Advances in wound care最新文献

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Alginate Formulation for Wound Healing Applications. 用于伤口愈合的藻酸盐配方。
IF 5.8 3区 医学
Advances in wound care Pub Date : 2024-11-12 DOI: 10.1089/wound.2024.0081
Louai Alrata, Dahlia Abdulsattar, Sabrina Madrigal, Sophia R Pyeatte, Mohamed Zaghloul, Wahid Abu-Amer, Batool Arif, Tarek Alhamad, Maria Remedi, Yiing Lin, Mohamed A Zayed
{"title":"Alginate Formulation for Wound Healing Applications.","authors":"Louai Alrata, Dahlia Abdulsattar, Sabrina Madrigal, Sophia R Pyeatte, Mohamed Zaghloul, Wahid Abu-Amer, Batool Arif, Tarek Alhamad, Maria Remedi, Yiing Lin, Mohamed A Zayed","doi":"10.1089/wound.2024.0081","DOIUrl":"https://doi.org/10.1089/wound.2024.0081","url":null,"abstract":"<p><p><b>Significance:</b> Alginate, sourced from seaweed, holds significant importance in industrial and biomedical domains due to its versatile properties. Its chemical composition, primarily comprising β-D-mannuronic acid and α-L-guluronic acid, governs its physical and biological attributes. This polysaccharide, extracted from brown algae and bacteria, offers diverse compositions impacting key factors such as molecular weight, flexibility, solubility, and stability. <b>Recent Advances:</b> Commercial extraction methods yield soluble sodium alginate essential for various biomedical applications. Extraction processes involve chemical treatments converting insoluble alginic acid salts into soluble forms. While biosynthesis pathways in bacteria and algae share similarities, differences in enzyme utilization and product characteristics are noted. <b>Critical Issues:</b> Despite its widespread applicability, challenges persist regarding alginate's stability, biodegradability, and bioactivity. Further understanding of its interactions in complex biological environments and the optimization of extraction and synthesis processes are imperative. Additionally, concerns regarding immune responses to alginate-based implants necessitate thorough investigation. <b>Future Directions:</b> Future research endeavors aim to enhance alginate's stability and bioactivity, facilitating its broader utilization in regenerative medicine and therapeutic interventions. Novel approaches focusing on tailored hydrogel formations, advanced drug delivery systems, and optimized cellular encapsulation techniques hold promise. Continued exploration of alginate's potential in tissue engineering and wound healing, alongside efforts to address critical issues, will drive advancements in biomedical applications.</p>","PeriodicalId":7413,"journal":{"name":"Advances in wound care","volume":" ","pages":""},"PeriodicalIF":5.8,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142611749","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Local Treatment of Wound Infections: A Review of Clinical Trials from 2013 to 2024. 伤口感染的局部治疗:2013年至2024年临床试验回顾。
IF 5.8 3区 医学
Advances in wound care Pub Date : 2024-11-12 DOI: 10.1089/wound.2024.0129
David Larson, Jamie Neelon, S L Rajasekhar Karna, Kristo Nuutila
{"title":"Local Treatment of Wound Infections: A Review of Clinical Trials from 2013 to 2024.","authors":"David Larson, Jamie Neelon, S L Rajasekhar Karna, Kristo Nuutila","doi":"10.1089/wound.2024.0129","DOIUrl":"https://doi.org/10.1089/wound.2024.0129","url":null,"abstract":"<p><p><b>Significance:</b> Management of infection is a critical aspect of wound care. It involves the application of various interventions to treat the wound and prevent the infection from spreading to other parts of the body, which may lead to serious complications, including sepsis. Local treatment of skin wound infections is the favored route of administration, reducing the risk of adverse systemic effects while providing very high therapeutic concentrations at the target site. The purpose of this article was to review clinical trials from 2013 and onward, focusing on local treatment of acute wounds and burns as well as chronic wounds as their primary outcome measurement. <b>Recent Advances:</b> Based on our