Alisha Oropallo

Objective: Wound cleansing is an essential part of wound bed preparation and its importance in wound management is supported by numerous international guidelines and consensus documents. Cleansing solutions are used by healthcare professionals for wounds and non-intact skin. However, some of these solutions may not be effective in addressing the condition of the wound or safe enough to be used in certain patients due to the solution's potential for irritation or toxicity. According to guidelines, solution of pure hypochlorous acid (pHA; free of hypochlorite derivatives) provides a good balance between safety and efficacy. This narrative review discusses the clinical evidence available on the use of a pHA solution (Vashe Wound Solution; Urgo Medical North America, US) formulated at 330ppm with a tightly controlled, slightly acidic pH (pH 3.5–5.5). Method: A literature search of the Embase, MEDLINE, Google Scholar and TRIP databases was conducted (firstly in December 2025 and updated in June 2026), for original clinical studies reporting the use of the pHA solution, including randomised controlled trials, comparative studies, observational studies, case series/reports and health economic evaluations. Outcomes relating to efficacy, safety, tolerability, acceptability and costs were synthesised narratively. Results: A total of 56 publications were identified and included in the analysis. These clinical evaluations analysed the data of 2968 wounds in 2682 patients, including 140 preterm infants, neonates and children. The treated indications were wounds presenting with risk or clinical signs of local infection, infected wounds, skin tissue or mucosa, including wounds at debridement stage or requiring thorough cleansing, and patients with fragile, immature or non-intact skin. Across the different studies, consistent and concordant outcomes were noted, with a favourable benefit/risk profile of the solution, regardless of the method of application, treated indications and patient populations. Cleansing with the pHA solution, using soaked gauze or different irrigation techniques, to remove debris, slough and foreign bodies from the wound and skin, was found to significantly reduce bacterial growth compared to saline, soap and water, or standard of care, resulting in fewer wound-related complications. The cleanser solution also appeared to facilitate wound debridement, promote wound healing and be cost-effective in numerous indications. The safety profile of the pHA solution was ‘very good’, and no complication related to its use was reported in any of the clinical evaluations, including in preterm infants. Conclusion: The clinical evidence identified in this review consistently supported the pHA solution with a slightly acidic pH as a useful option in the management of wounds and non-intact skin, aligned with its intended use, particularly in situations where infection control and tissue tolerability are important considerations. Conducting additional high-quality comparative studies would be worthwhile to strengthen the available evidence.

Aims: The social drivers of diabetic foot disease (SDDFD) impact ulcer incidence and outcomes, but how is relatively unknown. We aimed to build a conceptual model positing how three SDDFD—poverty, insurance, and government assistance—influence outcomes for patients with diabetic foot ulcers. Materials and Methods: To inform the model, we conducted a scoping review of studies linking poverty, insurance, and/or government assistance with diabetic foot ulcer outcomes using Levac and colleagues' 6‐stage framework, the Preferred Reporting Items for Systematic Review and Meta‐analysis extension for scoping reviews, and the SPIDER tool. We searched PubMed, CINAHL, and Embase for original research articles set in the United States and published between 1 January 2005 and 7 November 2025. We excluded those published in a language other than English, case reports, abstracts, and studies of other SDDFD. Results: Data from 35 included studies informed our conceptual model, depicting a complex causal pathway between SDDFD and outcomes, often mediated by healthcare system factors and moderated by patients' abilities to adhere to healthcare recommendations. Multidisciplinary teams might ameliorate the risk of amputations associated with poverty, lack of insurance, or qualifying for government assistance. Additionally, the model highlights reinforcing feedback loops, both positive and negative. Conclusion: Our model can be used to inform mediation and moderation analyses and help avoid collider‐conditioning bias during statistical analyses. It can help identify potential points of intervention within the healthcare system for those working to dampen the negative effects of SDDFD on outcomes.

Objective: This multicenter, prospective, single-arm study evaluated the safety and preliminary clinical performance of a flowable porcine urinary bladder matrix (UBM) particulate for managing tunneling and undermining features in complex wounds. These features are associated with delayed healing, chronic inflammation, and infection risk. Flowable UBM enables targeted delivery into wound tunnels and cavities. Method: Twenty-five subjects from 3 United States (U.S.) sites were enrolled, with 21 meeting protocol criteria for analysis (15 with undermining and 6 with tunneling wounds). Participants received flowable UBM applied directly to tunneling or undermining areas, along with additional UBM particulate or sheet forms applied to the wound surface. The primary endpoint was the percentage reduction in tunneling volume or undermining depth at 12 weeks, with secondary assessment of reduction in overall wound volume. Safety was evaluated through evaluation of device-related adverse events. Results: At 12 weeks, 90.5% of wounds demonstrated positive response, with mean ± standard deviation and median reduction in tunneling or undermining dimensions of 84.6 ± 29.3% and 100.0%, respectively. Complete resolution of these features occurred in 52.4% of wounds (53.3% in undermining and 50.0% in tunneling wounds) with higher closure rates in non-pressure wounds compared to pressure injuries. No device-related adverse events were reported. Conclusions: Overall, flowable UBM was well tolerated and associated with favorable clinical trajectories demonstrated by reduction in tunneling and undermining dimensions; however, comparative effectiveness cannot be inferred from this limited single-arm pilot study. Further controlled studies are needed to confirm comparative effectiveness and optimize clinical use.

