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Impact of secukinumab with modified nourishing blood and moisturising decoction on superficial fungal infections in patients with psoriasis with blood-dryness pattern. 舒金单抗加味养血保湿汤对血干型银屑病患者浅表真菌感染的影响
IF 1.7 4区 医学 Q3 DERMATOLOGY Pub Date : 2026-01-02 DOI: 10.12968/jowc.2024.0452
Qingting Liu, Li Han, Lili Shi, Xiyun Mao
<p><strong>Objective: </strong>This study aimed to evaluate the effects of the interleukin (IL)-17A inhibitor secukinumab in conjunction with a modified nourishing blood and moisturising decoction (NBMD) on superficial fungal infections in patients with psoriasis with blood-dryness pattern (a traditional Chinese medicine (TCM) subtype characterised by dry, scaly skin and pruritus; the approximate Western clinical equivalent being mild-to-moderate chronic plaque psoriasis with xerotic (dry-type) features).</p><p><strong>Method: </strong>A cohort of patients diagnosed with psoriasis with blood-dryness pattern were enrolled and randomised into three treatment groups: one receiving secukinumab monotherapy (control group); a matched group receiving tumour necrosis factor (TNF)-α inhibitor (etanercept) plus NBMD therapy (match group), and a third group receiving combination therapy with secukinumab and NBMD therapy (study group). Clinical efficacy was assessed using the Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI). Peripheral blood Th17 cells and serum levels of IL-17A and IL-22 were measured before and after 12 weeks of treatment. The incidence of superficial fungal infections was recorded at three, six and 12 months. Statistical analysis was performed using SPSS version 22.0, employing Chi-squared tests and repeated measures analysis of variance. Absolute risk reduction was calculated to quantify infection risk differences.</p><p><strong>Results: </strong>A total of 216 patients were included in the study, 72 in each of the three groups. Compared with the control group, both the study group and the match group demonstrated superior clinical outcomes. At the 12-month follow-up, PASI 90 (≥90% reduction) response rates were significantly higher in the study group (76.39%) and match group (73.61%) than in the control group (51.39%). Quality of life measures (DLQI) and TCM symptom scores also showed significantly greater improvements in the combination groups (Cohen's d=0.85 for DLQI and 0.76 for TCM symptom scores, representing large and medium-to-large effects, respectively; p<0.001). Immunological analyses revealed that both the study group and match group exhibited more pronounced reductions in Th17 cells, IL-17A and IL-22 levels compared with the control group, indicating enhanced modulation of the IL-17 inflammatory pathway. Notably, the 12-month incidence of superficial fungal infections was markedly lower in the study group (12.5%) and match group (13.9%) than in the control group (30.6%). The adjusted hazard ratios were 0.41 (p<0.01) for the study group and 0.45 (p<0.01) for the match group, demonstrating a significantly reduced risk with combination therapy.</p><p><strong>Conclusion: </strong>In this study, combining secukinumab with a modified nourishing and moisturising TCM regimen yielded superior clinical outcomes, including greater symptom relief, improved quality of life, and a reduced risk of superfic
目的:本研究旨在评价白细胞介素(IL)-17A抑制剂secukinumab联合改良养血保湿汤(NBMD)治疗血干型银屑病(一种以皮肤干燥、鳞屑、瘙痒为特征的中医亚型)患者浅表真菌感染的效果;西方临床近似等同于轻至中度慢性斑块型银屑病,伴有干燥(干型)特征。方法:入选一组诊断为银屑病血干型的患者,随机分为三个治疗组:一组接受secukinumab单药治疗(对照组);匹配组接受肿瘤坏死因子(TNF)-α抑制剂(依那西普)加NBMD治疗(匹配组),第三组接受secukinumab和NBMD治疗联合治疗(研究组)。采用银屑病面积及严重程度指数(PASI)和皮肤病生活质量指数(DLQI)评价临床疗效。治疗前后12周检测外周血Th17细胞及血清IL-17A、IL-22水平。分别于3个月、6个月和12个月记录浅表真菌感染的发生率。统计学分析采用SPSS 22.0版,采用卡方检验和重复测量方差分析。计算绝对风险降低量以量化感染风险差异。结果:共纳入216例患者,三组各72例。与对照组相比,研究组和配型组均表现出较好的临床效果。在12个月的随访中,研究组(76.39%)和配对组(73.61%)的PASI 90缓解率(降低≥90%)明显高于对照组(51.39%)。生活质量测量(DLQI)和中医症状评分在联合组也显示出更大的改善(DLQI的Cohen’s d=0.85,中医症状评分的Cohen’s d= 0.76,分别代表大效果和中大型效果;结论:在本研究中,与生物单药治疗相比,将secukinumab与改良的滋养和保湿中医方案联合使用可获得更好的临床结果,包括更大的症状缓解,改善生活质量,降低浅表真菌感染的风险。
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引用次数: 0
Gluteal-anogenital-perineal reconstruction in patients with chronic hidradenitis suppurativa and related squamous cell carcinoma. 慢性化脓性汗腺炎及相关鳞状细胞癌患者的臀-肛门-会阴重建术。
IF 1.7 4区 医学 Q3 DERMATOLOGY Pub Date : 2026-01-02 DOI: 10.12968/jowc.2024.0123
Özgür Agdogan

Objective: Hidradenitis suppurativa (HS) presents a hard-to-heal (chronic) wound environment, which can predispose individuals to squamous cell carcinoma (SCC). This study evaluates the treatment and reconstructive options for patients with HS, who have been cared for at the author's clinic. The aim of this article is to contribute insights into effective treatment methods and to provide a roadmap for wound management for this patient group.

Method: The evaluation encompassed factors such as age, sex, presence of comorbidities, anatomical location of HS, extent of tissue involvement, incidence of SCC and details of surgical reconstruction methods.

Results: Preoperative diagnostic biopsies were conducted on 18 patients with hard-to-heal wounds and SCC was identified in four patients.

