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Collagen–ORC Versus Standard Treatment in Diabetic Foot Ulcers: A Systematic Review and Meta-Analysis of Randomised Trials 胶原- orc与标准治疗糖尿病足溃疡:随机试验的系统评价和荟萃分析。
IF 2.5 3区 医学 Q2 DERMATOLOGY Pub Date : 2025-11-17 DOI: 10.1111/iwj.70782
George Theodorakopoulos, David G. Armstrong
<p>Diabetic foot ulcers (DFUs) are a major cause of infection, hospitalisation, and amputation. Collagen-based dressings—especially collagen combined with oxidised regenerated cellulose (ORC)—are proposed to improve healing by modulating matrix metalloproteinases (MMPs), stabilising the extracellular matrix (ECM), and tempering inflammation; some formulations also include antimicrobial or bioactive adjuncts. We conducted a systematic review of randomised controlled trials (RCTs) following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidance. Adults with DFUs were eligible. Interventions included collagen-alone or collagen-combination dressings (e.g., collagen–oxidised regenerated cellulose [collagen–ORC]/silver, collagen–chitosan) versus standard of care (SOC) or alternative dressings. To ensure comparable outcomes, the quantitative synthesis was pre-specified and restricted to complete wound closure (yes/no, intention-to-treat [ITT]) from collagen-combination RCTs with aligned constructs; other outcomes were synthesised narratively. Meta-analyses were performed in Microsoft Excel using Mantel–Haenszel methods for risk ratios (RR) with a fixed-effect primary model and DerSimonian–Laird random-effects sensitivity analysis; heterogeneity was summarised with Cochran's Q, between-study variance (<i>τ</i><sup>2</sup>), and Higgins' <i>I</i><sup>2</sup> statistic (<i>I</i><sup>2</sup>), and a 95% prediction interval was reported for random-effects. (Protocol not registered). Six studies (five randomized controlled trials and one single-blinded non-randomized comparative study; total <i>n</i> = 314) met inclusion. In a focused meta-analysis of the two collagen-combination RCTs, treatment was associated with a higher probability of complete wound closure versus control (RR 1.69, 95% confidence interval [CI] 1.05–2.72; <i>I</i><sup>2</sup> = 0%). One assessor-blinded RCT of collagen alone reported higher 12-week closure versus a placebo dressing and was not pooled due to heterogeneity. Across studies, signals also favored collagen-based care for earlier area reduction and, in one trial, fewer infection-related withdrawals; mechanistic work showed reductions in MMP-9/TIMP-2. However, most trials were small and single-centre, comparators and adjuncts varied, follow-up was short (~8 days–24 weeks, clinical endpoints typically 4–20 weeks), outcome definitions were non-standardised, and key confounders (off-loading, infection management, vascular status, glycaemic control) were inconsistently addressed. Collagen-based dressings—particularly collagen-combination formulations—appear to improve complete closure when added to the standard of care (SOC) for diabetic foot ulcers (DFUs), but the evidence is limited by study size, heterogeneity, and risk of bias. Larger, prospectively registered, multicentre RCTs with standardised outcomes and longer follow-up are needed to define clinical and cost-effectiveness and to identify which pa
糖尿病足溃疡(DFUs)是感染、住院和截肢的主要原因。胶原蛋白为基础的敷料-特别是胶原蛋白与氧化再生纤维素(ORC)结合-被提出通过调节基质金属蛋白酶(MMPs),稳定细胞外基质(ECM)和缓和炎症来改善愈合;一些制剂还包括抗菌或生物活性佐剂。我们按照系统评价和荟萃分析的首选报告项目(PRISMA)指南对随机对照试验(rct)进行了系统评价。患有dfu的成年人是合格的。干预措施包括单独胶原蛋白或胶原蛋白组合敷料(例如,胶原氧化再生纤维素[胶原- orc]/银,胶原-壳聚糖)与标准护理(SOC)或替代敷料。为了确保结果的可比性,定量综合是预先指定的,并且仅限于具有对齐结构的胶原联合rct的完全伤口闭合(是/否,意向治疗[ITT]);其他结果以叙述的方式综合。meta分析采用Mantel-Haenszel方法,采用固定效应为主模型和DerSimonian-Laird随机效应敏感性分析,在Microsoft Excel中进行风险比分析;异质性用Cochran’s Q、研究间方差(τ2)和Higgins’I2统计量(I2)来总结,随机效应的预测区间为95%。(协议未注册)。6项研究(5项随机对照试验和1项单盲非随机对照研究,共n = 314)符合纳入标准。在对两项胶原蛋白联合rct的集中荟萃分析中,与对照组相比,治疗与更高的伤口完全闭合概率相关(RR 1.69, 95%可信区间[CI] 1.05-2.72; I2 = 0%)。单独使用胶原蛋白的一项评估盲RCT报告了比安慰剂敷料更高的12周闭合性,但由于异质性,未进行汇总。在所有研究中,信号也支持基于胶原蛋白的护理,用于早期的区域缩小,在一项试验中,更少的感染相关的退出;机制研究显示MMP-9/TIMP-2降低。然而,大多数试验都是小型和单中心的,比较物和辅助物各不相同,随访时间短(~8天-24周,临床终点通常为4-20周),结果定义非标准化,关键混杂因素(卸载、感染管理、血管状态、血糖控制)的处理不一致。胶原蛋白为基础的敷料,特别是胶原蛋白组合配方,当添加到糖尿病足溃疡(DFUs)的标准护理(SOC)中时,似乎可以改善完全闭合,但证据受到研究规模、异质性和偏倚风险的限制。需要更大规模的、前瞻性注册的、具有标准化结果和更长随访时间的多中心随机对照试验来确定临床和成本效益,并确定哪些患者受益最大。胶原- orc敷料通过影响炎症微环境和支持组织修复,有望作为DFUs的辅助治疗。然而,目前证据的确定性仍然有限,强调需要进一步的高质量随机研究。
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引用次数: 0
Testing Sonication and Different Transport Media to Enhance Microbial Detection in Hard-to-Heal Venous Leg Ulcers 测试超声和不同的运输介质以提高难以愈合的腿部静脉溃疡的微生物检测。
IF 2.5 3区 医学 Q2 DERMATOLOGY Pub Date : 2025-11-16 DOI: 10.1111/iwj.70778
Adéla Holubová, Niels A. J. Cremers, Martin Krause, Lada Cetlová, Jana Matějková, Andrea Pokorná

