Clinical efficacy and safety of a silver ion-releasing foam dressing on hard-to-heal wounds: a meta-analysis.

OBJECTIVE: Delayed or stalled healing in open wounds can result from persisting chronic inflammation related to infection and/or persistent bacterial colonisation and biofilm. Treatment of hard-to-heal wounds focuses on debridement and exudate management, but also on infection prevention and control. Silver dressings have been evaluated in randomised clinical trials (RCTs); this meta-analysis evaluated the efficacy and safety of a silver ion-releasing foam dressing (Biatain Ag; Coloplast A/S, Denmark) to treat hard-to-heal wounds. METHOD: Literature databases (PubMed and Cochrane Library) were searched for studies on silver ion-releasing foam dressings in the treatment of hard-to-heal wounds. Individual patient data from four RCTs were obtained and included in the meta-analysis. RESULTS: Findings showed that treatment with the silver ion-releasing foam dressing was associated with a significantly higher relative reduction in wound area after four (least squares-mean difference (LS-MD): -12.55%, 95% confidence interval (CI): (-15.95, -9.16); p<0.01) and six weeks of treatment (LS-MD: -11.94%, 95%CI: (-17.21, -6.68); p<0.01) compared with controls. Significant benefits were also observed for time to disappearance of odour (hazard ratio: 1.61, 95%CI: (1.31, 1.98); p<0.01), relative reduction of exudate (LS-MD: -5.15, 95%CI: (-7.36, -2.94); p<0.01), proportion of patients with periwound erythema (relative risk (RR): 0.81, 95%CI: (0.69; 0.94); p<0.01), and less pain at dressing removal (LS-MD: -0.35, 95%CI: (-0.63, -0.06); p=0.02). No differences regarding safety outcomes were identified. CONCLUSION: This meta-analysis has demonstrated beneficial outcomes and a good tolerability profile for silver ion-releasing foam dressings in the treatment of moderate-to-highly exuding wounds with delayed healing compared with control dressings.

Impact of primary dressings on healing of venous leg ulcers: a French cohort study from the healthcare insurance database.

OBJECTIVE: Multicomponent bandages (MCBs) are recommended by the French Authority for Health (Haute Autorité de Santé) as first-line treatment for venous leg ulcers (VLUs). A first analysis of the data collected from the French administrative healthcare database (Système National des Données de Santé (SNDS)) on 25,255 patients with a VLU supported superiority of MCBs versus short stretch bandages when considering the healing outcomes and costs associated with closure of these wounds. The aim of this study was to assess how beneficial the primary dressing (technology lipido-colloid nano-oligosaccharide factor (TLC NOSF) or control dressing group (CDG)) could be, when used in combination with MCBs in the treatment of VLUs. METHOD: Data from the SNDS were collected for patients meeting the following inclusion criteria: treatment for a VLU with MCBs and with the same dressing type (TLC-NOSF or CDG) during the whole treatment period. Healing outcomes were documented on the global cohorts and propensity score-matched cohorts. The mean healthcare cost and the ecological impact were calculated for those patients healed within the study period. RESULTS: In total, 12,507 patients met the criteria for treatment with both MCBs and TLC-NOSF dressings (n=1134) versus MCBs and CDG (n=11,373); with 1134 and 2268 patients per group following propensity score matching. Healing outcomes were favourable for the TLC-NOSF group in the global cohort and were enhanced in the propensity score-matched cohorts. At every point of the analysis, the adjusted healing rates were significantly higher in the TLC-NOSF group than in the CDG group (p<0.001). In the propensity score-matched cohorts (n=3402), the healing rate at three months was 52% in the TLC-NOSF group versus 37% in the CDG group (p<0.001). The median healing time was 87 days versus 125.5 days in the TLC-NOSF and CDG groups, respectively (p<0.0001). TLC-NOSF dressings significantly reduced the average treatment cost per healed ulcer (€2099) by 23.7% compared with dressings without TLC-NOSF (€2751) (p<0.001), as well as the resources used. CONCLUSION: This SNDS analysis confirms, in the largest real-life study performed in VLU management, the superiority of the TLC-NOSF dressings versus those not impregnated with the NOSF compound. Better clinical outcomes associated with cost savings and a positive ecological impact support the combination of MCBs and TLC-NOSF dressings and should be considered as an optimal standard of care for the global management of VLUs. These outcomes reinforce the current positions of the international guidelines on the use of NOSF impregnated dressings (UrgoStart range; Laboratoires Urgo, France) in this pathology.