literature search, 49 clinical trials were focusing on treating infected chronic wounds, and 6 trials studied infection as their primary outcome in acute wounds during the last 10 years. <b>Critical Issues:</b> Currently commercially available local treatments do not prevent the onset of invasive infection. Therefore, there is a need for more effective local therapies. <b>Future Directions:</b> Despite multiple preclinical studies introducing novel and promising strategies in terms of novel antimicrobial agents and delivery methods to prevent and treat skin wound infections locally, many have yet to be tested in a clinical setting. These preclinically tested approaches could still be valuable additions to today's care of infected skin wounds.</p>","PeriodicalId":7413,"journal":{"name":"Advances in wound care","volume":" ","pages":""},"PeriodicalIF":5.8,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142611753","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
A Prospective Observational Study to Evaluate the Effectiveness of Platelet-Rich Plasma Therapy for Complex Wounds: Influential Clinical Variables on Wound Healing Outcomes. 评估富血小板血浆疗法对复杂伤口疗效的前瞻性观察研究:影响伤口愈合结果的临床变量。
IF 5.8 3区 医学
Advances in wound care Pub Date : 2024-11-07 DOI: 10.1089/wound.2024.0102
Verónica Salgado-Pacheco, Ramon Oller, Marta Ferrer-Solà, Clara Masó-Albareda, Marta Casals-Zorita, Elisabet Sarri, Emma Puigoriol-Juvanteny, Joan Espaulella-Panicot, Marta Otero-Viñas
{"title":"A Prospective Observational Study to Evaluate the Effectiveness of Platelet-Rich Plasma Therapy for Complex Wounds: Influential Clinical Variables on Wound Healing Outcomes.","authors":"Verónica Salgado-Pacheco, Ramon Oller, Marta Ferrer-Solà, Clara Masó-Albareda, Marta Casals-Zorita, Elisabet Sarri, Emma Puigoriol-Juvanteny, Joan Espaulella-Panicot, Marta Otero-Viñas","doi":"10.1089/wound.2024.0102","DOIUrl":"10.1089/wound.2024.0102","url":null,"abstract":"<p><p><b>Objective:</b> Autologous platelet-rich plasma (PRP) has shown promising outcomes in treating wounds, but the profile of patients benefiting most from this therapy is not known. This study aimed to identify influential variables in the success of this therapy, analyzing its personalized therapeutic potential for complex wounds. <b>Approach:</b> A prospective observational study was conducted in elderly patients with complex wounds receiving autologous PRP. Patient's data about sociodemographic parameters, comorbidities, frailty (FI-VIG score), complete blood count including albumin, wound depth, location, chronicity, and etiology were collected at the beginning of the study. The wound area was monitored weekly. The data were analyzed using descriptive and inferential statistics, longitudinal data analysis, and survival analysis. <b>Results:</b> Ninety-seven elderly patients were included. The FI-VIG, baseline wound area, depth, and etiology were significantly correlated with wound outcome. Strong differences in wound area variation from treatment initiation were observed in healed wounds (13% reduction/week) compared with stagnant and complicated wounds (1 and 2% reduction/week, respectively). The healing time analysis showed that nearly 80% of patients required at least 15 weeks for complete healing. In addition, patients with smaller wound sizes, younger age, or lower FI-VIG scores had shorter healing times. <b>Innovation:</b> This is the first study that identifies prognostic indicators for wound outcomes to guide clinician decision-making for using autologous PRP. It also highlights the relevance of patient health baseline and wound features and evolution for the success of this therapy. <b>Conclusion:</b> This study demonstrates that personalizing autologous PRP therapy to treat complex wounds in elderly patients is possible.</p>","PeriodicalId":7413,"journal":{"name":"Advances in wound care","volume":" ","pages":""},"PeriodicalIF":5.8,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142589742","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Topical Reconstituted High-Density Lipoproteins Elicit Anti-Inflammatory Effects in Diabetic Wounds. 局部冲调型高密度脂蛋白在糖尿病伤口中产生抗炎作用