Hard-to-heal wounds are frequently associated with underlying conditions such as diabetes, vascular disease, and biofilm-related infections. Accurate identification of microbial origin is essential, but is often hindered by biofilms. This study evaluated whether sonication of wound dressings, combined with different sample transport methods, improves bacterial detection in venous leg ulcers. In a prospective observational case–control study, six patients with hard-to-heal venous leg ulcers received treatments with medical-grade honey (MGH) (n = 1), ceramic dressings – “Cerdak” (n = 2), or hydroactive dressings (n = 3). Three microbiological samples were collected per patient: (1) conventional wound swab (Levin's technique) in Amies medium; (2) sonicate fluid from used dressings transported in sterile tubes without medium; and (3) sonicate fluid in haemoculture tubes (BACT/ALERT). Total pathogen count and diversity were compared across sampling methods. Patient quality of life (QoL) was assessed using the Wound-QoL instrument. Sonication revealed additional pathogens not detected by conventional swabs. The highest number of pathogens was found in sonicate fluid transported in haemoculture tubes (n = 43), followed by swabs (n = 39) and sterile tube transport (n = 30). Adequate treatment significantly improved patients' QoL during the healing process. Dressing sonication, especially with haemoculture tube transport, enhances microbial identification and may improve diagnosis and management of hard-to-heal wounds.

难以愈合的伤口通常与糖尿病、血管疾病和生物膜相关感染等潜在疾病有关。微生物来源的准确鉴定是必不可少的,但往往受到生物膜的阻碍。本研究评估了伤口敷料的超声,结合不同的样品运输方法,是否提高了静脉性腿部溃疡的细菌检测。在一项前瞻性观察性病例对照研究中,6例难以治愈的腿部静脉溃疡患者接受了医用级蜂蜜(MGH) (n = 1)、陶瓷敷料“Cerdak”(n = 2)或水活性敷料(n = 3)的治疗。每位患者采集3种微生物样本:(1)常规伤口拭子(Levin’s技术),Amies培养基;(二)用过的敷料中的声波液,在无菌管中无介质输送;(3)血液培养管中的声波流体(BACT/ALERT)。不同采样方法的病原菌总数和多样性比较。采用Wound-QoL仪评估患者生活质量(QoL)。超声检查发现了常规拭子未检测到的其他病原体。在血液培养管中运输的声波液体中发现的病原体数量最多(n = 43),其次是拭子(n = 39)和无菌管运输(n = 30)。适当的治疗可显著改善患者在愈合过程中的生活质量。敷料超声,特别是血液培养管运输,可以提高微生物鉴定,并可能改善难以愈合的伤口的诊断和管理。
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引用次数: 0
Application and Efficacy Evaluation of a Modified Ostomy Appliance in Managing Peristomal Irritant Contact Dermatitis: A Randomised Controlled Trial 改良造口器在治疗口周刺激性接触性皮炎中的应用及疗效评价:一项随机对照试验
IF 2.5 3区 医学 Q2 DERMATOLOGY Pub Date : 2025-11-15 DOI: 10.1111/iwj.70794
Xiaoxiao Ying, Luqiao Huang, Feng Yu, Chan Xu