Conclusion: It is essential to take a biopsy of HS lesions before surgical intervention in order to identify potential SCC. This step provides critical information for treatment planning. For patients requiring extensive abdominopelvic resection due to HS-induced SCC, the vertical rectus abdominis myocutaneous flap is an ideal and practical option. Additionally, proactive measures can mitigate complications with the donor area.

目的:化脓性汗腺炎(HS)是一种难以愈合的(慢性)伤口环境,可使个体易患鳞状细胞癌(SCC)。本研究评估了治疗和重建方案的病人与HS,谁曾在笔者的诊所照顾。本文的目的是为有效的治疗方法提供见解,并为这一患者群体的伤口管理提供路线图。方法:评估因素包括年龄、性别、合并症的存在、HS的解剖位置、组织受累程度、SCC的发生率和手术重建方法的细节。结果:对18例难愈合创面进行术前诊断活检,其中4例发现鳞状细胞癌。结论:手术前对HS病变进行活检以识别潜在的SCC是必要的。这一步骤为治疗计划提供了关键信息。对于因hs诱导的鳞状细胞癌而需要广泛切除的患者,垂直腹直肌肌皮瓣是一种理想和实用的选择。此外,积极的措施可以减轻供体区的并发症。
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引用次数: 0
Human amniotic membrane extract for the management of diabetic foot ulcers: a randomised comparative study. 人羊膜提取物治疗糖尿病足溃疡:一项随机对照研究。
IF 1.7 4区 医学 Q3 DERMATOLOGY Pub Date : 2026-01-02 DOI: 10.12968/jowc.2022.0028
Mohammad Azimi Alamouti, Niloufar Shayan, Maryam Momeni, Azam Koohkan, Ensiyeh Hajizadeh-Saffar, Masoumeh Nouri, Maryam MahdaviMehr, Maliheh Mahmoudi, Mahin Jamshidi Makiani, Marzieh Ebrahimi

Previous studies by the authors have shown that human amniotic membrane extract (AME) potentially improves epithelial damage in corneal and skin lesions. However, questions about its role in diabetic foot ulcer (DFU) treatment remain unanswered. In this study, patients with hard-to-heal DFUs were randomly selected after screening and, after confirming the safety of the AME in an initial selection of patients, the remaining participants were divided into two groups. The treatment group received an AME product (DiAMX, Royan Stem Cell Technology, Iran) (concentration 1mg/ml) with standard of care (SoC), topically, every 48 hours for the first week and then every 72 hours until complete closure. The control group received SoC. Patients were visited weekly, and any improvement, reduction in the wound area and any side-effects were recorded. The results of the safety phase (without the control group) showed that the AME had no adverse events. In the efficacy phase, there was no significant difference in baseline characteristics between the treatment and control groups. The results showed that the wound healing rate was 100% in the treatment group and 77.5±3.12% in the control group (p<0.0001) at week 6. All wounds (n=15) were closed in the treatment group and seven wounds had closed in the control group (p<0.0001). The findings of this study showed that the topical use of DiAMX, in addition to SoC, was patient-friendly, inexpensive, safe and effective in healing hard-to-heal DFUs.

作者先前的研究表明,人羊膜提取物(AME)可能改善角膜和皮肤病变的上皮损伤。然而,关于其在糖尿病足溃疡(DFU)治疗中的作用的问题仍然没有答案。在本研究中,筛选后随机选择难以治愈的DFUs患者,在初步选择患者中确认AME的安全性后,将其余参与者分为两组。治疗组接受AME产品(DiAMX, Royan Stem Cell Technology,伊朗)(浓度1mg/ml)标准护理(SoC),局部,第一周每48小时一次,然后每72小时一次,直到完全闭合。对照组给予SoC。每周对患者进行随访,记录任何改善、伤口面积减少和任何副作用。安全期(无对照组)结果显示,AME无不良事件发生。在疗效期,治疗组和对照组的基线特征无显著差异。结果显示,治疗组创面愈合率为100%,对照组创面愈合率为77.5±3.12% (p
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引用次数: 0
Negative pressure wound therapy in paediatric scoliosis surgery: a pilot study. 负压伤口治疗在小儿脊柱侧凸手术:一项试点研究。
IF 1.7 4区 医学 Q3 DERMATOLOGY Pub Date : 2026-01-02 DOI: 10.12968/jowc.2023.0112
Stacy Ng Wei Ling, Nicole Lee Kim Kuan, Mini Abraham, Pan Woei Jack, Kevin Lim Boon Leong

Objective: To evaluate the use of negative pressure wound therapy (NPWT) in healing closed spinal incisions following scoliosis deformity surgery in a paediatric cohort.

Method: A retrospective review of patients <21 years of age who underwent posterior spinal instrumentation and fusion for severe scoliosis between 2019-2022. Patients were divided into two groups. The first comprised patients with idiopathic scoliosis (IS) treated with 3M Prevena (SolventumUS) application (Group P-IS). They were compared against a matched group who received standard dressings (Group S-IS). The second group comprised patients with non-idiopathic scoliosis (NIS) treated with 3M Prevena application (Group P-NIS), and who were compared against a matched group who received standard dressings (Group S-NIS).

Results: The first group had a total of 31 patients (Group P-IS) who were compared to 35 patients (Group S-IS). Seroma formation, wound dehiscence, surgical site infections (SSIs), duration of hospitalisation and the number of visits until complete wound healing was higher in Group S-IS, although statistical significance (p<0.05) was not reached. In the second group, a total of 17 patients (Group P-NIS) were compared against 13 patients (Group S-NIS). Seroma formation, duration of hospitalisation and number of visits until complete wound healing was higher in Group S-NIS.

