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Hypothermically stored amniotic membrane in the management of hard-to-heal wounds of the lower extremities: a retrospective case series. 低温储存羊膜在处理难以愈合的下肢伤口:回顾性病例系列。
IF 1.7 4区 医学 Q3 DERMATOLOGY Pub Date : 2025-10-02 DOI: 10.12968/jowc.2025.0194
Brock A Liden, Kelly A Kimmerling, Katie C Mowry

Objective: Lower extremity hard-to-heal wounds affect >2.4 million people in the US and are characterised by excessive inflammation. One potential management technique is the use of placental-derived allografts, which contain an extracellular matrix scaffold and key regulatory proteins. The aim of this study was to compare, using wound closure analyses, the clinical outcomes of patients using a hypothermically stored amniotic membrane (HSAM) allograft as a protective barrier, which retains the structure and content of native amnion for supporting healing of lower extremity open wounds via intact or meshed techniques.

Method: A retrospective chart review identified adult patients from January 2017-October 2018 who had received HSAM for lower extremity open wounds. Application of HSAM included either an intact or a meshed technique for graft application. Baseline patient demographics were collected, along with wound parameters from baseline until wound closure.

Results: The experimental cohort comprised 13 patients with an average starting wound size of 12.5cm2 and who received an average of 5.5 applications of HSAM. Kaplan-Meier survival analysis revealed a median wound closure time of 63 days for the combined cohort, with 48 days and 63 days for intact and meshed techniques, respectively. Wound closure incidence showed that seven patients achieved 100% wound closure; the technique used did not affect closure incidence.

Conclusion: The findings of this study provide evidence that supports further examination of HSAM as a protective barrier for the management of lower extremity hard-to-heal wounds.

目的:下肢难以愈合的伤口影响了美国约240万人,其特征是过度炎症。一种潜在的治疗技术是使用胎盘来源的同种异体移植物,它含有细胞外基质支架和关键的调节蛋白。本研究的目的是通过伤口闭合分析,比较使用低温储存羊膜(HSAM)异体移植作为保护屏障的患者的临床结果,该保护屏障保留了天然羊膜的结构和内容,通过完整或网状技术支持下肢开放性伤口的愈合。方法:回顾性分析2017年1月至2018年10月接受HSAM治疗下肢开放性伤口的成年患者。HSAM的应用包括完整的或网状的移植应用。收集基线患者人口统计数据,以及从基线到伤口闭合的伤口参数。结果:实验队列包括13例患者,平均起始伤口大小为12.5cm2,平均接受5.5次HSAM。Kaplan-Meier生存分析显示,联合队列的中位伤口愈合时间为63天,完整和网状技术的中位伤口愈合时间分别为48天和63天。创面愈合发生率:7例创面100%愈合;所使用的技术不影响闭合发生率。结论:本研究结果为进一步研究HSAM作为治疗下肢难愈合伤口的保护屏障提供了证据。
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引用次数: 0
Outcomes of a multicomponent compression system in a hot environment: a clinical evaluation. 多组分压缩系统在高温环境中的效果:临床评价。
IF 1.7 4区 医学 Q3 DERMATOLOGY Pub Date : 2025-10-02 Epub Date: 2025-09-16 DOI: 10.12968/jowc.2025.0166
Jean-Patrick Benigni, Jean-François Uhl, Wassila Taha, Pascal Filori, Florence Balet

Objective: To assess the effects of the UrgoKTwo (Laboratoires URGO, France) compression system on the leg volume, interface pressures, static stiffness index (SSI), comfort and slippage in a very hot environment.

Method: Volunteers from among hospital staff in the Diabetic Foot Center (Cairo, Egypt), whose work involved standing for long periods, and who presented with a pitting oedema, were included in this study. The parameters were assessed at baseline, after four hours of wearing the compression system (T+4h), and following a treadmill test. Leg volume was assessed using HandySCAN 3D Laser (Creaform, Canada).

Results: A total of 20 volunteers took part. The compression system was applied with an interface pressure of 45±3mmHg at baseline. After four hours of wearing the compression system, there was a significant reduction in mean leg volume of 81ml, which represented 2.9% of the mean volume (p<0.001). The SSI calculated at inclusion after bandage application (13±4.8mmHg) increased significantly at T+4h (15.9±4.9mmHg) (p<0.001). This was due to a decrease in resting pressure to 30mmHg without notable slippage. Despite the hot environment, the compression system remained very comfortable to study participants (mean visual analogue scale score: 8±1.6).