L-PRF in extra-oral wound care.

Leukocyte- and platelet-rich fibrin (L-PRF), a by-product of centrifuged autologous whole blood, contains high concentrations of platelets, leukocytes, and fibrin (the latter spontaneously creating a strong 3-D network (a membrane)). L-PRF membranes possess several characteristics essential in wound healing, including a barrier function, an antibacterial and analgesic activity, and the release of growth factors enhancing tissue regeneration and neo-vasculogenesis. This review investigated the role of L-PRF in treating non-responding chronic wounds such as diabetic foot, venous leg ulcers, pressure ulcers, complex wounds, leprosy ulcers (Hansen's Disease), and other demanding wounds. Chronic wounds affect millions worldwide, negatively impacting their quality of life, productivity, and life expectancy while incurring high treatment costs for themselves and private and public health systems. L-PRF has demonstrated clear adjunctive advantages in treating chronic skin wounds, shortening the time to complete wound closure, and improving patient-reported outcome measures (including reducing pain and minimizing the need for analgesics). Also, in other demanding wounds, L-PRF facilitates healing. To help clinicians, this article also proposes recommendations for the use of L-PRF in the treatment of extra-oral wounds.

The use of a multimodal wound matrix to treat a variety of hard-to-heal wounds: a case series surveillance.

OBJECTIVE: This case series examines the use of a multimodal wound matrix (MWM) trialled in a selection of clinical practice settings and on a variety of hard-to-heal wounds. The objective was to evaluate the effects of MWM and its performance in managing such wounds, regardless of clinical setting and ulcer type. METHOD: Treatment of the MWM was conducted by independent wound care practitioners on wounds that were of >4 weeks duration. Treatment was once a week. Assessment was taken after four weeks and at week 12 of the study to assess percentage area reduction (PAR) compared to baseline measurements taken at the first treatment visit. Complete (100%) re-epithelialisation was also recorded. RESULTS: A total of 63 wounds were treated with MWM, and ulcer types were grouped as: diabetic foot ulcers (n=21); venous leg ulcers (n=18); pressure injuries (n=10); and others (n=14). Of the wounds, 78% had 100% re-epithelialisation, with an average PAR of 57% at four weeks and 86% at 12 weeks. The average time to resolution for those wounds that closed was 7.9 weeks. CONCLUSION: Results from this series of independent case studies support the application of MWM to potentially benefit healing in hard-to-heal wounds of different aetiologies of any duration and in a variety of clinical settings.

Follicular unit grafting in chronic ulcers: a valuable technique for integrated management

Abstract Chronic ulcers significantly affect the quality of life of patients and impose a high cost on the healthcare system. The therapeutic management should be comprehensive, taking into consideration the etiological diagnosis of the wound and the characteristics of the wound bed when deciding on a therapeutic proposal appropriate to the healing phase, correcting factors that delay healing. During the epithelialization phase, repair techniques with grafts are recommended to shorten re-epithelialization time, improve the quality of scar tissue, and achieve adequate pain management. Currently, due to the reported benefits of skin appendages, the technique of follicular unit auto-grafting obtained with a scalp punch is among the chosen strategies for wound repair. This is a minimally invasive, outpatient practice, whose technique has advantages over the donor site, patients recovery and well-being.

Treatment of bacterially contaminated lower extremity ulcers with a fatty acid-containing wound matrix: a case series.