IF 5.8 3区 医学
Advances in wound care Pub Date : 2024-11-06 DOI: 10.1089/wound.2023.0162
Zahra Lotfollahi, Joanne T M Tan, Victoria A Nankivell, Lauren Sandeman, Sanuri Liyanage, Emma L Solly, Liam Stretton, Anna E Williamson, Joseph Dawson, Stephen J Nicholls, Peter J Psaltis, Robert Fitridge, Christina A Bursill
{"title":"Topical Reconstituted High-Density Lipoproteins Elicit Anti-Inflammatory Effects in Diabetic Wounds.","authors":"Zahra Lotfollahi, Joanne T M Tan, Victoria A Nankivell, Lauren Sandeman, Sanuri Liyanage, Emma L Solly, Liam Stretton, Anna E Williamson, Joseph Dawson, Stephen J Nicholls, Peter J Psaltis, Robert Fitridge, Christina A Bursill","doi":"10.1089/wound.2023.0162","DOIUrl":"https://doi.org/10.1089/wound.2023.0162","url":null,"abstract":"<p><p><b>Objective:</b> Reconstituted high-density lipoproteins (rHDL) improve wound healing in diabetes. We aimed to determine if rHDL elicit anti-inflammatory effects in diabetic wounds, as a mechanism to explain their wound healing benefits. <b>Approach:</b> Diabetes was induced using streptozotocin in C57Bl6/J mice. Two full-thickness wounds were placed on the subflanks of diabetic and nondiabetic (ND) mice. Phosphate-buffered saline (PBS) or rHDL (50 µg/wound/day) were applied topically. Wound closure was assessed daily. Inflammatory gene transcripts were measured by qPCR and proteins by Western blotting and enzyme-linked immunosorbent assay in wounds collected at baseline, 24 h, and 3 days postwounding. Wound macrophages were assessed by flow cytometry 7 days postwounding. The fate of fluorescent 3,3-dioctadecyloxacarbocyanine, perchlorate (DiO)-labeled rHDL was tracked by flow cytometry, fluorescent imaging, and microscopy. <b>Results:</b> In diabetic mice, rHDL increased wound closure rates at days 6 (+288%, p < 0.01) and 7 (+639%, p < 0.0001) postwounding, compared with PBS controls. After 3 days, rHDL-treated diabetic wounds had lower <i>Rela</i> (-65%) and C-C motif chemokine ligand 2 (<i>Ccl2</i>) (-59%) mRNA levels and CCL2 protein (29%) than PBS controls, p < 0.05 for all. Wound macrophage content was higher in diabetic than ND wounds, but rHDL did not change macrophage content or polarity. DiO-rHDL were taken up by key wound cells including fibroblasts, macrophages, keratinocytes and endothelial cells, and retained in wounds for at least 48 h. <b>Innovation:</b> rHDL exerts anti-inflammatory effects in diabetic wounds early postwounding, which may contribute to its wound healing properties. <b>Conclusion:</b> The anti-inflammatory properties of rHDL in diabetic wounds present topical rHDL as a novel treatment option for improving healing in patients with diabetic foot ulcers.</p>","PeriodicalId":7413,"journal":{"name":"Advances in wound care","volume":" ","pages":""},"PeriodicalIF":5.8,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142589774","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Prediction of Healing Trajectory of Chronic Wounds Using a Machine Learning Approach. 利用机器学习方法预测慢性伤口的愈合轨迹
IF 5.8 3区 医学
Advances in wound care Pub Date : 2024-11-06 DOI: 10.1089/wound.2024.0095
Anissa C Dallmann, Mary Sheridan, Soeren Mattke, William Ennis
{"title":"Prediction of Healing Trajectory of Chronic Wounds Using a Machine Learning Approach.","authors":"Anissa C Dallmann, Mary Sheridan, Soeren Mattke, William Ennis","doi":"10.1089/wound.2024.0095","DOIUrl":"10.1089/wound.2024.0095","url":null,"abstract":"<p><p><b>Objective:</b> New treatment options are emerging for chronic wounds, which represent a growing problem because of population ageing and increasing burden of chronic disease. While promising, the existing evidence for advanced modalities is commonly derived from small and/or poorly controlled studies and clear criteria for selecting patients, who are likely to benefit from these expensive options are lacking. In this study, we develop and validate a machine learning model to predict if a chronic