Conclusion: The findings of this clinical trial showed that the compression system helped reduce oedema in a very hot environment from the initial hours of wear. The SSI, which increased over the course of the trial, is an essential factor in reinforcing venous haemodynamics of the calf muscle pump.

目的:评价UrgoKTwo (Laboratoires URGO, France)压缩系统在高温环境下对腿部体积、界面压力、静态刚度指数(SSI)、舒适性和滑移性的影响。方法:志愿者来自糖尿病足中心(埃及开罗)的医院工作人员,他们的工作涉及长时间站立,并且出现凹陷性水肿,他们被纳入本研究。在基线、佩戴压缩系统4小时后(T+4h)和跑步机测试后评估参数。使用HandySCAN 3D Laser (Creaform, Canada)评估腿部体积。结果:共有20名志愿者参与。压缩系统在基线时施加45±3mmHg的界面压力。在使用压缩系统4小时后,腿部平均体积明显减少81ml,为平均体积的2.9%(结论:本临床试验结果表明,压缩系统从最初的几个小时开始,就有助于减少在高温环境下的水肿。SSI在试验过程中增加,是加强小腿肌肉泵静脉血流动力学的重要因素。
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引用次数: 0
Clinical experience depicting wound regression trends with carePATCH: a case series. 用carePATCH描述伤口消退趋势的临床经验:一个病例系列。
IF 1.7 4区 医学 Q3 DERMATOLOGY Pub Date : 2025-10-02 Epub Date: 2025-09-18 DOI: 10.12968/jowc.2025.0392
Nan E Hodge, Corey B Dahl, Brian B Liljenquist, Eric J Thomas

Objective: The objective of this case series was to assess the clinical outcomes of standard of care (SoC) supplemented with carePATCH (ExtremityCare LLC, US) a dehydrated, dual-layer amniotic membrane allograft, in mediating hard-to-heal wounds that had failed to respond to SoC alone.

Method: Data were collected from electronic health records of patients seen between November 2023 and January 2025 at a single wound care provider group (WelsCare LLC, US). Patients aged ≥18 years with hard-to-heal wounds failing to achieve ≥50% surface area reduction within 30 days of documented SoC treatment were included. carePATCH was applied as an adjunct to SoC following debridement of the wound in accordance with best wound care practices. Changes in wound surface area, percentage area reduction (PAR) and clinical parameters were assessed at baseline, at final application and at one week post final application.

Results: A total of 13 patients (eight male, five female, mean age: 75.1 years) were included. A total of 13 wounds, including venous leg ulcers (n=6), pressure ulcers (n=5), post-surgical wounds (n=1) and venous stasis/arterial wounds (n=1) were evaluated. Median PAR (for all wounds combined) at final application was 77.4%, increasing to 100% at one week post final application. Statistical analysis demonstrated significant improvement in PAR outcomes (p=0.017 at final application; p=0.003 at one week post final application). Box- and-whisker plots revealed consistent surface area reduction across all wound types, with measurements remaining stable one week post final application.

Conclusion: This case series provides encouraging results for the use of carePATCH as an adjunct to SoC in mediating chronic wounds. Patient outcome data support positive clinical experiences with regard to wound regression.

目的:本病例系列的目的是评估标准护理(SoC)补充carePATCH (ExtremityCare LLC, US)的临床结果,carePATCH是一种脱水的双层羊膜同种异体移植物,用于治疗单独对SoC没有反应的难以愈合的伤口。方法:数据收集于2023年11月至2025年1月在单一伤口护理提供者组(WelsCare LLC, US)就诊的患者的电子健康记录。年龄≥18岁且难以愈合的伤口在有记录的SoC治疗30天内未能达到≥50%的表面面积缩小的患者被纳入。根据最佳伤口护理实践,在伤口清创后应用carePATCH作为SoC的辅助。在基线、最终应用时和最终应用后一周评估创面面积、面积缩小百分比(PAR)和临床参数的变化。结果:共纳入13例患者,其中男8例,女5例,平均年龄75.1岁。共评估13处创面,包括下肢静脉溃疡(n=6)、压疮(n=5)、术后创面(n=1)和静脉淤血/动脉创面(n=1)。最终应用时的中位PAR(所有伤口合并)为77.4%,在最终应用后一周增加到100%。统计分析显示PAR结果有显著改善(最终应用时p=0.017;最终应用后一周p=0.003)。箱形和须状图显示,所有伤口类型的表面积减少一致,在最终应用后一周测量保持稳定。结论:本病例系列为使用carePATCH作为SoC辅助治疗慢性伤口提供了令人鼓舞的结果。患者结果数据支持积极的临床经验,关于伤口消退。
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引用次数: 0
Enhancing patient outcomes through effective implementation of pressure ulcer guidelines. 通过有效实施压疮指南来提高患者的治疗效果。
IF 1.7 4区 医学 Q3 DERMATOLOGY Pub Date : 2025-10-02 DOI: 10.12968/jowc.2024.0118
Hannah Wilson, Pinar Avsar, Declan Patton, Zena Moore