Conclusion: In this study, NPWT following primary closure in scoliosis surgery resulted in reduced seroma formation, wound dehiscence and SSIs in patients with IS, and reduced seroma formation in NIS patients. NPWT was beneficial in augmenting wound healing following paediatric spinal surgery and should be further examined in larger-scale prospective studies.

目的:评价负压伤口治疗(NPWT)在儿童脊柱侧凸畸形手术后闭合性脊柱切口愈合中的应用。方法:对患者进行回顾性分析结果:第一组共31例(P-IS组),S-IS组35例(P-IS组)。S-IS组的血清肿形成、伤口开裂、手术部位感染(ssi)、住院时间和伤口完全愈合前的就诊次数更高,但有统计学意义(p)。结论:在本研究中,脊柱侧凸手术初次闭合后的NPWT减少了IS患者的血清肿形成、伤口开裂和ssi,减少了NIS患者的血清肿形成。NPWT有利于增加小儿脊柱手术后的伤口愈合,应在更大规模的前瞻性研究中进一步研究。
{"title":"Negative pressure wound therapy in paediatric scoliosis surgery: a pilot study.","authors":"Stacy Ng Wei Ling, Nicole Lee Kim Kuan, Mini Abraham, Pan Woei Jack, Kevin Lim Boon Leong","doi":"10.12968/jowc.2023.0112","DOIUrl":"10.12968/jowc.2023.0112","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the use of negative pressure wound therapy (NPWT) in healing closed spinal incisions following scoliosis deformity surgery in a paediatric cohort.</p><p><strong>Method: </strong>A retrospective review of patients <21 years of age who underwent posterior spinal instrumentation and fusion for severe scoliosis between 2019-2022. Patients were divided into two groups. The first comprised patients with idiopathic scoliosis (IS) treated with 3M Prevena (SolventumUS) application (Group P-IS). They were compared against a matched group who received standard dressings (Group S-IS). The second group comprised patients with non-idiopathic scoliosis (NIS) treated with 3M Prevena application (Group P-NIS), and who were compared against a matched group who received standard dressings (Group S-NIS).</p><p><strong>Results: </strong>The first group had a total of 31 patients (Group P-IS) who were compared to 35 patients (Group S-IS). Seroma formation, wound dehiscence, surgical site infections (SSIs), duration of hospitalisation and the number of visits until complete wound healing was higher in Group S-IS, although statistical significance (p<0.05) was not reached. In the second group, a total of 17 patients (Group P-NIS) were compared against 13 patients (Group S-NIS). Seroma formation, duration of hospitalisation and number of visits until complete wound healing was higher in Group S-NIS.</p><p><strong>Conclusion: </strong>In this study, NPWT following primary closure in scoliosis surgery resulted in reduced seroma formation, wound dehiscence and SSIs in patients with IS, and reduced seroma formation in NIS patients. NPWT was beneficial in augmenting wound healing following paediatric spinal surgery and should be further examined in larger-scale prospective studies.</p>","PeriodicalId":17590,"journal":{"name":"Journal of wound care","volume":"35 1","pages":"68-74"},"PeriodicalIF":1.7,"publicationDate":"2026-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145959818","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
Rethinking regulatory tiers: Medicare real-world evidence shows CAMP outcomes are independent of FDA regulatory classification. 重新考虑监管级别:医疗保险现实世界的证据表明CAMP结果独立于FDA监管分类。
IF 1.7 4区 医学 Q3 DERMATOLOGY Pub Date : 2026-01-02 Epub Date: 2025-12-19 DOI: 10.12968/jowc.2025.0609
William H Tettelbach, David G Armstrong, Travis Tucker, Thomas A Davenport, Lynnette A Morrison, David B Alper, Jonathan Johnson, Lee C Rogers, Jeffery A Niezgoda, Jennie Feight, Kevin Nolan, Daniel Kapp, Naz Wahab, Martha R Kelso
<p><strong>Objective: </strong>Cellular, acellular, and matrix-like products (CAMPs) are widely used for treating hard-to-heal lower-extremity diabetic ulcers (LEDUs) and venous leg ulcers (VLUs); yet, limited evidence exists to demonstrate that clinical outcomes differ across the US Food and Drug Administration's (FDA) regulatory categories: section 361 products; 510(k) devices; and premarket approval products. Despite substantial differences in evidentiary requirements, the FDA's regulatory categories largely distinguish CAMPs by their origin, degree of manipulation and intended purpose, rather than by demonstrated comparative effectiveness. The Centers for Medicare and Medicaid Services' (CMS) commissioned technology assessments and systematic reviews similarly report insufficient evidence that any specific CAMP category consistently outperforms another. Prospective randomised 'controlled' trials rarely include the complex, multimorbid populations seen in routine practice and 'real-world' data, whether collected prospectively or retrospectively. Yet routine practice and real-world data are essential for understanding how these technologies perform in actual Medicare beneficiaries. This study evaluated whether regulatory classification predicts real-world clinical effectiveness and how CAMP-treated episodes compare with standard of care (SoC) alone.</p><p><strong>Method: </strong>To address this evidence gap, a retrospective cohort study using 2.65 million LEDU and 745,411 VLU episodes from the CMS 100% Limited Data Set (2016-2024) was conducted. Episodes receiving CAMPs were stratified by FDA regulatory categories, and four-way 1:1 matching was applied to balance cohorts across age, comorbidities, episode year, time to treatment and debridement depth. Outcomes included episode length of treatment (LoT), CAMP LoT, amputations, infections, mortality and hospital utilisation. Multiple comparisons were controlled using Bonferroni-adjusted alpha thresholds.</p><p><strong>Results: </strong>Across matched cohorts (n=3585 LEDUs and n=2492 VLUs episodes per group), differences in outcomes between CAMP regulatory pathways were minimal. In contrast, all CAMP categories significantly outperformed standard of care (SoC) alone. CAMP-treated episodes demonstrated lower mortality, fewer major amputations, and substantially reduced inpatient, emergency department, intensive care unit and coronary care unit use compared with SoC-alone episodes. These benefits were consistent across wound sizes (<20cm<sup>2</sup> and ≥20cm<sup>2</sup>), and across both LEDU and VLU aetiologies, with only two VLU exceptions: overall episode LoT and minor amputation rates, which did not differ significantly from SoC after adjustment for multiple comparisons. Although CAMP LoT varied modestly across regulatory categories, these differences did not translate into meaningful differences in clinical outcomes. SoC-alone episodes exhibited slightly shorter episode LoT but at the expense
目的:细胞、非细胞和基质样产品(camp)广泛用于治疗难以愈合的下肢糖尿病溃疡(LEDUs)和下肢静脉溃疡(VLUs);然而,有限的证据表明美国食品和药物管理局(FDA)监管类别的临床结果不同:第361节产品;510 (k)设备;及上市前批准产品。尽管在证据要求方面存在实质性差异,但FDA的监管类别在很大程度上根据camp的来源、操纵程度和预期目的来区分camp,而不是通过证明的相对有效性来区分camp。医疗保险和医疗补助服务中心(CMS)委托进行的技术评估和系统审查同样没有足够的证据表明任何特定的CAMP类别始终优于其他类别。前瞻性随机“对照”试验很少包括在常规实践和“现实世界”数据中看到的复杂、多病人群,无论是前瞻性收集还是回顾性收集。然而,日常实践和真实世界的数据对于理解这些技术如何在实际的医疗保险受益人中发挥作用至关重要。本研究评估了监管分类是否能预测现实世界的临床效果,以及camp治疗的发作与单独标准治疗(SoC)的比较。方法:为了解决这一证据缺口,我们对来自CMS 100%有限数据集(2016-2024)的265万LEDU和745,411例VLU进行了回顾性队列研究。接受camp治疗的患者按FDA监管类别进行分层,并采用1:1匹配来平衡年龄、合并症、发作年份、治疗时间和清创深度的队列。结果包括治疗时间(LoT)、CAMP LoT、截肢、感染、死亡率和医院使用率。多重比较采用Bonferroni-adjusted alpha阈值进行控制。结果:在匹配的队列中(每组n=3585 ledu和n=2492 vlu发作),CAMP调节通路之间的结果差异很小。相比之下,所有CAMP类别的表现都明显优于单独的标准护理(SoC)。与单独使用soc相比,camp治疗的发作表现出更低的死亡率、更少的主要截肢,并且大大减少了住院、急诊、重症监护和冠状动脉监护病房的使用。这些益处在伤口大小(2和≥20cm2), LEDU和VLU病因中都是一致的,只有两个VLU例外:总体发作LoT和轻微截肢率,经过多次比较调整后,与SoC没有显著差异。尽管CAMP LoT在不同的监管类别中存在适度的差异,但这些差异并没有转化为临床结果的有意义的差异。单独的soc发作表现出稍短的LoT发作,但代价是明显更高的并发症和医疗保健利用率。结论:在难以愈合伤口的医疗保险受益人中,调节途径或类别不能有效地预测现实世界的临床效果。与单独使用SoC相比,CAMP治疗加SoC治疗,无论其调节分类如何,都能持续改善预后,减少并发症和医院使用率,不分伤口大小和病因。这些发现表明,基于FDA监管类别的分层报销框架缺乏实证依据。相反,支付政策应优先考虑以患者为中心的结果的改善,包括截肢、感染、住院和医疗保险总支出的减少。证据支持基于结果而不是基于监管类别的CAMP报销,并强调了及时启动CAMP(≈30天)以及遵循使用参数一致应用的重要性。
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引用次数: 0
Microbiological characteristics and risk factors for multidrug-resistant organism infections in diabetic foot ulcer. 糖尿病足溃疡多药耐药菌感染的微生物学特征及危险因素
IF 1.7 4区 医学 Q3 DERMATOLOGY Pub Date : 2026-01-02 DOI: 10.12968/jowc.2023.0041
Yiru Bao, Yue Shi, Chaojun Zhu, Zheng Liang, Qiang Xu, Zhaohui Zhang

