Objective: Lower extremity hard-to-heal wounds affect >2.4 million people in the US and are characterised by excessive inflammation. One potential management technique is the use of placental-derived allografts, which contain an extracellular matrix scaffold and key regulatory proteins. The aim of this study was to compare, using wound closure analyses, the clinical outcomes of patients using a hypothermically stored amniotic membrane (HSAM) allograft as a protective barrier, which retains the structure and content of native amnion for supporting healing of lower extremity open wounds via intact or meshed techniques.
Method: A retrospective chart review identified adult patients from January 2017-October 2018 who had received HSAM for lower extremity open wounds. Application of HSAM included either an intact or a meshed technique for graft application. Baseline patient demographics were collected, along with wound parameters from baseline until wound closure.
Results: The experimental cohort comprised 13 patients with an average starting wound size of 12.5cm2 and who received an average of 5.5 applications of HSAM. Kaplan-Meier survival analysis revealed a median wound closure time of 63 days for the combined cohort, with 48 days and 63 days for intact and meshed techniques, respectively. Wound closure incidence showed that seven patients achieved 100% wound closure; the technique used did not affect closure incidence.
Conclusion: The findings of this study provide evidence that supports further examination of HSAM as a protective barrier for the management of lower extremity hard-to-heal wounds.
{"title":"Hypothermically stored amniotic membrane in the management of hard-to-heal wounds of the lower extremities: a retrospective case series.","authors":"Brock A Liden, Kelly A Kimmerling, Katie C Mowry","doi":"10.12968/jowc.2025.0194","DOIUrl":"https://doi.org/10.12968/jowc.2025.0194","url":null,"abstract":"<p><strong>Objective: </strong>Lower extremity hard-to-heal wounds affect >2.4 million people in the US and are characterised by excessive inflammation. One potential management technique is the use of placental-derived allografts, which contain an extracellular matrix scaffold and key regulatory proteins. The aim of this study was to compare, using wound closure analyses, the clinical outcomes of patients using a hypothermically stored amniotic membrane (HSAM) allograft as a protective barrier, which retains the structure and content of native amnion for supporting healing of lower extremity open wounds via intact or meshed techniques.</p><p><strong>Method: </strong>A retrospective chart review identified adult patients from January 2017-October 2018 who had received HSAM for lower extremity open wounds. Application of HSAM included either an intact or a meshed technique for graft application. Baseline patient demographics were collected, along with wound parameters from baseline until wound closure.</p><p><strong>Results: </strong>The experimental cohort comprised 13 patients with an average starting wound size of 12.5cm<sup>2</sup> and who received an average of 5.5 applications of HSAM. Kaplan-Meier survival analysis revealed a median wound closure time of 63 days for the combined cohort, with 48 days and 63 days for intact and meshed techniques, respectively. Wound closure incidence showed that seven patients achieved 100% wound closure; the technique used did not affect closure incidence.</p><p><strong>Conclusion: </strong>The findings of this study provide evidence that supports further examination of HSAM as a protective barrier for the management of lower extremity hard-to-heal wounds.</p>","PeriodicalId":17590,"journal":{"name":"Journal of wound care","volume":"34 10","pages":"782-788"},"PeriodicalIF":1.7,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145275138","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}
Pub Date : 2025-10-02Epub Date: 2025-09-16DOI: 10.12968/jowc.2025.0166
Jean-Patrick Benigni, Jean-François Uhl, Wassila Taha, Pascal Filori, Florence Balet
Objective: To assess the effects of the UrgoKTwo (Laboratoires URGO, France) compression system on the leg volume, interface pressures, static stiffness index (SSI), comfort and slippage in a very hot environment.
Method: Volunteers from among hospital staff in the Diabetic Foot Center (Cairo, Egypt), whose work involved standing for long periods, and who presented with a pitting oedema, were included in this study. The parameters were assessed at baseline, after four hours of wearing the compression system (T+4h), and following a treadmill test. Leg volume was assessed using HandySCAN 3D Laser (Creaform, Canada).