OBJECTIVE: The aim was to evaluate the effectiveness of a marine omega fatty acid-containing multimodal wound matrix (MWM) in reducing bacterial contamination and supporting wound area reduction (WAR) in patients with hard-to-heal wounds of varying aetiologies. METHOD: A prospective, single-site, pilot case series of patients with hard-to-heal wounds. All wounds were considered non-healing prior to inclusion as they had failed to achieve at least 50% WAR after at least four weeks of standard of care (SoC) treatments. Patients were seen once weekly for wound assessments, matrix application and dressing changes. Baseline and weekly fluorescence images, standard wound images and wound measurements were obtained. RESULTS: A total of three patients, two with venous leg ulcers (VLUs) and one with a diabetic foot ulcer (DFU) were enrolled in this pilot study. The mean baseline wound age prior to study enrolment was 24 weeks, with a mean baseline wound size of 8.61cm2. The two VLUs went on to complete closure. The DFU displayed a total WAR of 53% by six weeks, when the patient was lost to follow-up due to a geographical relocation. The mean percentage area reduction of all wounds combined was 82% upon study completion. CONCLUSION: The use of MWM proved to be effective and safe in this patient cohort. The wounds included in this case series failed to enter a healing trajectory with SoC wound therapies. The MWM supported wound closure and reduced bacterial loads in this patient cohort.

Single-center clinical experience of cyanoacrylate embolization method for incompetent perforating veins in treating CEAP-6 patients.

OBJECTIVE: The most severe form of chronic venous insufficiency includes venous leg ulcers in the CEAP-6 stage. The aim of this study is to evaluate the relationship between incompetent perforator veins occluding with cyanoacrylate and closure of perforator veins and healing of venous leg ulcers in patients at the CEAP-6 stage. METHODS: A total of 187 patients who underwent cyanoacrylate application to incompetent perforator veins due to venous leg ulcers from 2018 to 2021 were retrospectively reviewed. Twelve months after the procedure, patients were evaluated for perforator vein closure, ulcer diameter, and Venous Clinical Severity Scale. Receiver operating characteristic analysis was used to estimate the probability of postoperative nonocclusion of the perforating vein based on the preoperative ulcers' diameters and the perforating veins' mean diameters. Univariate and multivariate binary logistic regression analyses were conducted to identify the risk factors associated with incomplete closure of the perforating vein. RESULTS: At the 12 months, 87.1% of patients experienced incompetent perforator veins closure, leading to complete healing of venous leg ulcers. Preoperative ulcer diameter significantly decreased from 7.20 ± 3.48 cm2 to 0.28 ± 0.77 cm2 after the procedure (P < .001). On average, 3.5 ± 1.01 perforating veins were treated, with a diameter of 4.09 ± 0.41 mm. No postoperative paresthesia or deep vein thrombosis occurred. Preoperative Venous Clinical Severity Scale scores decreased significantly from 17.85 ± 3.06 to 8.03 ± 3.53 postoperatively (P < .001). Patients with nonoccluded perforating veins had larger preoperative ulcer diameters (13.77 ± 1.78 cm2) than those with occluded perforating veins (6.24 ± 2.47 cm2; P < .001). The mean perforating vein diameter was also larger in nonoccluded perforating veins patients (4.45 ± 0.41 mm) than in occluded perforating veins patients (4.04 ± 0.38 mm; P < .001). The sensitivity, specificity, and accuracy of the preoperative ulcer diameter cutoff point of 11.25 cm2 for the possibility of postoperative nonocclusion of perforating veins were 100% each. In contrast, those for the preoperative mean perforating vein diameter cutoff point of 4.15 mm were determined as 66.7%, 79.1%, and 77.5%, respectively. The presence of diabetes mellitus increased the likelihood of incompetent perforator veins, remaining open by 3.4 times (95% confidence interval: 1.11-10.44; P = .032), whereas a 1 mm larger mean perforating vein diameter increased this likelihood by 9.36 times (95% confidence interval: 3.47-25.29; P < .001). CONCLUSIONS: This study demonstrates that occlusion of incompetent perforator veins with cyanoacrylate is effective, safe, and associated with low complication rates in CEAP-6 patients. The findings support that cyanoacrylate occlusion of perforator veins may be a valuable option in the treatment of venous leg ulcers.

Computational therapeutic repurposing of tavaborole targeting arginase-1 for venous leg ulcer.

