年最新估计汇编。
IF 5.8 3区 医学 Q1 DERMATOLOGY Pub Date : 2023-12-01 DOI: 10.1089/wound.2023.0150
Chandan K Sen

Significance: Chronic wounds affect 10.5 million (up 2.3 million from the 2014 update) of U.S. Medicare beneficiaries. Chronic wounds impact the quality of life of nearly 2.5% of the total population of the United States. This fraction is larger in the elderly. These wounds can lead to a range of complications and health care costs. Given the aging population, the continued threat of diabetes and obesity worldwide, and the persistent problem of infection, it is expected that chronic wounds will continue to be a substantial clinical, social, and economic challenge. Disparities in the prevalence and management of chronic wounds exist, with underserved communities and marginalized populations often facing greater challenges in accessing quality wound care. These disparities exacerbate the public health burden. Recent Advances: U.S. Centers for Medicare and Medicaid Services had proposed revision of its local coverage determination limiting the use of skin substitute grafts/cellular and/or tissue-based products for the treatment of diabetic foot ulcers and venous leg ulcers in the U.S. Medicare population. In response to the comment phase, this proposal has been put on hold. The U.S. Food and Drug Administration (FDA) has renewed its focus on addressing nonhealing chronic wounds and has outlined efforts to address identified barriers to product development for nonhealing chronic wounds. The new approach places emphasis on engaging key wound healing stakeholders, including academia, professional associations, patient groups, reimbursement organizations, and industry. Finally, recent advances demonstrating that wounds closed by current FDA definition of wound closure may remain functionally open because of deficiencies in restoration of barrier function warrant revisiting the wound closure endpoint. Such "closed" wounds that are functionally open, also known as invisible wounds, are likely to be associated with high wound recurrence. Future Directions: Addressing the public health problem of chronic wounds will require a multifaceted approach that includes prevention, improved wound care management, and addressing the underlying risk factors.

重要意义:慢性创伤影响1050万(比2014年更新增加230万)美国医疗保险受益人。慢性创伤影响着美国近2.5%总人口的生活质量。这一比例在老年人中更大。这些伤口会导致一系列并发症和医疗费用。鉴于人口老龄化、全球糖尿病和肥胖症的持续威胁以及持续存在的感染问题,预计慢性伤口将继续是一个重大的临床、社会和经济挑战。慢性伤口的流行率和管理存在差异,服务不足的社区和边缘化人群在获得优质伤口护理方面往往面临更大的挑战。这些差距加剧了公共卫生负担。最新进展:自2023年10月1日起,美国CMS宣布修订其本地覆盖率决定,限制在美国联邦医疗保险人群中使用皮肤替代移植物/细胞和/或组织产品治疗糖尿病足溃疡和静脉性腿溃疡。美国食品药品监督管理局重新将重点放在解决不愈合的慢性伤口上,并概述了解决不愈合慢性伤口产品开发障碍的努力。新方法强调让关键的伤口愈合利益相关者参与进来,包括学术界、专业协会、患者团体、报销组织和行业。最后,最近的进展表明,根据美国食品药品监督管理局目前对伤口闭合的定义闭合的伤口可能由于屏障功能恢复方面的缺陷而保持功能开放,因此有必要重新考虑伤口闭合终点。这种功能开放的“闭合”伤口,也称为隐形伤口,可能与伤口复发率高有关。未来的方向:解决慢性伤口的公共卫生问题需要采取多方面的方法,包括预防、改进伤口护理管理和解决潜在的风险因素。
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引用次数: 0
A Novel Randomized Trial Protocol for Evaluating Wound Healing Interventions. 一种新的评估创伤愈合干预措施的随机试验方案。
IF 4.9 3区 医学 Q1 DERMATOLOGY Pub Date : 2023-12-01 Epub Date: 2023-09-05 DOI: 10.1089/wound.2023.0058
Richard Hillson Bull, Donna Clements, Agnes Juguilon Collarte, Keith Gordon Harding

