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.

An objective comparative study of non-surgical cleansing techniques and cleanser types in bacterial burden management.

Cleansing is a vital component of effective wound hygiene and biofilm management, often accomplished through vigorous mechanical action or through soaking with moistened gauze. In the present study, a quantitative comparison of the effectiveness of different cleansing techniques and solutions in removing bacteria was conducted on 71 chronic wounds using bacterial fluorescence imaging as a real-time diagnostic for moderate to high bacterial loads. Vigorous gauze cleansing for 30 s proved most effective by reducing bacterial fluorescence by 33.99%, surpassing 10-min soaking in bacterial reduction (13.24%). Among different cleansers, no statistically significant differences in effectiveness were observed, but povidone-iodine showed the strongest trend towards bacterial reduction. Sub-analysis highlighted the superiority of antiseptic cleansers over saline and gentle soap (-33.30% vs. -1.80% bacterial reduction respectively). Five percent acetic acid was also shown to be more effective in removing specific bacterial strains (Pseudomonas aeruginosa). Findings from studies like this contribute to refining wound hygiene guidelines and clinical algorithms for bacterial and biofilm management.

Reducing lower extremity hospital-acquired pressure injuries: a multidisciplinary clinical team approach.

OBJECTIVE: Optimal methods of reducing incidence of hospital-acquired pressure injuries (HAPIs) remain to be determined. We assessed changes in yearly incidence of lower extremity HAPIs before and after an intervention aimed at reducing these wounds. METHOD: In 2012, we implemented a three-pronged intervention to reduce the incidence of HAPIs. The intervention included: a multidisciplinary surgical team; enhanced nursing education; and improved quality data reporting. Yearly incidence of lower extremity HAPIs was tracked. RESULTS: Pre-intervention, incidence of HAPIs was 0.746%, 0.751% and 0.742% in 2009, 2010 and 2011, respectively. Post-intervention, incidence of HAPIs was 0.002%, 0.051%, 0.038%, 0.000% and 0.006% in 2013, 2014, 2015, 2016 and 2017, respectively. Mean incidence of HAPIs was reduced from 0.746% before the intervention to 0.022% after the intervention (p<0.001). CONCLUSION: An intervention by a multidisciplinary surgical team enhanced nursing education, and improved quality data reporting reduced the incidence of lower extremity HAPIs.

Treatment patterns and outcomes of Medicare enrolees who developed venous leg ulcers.

OBJECTIVE: To retrospectively evaluate the comorbidities, treatment patterns and outcomes of Medicare enrolees who developed venous leg ulcers (VLUs). METHOD: Medicare Limited Data Standard Analytic Hospital Inpatient and Outpatient Department Files were used to follow patients who received medical care for a VLU between 1 October 2015 and 2 October 2019. Patients diagnosed with chronic venous insufficiency (CVI) and a VLU were propensity matched into four groups based on their treatment regimen. Episode claims were used to document demographics, comorbidities and treatments of Medicare enrolees who developed VLUs, as well as important outcomes, such as time to ulcer closure, rates of complications and hospital utilisation rates. Outcomes were compared across key propensity-matched groups. RESULTS: In total, 42% of Medicare enrolees with CVI (n=1,225,278), developed at least one VLU during the study, and 79% had their episode claim completed within one year. However, 59% of patients developed another VLU during the study period. This analysis shows that only 38.4% of VLU episodes received documented VLU conservative care treatment. Propensity-matched episodes that received an advanced treatment or high-cost skin substitutes for a wound which had not progressed by 30 days demonstrated the best outcomes when their cellular, acellular, matrix-like product (CAMP) treatment was applied weekly or biweekly (following parameters for use). Complications such as rates of infection (33%) and emergency department visits (>50%) decreased among patients who received an advanced treatment (following parameters for use). CONCLUSION: Medicare enrolees with CVI have diverse comorbidities and many do not receive sufficient management, which contributes to high rates of VLUs and subsequent complications. Medicare patients at risk of a VLU who receive early identification and advanced CAMP treatment demonstrated improved quality of life and significantly reduced healthcare resource utilisation.

The effect of nutrition on stroke risk: A systematic review.

Background: An estimated 33% reduction in cardiovascular events can be achieved when incorporating whole grains, fruits, vegetables, poultry, nuts, and vegetable oils in the diet along with reduced consumption of refined carbohydrates, processed meats, and sugar sweetened beverages. We performed a systematic review to analyze the impact of nutritional intervention on stroke risk, as there is no current consensus concerning dietary recommendation for primary and secondary stroke prevention. Methods: A literature search of the PubMed database from January 2010 to June 2020 was performed using combinations of the following search terms: carotid disease, carotid artery disease, carotid stenosis, carotid intima-media thickness (CIMT), diet, nutrition, micronutrition, embolic stroke, and stroke. We used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2009 checklist. Results: 28 studies met our inclusion criteria. Multiple studies showed an inverse relationship between consumption of vegetables and fruits and stroke risk. Vitamin B12 or a combination of B Vitamins was the most common supplement studied in stroke prevention. Only one RCT showed the use of B12 (500 micrograms/day) correlated with lower CIMT at follow up in healthy vegetarians. Discussion: The key findings from this systematic review indicate that adopting a diet rich in fruits and vegetables earlier in life may lower stroke risk compared with meats and fat intake. B vitamins also appear to confer some protection against stroke. However, not enough data exists to support the use of multivitamins, calcium, soy products and other supplements for primary or secondary stroke prevention.

Chronic venous insufficiency: a comprehensive review of management.