Venous leg ulcers (VLUs) pose a growing healthcare challenge due to aging, obesity, and sedentary lifestyles. Despite various treatments available, addressing the complex nature of VLUs remains difficult. In this context, this study investigates repurposing boronated drugs to inhibit arginase 1 activity for VLU treatment. The molecular docking study conducted by Schrodinger GLIDE targeted the binuclear manganese cluster of arginase 1 enzyme (2PHO). Further, the ligand-protein complex was subjected to molecular dynamic studies at 500 ns in Gromacs-2019.4. Trajectory analysis was performed using the GROMACS simulation package of protein RMSD, RMSF, RG, SASA, and H-Bond. The docking study revealed intriguing results where the tavaborole showed a better docking score (-3.957 Kcal/mol) compared to the substrate L-arginine (-3.379 Kcal/mol) and standard L-norvaline (-3.141 Kcal/mol). Tavaborole interaction with aspartic acid ultimately suggests that the drug molecule binds to the catalytic site of arginase 1, potentially influencing the enzyme's function. The dynamics study revealed the compounds' stability and compactness of the protein throughout the simulation. The RMSD, RMSF, SASA, RG, inter and intra H-bond, PCA, FEL, and MMBSA studies affirmed the ligand-protein and protein complex flexibility, compactness, binding energy, van der waals energy, and solvation dynamics. These results revealed the stability and the interaction of the ligand with the catalytic site of arginase 1 enzyme, triggering the study towards the VLU treatment.

Consistency of wound care in Leg Clubs.

Mr B had lost his wife of 65 years and was distraught, but he tried to move on with life. However, while playing football he injured his leg, which then developed into a venous ulcer that was to last for many years. Unfortunately, his care was inconsistent, and the wound was not progressing. He found the local Leg Club and decided to self-refer. He not only went on to achieve wound closure rapidly, but he found a social atmosphere in the club, made friends and learned how to prevent the wound from recurring. He felt that consistency of care was the reason for the rapid progress.

Managing venous leg ulceration: variance and variety.

Frameworks of care have been developed to enhance and standardise care for those with venous leg ulcers. Community nurses are faced with an array of frameworks and guidance documents on which to base their care. This article outlines and discusses variations in the information provided within the body of evidence relating to the care of venous leg ulcers. It is based on the findings of ongoing study for a PhD thesis.

The Impact of Nutritional Condition and Compression Treatment on Venous Ulcer Recovery: A Systematic Review.

Venous ulcers are open wounds commonly associated with chronic venous insufficiency. Each patient's healing process is unique, and factors like nutrition and compression therapy can affect it. Compression therapy and optimal nutritional status can assist in improving venous blood circulation, decreasing swelling, and promoting wound healing. This in-depth review looks at all the recent research on how nutrition and compression therapy can help heal venous ulcers, aiming to develop evidence-based guidelines for improving treatment outcomes. The systematic review, registered in the International Prospective Register of Systematic Reviews (PROSPERO) and following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) principles, conducted an extensive electronic search in databases such as PubMed, MEDLINE, Cochrane, Web of Science, and Scopus. Using Medical Subject Headings (MeSH) terms and different types of studies, the search method focused on studies that directly looked at how nutrition and compression therapy affected the healing of venous ulcers. After deduplicating and screening publications, a collaborative full-text review was conducted to determine their inclusion. As a result, several research studies were chosen for the qualitative synthesis. The authors created a data extraction form to document important variables such as demographics, therapy specifics, and wound features. Several studies on patients with venous ulcers have shown that consuming basic nutrients can improve wound healing. Treatment results differed depending on the types of compression and pressure intensity. Although minimal data indicates the possible benefits of two-layer therapy, a definitive comparison is still uncertain. Further clinical studies are necessary to investigate a wider range of dietary factors and to evaluate different treatments in similar situations.

Improved Wound Healing by Direct Cold Atmospheric Plasma Once or Twice a Week: A Randomized Controlled Trial on Chronic Venous Leg Ulcers.