Significance: Chronic wounds are a growing public-health and economic burden. In the United States, about one-sixth of Medicare beneficiaries (~10.5 million people) carry a chronic wound, with Medicare spending an estimated $22.5 billion annually and global wound-care expenditure reached $148.65 billion in 2022. This review, written for clinicians and biomedical engineers, is organized from basic to advanced.Recent Advances: It defines normal skin architecture and regional variation, classifies the full spectrum of skin injury, and describes the body’s coupled tissue repair and immune response. It quantifies the epidemiology, risk, and mortality of the principal chronic wounds: arterial/ischemic, venous leg, and diabetic foot ulcers, pressure injury, and non-healing surgical wounds, and summarizes the clinical evidence and biological mechanisms of current chronic wound management strategies including revascularization, pressure redistribution, hyperbaric oxygen, debridement, infection control, and moisture-balancing, negative-pressure, growth factor, and skin substitute treatments, and it points to the databases, guidelines, and registries that anchor evidence-based practice.Critical Issues: The normal acute trajectory, which recovers only to about 70-80% of tensile strength, is contrasted with chronic wounds that stall in a self-sustaining inflammatory state marked by sustained neutrophils, cytokines, and M1 macrophages, bacterial biofilm, elevated matrix metalloproteinases, fibroblast senescence, and stalled keratinocytes, that recur or resist standard care despite management.Future Directions: Urgent unmet needs, from durable infection control to true regeneration and personalized care, are increasingly addressed through medical devices and engineered biomaterials.

Cellular, acellular or matrix‐like products (CAMPs), also referred to as ‘skin substitutes’, are applied to chronic wounds to help expedite healing when standard therapies fail. However, their efficacy is compromised by infection, and possibly high bacterial loads, as suggested in prior literature. This prospective observational pilot study explored the association between bacterial burden and early healing outcomes in chronic diabetic foot ulcers and venous leg ulcers following skin substitute application. Bacterial fluorescence imaging was performed immediately prior to skin substitute placement to identify areas of high bacterial load (positive fluorescence), with wound area reduction tracked at 4 ± 1 weeks postapplication. Of the 10 patients analysed, the primary endpoint of achieving 40% wound area reduction was met by 4/5 of baseline fluorescence negative wounds, compared to 0/5 baseline fluorescence positive wounds ( p < 0.05). The baseline fluorescence negative group showed a 68.0% wound area reduction, in contrast to the baseline fluorescence positive group, which showed a 33.7% increase in wound area ( p < 0.05). Taken together with existing evidence, these findings suggest that elevated bacterial load during CAMP application significantly impedes early wound healing. Bacterial fluorescence imaging is an effective tool to optimise wound bed preparation and identify the best candidate for skin substitute application.

Introduction: Chronic wounds affect approximately six million people in the United States. Despite established multidisciplinary wound care protocols, patient adherence to follow-up care remains suboptimal. We aimed to understand the impact of social drivers of health on patient decision-making for improving wound care follow-up adherence. Methods: We conducted a retrospective review of all hospitalized patients who consulted in-house wound care staff at a tertiary care center between August 2017 and June 2020, regardless of primary admission diagnosis. Referred patients received standardized care from a multidisciplinary team at an outpatient wound care facility. Primary endpoints were pre-discharge scheduling and follow-up rates. Follow-up efficacy was assessed through 90-day hospital readmission rates. Results: Of 444 patients, 205 (46.2%) were readmitted or expired within 90 days. Adjusted analysis identified lack of follow-up care reception as an independent predictor of hospital readmission (hazard ratio 2.39; 95% CI, 1.45–3.89; p < 0.001). Among 156 (35.1%) patients who scheduled follow-up, 110 (70.5%) adhered to their appointment. Patients not scheduling follow-up were older (median age 79 vs. 70 years, p < 0.001), longer hospital stays (median 9 vs. 6 days, p < 0.0001), and more frequently discharged to skilled nursing facilities (47.6% vs. 26.3%, p < 0.0001). Among scheduled patients, skilled nursing home residents demonstrated lower follow-up adherence (OR 0.3; 95% CI, 0.14–0.65; p < 0.01). Conclusions: Pre-hospital discharge communication for scheduling follow ups serves as a critical intervention point in patient decision-making for wound follow-up. Considering the limitations of a retrospective single-center study, we find that pre-discharge education about follow-up scheduling for high-risk groups, including patients ≥ 80 years and skilled nursing facility residents, may improve follow-up adherence and reduce readmissions.