Pressure ulcers (PUs) pose significant challenges in healthcare despite there being evidence-based guidelines for their prevention and treatment. This article examines the impact of guideline implementation on PU incidence, patient quality of life and healthcare costs. Implementation of guideline recommendations, including multifactorial evidence-based interventions and care bundles, have led to a significant reduction in PU incidence and improvement in patient outcomes across diverse healthcare settings. While guidelines offer valuable recommendations, their implementation faces challenges, including healthcare professionals' lack of awareness and knowledge regarding guideline existence and importance. Strategies such as education programmes, and developing guidelines with clear language and easy-to-follow recommendations, are crucial for enhancing guideline uptake. Furthermore, patient and caregiver involvement in PU prevention and treatment is essential for promoting self-care and active participation in care and, in turn, active participation in guideline recommendations. Addressing these challenges through increased awareness, education and patient involvement is vital for improving guideline implementation and patient outcomes with regards to PU prevention and treatment.

尽管有基于证据的预防和治疗指南,但压疮(PUs)对医疗保健构成了重大挑战。本文探讨指南实施对PU发病率、患者生活质量和医疗成本的影响。指南建议的实施,包括多因素循证干预和护理包的实施,在不同的医疗环境中显著降低了PU发病率,改善了患者的预后。虽然指南提供了有价值的建议,但其实施面临挑战,包括医疗保健专业人员缺乏对指南存在和重要性的认识和知识。诸如教育计划和制定具有明确语言和易于遵循的建议的指南等战略对于加强指南的吸收至关重要。此外,患者和护理人员参与PU预防和治疗对于促进自我保健和积极参与护理以及积极参与指南建议至关重要。通过提高认识、教育和患者参与来应对这些挑战,对于改善指南的实施和在PU预防和治疗方面的患者结果至关重要。
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引用次数: 0
A complex scalp wound following a myiasis infestation: cranial burr holes and negative pressure wound therapy. 蝇蛆病感染后的复杂头皮伤口:颅刺孔和负压伤口治疗。
IF 1.7 4区 医学 Q3 DERMATOLOGY Pub Date : 2025-10-02 DOI: 10.12968/jowc.2023.0108
Yuri Thomé Machado Petrillo, Eduardo Furtado Coronel, Matheus Daniel Faleiro, Pedro Adolfo de Andrade Sarmento, Fabiano Pasqualotto Soares, Carla Jeanine Sulzbach, Mariana Kumaira Fonseca

Myiasis is a parasitic infection common in tropical areas, such as Brazil. It is caused by infestation of maggots of various fly species in humans. Here, the case of a 38-year-old female patient, with no comorbidities, who was referred to the authors' centre due to a scalp wound infested with larvae and complete soft tissue loss, is presented. A computed tomography scan revealed no evidence of osteomyelitis or intracranial compromise. Since the initial debridement and mechanical removal of the larvae resulted in a large and complex wound, the patient underwent a combined wound approach based on cranial burr holes and negative pressure wound therapy followed by skin graft. The wound revealed excellent skin graft survival, and the patient was safely discharged home. No complications were observed in the follow-up period.