Irritant contact dermatitis is a common peristomal skin complication. Due to the continuous irritation from intestinal fluids and faeces, the healing of this dermatitis is slow and the condition severely impairs patients' quality of life. The study aimed to evaluate the efficacy of a modified insertable ostomy appliance in promoting healing and improving patient outcomes. A randomised controlled trial was conducted from January 2022 to December 2024 in a tertiary hospital. The enrolled patients, all diagnosed with irritant contact dermatitis, were randomly assigned to two groups. The control group wore the conventional two-piece ostomy appliance, while the experimental group wore the modified insertable ostomy appliance. Outcomes were assessed on Days 3, 7, 14 and 28. The primary outcome was the healing rate (Discoloration, Erosion and Tissue overgrowth [DET] score ≤ 2) at Day 28. Secondary outcomes included the DET score, Visual Analogue Scale (VAS) pain score, Stoma Quality of Life questionnaire (Stoma-QOL) score and the incidence of appliance leakage. A total of 89 eligible participants completed the trial. The experimental group showed a significantly higher 28-day healing rate (73.3% vs. 29.5%, p < 0.001), lower DET scores (Day 28: 2.0 vs. 4.5, p < 0.001), reduced VAS scores (Day 28: 1.5 vs. 2.0, p < 0.001), higher Stoma-QOL scores (Day 28: 55.67 vs. 51.64, p < 0.001) and lower leakage rate (13.3% vs. 93.2%, p < 0.001). The modified ostomy appliance significantly improves healing, reduces pain and enhances quality of life, representing a novel solution for clinical practice.

刺激性接触性皮炎是一种常见的皮肤并发症。由于肠道液体和粪便的持续刺激,这种皮炎愈合缓慢,严重影响患者的生活质量。该研究旨在评估改良的可插入式造口器在促进愈合和改善患者预后方面的功效。随机对照试验于2022年1月至2024年12月在某三级医院进行。所有被诊断为刺激性接触性皮炎的患者被随机分为两组。对照组使用传统的两片式造口器,实验组使用改良的可插入式造口器。在第3、7、14和28天评估结果。主要观察指标为第28天的愈合率(变色、糜烂和组织过度生长[DET]评分≤2)。次要结果包括DET评分、视觉模拟评分(VAS)疼痛评分、Stoma- qol评分和矫治器泄漏发生率。共有89名符合条件的参与者完成了试验。实验组28天愈合率显著提高(73.3% vs. 29.5%, p < 0.001), DET评分显著降低(第28天:2.0 vs. 4.5, p < 0.001), VAS评分显著降低(第28天:1.5 vs. 2.0, p < 0.001), Stoma-QOL评分显著提高(第28天:55.67 vs. 51.64, p < 0.001),渗漏率显著降低(13.3% vs. 93.2%, p < 0.001)。改良的造口器显著改善愈合,减轻疼痛,提高生活质量,为临床实践提供了一种新的解决方案。
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引用次数: 0
Scar Quality After Burns in Relation to Skin Type, Classified by Device-Based Colour Measurement, as an Alternative for the Fitzpatrick Questionnaire 烧伤后疤痕质量与皮肤类型的关系,通过基于设备的颜色测量进行分类,作为Fitzpatrick问卷的替代方案。
IF 2.5 3区 医学 Q2 DERMATOLOGY Pub Date : 2025-11-14 DOI: 10.1111/iwj.70788
Kim L. M. Gardien, Anouk Pijpe, Kelly Kwa, Martijn B. A. van der Wal, Wim E. Tuinebreijer, Esther Middelkoop