Results: A total of 20 volunteers took part. The compression system was applied with an interface pressure of 45±3mmHg at baseline. After four hours of wearing the compression system, there was a significant reduction in mean leg volume of 81ml, which represented 2.9% of the mean volume (p<0.001). The SSI calculated at inclusion after bandage application (13±4.8mmHg) increased significantly at T+4h (15.9±4.9mmHg) (p<0.001). This was due to a decrease in resting pressure to 30mmHg without notable slippage. Despite the hot environment, the compression system remained very comfortable to study participants (mean visual analogue scale score: 8±1.6).
Conclusion: The findings of this clinical trial showed that the compression system helped reduce oedema in a very hot environment from the initial hours of wear. The SSI, which increased over the course of the trial, is an essential factor in reinforcing venous haemodynamics of the calf muscle pump.
目的:评价UrgoKTwo (Laboratoires URGO, France)压缩系统在高温环境下对腿部体积、界面压力、静态刚度指数(SSI)、舒适性和滑移性的影响。方法:志愿者来自糖尿病足中心(埃及开罗)的医院工作人员,他们的工作涉及长时间站立,并且出现凹陷性水肿,他们被纳入本研究。在基线、佩戴压缩系统4小时后(T+4h)和跑步机测试后评估参数。使用HandySCAN 3D Laser (Creaform, Canada)评估腿部体积。结果:共有20名志愿者参与。压缩系统在基线时施加45±3mmHg的界面压力。在使用压缩系统4小时后,腿部平均体积明显减少81ml,为平均体积的2.9%(结论:本临床试验结果表明,压缩系统从最初的几个小时开始,就有助于减少在高温环境下的水肿。SSI在试验过程中增加,是加强小腿肌肉泵静脉血流动力学的重要因素。
{"title":"Outcomes of a multicomponent compression system in a hot environment: a clinical evaluation.","authors":"Jean-Patrick Benigni, Jean-François Uhl, Wassila Taha, Pascal Filori, Florence Balet","doi":"10.12968/jowc.2025.0166","DOIUrl":"https://doi.org/10.12968/jowc.2025.0166","url":null,"abstract":"<p><strong>Objective: </strong>To assess the effects of the UrgoKTwo (Laboratoires URGO, France) compression system on the leg volume, interface pressures, static stiffness index (SSI), comfort and slippage in a very hot environment.</p><p><strong>Method: </strong>Volunteers from among hospital staff in the Diabetic Foot Center (Cairo, Egypt), whose work involved standing for long periods, and who presented with a pitting oedema, were included in this study. The parameters were assessed at baseline, after four hours of wearing the compression system (T+4h), and following a treadmill test. Leg volume was assessed using HandySCAN 3D Laser (Creaform, Canada).</p><p><strong>Results: </strong>A total of 20 volunteers took part. The compression system was applied with an interface pressure of 45±3mmHg at baseline. After four hours of wearing the compression system, there was a significant reduction in mean leg volume of 81ml, which represented 2.9% of the mean volume (p<0.001). The SSI calculated at inclusion after bandage application (13±4.8mmHg) increased significantly at T+4h (15.9±4.9mmHg) (p<0.001). This was due to a decrease in resting pressure to 30mmHg without notable slippage. Despite the hot environment, the compression system remained very comfortable to study participants (mean visual analogue scale score: 8±1.6).</p><p><strong>Conclusion: </strong>The findings of this clinical trial showed that the compression system helped reduce oedema in a very hot environment from the initial hours of wear. The SSI, which increased over the course of the trial, is an essential factor in reinforcing venous haemodynamics of the calf muscle pump.</p>","PeriodicalId":17590,"journal":{"name":"Journal of wound care","volume":"34 10","pages":"816-823"},"PeriodicalIF":1.7,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145275162","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}
Pub Date : 2025-10-02Epub Date: 2025-09-18DOI: 10.12968/jowc.2025.0392
Nan E Hodge, Corey B Dahl, Brian B Liljenquist, Eric J Thomas
Objective: The objective of this case series was to assess the clinical outcomes of standard of care (SoC) supplemented with carePATCH (ExtremityCare LLC, US) a dehydrated, dual-layer amniotic membrane allograft, in mediating hard-to-heal wounds that had failed to respond to SoC alone.
Method: Data were collected from electronic health records of patients seen between November 2023 and January 2025 at a single wound care provider group (WelsCare LLC, US). Patients aged ≥18 years with hard-to-heal wounds failing to achieve ≥50% surface area reduction within 30 days of documented SoC treatment were included. carePATCH was applied as an adjunct to SoC following debridement of the wound in accordance with best wound care practices. Changes in wound surface area, percentage area reduction (PAR) and clinical parameters were assessed at baseline, at final application and at one week post final application.