蝇蛆病是热带地区常见的一种寄生虫感染,如巴西。它是由各种蝇类的蛆侵入人体而引起的。在这里,一个38岁的女性患者,没有合并症,谁被转介到作者的中心,由于头皮伤口感染幼虫和完全软组织损失,是提出的。计算机断层扫描显示没有骨髓炎或颅内损伤的证据。由于最初的清创和机械去除幼虫导致了一个大而复杂的伤口,患者接受了基于颅刺孔和负压伤口治疗的联合创面方法,然后进行皮肤移植。伤口显示良好的植皮存活,病人安全出院回家。随访期间无并发症发生。
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引用次数: 0
A clinical investigation of a new gelling fibre dressing containing silver for the management of partial-thickness burns. 一种新型含银胶凝纤维敷料治疗部分烧伤的临床研究。
IF 1.7 4区 医学 Q3 DERMATOLOGY Pub Date : 2025-10-02 DOI: 10.12968/jowc.2025.0233
Christopher J Lewis, Malene Høj Outzen, Charlotte Hindsberger, Baljit Dheansa, Christopher Wearn, Kayvan Shokrollahi, Joana Pinto, Kristine Gjødsbøl, Fadi Issa

Objective: To evaluate the performance and safety of Biatain Fiber Ag (Coloplast A/S, Denmark), a new gelling fibre wound dressing containing silver, based on percentage of wounds healed in partial-thickness burns within two weeks.

Method: This non-comparative, one-armed, open-labelled, multicentre study, included patients from five different sites in the UK between October 2023 and April 2024. The primary endpoint was whether a wound healed or not. Adverse events were also assessed.

Results: In total, 51 patients with a partial-thickness burn wound that was either infected or at risk of infection, and with medium-to-high levels of exudate, were part of the full analysis set. The proportion of wounds healed within two weeks of treatment was 83.7% (95% confidence interval (CI): 69.3, 93.2) of the 43 patients completing the investigation. In a post hoc sensitivity analysis, assuming that missing data on wound healing were either missing at random or corresponded to a non-healed wound, the estimated proportion of wounds healed was 74.8% (95% CI: 60.7, 85.1). In the pre-planned sensitivity analysis, where all missing data on wound healing were assumed to correspond to a non-healed wound, it was 70.6% (95% CI: 56.2, 82.5). A total of seven adverse events were found related to the investigational device; all were non-serious.

Conclusion: In this study, treatment of partial-thickness burns with the investigational device showed that the percentage of healed wounds within two weeks was comparable to the performance of similar products. In addition, the results revealed no safety concerns. This new gelling fibre wound dressing containing silver may therefore have a notable clinical implication for wound healing in patients with acute wounds that are infected or at risk of infection.

目的:以两周内局部烧伤创面愈合率为指标,评价新型含银胶凝纤维敷料Biatain Fiber Ag (Coloplast A/S, Denmark)的性能和安全性。方法:这项非比较、单臂、开放标签、多中心的研究,包括2023年10月至2024年4月期间来自英国五个不同地点的患者。主要终点是伤口是否愈合。对不良事件也进行了评估。结果:总共有51例部分厚度烧伤创面感染或有感染风险,并有中高渗出物,是完整分析集的一部分。在完成调查的43例患者中,2周内伤口愈合的比例为83.7%(95%可信区间(CI): 69.3, 93.2)。在事后敏感性分析中,假设缺失的伤口愈合数据是随机缺失的,或者对应于未愈合的伤口,估计伤口愈合的比例为74.8% (95% CI: 60.7, 85.1)。在预先计划的敏感性分析中,假设所有缺失的伤口愈合数据对应于未愈合的伤口,这一比例为70.6% (95% CI: 56.2, 82.5)。总共发现7个不良事件与研究器械有关;所有人都不严肃。结论:在本研究中,使用研究装置治疗部分厚度烧伤,两周内伤口愈合的百分比与同类产品的性能相当。此外,结果显示没有安全问题。因此,这种新的含银胶凝纤维伤口敷料可能对感染或有感染风险的急性伤口愈合患者具有显着的临床意义。
{"title":"A clinical investigation of a new gelling fibre dressing containing silver for the management of partial-thickness burns.","authors":"Christopher J Lewis, Malene Høj Outzen, Charlotte Hindsberger, Baljit Dheansa, Christopher Wearn, Kayvan Shokrollahi, Joana Pinto, Kristine Gjødsbøl, Fadi Issa","doi":"10.12968/jowc.2025.0233","DOIUrl":"10.12968/jowc.2025.0233","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the performance and safety of Biatain Fiber Ag (Coloplast A/S, Denmark), a new gelling fibre wound dressing containing silver, based on percentage of wounds healed in partial-thickness burns within two weeks.</p><p><strong>Method: </strong>This non-comparative, one-armed, open-labelled, multicentre study, included patients from five different sites in the UK between October 2023 and April 2024. The primary endpoint was whether a wound healed or not. Adverse events were also assessed.</p><p><strong>Results: </strong>In total, 51 patients with a partial-thickness burn wound that was either infected or at risk of infection, and with medium-to-high levels of exudate, were part of the full analysis set. The proportion of wounds healed within two weeks of treatment was 83.7% (95% confidence interval (CI): 69.3, 93.2) of the 43 patients completing the investigation. In a post hoc sensitivity analysis, assuming that missing data on wound healing were either missing at random or corresponded to a non-healed wound, the estimated proportion of wounds healed was 74.8% (95% CI: 60.7, 85.1). In the pre-planned sensitivity analysis, where all missing data on wound healing were assumed to correspond to a non-healed wound, it was 70.6% (95% CI: 56.2, 82.5). A total of seven adverse events were found related to the investigational device; all were non-serious.</p><p><strong>Conclusion: </strong>In this study, treatment of partial-thickness burns with the investigational device showed that the percentage of healed wounds within two weeks was comparable to the performance of similar products. In addition, the results revealed no safety concerns. This new gelling fibre wound dressing containing silver may therefore have a notable clinical implication for wound healing in patients with acute wounds that are infected or at risk of infection.</p>","PeriodicalId":17590,"journal":{"name":"Journal of wound care","volume":"34 10","pages":"797-804"},"PeriodicalIF":1.7,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145275019","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Cost-effectiveness of an enhanced silver-containing dressing in treating hard-to-heal venous leg ulcers. 增强型含银敷料治疗难以愈合的腿部静脉溃疡的成本效益。
IF 1.7 4区 医学 Q3 DERMATOLOGY Pub Date : 2025-10-02 Epub Date: 2025-09-26 DOI: 10.12968/jowc.2025.0267
Julian F Guest