wound, independent of etiology, is expected to heal within 12 weeks to identify cases in potential need of advanced treatment options. <b>Approach:</b> Retrospective analysis of electronic health record data from 2014 to 2018 covering 532 wound care clinics in the United States and 261,398 patients with 620,356 unique wounds. Prediction of 12-week healing trajectories with a machine learning model. <b>Results:</b> The best-performing model in a training dataset of a randomly drawn 75% subset of wounds contained variables for patient demographics, comorbidities, wound characteristics at initial presentation, and changes in wound dimensions over time, with the latter group being the most influential predictors. The final machine learning model had a high predictive accuracy with area under the receiver operating characteristic curves of 0.9 and 0.92 after 4 and 5 weeks of treatment, respectively. <b>Innovation:</b> A machine learning model can identify chronic wounds at risk of not healing by week 12 with high accuracy in the early weeks of treatment. <b>Conclusions</b>: If embedded in real-world care, the generated information could be able to guide effective and efficient treatment decisions.</p>","PeriodicalId":7413,"journal":{"name":"Advances in wound care","volume":" ","pages":""},"PeriodicalIF":5.8,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142589765","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Current State of Science in Negative Pressure Wound Therapy. 负压伤口疗法的科学现状。
IF 5.8 3区 医学
Advances in wound care Pub Date : 2024-11-04 DOI: 10.1089/wound.2024.0180
Stéphanie F Bernatchez
{"title":"Current State of Science in Negative Pressure Wound Therapy.","authors":"Stéphanie F Bernatchez","doi":"10.1089/wound.2024.0180","DOIUrl":"https://doi.org/10.1089/wound.2024.0180","url":null,"abstract":"<p><p><b>Significance:</b> Negative pressure wound therapy (NPWT) was introduced in clinical practice in the early 1990s and has become widely used to manage wounds in inpatient and outpatient care. <b>Recent Advances:</b> Evolutions of the initial technology include the development of new dressing interfaces and tubing configurations, the addition of instillation to improve cleansing, and various changes in design to improve portability. Research has been conducted to understand mechanisms of action and to demonstrate clinical utility. NPWT has been suggested as a valuable approach for various complex and/or nonhealing wounds, and recommendations for its use have emerged in several guidelines. <b>Future Directions:</b> The evidence, composed of a combination of randomized controlled trials, case series, cohort studies, real-world evidence, systematic reviews, meta-analyses, and expert opinion, is heterogeneous and still building. This special mini forum issue presents the current state of the science for NPWT and new studies providing insights on some innovative ways clinicians use this technology to help improve outcomes in a variety of wound types.</p>","PeriodicalId":7413,"journal":{"name":"Advances in wound care","volume":" ","pages":""},"PeriodicalIF":5.8,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142575026","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Nitrous Oxide to Reduce Wound Care-Related Pain in Adults: A Systematic Review and Meta-Analysis. 氧化亚氮减轻成人伤口护理相关疼痛:系统综述和荟萃分析。
IF 5.8 3区 医学
Advances in wound care Pub Date : 2024-11-01 Epub Date: 2024-04-16 DOI: 10.1089/wound.2023.0211
Ziyang Wang, Fei Wang, Xiaochen Jiang, Weifeng Wang, Yihui Xing, Xueling Qiu, Chenxi Sun, Lu Tang