Objective: Diabetic foot ulcer (DFU) is one of the most common complications of diabetes, and causes significant morbidity, mortality and healthcare expenditure. Multidrug-resistant organism (MDRO) infection is considered a major threat to the treatment of DFUs. This study investigated the risk factors for MDRO infections in DFUs.

Method: This was a retrospective case-control study. Patients diagnosed with DFU and MDRO infections were included in the observation group. The same number of patients hospitalised during the same period and who were diagnosed with DFU but without MDRO infection were matched and selected as the control group. Binary logistic regression analysis was performed to evaluate the risk factors for multidrug-resistant organism (MDRO) infections in DFUs by analysing the clinical data. The receiver operating characteristic (ROC) curve was used for evaluation.

Results: The electronic medical records of 110 patients (55 in each group, with similar sex and age) were reviewed. The results of binary logistic regression analysis showed that: history of antibiotic exposure (odds ratio (OR)=11.878; 95% confidence interval (CI): 3.064, 46.046; p<0.001); history of hospitalisation within one year (OR=3.198; 95% CI: 1.156, 8.846; p=0.025); hypertension (OR=3.976; 95% CI: 1.444, 10.951; p=0.008); and osteomyelitis (OR=21.667; 95% CI: 3.427, 137.002; p=0.001) were significant risk factors for MDRO infection in patients with a DFU. The logistic regression model for MDRO infection in patients with a DFU was fitted as follows: Logit (P) = (-3.482) + (2.475) × history of antibiotic exposure + (1.163) × history of hospitalisation within 1 year + (1.380) × hypertension + (3.076) × osteomyelitis. The ROC curve evaluation model was plotted. The area under the curve was 0.861 (95% CI: 0.794, 0.927; p<0.001).