This study aimed to determine if skin types can be accurately assessed via melanin scores measured with a colormeter, and whether scar characteristics of people with different skin types are different at various stages of healing. Melanin scores of a Cortex DSM Colormeter were validated against the Fitzpatrick skin type questionnaire in healthy volunteers and unaffected skin of burn and scar patients (N = 137) to determine melanin index cut-offs per skin type. Scar quality in children and adults at 3, 6, and 12 months post-burn using DSM Colormeter and the Patient and Observer Scar Assessment Scale (POSAS) was analysed in a cohort of > 1000 patients. Data from 137 individuals showed good correlation between melanin index and Fitzpatrick skin types (Spearman's rho: 0.72 Dermaspectrometer, 0.69 DSM II; p < 0.0001). Scar characteristics varied by skin type for erythema, pigmentation, vascularization, and overall POSAS scores. Children had significantly thicker scars than adults, regardless of skin type, varying from 0.3 to 1.4 points difference on the observer scale at 12 months post burn. We conclude that skin type can be objectively classified using the melanin index, showing a strong correlation with the Fitzpatrick questionnaire. Skin type influences scar outcomes, especially pigmentation and vascularization. Children, particularly those with lighter skin, tend to develop thicker scars than adults. Recognising these differences can improve scar management and patient education.

这项研究旨在确定皮肤类型是否可以通过颜色计测量的黑色素分数来准确评估,以及不同皮肤类型的人在不同的愈合阶段是否有不同的疤痕特征。在健康志愿者和未受影响的烧伤和疤痕患者皮肤(N = 137)中,根据Fitzpatrick皮肤类型问卷验证皮质DSM色度计的黑色素评分,以确定每种皮肤类型的黑色素指数截止值。使用DSM色度计和患者与观察者疤痕评估量表(POSAS)对儿童和成人在烧伤后3、6和12个月的疤痕质量进行了分析。来自137个个体的数据显示黑色素指数与Fitzpatrick皮肤类型之间存在良好的相关性(Spearman’s rho: 0.72 Dermaspectrometer, 0.69 DSM II; p
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引用次数: 0
Clinical Outcomes and Characterisation of the Autologous Adipose Tissue Harvested With Superficial Enhanced Fluid Fat Injection Method for Treatment of Diabetic Foot Ulcer Undergoing Minor Amputation (SEFFIDiFA Trial) 浅表强化液体脂肪注射法获取自体脂肪组织治疗轻度截肢糖尿病足溃疡的临床结果和特征(SEFFIDiFA试验)
IF 2.5 3区 医学 Q2 DERMATOLOGY Pub Date : 2025-11-14 DOI: 10.1111/iwj.70784
Nicola Leone, Francesco Andreoli, Mattia Migliari, Federica Guerra, Samantha Sperduti, Livio Casarini, Roberto Silingardi, Stefano Gennai

Diabetic foot ulcers (DFUs) are severe complications of diabetes that often lead to major amputations. Despite care advancements, approximately 50% of minor amputations do not heal, resulting in major amputations and increased mortality. This study evaluated the effectiveness of adipose-derived stem cells (ASCs) obtained through superficial enhanced fluid fat injection (SEFFI) in improving healing rates after minor amputations in DFUs. It was a prospective, single-arm, observational cohort study. The patients were monitored for half a year using monthly assessments. The primary endpoint was the healing rate of the amputation stumps after minor amputations coupled with ASC injections. Secondary endpoints included safety, feasibility, adverse events and analysis of variables associated with healing including the analysis of the injected mesenchymal adipose stem cell populations. Of the 256 screened patients, 40 were enrolled. At 6 months, 55% of the treated stumps had healed completely. The median healing time was 69 days. Technical success was achieved in all cases without device-related complications. Multivariable Cox models identified haemodialysis, opioid use and the injected number of CD45-positive cells as risk factors for healing failure. CD73 expression was positively associated with healing. The SEFFIDiFA trial demonstrated a promising 69% healing probability at 6 months post-amputation. This minimally invasive approach showed a higher healing rate with fewer complications. This study supports the potential of ASCs in enhancing wound healing in DFUs and highlights the importance of CD73 expression for successful outcomes. Further research is warranted to validate these findings and optimise the technique.