{"title":"Nitrous Oxide to Reduce Wound Care-Related Pain in Adults: A Systematic Review and Meta-Analysis.","authors":"Ziyang Wang, Fei Wang, Xiaochen Jiang, Weifeng Wang, Yihui Xing, Xueling Qiu, Chenxi Sun, Lu Tang","doi":"10.1089/wound.2023.0211","DOIUrl":"10.1089/wound.2023.0211","url":null,"abstract":"<p><p><b>Significance:</b> As an essential procedure, wound care comes with acute pain, which is short but high in intensity, causing patients to fear and affecting subsequent treatment. Nitrous oxide (N<sub>2</sub>O) is used to relieve pain related to wound care; however, evidence regarding its application is conflicting. Thus, this systematic review and meta-analysis was performed to evaluate the efficacy of N<sub>2</sub>O in wound care-related pain. <b>Recent Advances:</b> Randomized controlled trials that investigated the effect of N<sub>2</sub>O in adults undergoing wound care were systematically searched from PubMed, Embase, the Cochrane Library, Web of Science, Scopus, and ClinicalTrials.gov up to February 2023. The primary outcome was the pain score. Secondary outcomes included patients' satisfaction and side effects. <b>Critical Issues:</b> Through screening the 265 identified articles, seven and six studies were finally included in the systematic review and meta-analysis, respectively. Pooled analysis suggested that there was no significant difference in reducing wound care-related pain between the N<sub>2</sub>O group and the control group (mean difference [MD], -0.02, 95% confidence interval [CI], -1.46, 1.42; <i>p</i> = 0.98, <i>I</i><sup>2</sup> = 96%). Subgroup analyses indicated that there was a significant difference in favor of N<sub>2</sub>O for burns, not for ulcers, and N<sub>2</sub>O was superior to oxygen and similar to topical or intravenous anesthesia. There was no significant difference in patients' satisfaction or the incidence of side effects between groups. <b>Future Directions:</b> This review suggests that N<sub>2</sub>O might be effective for pain management in patients undergoing wound care. Caution must be taken when interpreting these results due to the high risk of biased methods in the included studies.</p>","PeriodicalId":7413,"journal":{"name":"Advances in wound care","volume":" ","pages":"542-552"},"PeriodicalIF":5.8,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140179051","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Standardized Reporting of Research on Exosomes to Ensure Rigor and Reproducibility. 外泌体研究的标准化报告,以确保严谨性和可重复性。
IF 5.8 3区 医学
Advances in wound care Pub Date : 2024-11-01 Epub Date: 2024-07-26 DOI: 10.1089/wound.2024.0093
Anita Yadav, Yi Xuan, Chandan K Sen, Subhadip Ghatak
{"title":"Standardized Reporting of Research on Exosomes to Ensure Rigor and Reproducibility.","authors":"Anita Yadav, Yi Xuan, Chandan K Sen, Subhadip Ghatak","doi":"10.1089/wound.2024.0093","DOIUrl":"10.1089/wound.2024.0093","url":null,"abstract":"<p><p><b>Significance:</b> The study of extracellular vesicles (EVs), especially exosomes, has unlocked new avenues in understanding cellular communication and potential therapeutic applications. <b>Recent Advances:</b> Advancements in EV research have shown significant contributions from the International Society for Extracellular Vesicles (ISEV), in establishing methodological standards. The evolution of the Minimal Information for Studies of Extracellular Vesicles (MISEV) guidelines from 2014 to 2023 reflects enhanced research rigor and reproducibility. The launch of EV-TRACK platform promotes uniformity and reproducibility by providing a centralized repository for data sharing and standardization practices. Furthermore, databases like EVpedia and ExoCarta have facilitated data sharing and collaboration within the scientific community. Concurrently, exosome-based therapies have emerged as a forefront area within regenerative medicine and targeted drug delivery, showcasing the potential of exosomes in promoting tissue regeneration. <b>Critical Issues:</b> Despite advancements, the field grapples with challenges such as vesicular heterogeneity, EV isolation complexity, and standardization. These issues impact research reproducibility and clinical applications. The inconsistency in exosomal preparations in clinical trials poses significant challenges to therapeutic efficacy and safety. <b>Future Directions:</b> The review outlines critical areas for future research, including the need for technological innovation in EV isolation and characterization, the establishment of standardized protocols, and a deeper understanding of exosome biology. The review also highlights the need to reassess guidelines, develop new EV isolation and characterization technologies, and establish standardized protocols to overcome current limitations. Emphasis is placed on interdisciplinary research and collaboration to address the complexities of EV biology, improve clinical trial design, and ultimately realize exosome's therapeutic and diagnostic potential. Continued evaluation and rigorous scientific validation are essential for successful exosome integration.