Conclusion: The findings of this study showed that history of antibiotic exposure, history of hospitalisation within one year, hypertension, and osteomyelitis in combination were the risk factors for MDRO infections in patients with DFUs.

目的:糖尿病足溃疡(DFU)是糖尿病最常见的并发症之一,其发病率、死亡率和医疗费用都很高。耐多药生物(MDRO)感染被认为是DFUs治疗的主要威胁。本研究探讨了DFUs中MDRO感染的危险因素。方法:回顾性病例对照研究。将诊断为DFU和MDRO感染的患者纳入观察组。在同一时期住院的相同数量的诊断为DFU但没有MDRO感染的患者进行匹配,并选择作为对照组。通过对临床资料的分析,采用二元logistic回归分析,评价DFUs患者多药耐药菌(MDRO)感染的危险因素。采用受试者工作特征(ROC)曲线进行评价。结果:回顾了110例患者的电子病历,每组55例,性别、年龄相近。二元logistic回归分析结果显示:抗生素暴露史(优势比(OR)=11.878;95%置信区间(CI): 3.064, 46.046;结论:本研究结果显示抗生素暴露史、一年内住院史、高血压和骨髓炎合并是DFUs患者MDRO感染的危险因素。
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引用次数: 0
Multicomponent reduced compression therapy and TLC-NOSF dressings in leg ulcers with or without arterial component. 多组分减压治疗和TLC-NOSF敷料在有或无动脉成分的腿部溃疡中的应用。
IF 1.7 4区 医学 Q3 DERMATOLOGY Pub Date : 2026-01-02 Epub Date: 2025-12-23 DOI: 10.12968/jowc.2025.0535
Rodrigo Rial, Pilar Ruiz Alvarez, Jose Miguel Gallego, Guillermo Moñux, Luis Sanchez Hervás, Serge Bohbot
<p><strong>Objective: </strong>This study was performed to assess the clinical performance of a multicomponent reduced compression system (applying ~20mmHg) and dressings based on lipido-colloid technology with nano-oligosaccharide factor (TLC-NOSF) in the management of patients with venous leg ulcers (VLUs) and mixed leg ulcers (MLUs with arterial component).</p><p><strong>Method: </strong>A prospective, multicentre, non-comparative clinical trial was conducted in the Angiology and Vascular Surgery Units in three hospitals in Madrid, Spain. Adults with VLUs or MLUs, confirmed by an ankle-brachial pressure index >0.6, were treated with UrgoK2 Lite Latex Free and UrgoStart dressings (both Laboratoires Urgo, France) for 12 weeks. The primary endpoint was complete ulcer closure by week 12. Secondary endpoints included time-to-heal, change in wound area, leg oedema resolution, change in ankle circumference, ease of application and adherence to compression therapy, adverse events (AEs), and acceptability of the treatment strategy.</p><p><strong>Results: </strong>A total of 45 patients with LUs (mean age 70.0 years; 64% male; 44% obese) were included. Based on vascular assessment, 24 patients had VLUs and 21 had MLUs, associated with leg oedema in 89% of cases. The LUs were recurrent in 60% of cases, and lasted ≥6 months in 58% of cases. The wound areas were relatively large (median value: 9.4cm<sup>2</sup>, interquartile range (IQR): 5.9-11.8cm<sup>2</sup>), and mostly covered by sloughy tissue. Impaired perilesional skin was reported in 93% of patients. By the final visit, 71% of VLUs had healed, 25% had improved and 4% remained unchanged. Despite an initial poorer healing prognosis than for VLUs, 43% of MLUs healed and 43% improved. The median time-to-heal was nine weeks (IQR: 6-11 weeks), with no relevant difference between the two types of leg ulcer (LU). These good healing progressions were also supported by consistent and steady reductions in wound surface area throughout the 12 weeks of treatment, regardless of LU aetiology, resulting in a relative wound area reduction of 100% (median value; IQR: 93.8-100.0%) in VLUs and 98.6% (median value; IQR: 55.6-100.0%) in MLUs. Leg oedema resolved in all patients by week 8 (except two missing data), while mean ankle circumference reduced from 24.5±2.7cm at baseline to 21.4±2.4cm at final measurement. The application of the compression system was judged 'very easy' in 85% of cases and 'easy' in 15%. Full adherence to compression therapy was reported in 80% of patients during the first weeks of treatment and increased to 97% by week 8. Only two AEs, unrelated to the evaluated treatments, were reported throughout the study period. At the final visit, the association of the multicomponent reduced compression system and TLC-NOSF dressings in the management of VLUs and MLUs was considered 'very satisfactory' in 98% of cases and 'satisfactory' in 2% by the healthcare professionals involved in this study.</p><p>