糖尿病足溃疡(DFUs)是糖尿病的严重并发症,通常导致大面积截肢。尽管护理取得了进步,但大约50%的小截肢无法愈合,导致大截肢和死亡率增加。本研究评估了通过浅表强化液体脂肪注射(SEFFI)获得的脂肪来源干细胞(ASCs)在提高轻度截肢后DFUs愈合率方面的有效性。这是一项前瞻性、单组、观察性队列研究。对患者进行为期半年的月度监测。主要终点是小截肢联合ASC注射后残肢的治愈率。次要终点包括安全性、可行性、不良事件和与愈合相关的变量分析,包括注射间充质脂肪干细胞群体的分析。在256名筛选的患者中,有40人入选。6个月时,55%的治疗残肢完全愈合。中位愈合时间为69天。所有病例均取得技术成功,无器械相关并发症。多变量Cox模型确定血液透析、阿片类药物使用和注射cd45阳性细胞数量是愈合失败的危险因素。CD73表达与愈合呈正相关。SEFFIDiFA试验显示,截肢后6个月的愈合率为69%。这种微创入路具有较高的治愈率和较少的并发症。这项研究支持ASCs在促进DFUs伤口愈合方面的潜力,并强调了CD73表达对成功结果的重要性。需要进一步的研究来验证这些发现并优化该技术。
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引用次数: 0
Predictors of Post-Amputation Complications in Major Lower Limb Amputations: The Role of WIfI Scoring and Pre-Amputation Transcutaneous Oximetry (TcPO2) WIfI评分和截肢前经皮血氧测定(TcPO2)对下肢大截肢术后并发症的预测作用
IF 2.5 3区 医学 Q2 DERMATOLOGY Pub Date : 2025-11-14 DOI: 10.1111/iwj.70785
Julian-Dario Rembe, Muayad Aal-Jelo, Polina Shabes, Katharina H. Wolters, Mansur Duran, Markus Wagenhäuser, Hubert Schelzig, Waseem Garabet

This study evaluates the predictive value of the WIfI (Wound, Ischemia, and foot Infection) classification system and pre-amputation transcutaneous oxygen pressure (TcPO2) measurements in forecasting post-amputation complications in major lower limb amputations (MLLA). A retrospective analysis was conducted on 132 MLLA patients with complete WIfI data and 87 patients with documented TcPO2 values. Associations between WIfI stage, TcPO2, and post-amputation outcomes—including healing time, surgical revisions, re-amputation, and wound complications—were assessed using statistical modeling and receiver operating characteristic (ROC) curve analyses. Higher WIfI stages correlated with prolonged healing (WIfI 4 failure rate: 12.8%) but did not significantly predict complications. Unexpectedly, WIfI 2 patients had a 4.4-fold higher risk of revision (p = 0.011) and a 3.1-fold higher re-amputation risk (p = 0.033) compared to WIfI 4. TcPO2 levels showed a significant relationship with healing outcomes, with a 36.9% failure rate in TcPO2 < 15 mmHg. A TcPO2 cut-off of > 46 mmHg optimized healing prediction (HR = 2.81, p = 0.004). TcPO2 is a stronger predictor of post-amputation complications than WIfI staging. A cut-off of > 46 mmHg at the amputation site is recommended to improve healing outcomes.

本研究评估WIfI(伤口、缺血和足部感染)分类系统和截肢前经皮氧压(TcPO2)测量在预测主要下肢截肢(MLLA)截肢后并发症中的预测价值。回顾性分析132例WIfI数据完整的MLLA患者和87例记录TcPO2值的患者。WIfI分期、TcPO2和截肢后结果(包括愈合时间、手术修复、再截肢和伤口并发症)之间的关系通过统计建模和受试者工作特征(ROC)曲线分析进行评估。较高的WIfI分期与较长的愈合时间相关(WIfI 4失败率:12.8%),但对并发症无显著预测。出乎意料的是,WIfI 2患者的翻修风险比WIfI 4高4.4倍(p = 0.011),再截肢风险比WIfI 4高3.1倍(p = 0.033)。TcPO2水平与愈合结果有显著关系,当TcPO2 = 15 mmHg时,失败率为36.9%。TcPO2截止值为46 mmHg优化了愈合预测(HR = 2.81, p = 0.004)。TcPO2比WIfI分期更能预测截肢后并发症。建议在截肢部位切断46毫米汞柱,以改善愈合效果。
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引用次数: 0
Negative Pressure Wound Therapy With Instillation and Closed Incision Negative Pressure Therapy Use in South Africa: Expert Panel Recommendations 负压伤口治疗与灌注和闭合切口负压治疗在南非的应用:专家小组的建议。
IF 2.5 3区 医学 Q2 DERMATOLOGY Pub Date : 2025-11-13 DOI: 10.1111/iwj.70790
Ethel Andrews, Emmanuel Arko-Cobbah, Fébé Bruwer, Saadia Laher, Sanesh Miseer, Maeyane S. Moeng, Anati Ngcakani, Devan Scott, Suléman Vadia, Sadhana Trivedi