Objective: This study compared the effect of two frequencies of direct cold atmospheric plasma (direct-CAP) treatment with standard of care (SOC) alone on healing of venous leg ulcers (VLUs). Approach: Open-label, randomized controlled trial (ClinicalTrials.gov NCT04922463) on chronic VLUs at two home care organizations in the Netherlands. All three groups received SOC for 12 weeks or until healing. In addition, treatment groups received direct-CAP once (1× direct-CAP) or twice (2× direct-CAP) a week, at specialized wound care facilities and the patients' residences. Primary outcome was percentage of wounds healed. Secondary outcomes included wound area reduction and adverse events. Results: In total, 46 patients were randomly allocated to receive SOC only (n = 15), SOC + direct-CAP once a week (n = 17), or SOC + direct-CAP twice a week (n = 14). A higher percentage of wounds healed within 12 weeks in the treatment groups 53.3% (1× direct-CAP, p = 0.16) and 61.5% (2× direct-CAP, p = 0.08) versus 25.0% (control). The largest wound area reduction was obtained with 2× direct-CAP (95.2%, p = 0.07), followed by 1× direct-CAP (63.9%, p = 0.58), versus control (52.8%). Absolute wound area reduced significantly compared with baseline in both treatment groups (p ≤ 0.001), not in control (p = 0.11). No device-related serious adverse events occurred. Innovation: Direct-CAP applied once or twice a week could substantially improve wound healing of VLUs in primary care. Conclusion: Together with other clinical safety and efficacy data, these results support the integration of direct-CAP as a valuable therapy for complex wounds.

Comparative Effectiveness of Placental Allografts in the Treatment of Diabetic Lower Extremity Ulcers and Venous Leg Ulcers in U.S. Medicare Beneficiaries: A Retrospective Observational Cohort Study Using Real-World Evidence.

Objective: To compare the effectiveness of cellular tissue products (CTP) versus standard care in U.S. Medicare beneficiaries with diabetic lower extremity ulcers (DLEUs) or venous leg ulcers (VLUs). Approach: We performed a retrospective cohort study using real-world evidence from U.S. Medicare claims for DLEUs or VLUs between 2016 and 2020. There were three cohorts evaluated: viable cryopreserved placental membrane (vCPM) or viable lyopreserved placental membrane (vLPM); other CTP; and standard care. Claims were collapsed into episodes of care. Univariate and bivariate statistics were used to examine the frequency distribution of demographics and clinical variables. Multivariable zero-inflated binomial regressions were used to evaluate mortality and recurrence trends. Logistic regression compared three adverse outcomes (AOs): amputation; 1-year mortality; and wound recurrence. Results: There were 333,362 DLEU episodes among 261,101 beneficiaries, and 122,012 VLU episodes among 80,415 beneficiaries. DLEU treatment with vLPM was associated with reduced 1-year mortality (-26%), reduced recurrence (-91%), and reduced AOs (-71%). VLU treatment with vCPM or vLPM was associated with reduced 1-year mortality (-23%), reduced recurrence (-80%), and 66.77% reduction in AOs. These allografts were also associated with a 49% and 73% reduced risk of recurrence in DLEU and VLU, respectively, compared with other CTPs. Finally, vCPM or vLPM were associated with noninferior prevention of AOs related to amputation, mortality, and recurrence (95% CI: 0.69-1.14). Conclusions: DLEUs and VLUs treated with vCPM and vLPM allografts are associated with lowered 1-year mortality, wound recurrence, and AOs in DLEUs and VLUs compared with standard care. Decision makers weighing coverage of placental allografts should consider these added short- and long-term clinical benefits relative to costly management and high mortality of Medicare's most frequent wounds.

Sub-ulcer Foam Sclerotherapy in Patients with Venous Leg Ulcer, Analysis and Technical Aspects of 134 Consecutive Patients.

OBJECTIVE: For this retrospective study, we analyzed the sub-ulcer foam sclerotherapy technique in patients with venous leg ulcer (VLU). METHODS: This study included 134 patients treated with sub-ulcer foam sclerotherapy at the Oulu University Hospital vascular outpatient clinic from January 2012 to December 2021. All included patients received sub-ulcer foam sclerotherapy as part of the treatment strategy for superficial venous insufficiency. Compression therapy and local wound care were organized for VLU treatment. A follow-up visit was scheduled for one month after the sub-ulcer foam sclerotherapy. Change in ulcer size, local (skin necrosis, infection) or systemic (deep vein thrombosis, pulmonary embolism) complications, and time to ulcer healing were monitored. The occurrence of major limb-related complications (amputation, surgical revision) was monitored for one year postoperatively. RESULTS: One month after sub-ulcer treatment, ulcers were smaller or completely healed in 108 (81%) patients. Ulcer healing was completed in 123 (92%) patients at one year and 131 (98%) patients at two years. Complications were recorded in four (3%) patients, three (2%) who were diagnosed with erysipelas requiring antibiotic treatment and one (1%) patient diagnosed with local dermatitis. During the one-year follow-up, no major limb-related complications (surgical revisions or amputations) arose. CONCLUSIONS: Sub-ulcer foam sclerotherapy may be a feasible addition to superficial vein reflux elimination in patients with VLU and a low risk for complications.