目的:评价多组分减压系统(施加~20mmHg)和基于纳米低聚糖因子脂质胶体技术(TLC-NOSF)敷料治疗静脉性腿溃疡(VLUs)和混合性腿溃疡(MLUs合并动脉成分)的临床效果。方法:在西班牙马德里三家医院的血管内科和血管外科进行了一项前瞻性、多中心、非比较临床试验。经踝关节-肱压力指数>.6证实,患有vlu或mlu的成人使用UrgoK2 Lite Latex Free和UrgoStart敷料(均为法国Urgo实验室)治疗12周。主要终点是溃疡在第12周完全闭合。次要终点包括愈合时间、伤口面积变化、腿部水肿消退、踝关节围度变化、压迫治疗的应用和依从性、不良事件(ae)和治疗策略的可接受性。结果:共纳入45例LUs患者(平均年龄70.0岁,男性64%,肥胖44%)。根据血管评估,24例患者有vlu, 21例有mlu, 89%的病例伴有腿部水肿。60%的病例复发,58%的病例持续≥6个月。创面面积较大(中位值:9.4cm2,四分位间距(IQR): 5.9-11.8cm2),多为泥质组织覆盖。93%的患者报告病灶周围皮肤受损。到最后一次访问时,71%的vlu愈合,25%改善,4%保持不变。尽管最初的愈合预后比vlu差,但43%的mlu愈合,43%的mlu改善。中位愈合时间为9周(IQR: 6-11周),两种类型腿部溃疡(LU)之间无相关差异。这些良好的愈合进展也得到了整个12周治疗期间伤口表面积持续稳定减少的支持,无论LU的病因如何,导致vlu的相对伤口面积减少100%(中值;IQR: 93.8-100.0%), mlu的相对伤口面积减少98.6%(中值;IQR: 55.6-100.0%)。所有患者的腿部水肿在第8周消失(除了两个缺失的数据),而平均踝围从基线时的24.5±2.7cm减少到最终测量时的21.4±2.4cm。加压系统的应用在85%的病例中被认为“非常容易”,在15%的病例中被认为“容易”。在治疗的第一周,80%的患者完全坚持压迫治疗,到第8周增加到97%。在整个研究期间,仅报道了两例与评估治疗无关的不良事件。在最后一次访问时,参与本研究的医疗保健专业人员认为,98%的病例认为多组分减压系统和TLC-NOSF敷料在vlu和mlu管理中的关联“非常满意”,2%的病例认为“满意”。结论:多组分减压治疗联合TLC-NOSF敷料可使创面愈合率高,腿部水肿消退,粘连性好,耐受性好。这些发现支持在vlu或mlu患者中使用评估策略。多组分减压治疗可促进不能耐受强压迫或有禁忌的患者早期实施有效的压迫治疗。
{"title":"Multicomponent reduced compression therapy and TLC-NOSF dressings in leg ulcers with or without arterial component.","authors":"Rodrigo Rial, Pilar Ruiz Alvarez, Jose Miguel Gallego, Guillermo Moñux, Luis Sanchez Hervás, Serge Bohbot","doi":"10.12968/jowc.2025.0535","DOIUrl":"10.12968/jowc.2025.0535","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study was performed to assess the clinical performance of a multicomponent reduced compression system (applying ~20mmHg) and dressings based on lipido-colloid technology with nano-oligosaccharide factor (TLC-NOSF) in the management of patients with venous leg ulcers (VLUs) and mixed leg ulcers (MLUs with arterial component).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Method: &lt;/strong&gt;A prospective, multicentre, non-comparative clinical trial was conducted in the Angiology and Vascular Surgery Units in three hospitals in Madrid, Spain. Adults with VLUs or MLUs, confirmed by an ankle-brachial pressure index &gt;0.6, were treated with UrgoK2 Lite Latex Free and UrgoStart dressings (both Laboratoires Urgo, France) for 12 weeks. The primary endpoint was complete ulcer closure by week 12. Secondary endpoints included time-to-heal, change in wound area, leg oedema resolution, change in ankle circumference, ease of application and adherence to compression therapy, adverse events (AEs), and acceptability of the treatment strategy.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;A total of 45 patients with LUs (mean age 70.0 years; 64% male; 44% obese) were included. Based on vascular assessment, 24 patients had VLUs and 21 had MLUs, associated with leg oedema in 89% of cases. The LUs were recurrent in 60% of cases, and lasted ≥6 months in 58% of cases. The wound areas were relatively large (median value: 9.4cm&lt;sup&gt;2&lt;/sup&gt;, interquartile range (IQR): 5.9-11.8cm&lt;sup&gt;2&lt;/sup&gt;), and mostly covered by sloughy tissue. Impaired perilesional skin was reported in 93% of patients. By the final visit, 71% of VLUs had healed, 25% had improved and 4% remained unchanged. Despite an initial poorer healing prognosis than for VLUs, 43% of MLUs healed and 43% improved. The median time-to-heal was nine weeks (IQR: 6-11 weeks), with no relevant difference between the two types of leg ulcer (LU). These good healing progressions were also supported by consistent and steady reductions in wound surface area throughout the 12 weeks of treatment, regardless of LU aetiology, resulting in a relative wound area reduction of 100% (median value; IQR: 93.8-100.0%) in VLUs and 98.6% (median value; IQR: 55.6-100.0%) in MLUs. Leg oedema resolved in all patients by week 8 (except two missing data), while mean ankle circumference reduced from 24.5±2.7cm at baseline to 21.4±2.4cm at final measurement. The application of the compression system was judged 'very easy' in 85% of cases and 'easy' in 15%. Full adherence to compression therapy was reported in 80% of patients during the first weeks of treatment and increased to 97% by week 8. Only two AEs, unrelated to the evaluated treatments, were reported throughout the study period. At the final visit, the association of the multicomponent reduced compression system and TLC-NOSF dressings in the management of VLUs and MLUs was considered 'very satisfactory' in 98% of cases and 'satisfactory' in 2% by the healthcare professionals involved in this study.&lt;/p&gt;&lt;p&gt;","PeriodicalId":17590,"journal":{"name":"Journal of wound care","volume":"35 1","pages":"4-14"},"PeriodicalIF":1.7,"publicationDate":"2026-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145959893","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
In vitro performance of Biatain Superabsorber and use in management of moderately-to-highly exuding wounds. Biatain超吸收剂的体外性能及在中高渗伤口处理中的应用。
IF 1.7 4区 医学 Q3 DERMATOLOGY Pub Date : 2026-01-02 DOI: 10.12968/jowc.2025.0447
Klaus Zobel, Maurice Schmidt, Andrea Knobel, Joana Pinto, Marcus Philipp Moll, Niels Frank Jensen, Henrik Fallesen, Julie Hansen, Martin Vestergaard