The healthcare landscape in South Africa is challenging with a complex patient population and a stressed healthcare system. Negative pressure therapy-based systems such as negative pressure wound therapy with instillation and dwell (NPWTi-d) and closed incision negative pressure therapy (ciNPT) can help manage wounds or incisions. However, guidelines for South Africa-specific use are limited. An in-person meeting was held with 10 experts to develop South Africa-specific therapy use recommendations for NPWTi-d and ciNPT. Panel members recommended NPWTi-d use for wounds in need of cleansing. Normal saline and a 10-min dwell time were recommended with the caveat that the instillation solutions and dwell times can be changed based on the wound bed condition and the features of the instillation solution. A negative pressure cycle of 2–3 h and a negative pressure of −125 mmHg were also recommended for NPWTi-d. In patients, incisions, and surgical procedures at high risk of developing surgical site complications, ciNPT use was recommended. These general recommendations serve as a framework for NPWTi-d and/or ciNPT use in South Africa and should be updated as more region-specific evidence becomes available.

南非的医疗保健环境具有复杂的患者群体和压力重重的医疗保健系统的挑战。负压治疗为基础的系统,如负压伤口治疗与灌注和停留(NPWTi-d)和封闭切口负压治疗(ciNPT)可以帮助处理伤口或切口。然而,针对南非特定用途的指导方针是有限的。与10名专家举行了面对面会议,以制定针对NPWTi-d和ciNPT的南非特异性治疗使用建议。小组成员建议将NPWTi-d用于需要清洗的伤口。建议使用生理盐水和10分钟静置时间,但需要注意的是,注射溶液和静置时间可以根据伤口床的情况和注射溶液的特点而改变。NPWTi-d的负压周期为2-3小时,负压为-125 mmHg。对于手术部位并发症风险高的患者、切口和手术过程,推荐使用ciNPT。这些一般性建议可作为南非使用NPWTi-d和/或ciNPT的框架,并应在获得更多区域特定证据时予以更新。
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引用次数: 0
The Threshold Fallacy: Cutting the Evidence to Fit the Bed 阈值谬误:削减证据以适应床。
IF 2.5 3区 医学 Q2 DERMATOLOGY Pub Date : 2025-11-10 DOI: 10.1111/iwj.70783
Javier Arredondo Montero
<p>Systematic reviews should distill, not distort, primary data. Done rigorously, they guide practice and policy. But when methods alter original findings, they create false certainty, spread error, and mislead clinicians.</p><p>A central problem is the threshold fallacy: inventing cut-offs absent in primary studies to fabricate comparability. Continuous variables, such as albumin or BMI, can only be dichotomized using thresholds chosen by each study, which are embedded in its design and population. Each cut-off point carries distinct prognostic meaning, context, and parameters (sensitivity and specificity). Creating new thresholds post hoc does not harmonise evidence—it rewrites it. Liu et al.'s recent work (‘Risk factors for surgical site infections after orthopaedic surgery: a meta-analysis and systematic review’) [<span>1</span>] illustrates this.</p><p>Liu et al. combined arthroplasty, trauma fixation, oncologic reconstructions, spine surgery, and geriatric cohorts, among others, and without any stratified design. These differ in baseline risks, infection profiles, and prophylactic strategies, making pooled estimates meaningless. The very studies discussed as albumin case examples already illustrate this: Lau et al. [<span>2</span>] studied hip hemiarthroplasty in elderly patients (mean age 77–78 years), Namba et al. [<span>3</span>] studied spinal surgery in a middle-aged cohort (mean age 55), and Ren et al. [<span>4</span>] studied multicenter geriatric orthopaedics (mean age 67). They stem from radically different surgical contexts that should never be merged into a single category labelled ‘orthopaedic surgery’.