Objective: To estimate the cost-effectiveness of using a carboxymethylcellulose dressing containing ionic silver, ethylenediaminetetraacetic acid and benzethonium chloride (CISEB; Aquacel Ag+ Extra, Convatec Ltd., UK) compared with a dialkylcarbamoyl chloride-coated dressing (DACC; Cutimed Sorbact, Essity, Germany) in the treatment of hard-to-heal venous leg ulcers (VLUs), from the perspective of the UK's publicly-funded health services.

Method: Markov modelling simulated the management of hard-to-heal VLUs in the community and secondary care over 24 weeks. The modelling used data from a randomised controlled trial and estimated the relative cost-effectiveness of the two dressings, measured by the incremental cost per quality-adjusted life year (QALY) gained, based on 2022/23 prices.

Results: The findings of the modelling showed that starting treatment with CISEB instead of DACC resulted in a >25% increase in the probability of healing. However, the time to healing was similar in both groups, averaging at seven weeks per ulcer. The difference in the probability of healing between the two groups led to a cumulative gain in QALYs, resulting in a 5% improvement in health-related quality of life at 24 weeks. The higher healing rate in the CISEB group led to a ~14% reduction in the total cost of VLU management over 12 weeks and a 23% reduction over 24 weeks. Consequently, starting treatment with CISEB instead of DACC was identified as a potentially cost-effective intervention for treating hard-to-heal VLUs within the UK's health services, as it improved outcomes at a lower cost.

Conclusion: Considering the study's limitations, treating hard-to-heal VLUs with CISEB instead of DACC potentially offers a cost-effective strategy for the UK's health services, since it increases the likelihood of VLU healing for lower cost.