Objective: Superabsorbent wound dressings (SWDs) are often applied for the management of excess exudate in moderately-to-highly exuding wounds; however, in vitro performance characteristics, including absorptive capacity and retention of fluid, can vary significantly between SWD brands. The aims of this study were to: i. assess in vitro absorptive and retention capacities of a new non-adhesive SWD (Biatain Superabsorber, Coloplast A/S, Denmark) and four non-adhesive comparator SWDs (Zetuvit Plus (Hartmann, Germany); ConvaMax Superabsorber (Convatec, UK); Mextra Superabsorbent (Mölnlycke, Sweden); and Vliwasorb (Lohmann & Rauscher, Germany)); ii. assess the ability of the SWDs to reduce matrix metalloproteinase (MMP) activity in vitro; iii. assess bacterial retention within the new SWD; and iv. explore the clinical application of the new SWD in three cases studies.

Method: In vitro performance characteristics were assessed for the five SWDs, which included: free swell absorption; absorption under compression (40mmHg); retention of fluid under compression (40mmHg); and sequestration (protease activity reduction) of MMP-2 and MMP-9. Bacterial retention was assessed with the new SWD.

Results: Significant variations in in vitro performance characteristics between the SWDs were observed. The new SWD showed higher free swell absorption, retention of fluid under compression and absorption under compression than the comparators. MMP-2 and MMP-9-activity were reduced by 98% and 80%, respectively, after four hours' incubation with the new SWD, and it effectively absorbed and retained bacteria within the dressing. The three case reports highlighted benefits of using the new SWD in management of moderately-to-highly exuding wounds.

Conclusion: The new SWD, Biatain Superabsorber, showed good performance in the different in vitro comparative assessments, and clinical use of the dressing highlighted benefits in the management of wound exudate and in establishing an environment supporting wound healing.

目的:高吸水性创面敷料(SWDs)常用于中高渗液创面的过量渗液处理;然而,不同SWD品牌的体外性能特征,包括吸收能力和液体潴留,可能会有很大差异。本研究的目的是:1 .评估一种新型无黏附SWD (Biatain超级吸收剂,Coloplast a /S,丹麦)和四种无黏附比较SWD (Zetuvit Plus (Hartmann,德国))的体外吸收和保留能力;ConvaMax超级吸收器(Convatec,英国);Mextra Superabsorbent (Mölnlycke,瑞典);Vliwasorb (Lohmann & Rauscher,德国);2。体外评估SWDs降低基质金属蛋白酶(MMP)活性的能力;3。评估新社署内的细菌潴留情况;iv.透过三个个案研究,探讨新社会福利署的临床应用。方法:评估5种SWDs的体外性能特征,包括:自由膨胀吸收;压缩吸收(40mmHg);压缩下液体潴留(40mmHg);以及MMP-2和MMP-9的隔离(蛋白酶活性降低)。使用新的SWD评估细菌保留情况。结果:不同SWDs的体外性能特征有显著差异。新型SWD具有更高的自由膨胀吸收、压缩下的流体滞留和压缩下的吸收。与新SWD孵育4小时后,MMP-2和mmp -9活性分别降低98%和80%,并有效吸收和保留敷料内的细菌。这三个病例报告强调了使用新的SWD治疗中度至高度渗出伤口的好处。结论:新型SWD Biatain superabsorder在不同的体外比较评估中表现出良好的性能,临床应用在处理创面渗出液和建立支持创面愈合的环境方面具有突出的作用。
{"title":"In vitro performance of Biatain Superabsorber and use in management of moderately-to-highly exuding wounds.","authors":"Klaus Zobel, Maurice Schmidt, Andrea Knobel, Joana Pinto, Marcus Philipp Moll, Niels Frank Jensen, Henrik Fallesen, Julie Hansen, Martin Vestergaard","doi":"10.12968/jowc.2025.0447","DOIUrl":"10.12968/jowc.2025.0447","url":null,"abstract":"<p><strong>Objective: </strong>Superabsorbent wound dressings (SWDs) are often applied for the management of excess exudate in moderately-to-highly exuding wounds; however, in vitro performance characteristics, including absorptive capacity and retention of fluid, can vary significantly between SWD brands. The aims of this study were to: i. assess in vitro absorptive and retention capacities of a new non-adhesive SWD (Biatain Superabsorber, Coloplast A/S, Denmark) and four non-adhesive comparator SWDs (Zetuvit Plus (Hartmann, Germany); ConvaMax Superabsorber (Convatec, UK); Mextra Superabsorbent (Mölnlycke, Sweden); and Vliwasorb (Lohmann & Rauscher, Germany)); ii. assess the ability of the SWDs to reduce matrix metalloproteinase (MMP) activity in vitro; iii. assess bacterial retention within the new SWD; and iv. explore the clinical application of the new SWD in three cases studies.</p><p><strong>Method: </strong>In vitro performance characteristics were assessed for the five SWDs, which included: free swell absorption; absorption under compression (40mmHg); retention of fluid under compression (40mmHg); and sequestration (protease activity reduction) of MMP-2 and MMP-9. Bacterial retention was assessed with the new SWD.</p><p><strong>Results: </strong>Significant variations in in vitro performance characteristics between the SWDs were observed. The new SWD showed higher free swell absorption, retention of fluid under compression and absorption under compression than the comparators. MMP-2 and MMP-9-activity were reduced by 98% and 80%, respectively, after four hours' incubation with the new SWD, and it effectively absorbed and retained bacteria within the dressing. The three case reports highlighted benefits of using the new SWD in management of moderately-to-highly exuding wounds.</p><p><strong>Conclusion: </strong>The new SWD, Biatain Superabsorber, showed good performance in the different in vitro comparative assessments, and clinical use of the dressing highlighted benefits in the management of wound exudate and in establishing an environment supporting wound healing.</p>","PeriodicalId":17590,"journal":{"name":"Journal of wound care","volume":"35 1","pages":"15-25"},"PeriodicalIF":1.7,"publicationDate":"2026-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145959857","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
Fibroblast growth factor-inducible 14 signalling pathway in cutaneous wounds: a potential therapeutic target. 成纤维细胞生长因子诱导的14信号通路:一个潜在的治疗靶点。
IF 1.7 4区 医学 Q3 DERMATOLOGY Pub Date : 2026-01-02 DOI: 10.12968/jowc.2023.0091
Fangyan Jia, Qin Chen, Xiaoyu Wang, Yumin Xia