Results: A total of 13 patients (eight male, five female, mean age: 75.1 years) were included. A total of 13 wounds, including venous leg ulcers (n=6), pressure ulcers (n=5), post-surgical wounds (n=1) and venous stasis/arterial wounds (n=1) were evaluated. Median PAR (for all wounds combined) at final application was 77.4%, increasing to 100% at one week post final application. Statistical analysis demonstrated significant improvement in PAR outcomes (p=0.017 at final application; p=0.003 at one week post final application). Box- and-whisker plots revealed consistent surface area reduction across all wound types, with measurements remaining stable one week post final application.
Conclusion: This case series provides encouraging results for the use of carePATCH as an adjunct to SoC in mediating chronic wounds. Patient outcome data support positive clinical experiences with regard to wound regression.
{"title":"Clinical experience depicting wound regression trends with carePATCH: a case series.","authors":"Nan E Hodge, Corey B Dahl, Brian B Liljenquist, Eric J Thomas","doi":"10.12968/jowc.2025.0392","DOIUrl":"https://doi.org/10.12968/jowc.2025.0392","url":null,"abstract":"<p><strong>Objective: </strong>The objective of this case series was to assess the clinical outcomes of standard of care (SoC) supplemented with carePATCH (ExtremityCare LLC, US) a dehydrated, dual-layer amniotic membrane allograft, in mediating hard-to-heal wounds that had failed to respond to SoC alone.</p><p><strong>Method: </strong>Data were collected from electronic health records of patients seen between November 2023 and January 2025 at a single wound care provider group (WelsCare LLC, US). Patients aged ≥18 years with hard-to-heal wounds failing to achieve ≥50% surface area reduction within 30 days of documented SoC treatment were included. carePATCH was applied as an adjunct to SoC following debridement of the wound in accordance with best wound care practices. Changes in wound surface area, percentage area reduction (PAR) and clinical parameters were assessed at baseline, at final application and at one week post final application.</p><p><strong>Results: </strong>A total of 13 patients (eight male, five female, mean age: 75.1 years) were included. A total of 13 wounds, including venous leg ulcers (n=6), pressure ulcers (n=5), post-surgical wounds (n=1) and venous stasis/arterial wounds (n=1) were evaluated. Median PAR (for all wounds combined) at final application was 77.4%, increasing to 100% at one week post final application. Statistical analysis demonstrated significant improvement in PAR outcomes (p=0.017 at final application; p=0.003 at one week post final application). Box- and-whisker plots revealed consistent surface area reduction across all wound types, with measurements remaining stable one week post final application.</p><p><strong>Conclusion: </strong>This case series provides encouraging results for the use of carePATCH as an adjunct to SoC in mediating chronic wounds. Patient outcome data support positive clinical experiences with regard to wound regression.</p>","PeriodicalId":17590,"journal":{"name":"Journal of wound care","volume":"34 10","pages":"805-815"},"PeriodicalIF":1.7,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145275175","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}
Hannah Wilson, Pinar Avsar, Declan Patton, Zena Moore
Pressure ulcers (PUs) pose significant challenges in healthcare despite there being evidence-based guidelines for their prevention and treatment. This article examines the impact of guideline implementation on PU incidence, patient quality of life and healthcare costs. Implementation of guideline recommendations, including multifactorial evidence-based interventions and care bundles, have led to a significant reduction in PU incidence and improvement in patient outcomes across diverse healthcare settings. While guidelines offer valuable recommendations, their implementation faces challenges, including healthcare professionals' lack of awareness and knowledge regarding guideline existence and importance. Strategies such as education programmes, and developing guidelines with clear language and easy-to-follow recommendations, are crucial for enhancing guideline uptake. Furthermore, patient and caregiver involvement in PU prevention and treatment is essential for promoting self-care and active participation in care and, in turn, active participation in guideline recommendations. Addressing these challenges through increased awareness, education and patient involvement is vital for improving guideline implementation and patient outcomes with regards to PU prevention and treatment.