Follicular unit grafting in chronic ulcers: a valuable technique for integrated management.

Chronic ulcers significantly affect the quality of life of patients and impose a high cost on the healthcare system. The therapeutic management should be comprehensive, taking into consideration the etiological diagnosis of the wound and the characteristics of the wound bed when deciding on a therapeutic proposal appropriate to the healing phase, correcting factors that delay healing. During the epithelialization phase, repair techniques with grafts are recommended to shorten re-epithelialization time, improve the quality of scar tissue, and achieve adequate pain management. Currently, due to the reported benefits of skin appendages, the technique of follicular unit auto-grafting obtained with a scalp punch is among the chosen strategies for wound repair. This is a minimally invasive, outpatient practice, whose technique has advantages over the donor site, patients recovery and well-being.

Investigating low rates of compliance to graduated compression therapy for chronic venous insufficiency: A systematic review.

Chronic venous insufficiency (CVI) is a chronic lower limb progressive disorder with significant burden. Graduated compression therapy is the gold-standard treatment, but its underutilisation, as indicated in recent literature, may be contributing to the growing burden of CVI. The aim of this systematic review is to determine the reasons for poor compliance in patients who are prescribed graduated compression therapy in the management of chronic venous insufficiency. A systematic review of the literature was conducted to identify the reasons for non-compliance in wearing graduated compression therapy in the management of chronic venous insufficiency. The keyword search was conducted through Medline, PubMed, CINAHL, Cochrane library, AMED, and Embase databases from 2000 to April 2023. Qualitative and quantitative studies were included with no study design or language limits imposed on the search. The study populations were restricted to adults aged over 18 years, diagnosed with chronic venous insufficiency. Of the 856 studies found, 80 full-text articles were reviewed, with 14 being eligible for the review. Due to the variability in study designs, the results were summarised rather than subjected to meta-analysis. There are five main overarching themes for non-compliance, which are physical limitations, health literacy, discomfort, financial issues, and psychosocial issues with emerging sub-themes. Graduated compression therapy has the potential to reduce the burden of chronic venous insufficiency if patients are more compliant with their prescription.

Impact of great saphenous vein ablation on healing and recurrence of venous leg ulcers in patients with post-thrombotic syndrome: A retrospective comparative study.