</p><p>The meta-analytical model was switched between fixed and random effects based solely on whether <i>I</i><sup>2</sup> exceeded 50%, a rule that the <i>Cochrane Handbook</i> explicitly cautions against [<span>5</span>]. Between-study variance (<i>τ</i><sup>2</sup>), the fundamental measure of heterogeneity, was never reported. The outdated DerSimonian–Laird estimator was used, despite well-documented limitations in small or heterogeneous sets. Confidence intervals appear to be Wald-type, with no indication that more robust approaches such as the Hartung–Knapp–Sidik–Jonkman adjustment were considered. Contemporary guidance recommends variance estimators, such as REML or Paule–Mandel, coupled with robust confidence intervals, like HKSJ, especially in small or heterogeneous evidence bases.</p><p>The authors further state: ‘Risk estimates in each study were presented as odds ratios (OR) without distinguishing between OR, relative risks or hazard ratios’ [<span>1</span>]. ORs were imposed across all studies, ignoring the greater interpretability of relative risks in cohort designs and hazard ratios in time-to-event data. This decision is not trivial: ORs systematically exaggerate effect sizes when events are common, as in the case of surgical site infections, and are less meaningful for clinical risk communication.</p><p>Sensitivi
系统评价应该提炼而不是扭曲原始数据。严格执行,它们指导实践和政策。但是,当方法改变了最初的发现时,它们就产生了虚假的确定性,传播了错误,误导了临床医生。一个核心问题是阈值谬论:为了制造可比性,发明了初步研究中没有的界限。连续变量,如白蛋白或BMI,只能使用每个研究选择的阈值进行二分类,这些阈值嵌入其设计和人群中。每个分界点具有不同的预后意义、背景和参数(敏感性和特异性)。事后设立新的门槛并不能协调证据——而是改写了证据。Liu等人最近的工作(“骨科手术后手术部位感染的危险因素:荟萃分析和系统回顾”)[1]说明了这一点。Liu等人联合关节置换术、创伤固定、肿瘤重建、脊柱手术和老年队列等,没有任何分层设计。它们在基线风险、感染概况和预防策略方面存在差异,使得汇总估计毫无意义。作为白蛋白案例讨论的研究已经说明了这一点:Lau等人[2]研究了老年患者(平均年龄77-78岁)的髋关节置换术,Namba等人[3]研究了中年队列(平均年龄55岁)的脊柱手术,Ren等人[4]研究了多中心老年骨科(平均年龄67岁)。它们来自完全不同的外科背景,不应该被合并为一个单一的类别,即“骨科手术”。元分析模型仅根据I2是否超过50%在固定效应和随机效应之间切换,这是《科克伦手册》明确警告不要使用的规则。研究间方差(τ2),异质性的基本度量,从未被报道过。使用了过时的dersimonan - laird估计器,尽管在小型或异构集中有充分的局限性。置信区间似乎是沃尔德型的,没有迹象表明更稳健的方法,如Hartung-Knapp-Sidik-Jonkman调整被考虑。当代的指导建议使用方差估计器,如REML或Paule-Mandel,加上稳健的置信区间,如HKSJ,特别是在小型或异质证据基础中。作者进一步指出:“每项研究中的风险估计都以比值比(OR)表示,而没有区分OR、相对风险或风险比。”在所有研究中都施加了or,忽略了队列设计中相对风险的更大可解释性和事件时间数据中的风险比。这个决定不是微不足道的:当事件很常见时,如手术部位感染的情况下,ORs系统地夸大了效应大小,并且对临床风险沟通意义不大。敏感性分析仅限于留一程序,没有亚组探索、影响诊断或元回归。最后,该综述错误地将其分析标记为“多元元分析”。实际上,它只是汇集了多变量主要研究的调整后的or,这并不等同于真正的多变量或多结果元分析模型。这种用词不当可能会误导读者对所应用的方法的复杂程度。该审查引用了2009年PRISMA,而不是更新的2020年声明[6],无视报告标准十多年来的改进。此外,与其PROSPERO注册(CRD42024550661)有明显的不一致,该注册指定了分层设计,按年龄、性别、手术和地区进行计划的亚组分析,但最终没有进行这些分析。系统评价必须保护而不是扭曲证据基础。元分析重写了阈值,重复了数据,合并了人群,并依赖于过时的方法,这不仅不能综合证据,反而有重塑证据的风险。鉴于这些缺陷的严重性和可证明性,我相信编辑有必要采取行动,防止这种错误的陈述在科学记录中不受挑战。作者声明无利益冲突。数据共享不适用于本文,因为在当前研究期间没有生成或分析数据集。
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引用次数: 0
In Vitro, In Vivo, and Clinical Trial Approaches to Investigate the Effects of Medicinal Plants on Burn Wound Healing: A Systematic Review 研究药用植物对烧伤创面愈合影响的体外、体内和临床试验方法:系统综述。
IF 2.5 3区 医学 Q2 DERMATOLOGY Pub Date : 2025-11-06 DOI: 10.1111/iwj.70779
Mahdi Bagheri, Seyed Mohammad Zarei, Mostafa Soodmand, Hossein Mardani Nafchi, Mir Hossein Hashemi Poor