{"title":"Enhancing patient outcomes through effective implementation of pressure ulcer guidelines.","authors":"Hannah Wilson, Pinar Avsar, Declan Patton, Zena Moore","doi":"10.12968/jowc.2024.0118","DOIUrl":"https://doi.org/10.12968/jowc.2024.0118","url":null,"abstract":"<p><p>Pressure ulcers (PUs) pose significant challenges in healthcare despite there being evidence-based guidelines for their prevention and treatment. This article examines the impact of guideline implementation on PU incidence, patient quality of life and healthcare costs. Implementation of guideline recommendations, including multifactorial evidence-based interventions and care bundles, have led to a significant reduction in PU incidence and improvement in patient outcomes across diverse healthcare settings. While guidelines offer valuable recommendations, their implementation faces challenges, including healthcare professionals' lack of awareness and knowledge regarding guideline existence and importance. Strategies such as education programmes, and developing guidelines with clear language and easy-to-follow recommendations, are crucial for enhancing guideline uptake. Furthermore, patient and caregiver involvement in PU prevention and treatment is essential for promoting self-care and active participation in care and, in turn, active participation in guideline recommendations. Addressing these challenges through increased awareness, education and patient involvement is vital for improving guideline implementation and patient outcomes with regards to PU prevention and treatment.</p>","PeriodicalId":17590,"journal":{"name":"Journal of wound care","volume":"34 10","pages":"862-868"},"PeriodicalIF":1.7,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145275101","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}
Yuri Thomé Machado Petrillo, Eduardo Furtado Coronel, Matheus Daniel Faleiro, Pedro Adolfo de Andrade Sarmento, Fabiano Pasqualotto Soares, Carla Jeanine Sulzbach, Mariana Kumaira Fonseca
Myiasis is a parasitic infection common in tropical areas, such as Brazil. It is caused by infestation of maggots of various fly species in humans. Here, the case of a 38-year-old female patient, with no comorbidities, who was referred to the authors' centre due to a scalp wound infested with larvae and complete soft tissue loss, is presented. A computed tomography scan revealed no evidence of osteomyelitis or intracranial compromise. Since the initial debridement and mechanical removal of the larvae resulted in a large and complex wound, the patient underwent a combined wound approach based on cranial burr holes and negative pressure wound therapy followed by skin graft. The wound revealed excellent skin graft survival, and the patient was safely discharged home. No complications were observed in the follow-up period.
{"title":"A complex scalp wound following a myiasis infestation: cranial burr holes and negative pressure wound therapy.","authors":"Yuri Thomé Machado Petrillo, Eduardo Furtado Coronel, Matheus Daniel Faleiro, Pedro Adolfo de Andrade Sarmento, Fabiano Pasqualotto Soares, Carla Jeanine Sulzbach, Mariana Kumaira Fonseca","doi":"10.12968/jowc.2023.0108","DOIUrl":"10.12968/jowc.2023.0108","url":null,"abstract":"<p><p>Myiasis is a parasitic infection common in tropical areas, such as Brazil. It is caused by infestation of maggots of various fly species in humans. Here, the case of a 38-year-old female patient, with no comorbidities, who was referred to the authors' centre due to a scalp wound infested with larvae and complete soft tissue loss, is presented. A computed tomography scan revealed no evidence of osteomyelitis or intracranial compromise. Since the initial debridement and mechanical removal of the larvae resulted in a large and complex wound, the patient underwent a combined wound approach based on cranial burr holes and negative pressure wound therapy followed by skin graft. The wound revealed excellent skin graft survival, and the patient was safely discharged home. No complications were observed in the follow-up period.</p>","PeriodicalId":17590,"journal":{"name":"Journal of wound care","volume":"34 10","pages":"870-873"},"PeriodicalIF":1.7,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145275028","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}
Christopher J Lewis, Malene Høj Outzen, Charlotte Hindsberger, Baljit Dheansa, Christopher Wearn, Kayvan Shokrollahi, Joana Pinto, Kristine Gjødsbøl, Fadi Issa
Objective: To evaluate the performance and safety of Biatain Fiber Ag (Coloplast A/S, Denmark), a new gelling fibre wound dressing containing silver, based on percentage of wounds healed in partial-thickness burns within two weeks.
Method: This non-comparative, one-armed, open-labelled, multicentre study, included patients from five different sites in the UK between October 2023 and April 2024. The primary endpoint was whether a wound healed or not. Adverse events were also assessed.