BACKGROUND: The optimal treatment approach for patients with active venous leg ulcers (VLUs) and post-thrombotic syndrome (PTS) associated with great saphenous vein (GSV) reflux remains unclear. To address this gap, we retrospectively compared the outcomes of patients with post-thrombotic VLU with an intact GSV vs those with a stripped or ablated GSV. METHODS: We retrospectively analyzed data from 48 patients with active VLUs and documented PTS, who were treated at a single center between January 2018 and December 2022. Clinical information, including ulcer photographs, was recorded in a prospectively maintained digital database at the initial and follow-up visits. Two patient groups-group A (with an intact GSV) and group B (with a stripped or ablated GSV)-were compared in terms of time to complete healing, proportion of ulcers achieving complete healing, and ulcer recurrence during the follow-up period. RESULTS: There were no significant differences in age, gender, initial ulcer size, or ulcer duration between the two groups. All included patients had femoropopliteal post-thrombotic changes. Group A had significantly more completely healed ulcers (33 of 34 ulcers, 97%) compared with group B (10 of 14 ulcers, 71%) (P = .008). Group A also exhibited a significantly shorter time to complete ulcer healing (median: 42.5 days, interquartile range [IQR]: 65) compared with group B (median: 161 days, IQR: 530.5) (P = .0177), with a greater probability of ulcer healing (P = .0084). Long-term follow-up data were available for 45 of 48 patients (93.7%), with a mean duration of 39.6 months (range: 5.7-67.4 months). The proportion of ulcers that failed to heal or recurred during the follow-up period was significantly lower in group A (9 of 32 ulcers, 27%) compared with group B (11 of 13 ulcers, 85%) (P = .0009). In addition, in a subgroup analysis, patients with an intact but refluxing GSV (12 of 34) had a significantly shorter time to heal (median: 34 days, IQR: 57.25) (P = .0242), with a greater probability of ulcer healing (P = .0091) and significantly fewer recurrences (2 of 12, 16%) (P = .006) compared with group B. CONCLUSIONS: Our findings suggest that removal of the GSV through stripping or ablation in patients with post-thrombotic deep venous systems affecting the femoropopliteal segment may result in delayed ulcer healing and increased ulcer recurrence. Patients with an intact GSV had better outcomes, even when the refluxing GSV was left untreated. These findings emphasize the potential impact of GSV treatment on the management of VLUs in individuals with PTS. Further investigation is needed to validate these results and explore alternative therapeutic strategies to optimize outcomes for this patient population.

Dehydrated human amnion/chorion membrane to treat venous leg ulcers: a cost-effectiveness analysis.

OBJECTIVE: To evaluate the cost-effectiveness of dehydrated human amnion/chorion membrane (DHACM) in Medicare enrolees who developed a venous leg ulcer (VLU). METHOD: This economic evaluation used a four-state Markov model to simulate the disease progression of VLUs for patients receiving advanced treatment (AT) with DHACM or no advanced treatment (NAT) over a three-year time horizon from a US Medicare perspective. DHACM treatments were assessed when following parameters for use (FPFU), whereby applications were initiated 30-45 days after the initial VLU diagnosis claim, and reapplications occurred on a weekly to biweekly basis until completion of the treatment episode. The cohort was modelled on the claims of 530,220 Medicare enrolees who developed a VLU between 2015-2019. Direct medical costs, quality-adjusted life years (QALYs), and the net monetary benefit (NMB) at a willingness-to-pay threshold of $100,000/QALY were applied. Univariate and probabilistic sensitivity analyses (PSA) were performed to test the uncertainty of model results. RESULTS: DHACM applied FPFU dominated NAT, yielding a lower per-patient cost of $170 and an increase of 0.010 QALYs over three years. The resulting NMB was $1178 per patient in favour of DHACM FPFU over the same time horizon. The rate of VLU recurrence had a notable impact on model uncertainty. In the PSA, DHACM FPFU was cost-effective in 63.01% of simulations at the $100,000/QALY threshold. CONCLUSION: In this analysis, DHACM FPFU was the dominant strategy compared to NAT, as it was cost-saving and generated a greater number of QALYs over three years from the US Medicare perspective. A companion VLU Medicare outcomes analysis revealed that patients who received AT with a cellular, acellular and matrix-like product (CAMP) compared to patients who received NAT had the best outcomes. Given the added clinical benefits to patients at lower cost, providers should recommend DHACM FPFU to patients with VLU who qualify. Decision-makers for public insurers (e.g., Medicare and Medicaid) and commercial payers should establish preferential formulary placement for reimbursement of DHACM to reduce budget impact and improve the long-term health of their patient populations dealing with these chronic wounds. DECLARATION OF INTEREST: Support for this analysis was provided by MiMedx Group, Inc., US. JLD, and RAF are employees of MiMedx Group, Inc. WHT, BH, PS, BGC and WVP were consultants to MiMedx Group, Inc. VD, AO, MRK, JAN, NW and GAM served on the MiMedx Group, Inc. Advisory Board. MRK and JAN served on a speaker's bureau. WVP declares personal fees and equity holdings from Stage Analytics, US.

Use of amniotic membrane in hard-to-heal wounds: a multicentre retrospective study.