目的:从英国公共资助卫生服务的角度,评估使用含有离子银、乙二胺四乙酸和苄索氯铵的羧甲基纤维素敷料(CISEB; Aquacel Ag+ Extra, Convatec Ltd.,英国)与二烷基氨基甲酰氯涂层敷料(DACC; Cutimed Sorbact, Essity,德国)治疗难以愈合的静脉性腿部溃疡(VLUs)的成本效益。方法:采用马尔可夫模型模拟难愈性vlu在社区和二级护理24周内的处理情况。该模型使用了随机对照试验的数据,并根据2022/23年的价格,通过每个质量调整生命年(QALY)获得的增量成本来估算两种敷料的相对成本效益。结果:模型研究结果显示,以CISEB代替DACC开始治疗可使愈合概率增加约25%。然而,两组的愈合时间相似,平均每溃疡7周。两组之间愈合概率的差异导致QALYs的累积增加,导致24周时健康相关生活质量改善5%。CISEB组较高的治愈率使VLU治疗总费用在12周内降低了14%,在24周内降低了23%。因此,在英国的卫生服务中,用CISEB代替DACC开始治疗是一种潜在的具有成本效益的治疗难以治愈的vlu的干预措施,因为它以较低的成本改善了结果。结论:考虑到该研究的局限性,用CISEB代替DACC治疗难以治愈的VLU可能为英国的卫生服务提供了一种具有成本效益的策略,因为它以更低的成本增加了VLU愈合的可能性。
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引用次数: 0
Efficacy of a full-thickness decellularised placental membrane allograft compared to standard of care in diabetic foot ulcers: a prospective, randomised controlled trial. 与标准治疗相比,全层脱细胞胎盘膜异体移植治疗糖尿病足溃疡的疗效:一项前瞻性、随机对照试验。
IF 1.7 4区 医学 Q3 DERMATOLOGY Pub Date : 2025-10-02 Epub Date: 2025-10-07 DOI: 10.12968/jowc.2025.0428
Alexander M Reyzelman, Dean Vayser, Jason R Hanft, Shawn Cazzell, Maria S Surprenant, Haywan Chiu, Peter M Moyer, Sarah Ducharme, Gregory Tovmassian

This multicentre, randomised controlled trial evaluated the efficacy and safety of adjunctive full-thickness decellularised placental membrane (FT-DPM) in treating persistent and recalcitrant diabetic foot ulcers (DFUs) compared to standard of care (SoC). A total of 57 patients were analysed in the treatment group; the study product was applied to the wound bed post debridement and left in place for 5-9 days. Some 51 patients received SoC only, including debridement and moist wound therapy with alginates, foams or hydrogels. All wounds were offloaded. The findings of this study showed that the FT-DPM significantly improved wound closure rates at 12 weeks compared to SoC (48% versus 27%, respectively; p=0.0499, per-protocol analysis), with a significant percentage area reduction (79% versus 56%, respectively; p<0.05). Mild and moderate adverse events were similar between groups, while serious adverse events were more frequent in the SoC group compared with the FT-DPM group (29% versus 2%, respectively); none were related to treatment. These findings suggest that FT-DPM is an effective and innovative treatment for hard-to-heal (chronic) DFUs, offering a superior option to SoC, particularly for wounds that resist conventional treatments. This approach has the potential to significantly improve patient outcomes and reduce the societal burden of hard-to-heal wounds.

这项多中心、随机对照试验评估了辅助全层脱细胞胎盘膜(FT-DPM)治疗持续性和顽固性糖尿病足溃疡(DFUs)的疗效和安全性,并与标准治疗(SoC)进行了比较。治疗组共分析57例患者;研究品于创面清创后敷于创面,静置5-9天。51例患者仅接受SoC治疗,包括清创和海藻酸盐、泡沫或水凝胶湿润伤口治疗。所有的伤口都卸下来了。本研究结果显示,与SoC相比,FT-DPM在12周时显著提高了伤口关闭率(分别为48%对27%;p=0.0499,每方案分析),面积减少率显著(分别为79%对56%;p=0.0499)
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引用次数: 0
Safeguarding access, fiscal responsibility and innovation: a comprehensive reimbursement framework for CAMPs to preserve the Medicare Trust Fund. 保障准入、财政责任和创新:为营地提供全面的报销框架,以保留医疗保险信托基金。
IF 1.7 4区 医学 Q3 DERMATOLOGY Pub Date : 2025-10-02 Epub Date: 2025-09-03 DOI: 10.12968/jowc.2025.0396
William Tettelbach, David G Armstrong, Vickie Driver, Alisha Oropallo, Lee C Rogers, Daniel Kapp, Naz Wahab, David B Alper, Travis Tucker, Jennie Feight, Martha R Kelso

Executive summary: This manuscript presents a unified and comprehensive policy framework addressing the flat-fee reimbursement model for skin substitutes, also referred to as cellular, acellular, and matrix-like products (CAMPs), proposed by the Centers for Medicare & Medicaid Services (CMS). These products are vital to treating hard-to-heal wounds, which disproportionately affect older patients, and those patients who are disabled and medically underserved. While CMS aims to curtail excessive spending and introduce payment consistency, the current proposal threatens access to life-saving therapies, endangers patient outcomes, and may destabilise clinical delivery infrastructures and manufacturing ecosystems critical to wound care.