Background: Randomized controlled trials using complete healing as an endpoint suffer from poor statistical power, owing to the heterogeneity of wounds and their healing trajectories. The Food and Drug Administration (FDA) has recently consulted with expert groups to consider percentage area reduction (PAR) of the wound over a 4-week period as a valid intermediate endpoint, creating the opportunity for more powerful study designs. Methods: A within-subject controlled study design comparing the PAR of venous leg ulcers (VLU) in patients over 4 weeks receiving different interventions. Twenty-nine patients received multilayer compression over 4 weeks, followed by neuromuscular electrostimulation (NMES) of the leg muscle pump in addition to compression for a further 4 weeks. Paired comparison was then made of PAR between the two phases. A second cohort of 22 patients received only multilayer compression throughout both 4-week phases. Results: Patients randomized to NMES saw a significant increase in healing rate compared with compression alone, whereas patients receiving compression only saw no significant change in healing rate throughout the course of the study. Conclusions: Intermittent NMES of the common peroneal nerve significantly accelerates the healing of VLU. It is well tolerated by patients and deserves serious consideration as an adjuvant to compression therapy. PAR is a useful metric for comparing the performance of wound healing interventions, and the self-controlled trial design allows sensitive discrimination with a relatively small number of subjects over a reasonably short trial period. The study is reported according to the CONSORT reporting guidelines. Clinical Trial Registration: NCT03396731 (ClinicalTrials.gov).

背景:由于伤口及其愈合轨迹的异质性,以完全愈合为终点的随机对照试验的统计能力较差。美国食品药品监督管理局(FDA)最近咨询了专家组,将4周内伤口面积百分比减少(标准杆数)视为有效的中间终点,为更强大的研究设计创造了机会。方法:受试者内对照研究设计,比较4周以上接受不同干预的患者下肢静脉溃疡(VLU)的标准杆数。29名患者在4周内接受了多层压迫,随后除了再压迫4周外,还接受了腿部肌肉泵的神经肌肉电刺激(NMES)。然后对两个阶段之间的标准杆数进行配对比较。第二组22名患者在两个4周阶段均仅接受多层压迫。结果:与单独按压相比,随机接受NMES的患者的愈合率显著提高,而在整个研究过程中,接受按压的患者的治愈率没有显著变化。结论:腓总神经间歇性NMES可明显促进VLU的愈合。它对患者具有良好的耐受性,作为压迫治疗的辅助药物值得认真考虑。标准杆数是比较伤口愈合干预效果的有用指标,自我控制的试验设计允许在合理短的试验期内对相对较少的受试者进行敏感的区分。本研究根据CONSORT报告指南进行报告。临床试验注册:NCT03396731(ClinicalTrials.gov)。
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引用次数: 0
The Impact of Underlying Conditions on Quality-of-Life Measurement Among Patients with Chronic Wounds, as Measured by Utility Values: A Review with an Additional Study. 基础条件对慢性创伤患者生活质量测量的影响,以效用值衡量:一项补充研究综述。
IF 4.9 3区 医学 Q1 DERMATOLOGY Pub Date : 2023-12-01 Epub Date: 2023-10-09 DOI: 10.1089/wound.2023.0098
Kristen A Eckert, Caroline E Fife, Marissa J Carter

Significance: Quality of life (QoL) is important to patients with chronic wounds and is rarely formally evaluated. Understanding what comorbidities most affect the individual versus their wounds could be a key metric. Recent Advances: The last 20 years have seen substantial advances in QoL instruments and conversion of patient data to a single value known as the health utilities index (HUI). We review these advances, along with wound-related QoL, and analyze real-world comorbidities challenging wound care. Critical Issues: To understand the impact of underlying comorbidities in a real-world patient population, we examined a convenience sample of 382 patients seen at a hospital-based outpatient wound center. This quality reporting study falls outside the regulations that govern human subject research. Comorbid conditions were used to calculate HUIs using a variety of literature-reported approaches, while Wound-Quality-of-Life (W-QoL) questionnaire data were collected from patients during their first visit. The mean number of conditions per patient was 8; 229 patients (59.9%) had utility values for comorbidities/conditions, which were worse/lower than their wounds' values. Sixty-three (16.5%) patients had depression and/or anxiety, 64 (16.8%) had morbid obesity, and 204 (53.4%) had gait and mobility disorders, all of which could have affected W-QoL scoring. The mean minimum utility value (0.5) was within 0.05 units of an average of 13 studies reporting health utilities from wound care populations using the EuroQol 5 Dimension instrument. Future Directions: The comorbidity associated with the lowest utility value is what might most influence the QoL of patients with chronic wounds. This finding needs further investigation.