Results: In total, 51 patients with a partial-thickness burn wound that was either infected or at risk of infection, and with medium-to-high levels of exudate, were part of the full analysis set. The proportion of wounds healed within two weeks of treatment was 83.7% (95% confidence interval (CI): 69.3, 93.2) of the 43 patients completing the investigation. In a post hoc sensitivity analysis, assuming that missing data on wound healing were either missing at random or corresponded to a non-healed wound, the estimated proportion of wounds healed was 74.8% (95% CI: 60.7, 85.1). In the pre-planned sensitivity analysis, where all missing data on wound healing were assumed to correspond to a non-healed wound, it was 70.6% (95% CI: 56.2, 82.5). A total of seven adverse events were found related to the investigational device; all were non-serious.
Conclusion: In this study, treatment of partial-thickness burns with the investigational device showed that the percentage of healed wounds within two weeks was comparable to the performance of similar products. In addition, the results revealed no safety concerns. This new gelling fibre wound dressing containing silver may therefore have a notable clinical implication for wound healing in patients with acute wounds that are infected or at risk of infection.
{"title":"A clinical investigation of a new gelling fibre dressing containing silver for the management of partial-thickness burns.","authors":"Christopher J Lewis, Malene Høj Outzen, Charlotte Hindsberger, Baljit Dheansa, Christopher Wearn, Kayvan Shokrollahi, Joana Pinto, Kristine Gjødsbøl, Fadi Issa","doi":"10.12968/jowc.2025.0233","DOIUrl":"10.12968/jowc.2025.0233","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the performance and safety of Biatain Fiber Ag (Coloplast A/S, Denmark), a new gelling fibre wound dressing containing silver, based on percentage of wounds healed in partial-thickness burns within two weeks.</p><p><strong>Method: </strong>This non-comparative, one-armed, open-labelled, multicentre study, included patients from five different sites in the UK between October 2023 and April 2024. The primary endpoint was whether a wound healed or not. Adverse events were also assessed.</p><p><strong>Results: </strong>In total, 51 patients with a partial-thickness burn wound that was either infected or at risk of infection, and with medium-to-high levels of exudate, were part of the full analysis set. The proportion of wounds healed within two weeks of treatment was 83.7% (95% confidence interval (CI): 69.3, 93.2) of the 43 patients completing the investigation. In a post hoc sensitivity analysis, assuming that missing data on wound healing were either missing at random or corresponded to a non-healed wound, the estimated proportion of wounds healed was 74.8% (95% CI: 60.7, 85.1). In the pre-planned sensitivity analysis, where all missing data on wound healing were assumed to correspond to a non-healed wound, it was 70.6% (95% CI: 56.2, 82.5). A total of seven adverse events were found related to the investigational device; all were non-serious.</p><p><strong>Conclusion: </strong>In this study, treatment of partial-thickness burns with the investigational device showed that the percentage of healed wounds within two weeks was comparable to the performance of similar products. In addition, the results revealed no safety concerns. This new gelling fibre wound dressing containing silver may therefore have a notable clinical implication for wound healing in patients with acute wounds that are infected or at risk of infection.</p>","PeriodicalId":17590,"journal":{"name":"Journal of wound care","volume":"34 10","pages":"797-804"},"PeriodicalIF":1.7,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145275019","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-02Epub Date: 2025-09-26DOI: 10.12968/jowc.2025.0267
Julian F Guest
Objective: To estimate the cost-effectiveness of using a carboxymethylcellulose dressing containing ionic silver, ethylenediaminetetraacetic acid and benzethonium chloride (CISEB; Aquacel Ag+ Extra, Convatec Ltd., UK) compared with a dialkylcarbamoyl chloride-coated dressing (DACC; Cutimed Sorbact, Essity, Germany) in the treatment of hard-to-heal venous leg ulcers (VLUs), from the perspective of the UK's publicly-funded health services.
Method: Markov modelling simulated the management of hard-to-heal VLUs in the community and secondary care over 24 weeks. The modelling used data from a randomised controlled trial and estimated the relative cost-effectiveness of the two dressings, measured by the incremental cost per quality-adjusted life year (QALY) gained, based on 2022/23 prices.