OBJECTIVE: Hard-to-heal (chronic) wounds negatively impact patients and are a source of significant strain on the healthcare system and economy. These wounds are often resistant to standard of care (SoC) wound healing approaches due to a diversity of underlying pathologies. Cellular, acellular, and matrix-like products, such as amniotic membranes (AM), are a potential solution to these challenges. A growing body of evidence suggests that AM may be useful for treatment-resistant wounds; however, limited information is available regarding the efficacy of dehydrated amniotic membrane (DHAM) on multi-aetiology, hard-to-heal wounds. Therefore, we analysed the efficacy of DHAM treatment in reducing the size of hard-to-heal diabetic and venous leg ulcers (VLUs) that had failed to improve after SoC-based treatments. METHOD: In this multicentre retrospective study, we analysed wound size during clinic visits for patients being treated for either diabetic or VLUs. During each visit, the treatment consisted of debridement followed by application of DHAM. Each wound was measured after debridement and prior to DHAM application, and wound volumes over time or number of DHAM applications were compared. RESULTS: A total of 18 wounds in 11 patients were analysed as part of this study. Wounds showed a significant reduction in volume after a single DHAM application, and a 50% reduction in wound size was observed after approximately two DHAM applications. These findings are consistent with reports investigating DHAM treatment of diabetic ulcers that were not necessarily resistant to treatment. CONCLUSION: To our knowledge, this study is the first to directly compare the efficacy of standalone DHAM application to hard-to-heal diabetic and venous leg ulcers, and our findings indicate that DHAM is an effective intervention for resolving these types of wounds. This suggests that implementing this approach could lead to fewer clinic visits, cost savings and improved patient quality of life. DECLARATION OF INTEREST: This research was supported in part by Merakris Therapeutics, US, and facilitated access to deidentified patient datasets, which may represent a perceived conflict of interest; however, the primary data analysis was performed by FSB who is unaffiliated with Merakris Therapeutics. TCB is a founder, employee of and shareholder in Merakris Therapeutics; WSF is a co-founder of, consultant for, and shareholder in Merakris Therapeutics, and was also supported by the National Institutes of Health National Center for Advancing Translational Sciences Clinical and Translational Science Awards Grant KL2 Scholars Program (KL2TR001441). The research was also supported through endowments to WSF from the University of Texas Medical Branch Mimmie and Hallie Smith Endowed Chair of Transplant Research and the John L Hern University Chair in Transplant Surgery.

Bacterial Species Involved in Venous Leg Ulcer Infections and Their Sensitivity to Antibiotherapy-An Alarm Signal Regarding the Seriousness of Chronic Venous Insufficiency C6 Stage and Its Need for Prompt Treatment.

BACKGROUND: Venous leg ulcers (VLUs) are a common chronic wound condition susceptible to infection by various bacterial species. Understanding bacterial presence and antibiotic sensitivity is crucial for effective treatment. Methodsː Medical records of 60 patients diagnosed with the C6 chronic venous insufficiency stage were analyzed retrospectively. The patients were divided into an active recurrent VLU group (33 cases) and a first-onset active VLU group (27 cases). Bacterial identification, antibiotic sensitivity, and laboratory markers were assessed. Resultsː Pseudomonas aeruginosa was the most prevalent bacterial species in both the study (72.72%) and control (37.03%) groups, along with other common bacteria such as Proteus mirabilis, Enterococcus sp., Staphylococcus aureus, Acinetobacter baumannii, Klebsiella spp., and Escherichia coli. Furthermore, uncommon bacteria, including Providencia rettgeri, Group B Streptococcus, and Salmonella Paratyphi B, and a fungal infection with Candida albicans, were identified only in the study group, while Morganella morganii was found exclusively in the control group. Pseudomonas aeruginosa showed significant sensitivity to several antibiotics, particularly Amikacin and Meropenem. Nonspecific laboratory markers, such as CRP, fibrinogen, ESR, WBC, CK, neutrophils, and lymphocytes, revealed statistically significant differences between groups, indicating their potential as biomarkers for monitoring recurrent VLUs. Conclusionsː These results highlight the need for comprehensive diagnostic approaches to effectively manage VLU infections and improve patient outcomes. Further research is warranted to explore factors influencing the presence of uncommon bacteria and to develop targeted interventions for VLU management.