</p>","PeriodicalId":7413,"journal":{"name":"Advances in wound care","volume":" ","pages":"584-599"},"PeriodicalIF":5.8,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141417210","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
A First-in-Human Randomized Clinical Study Investigating the Safety and Tolerability of Stabilized Hypochlorous Acid in Patients with Chronic Leg Ulcers. 首次进行人体临床研究,调查稳定次氯酸对慢性腿部溃疡患者的安全性和耐受性。
IF 5.8 3区 医学
Advances in wound care Pub Date : 2024-11-01 Epub Date: 2024-07-04 DOI: 10.1089/wound.2024.0040
Magnus Mustafa Fazli, Klaus Kirketerp-Møller, David Peick Sonne, Torben Balchen, Glenn Gundersen, Elin Jørgensen, Thomas Bjarnsholt
{"title":"A First-in-Human Randomized Clinical Study Investigating the Safety and Tolerability of Stabilized Hypochlorous Acid in Patients with Chronic Leg Ulcers.","authors":"Magnus Mustafa Fazli, Klaus Kirketerp-Møller, David Peick Sonne, Torben Balchen, Glenn Gundersen, Elin Jørgensen, Thomas Bjarnsholt","doi":"10.1089/wound.2024.0040","DOIUrl":"10.1089/wound.2024.0040","url":null,"abstract":"<p><p><b>Objective:</b> Biofilm infections in chronic wounds are common and pose a significant clinical challenge. This challenge was addressed by developing the SoftOx Biofilm Eradicator (SBE) composed of hypochlorous acid (HOCl) and acetic acid with strong broad-spectrum antimicrobial activity. <b>Approach:</b> First-in-human study investigating the safety and tolerability as primary endpoints and wound size effect and antimicrobial efficacy as secondary endpoints of SBE treatment in chronic leg wound patients. The study was divided into two as follows: a randomized, double-blinded, Single Ascending Dose (SAD) phase (<i>n</i> = 16 SBE; <i>n</i> = 4 placebo), where patients were treated with SBE or saline (placebo) only once, followed by an open-label, Multiple Ascending Dose (MAD) phase (<i>n</i> = 8), where patients were treated with SBE once daily or twice daily over five days. Reporting is according to CONSORT guidelines. <b>Results:</b> SBE was safe and well-tolerated in chronic leg wound patients. There were no significant differences in pain during and after treatment with SBE or the placebo. The SBE treatment reduced bioburden in wounds compared to baseline, with 98% and 49% median reduction after SBE or placebo treatment, respectively. A dose-dependent trend in absolute wound size reduction was observed in the MAD groups with a median (min, max) change of -2.99 (-14.25, -1.5) cm<sup>2</sup> in the once-daily and -10.48 (-17.95, -0.38) cm<sup>2</sup> in the twice-daily group, respectively. <b>Innovation and Conclusion:</b> This study demonstrated the safe use of HOCl-based SBE in chronic leg wounds with promising trends of immediate antimicrobial action and beneficial effect on wound healing.</p>","PeriodicalId":7413,"journal":{"name":"Advances in wound care","volume":" ","pages":"529-541"},"PeriodicalIF":5.8,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141080307","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Clinical Efficacy of a Contralateral Shoe Lift in Patients with Diabetic Foot Ulcers and Induced Limb-Length Discrepancies: A Randomized Controlled Trial. 糖尿病足溃疡和诱发肢长不一致患者的对侧提鞋术的临床疗效:随机对照试验。
IF 5.8 3区 医学
Advances in wound care Pub Date : 2024-10-24 DOI: 10.1089/wound.2024.0151
Mateo López-Moral, Marta García-Madrid, Raúl J Molines-Barroso, Irene Sanz-Corbalán, Aroa Tardáguila-García, José Luis Lázaro-Martínez
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