Results: The findings of the modelling showed that starting treatment with CISEB instead of DACC resulted in a >25% increase in the probability of healing. However, the time to healing was similar in both groups, averaging at seven weeks per ulcer. The difference in the probability of healing between the two groups led to a cumulative gain in QALYs, resulting in a 5% improvement in health-related quality of life at 24 weeks. The higher healing rate in the CISEB group led to a ~14% reduction in the total cost of VLU management over 12 weeks and a 23% reduction over 24 weeks. Consequently, starting treatment with CISEB instead of DACC was identified as a potentially cost-effective intervention for treating hard-to-heal VLUs within the UK's health services, as it improved outcomes at a lower cost.
Conclusion: Considering the study's limitations, treating hard-to-heal VLUs with CISEB instead of DACC potentially offers a cost-effective strategy for the UK's health services, since it increases the likelihood of VLU healing for lower cost.
{"title":"Cost-effectiveness of an enhanced silver-containing dressing in treating hard-to-heal venous leg ulcers.","authors":"Julian F Guest","doi":"10.12968/jowc.2025.0267","DOIUrl":"https://doi.org/10.12968/jowc.2025.0267","url":null,"abstract":"<p><strong>Objective: </strong>To estimate the cost-effectiveness of using a carboxymethylcellulose dressing containing ionic silver, ethylenediaminetetraacetic acid and benzethonium chloride (CISEB; Aquacel Ag+ Extra, Convatec Ltd., UK) compared with a dialkylcarbamoyl chloride-coated dressing (DACC; Cutimed Sorbact, Essity, Germany) in the treatment of hard-to-heal venous leg ulcers (VLUs), from the perspective of the UK's publicly-funded health services.</p><p><strong>Method: </strong>Markov modelling simulated the management of hard-to-heal VLUs in the community and secondary care over 24 weeks. The modelling used data from a randomised controlled trial and estimated the relative cost-effectiveness of the two dressings, measured by the incremental cost per quality-adjusted life year (QALY) gained, based on 2022/23 prices.</p><p><strong>Results: </strong>The findings of the modelling showed that starting treatment with CISEB instead of DACC resulted in a >25% increase in the probability of healing. However, the time to healing was similar in both groups, averaging at seven weeks per ulcer. The difference in the probability of healing between the two groups led to a cumulative gain in QALYs, resulting in a 5% improvement in health-related quality of life at 24 weeks. The higher healing rate in the CISEB group led to a ~14% reduction in the total cost of VLU management over 12 weeks and a 23% reduction over 24 weeks. Consequently, starting treatment with CISEB instead of DACC was identified as a potentially cost-effective intervention for treating hard-to-heal VLUs within the UK's health services, as it improved outcomes at a lower cost.</p><p><strong>Conclusion: </strong>Considering the study's limitations, treating hard-to-heal VLUs with CISEB instead of DACC potentially offers a cost-effective strategy for the UK's health services, since it increases the likelihood of VLU healing for lower cost.</p>","PeriodicalId":17590,"journal":{"name":"Journal of wound care","volume":"34 10","pages":"824-834"},"PeriodicalIF":1.7,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145275098","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}
Pub Date : 2025-10-02Epub Date: 2025-10-07DOI: 10.12968/jowc.2025.0428
Alexander M Reyzelman, Dean Vayser, Jason R Hanft, Shawn Cazzell, Maria S Surprenant, Haywan Chiu, Peter M Moyer, Sarah Ducharme, Gregory Tovmassian
This multicentre, randomised controlled trial evaluated the efficacy and safety of adjunctive full-thickness decellularised placental membrane (FT-DPM) in treating persistent and recalcitrant diabetic foot ulcers (DFUs) compared to standard of care (SoC). A total of 57 patients were analysed in the treatment group; the study product was applied to the wound bed post debridement and left in place for 5-9 days. Some 51 patients received SoC only, including debridement and moist wound therapy with alginates, foams or hydrogels. All wounds were offloaded. The findings of this study showed that the FT-DPM significantly improved wound closure rates at 12 weeks compared to SoC (48% versus 27%, respectively; p=0.0499, per-protocol analysis), with a significant percentage area reduction (79% versus 56%, respectively; p<0.05). Mild and moderate adverse events were similar between groups, while serious adverse events were more frequent in the SoC group compared with the FT-DPM group (29% versus 2%, respectively); none were related to treatment. These findings suggest that FT-DPM is an effective and innovative treatment for hard-to-heal (chronic) DFUs, offering a superior option to SoC, particularly for wounds that resist conventional treatments. This approach has the potential to significantly improve patient outcomes and reduce the societal burden of hard-to-heal wounds.