Cutaneous wound healing consists of complex processes involving different types of cells and signalling pathways, and occurs in three phases (inflammatory, proliferative and tissue remodelling). The dysregulation of these processes leads to abnormal wound healing, manifesting as hard-to-heal (chronic) wounds at one extreme and pathological scarring at the other. Recent studies have shown that the tumour necrosis factor-like weak inducer of apoptosis (TWEAK)/fibroblast growth factor-inducible 14 (Fn14) signalling pathway regulates inflammatory, re-epithelialisation, collagen synthesis and angiogenesis processes, suggesting that it can modulate cutaneous wound healing. Despite numerous studies suggesting a relationship between the TWEAK/Fn14 axis and cutaneous wound healing, there has been little attention paid to this relationship to date. There is scarce direct evidence supporting that TWEAK/Fn14 axis-targeted therapies work in cutaneous wounds. This review summarises the evidence that TWEAK/Fn14 signalling is involved in wound repair as well as in tissue remodelling. In addition, TWEAK/Fn14 axis-targeted therapies in other diseases are highlighted, and their therapeutic potential in cutaneous wounds discussed.

皮肤伤口愈合是一个复杂的过程,涉及不同类型的细胞和信号通路,并分为三个阶段(炎症、增殖和组织重塑)。这些过程的失调导致伤口愈合异常,表现为一种极端的难以愈合(慢性)伤口和另一种极端的病理性瘢痕。最近的研究表明,肿瘤坏死因子样细胞凋亡弱诱导因子(TWEAK)/成纤维细胞生长因子诱导14 (Fn14)信号通路调节炎症、再上皮化、胶原合成和血管生成过程,表明它可以调节皮肤伤口愈合。尽管大量研究表明TWEAK/Fn14轴与皮肤伤口愈合之间存在关系,但迄今为止对这种关系的关注甚少。很少有直接证据支持TWEAK/Fn14轴靶向疗法在皮肤伤口中起作用。本文综述了有关TWEAK/Fn14信号参与伤口修复和组织重塑的证据。此外,强调了TWEAK/Fn14轴靶向治疗其他疾病,并讨论了其在皮肤伤口中的治疗潜力。
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引用次数: 0
Impact of multilayer compression bandages on subdressing pressure generated by a sNPWT: an experimental study. 多层压缩绷带对sNPWT下压影响的实验研究。
IF 1.7 4区 医学 Q3 DERMATOLOGY Pub Date : 2026-01-02 DOI: 10.12968/jowc.2024.0036
Shamisa Adeli

Objective: Venous leg ulcers (VLU) are a common, recurring condition resulting from venous stasis; they are especially prevalent in Northern Europe and the US. The overall prevalence of this condition is 1%, rising to 3% in patients >65 years of age. This study analysed the effect of a combination of single-use negative pressure wound therapy (sNPWT, VivereX NPWT system (Sunmedic AB, Vällinge, Sweden) and compression bandaging (CB) in the treatment of VLUs.

Method: An experimental in vivo extremity model was used to monitor and validate sub-dressing pressure.

Results: There was no effect of the multilayer CB on the sNPWT therapeutical pressure. To the best of the author's knowledge, this is the first experimental study to examine variations in sub-dressing pressure within sNPWT systems following the application of a CB.

Conclusion: In this study, therapeutical pressure induced by the VivereX device remained unaffected when used in combination with multilayer CB in the treatment of VLUs.

目的:下肢静脉性溃疡(VLU)是由静脉淤积引起的一种常见的复发性疾病;它们在北欧和美国尤其普遍。这种情况的总体患病率为1%,在65岁至65岁的患者中上升至3%。本研究分析了一次性负压创面治疗(sNPWT, VivereX NPWT系统(Sunmedic AB, Vällinge,瑞典)和压迫包扎(CB)联合治疗vlu的效果。方法:采用实验性肢体模型监测和验证敷料下压力。结果:多层CB对sNPWT治疗压力无影响。据作者所知,这是第一个在sNPWT系统中应用CB后检查亚敷设压力变化的实验研究。结论:在本研究中,VivereX装置与多层CB联合使用治疗vlu时,治疗压力不受影响。
{"title":"Impact of multilayer compression bandages on subdressing pressure generated by a sNPWT: an experimental study.","authors":"Shamisa Adeli","doi":"10.12968/jowc.2024.0036","DOIUrl":"10.12968/jowc.2024.0036","url":null,"abstract":"<p><strong>Objective: </strong>Venous leg ulcers (VLU) are a common, recurring condition resulting from venous stasis; they are especially prevalent in Northern Europe and the US. The overall prevalence of this condition is 1%, rising to 3% in patients >65 years of age. This study analysed the effect of a combination of single-use negative pressure wound therapy (sNPWT, VivereX NPWT system (Sunmedic AB, Vällinge, Sweden) and compression bandaging (CB) in the treatment of VLUs.</p><p><strong>Method: </strong>An experimental in vivo extremity model was used to monitor and validate sub-dressing pressure.</p><p><strong>Results: </strong>There was no effect of the multilayer CB on the sNPWT therapeutical pressure. To the best of the author's knowledge, this is the first experimental study to examine variations in sub-dressing pressure within sNPWT systems following the application of a CB.</p><p><strong>Conclusion: </strong>In this study, therapeutical pressure induced by the VivereX device remained unaffected when used in combination with multilayer CB in the treatment of VLUs.</p>","PeriodicalId":17590,"journal":{"name":"Journal of wound care","volume":"35 1","pages":"86-88"},"PeriodicalIF":1.7,"publicationDate":"2026-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145959822","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
期刊
Journal of wound care
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