意义:生活质量(QoL)对慢性伤口患者很重要,很少得到正式评估。了解哪些合并症对个体及其伤口的影响最大可能是一个关键指标。最近的进展:在过去的20年里,生活质量指标和将患者数据转换为一个称为健康效用指数(HUI)的单一值方面取得了重大进展。我们回顾了这些进展,以及与伤口相关的生活质量,并分析了现实世界中挑战伤口护理的合并症。关键问题:为了了解现实世界患者群体中潜在合并症的影响,我们检查了382名在医院门诊创伤中心就诊的患者的便利样本。这项质量报告研究不属于管理人类主题研究的法规范围。使用多种文献报道的方法,使用共病条件来计算HUI,同时在患者首次就诊期间收集伤口生活质量(W-QoL)问卷数据。每位患者的平均病情数为8例;229名患者(59.9%)的合并症/病症的效用值比伤口的效用值更差/更低。63名(16.5%)患者患有抑郁症和/或焦虑症,64名(16.8%)患者有病态肥胖,204名(53.4%)患者有步态和行动障碍,所有这些都可能影响W-QoL评分。平均最小效用值(0.5)在使用EuroQol 5 Dimension仪器报告伤口护理人群健康效用的13项研究的平均值的0.05个单位内。未来方向:与最低效用值相关的共病可能是对慢性伤口患者生活质量影响最大的因素。这一发现需要进一步调查。
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引用次数: 0
Maintaining and Restoring Gradients of Ions in the Epidermis: The Role of Ion and Water Channels in Acute Cutaneous Wound Healing. 维持和恢复表皮中离子的梯度:离子和水通道在急性皮肤伤口愈合中的作用。
IF 5.8 3区 医学 Q1 DERMATOLOGY Pub Date : 2023-12-01 Epub Date: 2023-06-06 DOI: 10.1089/wound.2022.0128
Kevin Mai, Emanual Maverakis, Jung Li, Min Zhao

Significance: Aquaporins and ion channels establish and regulate gradients of calcium, sodium, potassium, chloride, water, and protons in the epidermis. These elements have been found to play significant roles in skin biology and wound healing. In this study, we review our understanding of these channels and ion gradients, with a special emphasis on their role in acute wound healing. Recent Advances: Specifically, we assess the temporal and spatial arrangements of ions and their respective channels in the intact skin and during wound and healing to provide a novel perspective of the role of ionic gradients through the various stages of wound healing. Critical Issues: The roles of gradients of ions and channels in wound healing are currently not well understood. A collective analysis of their traits and arrangements in the skin during wound healing may provide a new perspective and understanding of the functionality of gradients of ions and channels in skin biology and wound healing. Future Directions: It is important to elucidate how the gradients of ions and ion channels regulate and facilitate wound healing. A better understanding of the ionic environments may identify novel therapeutic targets and improved strategies to promote wound healing and possibly treat other cutaneous diseases.