Background: Continuous diffusion of oxygen (CDO) to wounds has demonstrated better effectiveness in healing wounds than negative-pressure wound therapy (NPWT). However, there is limited evidence regarding the cost-effectiveness of CDO therapy and its comparison with NPWT. Objectives: The purpose of this analysis is to report on the cost-effectiveness of CDO and NPWT using published clinical results as well as real-world clinical outcomes and cost information. The objectives included analyzing the cost-effectiveness of CDO therapy across multiple wound types and anatomical locations, testing the data for robustness, and comparing the cost-effectiveness using results from controlled clinical studies for CDO and NPWT. Methods: A prospective patients database using real-world clinical results of 764 patients treated using CDO therapy in a broad range of clinical practices across a wide range of wound types and wound locations was analyzed. The clinical data were combined with real world billing data to draw statistically valid cost comparisons. Using 3 methodologies, the cost savings were demonstrated across 2 healthcare systems. Results: In the US, the average cost savings of CDO was US $14 238 vs NPWT to heal a wound. Kaplan-Meier analysis showed that CDO use in clinical practice had 79.2% full closure in 112 days compared with NPWT, which has 43.2% full closure in the same timeframe for similar wound sizes and severity. Discussion: There are two primary reasons for the significant cost savings. First, CDO therapy is much easier to apply and maintain than traditional NPWT, as CDO dressings can easily be changed by patients at home without the assistance of a nurse. The second reason is the substantially higher efficacy of CDO therapy. Conclusion: CDO is highly efficacious in clinical practice and cost-effective compared with NPWT and other therapies such as moist wound therapy and hyperbaric oxygen.

Background: Stage 3 pressure injuries (PIs) are full-thickness wounds associated with high morbidity, frequent infection-related complications, and substantial healthcare utilization in adults with compromised mobility. Real-world outcomes of cellular, acellular, and matrix-like products (CAMPs) for Stage 3 PIs in Medicare populations have not been well characterized. Methods: We conducted a retrospective, matched-cohort study using Medicare claims data (2016–2024). Stage 3 PI ulcer treatment episodes were constructed using a 90-day clean period (defined as ≥90 days without wound-related services) and a 90-day episode definition and evaluated in a hospital outpatient department (HOPD)/inpatient-only sample. Episodes receiving CAMPs (identified by Q- and A- Healthcare Common Procedure Coding System (HCPCS) codes) were matched 1:1 to standard-of-care (SOC) episodes (which included sharp debridement without CAMPs) using a prespecified set of exact and range-based covariates including demographics, comorbidity burden, PI location markers, and timing measures. Outcomes included episode characteristics, complications (including sepsis), healthcare utilization, costs, and mortality (death within 90 days of episode end). Two minimum-duration cohorts were analyzed (90 and 120 days). Results: For the 90-day minimum cohort (n=7223 matched episodes per group), CAMP episodes had lower mean PI-associated spending ($36,397 vs $39,886; p=0.0003) and lower mean total all-cause spending ($46,905 vs $50,686; p=0.0006). Compared with SOC, CAMP episodes were associated with lower complications and healthcare resources utilization, including lower sepsis (26.1% vs 36.1%; p<0.0001), lower major amputation (2.2% vs 3.1%; p=0.0004), fewer emergency department (ED) visits (1.34 vs 2.04; p<0.0001) and inpatient visits (1.52 vs 2.24; p<0.0001), and lower mortality (17.8% vs 22.3%; p<0.0001). Episode length was longer with CAMPs (323.8 vs 302.1 days; p<0.0001). Findings were consistent in the 120-day minimum cohort (n=6139 per group), including lower mean total all-cause spending ($51,585 vs $56,865; p<0.0001), lower sepsis (28.8% vs 39.9%; p<0.0001), lower major amputation (2.4% vs 3.3%; p=0.0041), fewer ED visits (1.50 vs 2.29; p<0.0001) and inpatient visits (1.70 vs 2.49; p<0.0001), and lower mortality (18.4% vs 22.8%; p<0.0001). Episode length remained longer with CAMPs (359.6 vs 339.1 days; p<0.0001). Conclusions: In matched Medicare Stage 3 PI episodes managed in the HOPD setting, CAMP use was associated with lower rates of sepsis, acute-care utilization, major amputations, mortality, total and PI ulcer–associated spending despite longer episode duration. These results further support confirmatory work incorporating greater clinical granularity and direct healing endpoints.