Use of synthetic drugs for the treatment of burn wounds has decreased due to adverse effects, and they are gradually being replaced by compounds obtained from natural products, especially medicinal plants. This review focused on pre-clinical and clinical studies examining the efficacy of medicinal plants in promoting burn wound healing. This systematic review was performed congruent with the guidance delineated in the PRISMA statement. Databases such as PubMed, Scopus, Embase and Web of Science, along with the search engines Google Scholar and Google, were utilised to retrieve published literatures from 2000 to 2023. Articles were screened according to the determined criteria and appraised using primary evaluation checklists. A total of 108 published articles met the eligibility criteria and were selected for discussion. Of these, 72 were in vivo studies, 28 were in vitro studies and 8 were clinical trials. Various medicinal plants discussed in this review improve the burn wound healing process due to the presence of diverse biological compounds with antioxidant, anti-inflammatory and antibacterial properties. These plants affect the four phases of wound healing. These plant species and their compounds could be potentially used for the development of effective natural remedies against burn wounds.

由于不良反应,用于治疗烧伤创面的合成药物的使用已经减少,它们正逐渐被从天然产物,特别是药用植物中获得的化合物所取代。本文综述了药用植物促进烧伤创面愈合的临床前和临床研究。该系统评价是按照PRISMA声明中所描述的指导进行的。利用PubMed、Scopus、Embase和Web of Science等数据库以及搜索引擎谷歌Scholar和谷歌检索2000年至2023年的已发表文献。根据确定的标准对文章进行筛选,并使用初步评估清单进行评估。共有108篇已发表的文章符合资格标准,并被选中进行讨论。其中72项为体内研究,28项为体外研究,8项为临床试验。本文讨论的各种药用植物由于其具有抗氧化、抗炎和抗菌特性的多种生物化合物而改善烧伤创面愈合过程。这些植物影响伤口愈合的四个阶段。这些植物种类及其化合物可能潜在地用于开发有效的烧伤创面自然疗法。
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引用次数: 0
A Hyaluronic Acid-Based Gel Ameliorates Wound Bed Appearance of Acute and Chronic Wounds: Prospective, Multicentric Clinical Investigation 基于透明质酸的凝胶改善急慢性伤口的伤口床外观:前瞻性,多中心临床研究。
IF 2.5 3区 医学 Q2 DERMATOLOGY Pub Date : 2025-11-05 DOI: 10.1111/iwj.70773
Jagienka Jautová, Juraj Váňa, Vladimír Medvecký, Edward Huľo, Erich Boroš, Yan Mykyta, Elisa Tramentozzi, Michele Moruzzi, Nicola Giordan

The aim of this study was to assess the performance and safety of daily treatment with a 0.2% hyaluronic acid-based hydrogel (Hyalo4 Skin Gel) in patients with chronic and acute wounds. The primary endpoint was the amelioration rate after 14 days of treatment, defined as the percentage of patients showing improvement in at least one of the following wound characteristics: wound tissue type, exudate amount, or type. Secondary endpoints included assessments of the treatment's effects on wound bed type, exudate amount and type, and patients' quality of life (EQ-5D QoL), as well as its safety and ease of application. Data were collected up to 56 days of treatment. A total of 170 patients were enrolled. Wound bed amelioration was observed in 46.0% of the patients after 14 days. The amelioration rate increased from 0.291 after 7 days to 0.561 after 56 days. The treatment promoted wound healing, increased granulation tissue formation, and normalized exudate levels. Additionally, QoL significantly improved, and the product was deemed easy to apply and safe, with no serious treatment-related adverse events reported. Being effective in enhancing the re-epithelialization of both acute and chronic wounds, Hyalo4 Skin Gel emerges as a promising strategy, improving clinical outcomes across a wide range of patients.

本研究的目的是评估每日使用0.2%透明质酸水凝胶(Hyalo4皮肤凝胶)治疗慢性和急性伤口患者的性能和安全性。主要终点是治疗14天后的改善率,定义为患者在以下伤口特征中至少一项表现出改善的百分比:伤口组织类型、渗出量或类型。次要终点包括评估治疗对伤口床类型、渗出物数量和类型、患者生活质量(EQ-5D QoL)的影响,以及其安全性和应用的易用性。数据收集至治疗56天。共有170名患者入组。术后14天,46.0%的患者伤口床改善。改良率由7 d后的0.291提高到56 d后的0.561。治疗促进了伤口愈合,增加了肉芽组织的形成,并使渗出物水平正常化。此外,生活质量显著提高,该产品被认为易于使用和安全,未报告严重的治疗相关不良事件。Hyalo4皮肤凝胶可以有效地促进急性和慢性伤口的再上皮化,是一种有前途的策略,可以改善广泛患者的临床结果。
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引用次数: 0
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International Wound Journal
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