摘要:本文提出了一个统一的、全面的政策框架,解决皮肤替代品的固定费用报销模式,也被称为细胞、非细胞和基质样产品(camp),由医疗保险和医疗补助服务中心(CMS)提出。这些产品对于治疗难以愈合的伤口至关重要,这些伤口对老年患者以及残疾和医疗服务不足的患者的影响尤为严重。虽然CMS旨在减少过度支出并引入支付一致性,但目前的提案威胁到获得挽救生命的疗法,危及患者的预后,并可能破坏对伤口护理至关重要的临床交付基础设施和制造生态系统的稳定。
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引用次数: 0
Real-world outcomes of autologous whole blood clot therapy for venous leg ulcers. 自体全血凝块治疗下肢静脉性溃疡的实际疗效。
IF 1.7 4区 医学 Q3 DERMATOLOGY Pub Date : 2025-10-02 DOI: 10.12968/jowc.2025.0419
Stephen Heisler, Rodney Samaan, Rene Lessing, Emre Ozker, Robert Snyder

Objective: Venous leg ulcers (VLUs) are hard-to-heal wounds primarily caused by venous insufficiency and venous hypertension. These wounds pose significant clinical and economic burdens, often failing to heal with standard compression therapy alone. Autologous whole blood clot (AWBC) therapy has emerged as a potential treatment for hard-to-heal wounds, complementing the body's natural wound healing mechanisms. This study aims to evaluate the outcomes of AWBC in a real-world setting for treating VLUs that have not responded to conventional therapies.

Method: A multicentre observational registry study was conducted between August 2021 and December 2024 (NCT04699305) across multiple countries. Patients with hard-to-heal VLUs were included to receive AWBC application. Median wound duration at baseline was 13.5 months (interquartile range: 5.25, 36.0). AWBC applications were used alongside compression therapy, and outcomes were assessed in terms of percentage area reduction (PAR) and complete wound healing.

Results: There were 56 patients in the study cohort. AWBC treatment resulted in a mean wound area reduction of 71.3%. Complete healing was achieved in 45% of patients, while 54% exhibited a PAR >90%. Among the wounds treated, 44% that had persisted for >1 year achieved complete healing. Treatment duration varied, with some patients requiring extended therapy (12-20 weeks) to achieve significant wound progression. Adverse events were minimal and unrelated to treatment.

Conclusion: In this study, AWBC therapy demonstrated high levels of effectiveness in treating hard-to-heal VLUs, particularly in patients whose wounds had failed to heal with standard compression therapy. AWBC therapy provides a supportive extracellular matrix, modulating inflammation and enhancing wound healing, demonstrating its valuable conjunction treatment to existing compression treatment protocols.

目的:下肢静脉性溃疡是由静脉功能不全和静脉高压引起的难以愈合的创伤。这些伤口造成了重大的临床和经济负担,通常仅用标准的压迫疗法无法愈合。自体全血凝块(AWBC)治疗已成为一种潜在的治疗难以愈合的伤口的方法,补充了人体的自然伤口愈合机制。本研究旨在评估AWBC在现实世界中治疗对常规疗法无反应的vlu的结果。方法:在2021年8月至2024年12月(NCT04699305)期间,在多个国家进行了一项多中心观察性注册研究。难以治愈的vlu患者接受AWBC应用。基线时中位伤口持续时间为13.5个月(四分位数差:5.25,36.0)。AWBC应用与压迫治疗一起使用,并根据面积减少百分比(PAR)和伤口完全愈合来评估结果。结果:研究队列中有56例患者。AWBC治疗导致平均伤口面积减少71.3%。45%的患者完全愈合,54%的患者PAR达到90%。在治疗的创面中,44%的创面持续治疗10 ~ 10年达到完全愈合。治疗时间各不相同,一些患者需要延长治疗(12-20周)以达到明显的伤口进展。不良事件最小,与治疗无关。结论:在这项研究中,AWBC治疗在治疗难以愈合的vlu方面表现出很高的有效性,特别是在使用标准压迫治疗伤口无法愈合的患者中。AWBC治疗提供支持性细胞外基质,调节炎症并促进伤口愈合,证明其与现有压迫治疗方案有价值的联合治疗。
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引用次数: 0
期刊
Journal of wound care
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