{"title":"Efficacy of a full-thickness decellularised placental membrane allograft compared to standard of care in diabetic foot ulcers: a prospective, randomised controlled trial.","authors":"Alexander M Reyzelman, Dean Vayser, Jason R Hanft, Shawn Cazzell, Maria S Surprenant, Haywan Chiu, Peter M Moyer, Sarah Ducharme, Gregory Tovmassian","doi":"10.12968/jowc.2025.0428","DOIUrl":"10.12968/jowc.2025.0428","url":null,"abstract":"<p><p>This multicentre, randomised controlled trial evaluated the efficacy and safety of adjunctive full-thickness decellularised placental membrane (FT-DPM) in treating persistent and recalcitrant diabetic foot ulcers (DFUs) compared to standard of care (SoC). A total of 57 patients were analysed in the treatment group; the study product was applied to the wound bed post debridement and left in place for 5-9 days. Some 51 patients received SoC only, including debridement and moist wound therapy with alginates, foams or hydrogels. All wounds were offloaded. The findings of this study showed that the FT-DPM significantly improved wound closure rates at 12 weeks compared to SoC (48% versus 27%, respectively; p=0.0499, per-protocol analysis), with a significant percentage area reduction (79% versus 56%, respectively; p<0.05). Mild and moderate adverse events were similar between groups, while serious adverse events were more frequent in the SoC group compared with the FT-DPM group (29% versus 2%, respectively); none were related to treatment. These findings suggest that FT-DPM is an effective and innovative treatment for hard-to-heal (chronic) DFUs, offering a superior option to SoC, particularly for wounds that resist conventional treatments. This approach has the potential to significantly improve patient outcomes and reduce the societal burden of hard-to-heal wounds.</p>","PeriodicalId":17590,"journal":{"name":"Journal of wound care","volume":"34 10","pages":"836-846"},"PeriodicalIF":1.7,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145275188","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}
Pub Date : 2025-10-02Epub Date: 2025-09-03DOI: 10.12968/jowc.2025.0396
William Tettelbach, David G Armstrong, Vickie Driver, Alisha Oropallo, Lee C Rogers, Daniel Kapp, Naz Wahab, David B Alper, Travis Tucker, Jennie Feight, Martha R Kelso
Executive summary: This manuscript presents a unified and comprehensive policy framework addressing the flat-fee reimbursement model for skin substitutes, also referred to as cellular, acellular, and matrix-like products (CAMPs), proposed by the Centers for Medicare & Medicaid Services (CMS). These products are vital to treating hard-to-heal wounds, which disproportionately affect older patients, and those patients who are disabled and medically underserved. While CMS aims to curtail excessive spending and introduce payment consistency, the current proposal threatens access to life-saving therapies, endangers patient outcomes, and may destabilise clinical delivery infrastructures and manufacturing ecosystems critical to wound care.
{"title":"Safeguarding access, fiscal responsibility and innovation: a comprehensive reimbursement framework for CAMPs to preserve the Medicare Trust Fund.","authors":"William Tettelbach, David G Armstrong, Vickie Driver, Alisha Oropallo, Lee C Rogers, Daniel Kapp, Naz Wahab, David B Alper, Travis Tucker, Jennie Feight, Martha R Kelso","doi":"10.12968/jowc.2025.0396","DOIUrl":"https://doi.org/10.12968/jowc.2025.0396","url":null,"abstract":"<p><strong>Executive summary: </strong>This manuscript presents a unified and comprehensive policy framework addressing the flat-fee reimbursement model for skin substitutes, also referred to as cellular, acellular, and matrix-like products (CAMPs), proposed by the Centers for Medicare & Medicaid Services (CMS). These products are vital to treating hard-to-heal wounds, which disproportionately affect older patients, and those patients who are disabled and medically underserved. While CMS aims to curtail excessive spending and introduce payment consistency, the current proposal threatens access to life-saving therapies, endangers patient outcomes, and may destabilise clinical delivery infrastructures and manufacturing ecosystems critical to wound care.</p>","PeriodicalId":17590,"journal":{"name":"Journal of wound care","volume":"34 10","pages":"768-777"},"PeriodicalIF":1.7,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145275164","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}
Stephen Heisler, Rodney Samaan, Rene Lessing, Emre Ozker, Robert Snyder
Objective: Venous leg ulcers (VLUs) are hard-to-heal wounds primarily caused by venous insufficiency and venous hypertension. These wounds pose significant clinical and economic burdens, often failing to heal with standard compression therapy alone. Autologous whole blood clot (AWBC) therapy has emerged as a potential treatment for hard-to-heal wounds, complementing the body's natural wound healing mechanisms. This study aims to evaluate the outcomes of AWBC in a real-world setting for treating VLUs that have not responded to conventional therapies.