意义:水通道蛋白和离子通道建立并调节表皮中钙、钠、钾、氯、水和质子的梯度。这些元素已被发现在皮肤生物学和伤口愈合中发挥重要作用。在这项研究中,我们回顾了我们对这些通道和离子梯度的理解,特别强调了它们在急性伤口愈合中的作用。最新进展:具体而言,我们评估了完整皮肤中以及伤口和愈合过程中离子及其各自通道的时间和空间排列,为离子梯度在伤口愈合各个阶段的作用提供了一个新的视角。关键问题:离子和通道的梯度在伤口愈合中的作用目前还不太清楚。对它们在伤口愈合过程中在皮肤中的特征和排列的集体分析可以为离子和通道的梯度在皮肤生物学和伤口愈合中的功能提供新的视角和理解。未来方向:阐明离子和离子通道的梯度如何调节和促进伤口愈合是很重要的。更好地了解离子环境可以确定新的治疗靶点和改进的策略,以促进伤口愈合并可能治疗其他皮肤疾病。
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引用次数: 0
Magnetic Resonance Imaging Techniques in Peripheral Arterial Disease. 外周动脉疾病的磁共振成像技术。
IF 5.8 3区 医学 Q1 DERMATOLOGY Pub Date : 2023-11-01 Epub Date: 2023-05-23 DOI: 10.1089/wound.2022.0161
Nisha Hosadurg, Christopher M Kramer

Significance: Peripheral arterial disease (PAD) leads to a significant burden of morbidity and impaired quality of life globally. Diabetes is a significant risk factor accelerating the development of PAD with an associated increase in the risk of chronic wounds, tissue, and limb loss. Various magnetic resonance imaging (MRI) techniques are being increasingly acknowledged as useful methods of accurately assessing PAD. Recent Advances: Conventionally utilized MRI techniques for assessing macrovascular disease have included contrast enhanced magnetic resonance angiography (MRA), noncontrast time of flight MRA, and phase contrast MRI, but have significant limitations. In recent years, novel noncontrast MRI methods assessing skeletal muscle perfusion and metabolism such as arterial spin labeling (ASL), blood-oxygen-level dependent (BOLD) imaging, and chemical exchange saturation transfer (CEST) have emerged. Critical Issues: Conventional non-MRI (such as ankle-brachial index, arterial duplex ultrasonography, and computed tomographic angiography) and MRI based modalities image the macrovasculature. The underlying mechanisms of PAD that result in clinical manifestations are, however, complex, and imaging modalities that can assess the interaction between impaired blood flow, microvascular tissue perfusion, and muscular metabolism are necessary. Future Directions: Further development and clinical validation of noncontrast MRI methods assessing skeletal muscle perfusion and metabolism, such as ASL, BOLD, CEST, intravoxel incoherent motion microperfusion, and techniques that assess plaque composition, are advancing this field. These modalities can provide useful prognostic data and help in reliable surveillance of outcomes after interventions.

意义:外周动脉疾病(PAD)在全球范围内造成了严重的发病负担和生活质量受损。糖尿病是加速PAD发展的重要风险因素,并增加慢性伤口、组织和肢体损伤的风险。各种磁共振成像(MRI)技术越来越被认为是准确评估PAD的有用方法。最近的进展:用于评估大血管疾病的常规MRI技术包括对比增强磁共振血管造影术(MRA)、非光栅飞行时间MRA和相位对比MRI,但有显著的局限性。近年来,出现了评估骨骼肌灌注和代谢的新的非光栅MRI方法,如动脉旋转标记(ASL)、血氧水平依赖性(BOLD)成像和化学交换饱和转移(CEST)。关键问题:传统的非MRI(如踝臂指数、动脉双相超声和计算机断层血管造影术)和基于MRI的模式对大血管系统成像。然而,导致临床表现的PAD的潜在机制是复杂的,需要评估血流受损、微血管组织灌注和肌肉代谢之间相互作用的成像模式。未来方向:评估骨骼肌灌注和代谢的非光栅MRI方法的进一步开发和临床验证,如ASL、BOLD、CEST、体素内非相干运动微灌注,以及评估斑块组成的技术,正在推进这一领域。这些模式可以提供有用的预后数据,并有助于对干预后的结果进行可靠的监测。
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引用次数: 0
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Advances in wound care
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