Method: A multicentre observational registry study was conducted between August 2021 and December 2024 (NCT04699305) across multiple countries. Patients with hard-to-heal VLUs were included to receive AWBC application. Median wound duration at baseline was 13.5 months (interquartile range: 5.25, 36.0). AWBC applications were used alongside compression therapy, and outcomes were assessed in terms of percentage area reduction (PAR) and complete wound healing.
Results: There were 56 patients in the study cohort. AWBC treatment resulted in a mean wound area reduction of 71.3%. Complete healing was achieved in 45% of patients, while 54% exhibited a PAR >90%. Among the wounds treated, 44% that had persisted for >1 year achieved complete healing. Treatment duration varied, with some patients requiring extended therapy (12-20 weeks) to achieve significant wound progression. Adverse events were minimal and unrelated to treatment.
Conclusion: In this study, AWBC therapy demonstrated high levels of effectiveness in treating hard-to-heal VLUs, particularly in patients whose wounds had failed to heal with standard compression therapy. AWBC therapy provides a supportive extracellular matrix, modulating inflammation and enhancing wound healing, demonstrating its valuable conjunction treatment to existing compression treatment protocols.
{"title":"Real-world outcomes of autologous whole blood clot therapy for venous leg ulcers.","authors":"Stephen Heisler, Rodney Samaan, Rene Lessing, Emre Ozker, Robert Snyder","doi":"10.12968/jowc.2025.0419","DOIUrl":"10.12968/jowc.2025.0419","url":null,"abstract":"<p><strong>Objective: </strong>Venous leg ulcers (VLUs) are hard-to-heal wounds primarily caused by venous insufficiency and venous hypertension. These wounds pose significant clinical and economic burdens, often failing to heal with standard compression therapy alone. Autologous whole blood clot (AWBC) therapy has emerged as a potential treatment for hard-to-heal wounds, complementing the body's natural wound healing mechanisms. This study aims to evaluate the outcomes of AWBC in a real-world setting for treating VLUs that have not responded to conventional therapies.</p><p><strong>Method: </strong>A multicentre observational registry study was conducted between August 2021 and December 2024 (NCT04699305) across multiple countries. Patients with hard-to-heal VLUs were included to receive AWBC application. Median wound duration at baseline was 13.5 months (interquartile range: 5.25, 36.0). AWBC applications were used alongside compression therapy, and outcomes were assessed in terms of percentage area reduction (PAR) and complete wound healing.</p><p><strong>Results: </strong>There were 56 patients in the study cohort. AWBC treatment resulted in a mean wound area reduction of 71.3%. Complete healing was achieved in 45% of patients, while 54% exhibited a PAR >90%. Among the wounds treated, 44% that had persisted for >1 year achieved complete healing. Treatment duration varied, with some patients requiring extended therapy (12-20 weeks) to achieve significant wound progression. Adverse events were minimal and unrelated to treatment.</p><p><strong>Conclusion: </strong>In this study, AWBC therapy demonstrated high levels of effectiveness in treating hard-to-heal VLUs, particularly in patients whose wounds had failed to heal with standard compression therapy. AWBC therapy provides a supportive extracellular matrix, modulating inflammation and enhancing wound healing, demonstrating its valuable conjunction treatment to existing compression treatment protocols.</p>","PeriodicalId":17590,"journal":{"name":"Journal of wound care","volume":"34 10","pages":"874-880"},"PeriodicalIF":1.7,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145275133","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}