Chronic venous insufficiency is an extensive progressive disease in need of public health attention. This insidious disease is a growing burden on patient quality of life and the health economy. Chronic venous insufficiency has become more pronounced in global populations, especially in regions exhibiting a higher rate of risk factors. It is critical for healthcare providers to recognise and intervene early to prevent ongoing and debilitating complications. This article provides a comprehensive review of chronic venous insufficiency outlining the anatomy, pathophysiology, clinical presentation, assessment and management options.

The anti-adhesive effect of anti-VEGF agents in experimental models: A systematic review.

Adhesions constitute a major problem in abdominal-pelvic and thoracic surgery with significant impact in the postoperative quality of life and healthcare services utilization. Adhesiogenesis is the result of increased fibrin formation, impaired fibrinolysis, angiogenesis, and fibrosis. Despite the recent advancements, the ideal anti-adhesive agent remains to be determined. To this end, we performed a comprehensive literature search in PubMed, EMBASE, and Scopus databases to identify studies investigating the antiadhesive role of anti-VEGF agents in peritoneal, pleural, and pericardial experimental adhesion models. Fifteen studies were eligible for inclusion with a total population of 602 animals (334 rats, 180 rabbits, and 88 mice). The majority of included studies (11/15) used bevacizumab, while three studies used other anti-VEGF antibodies and one study used an anti-VEGFR-antibody. A rat model was used in nine studies, while rabbit (n = 3) or mouse (n = 3) models were used less frequently. Eleven studies used peritoneal models, three studies used pleural models, and one study used a pericardial model. The scales (n = 12) and interval (Range: 1-42 days) used for the evaluation of adhesions varied between the studies. All studies demonstrated a significant decrease in adhesion scores between the anti-VEGF and control groups up to 42 days postprocedure. VEGF blockade resulted in decreased fibrosis in four out of five studies that used peritoneal models, while the effect on pleural models depended on the pleurodesis agent and was significant between 7 and 28 days. The effect of anti-VEGF agents on anastomosis integrity depends on the dose and the model that is used (inconclusive results).Current data support the anti-adhesive role of Anti-VEGF agents in all three serosal surfaces up to 6 weeks postprocedure. Further studies are needed to confirm the anti-adhesive role of anti-VEGF agents in pleural and pericardial adhesion experimental models and investigate any effect on anastomosis integrity in peritoneal models.

Wound care during the COVID-19 pandemic: improving outcomes through the integration of telemedicine.

COVID-19 is highly contagious and its rapid spread burdens the healthcare system. As the number of confirmed cases goes up, the shortage of medical resources has become a challenge. To avoid the collapse of the healthcare system during the fight with COVID-19, all healthcare workers, including wound care practitioners, should adapt to new roles and use any appropriate methods available to slow the spread of the virus. Integrating telemedicine into wound care during the outbreak helps maintain social distancing, preserve personal protective equipment and medical resources, and eliminate unnecessary exposure for both vulnerable patients and high-risk healthcare workers.

Quality of life improvement in patients with hard-to-heal leg wounds treated with Prontosan wound irrigation solution and wound gel.

OBJECTIVE: This study evaluated the impact of four weeks of treatment with Prontosan Wound Irrigation Solution and Prontosan Wound Gel (B. Braun Medical Inc., US) on adults with hard-to-heal leg wounds. Overall change (weeks 1-5) in the Global Quality of Life scale (GQOL), changes in body, psyche and everyday life (EDL) quality of life (QoL) subscores, and changes in wound appearance and size after treatment were assessed. METHOD: In this prospective, open-label, single-arm, five-centre study, non-hospitalised patients with no more than two wounds below the knee were recruited into the study; wounds were ≥5cm2 and ≤50cm2 and present for ≥4 weeks. The investigator or a designee applied the wound solution and gel to the wounds at clinic visits, and patients/caregivers applied the wound solution and gel at home. Wound-QoL questionnaires were completed at the initial screening and at each week of treatment. Wound size and photographs were obtained at pre- and post-treatment during clinic visits. RESULTS: A total of 43 patients were enrolled in the study. Mean GQOL scores decreased by 1.11 (46.1%). Body, psyche and EDL decreased by 1.17 (60.0%), 1.26 (41.8%) and 1.00 (42.2%), respectively. Wounds also showed improvement in odour, appearance and size. Adverse events were mild in intensity and transient in nature. CONCLUSION: This study demonstrated marked improvement in the QoL of patients with hard-to-heal leg wounds below the knee during four weeks of treatment with the wound solution and gel. Wounds also showed improvement in odour, appearance and size, and the treatment solution and gel were well tolerated. DECLARATION OF INTEREST: B. Braun Medical Inc. funded the research and preparation of this article. AK, DV, CRC and WC are employees of B. Braun Medical Inc. AO and RS declare no conflict of interest.

Human Amnion Chorion Membrane Allografts in the Treatment of Chronic Diabetic Foot Ulcers: A Literature Review.

OBJECTIVE: To discuss human amnion chorion (placental) membrane allograft (HACMA) use for the treatment of chronic diabetic foot ulcers (DFUs) and to evaluate the effectiveness, cost, and product waste of this therapy. DATA SOURCES: PubMed, Cochrane, and OVID databases. STUDY SELECTION: Twenty-four articles pertaining to HACMA and DFUs published from 2016 to 2020 were selected. DATA EXTRACTION: The data collected included type of wound care product, study design, study size, baseline size of DFU, cost, product wastage, number of applications, and wound healing outcomes. DATA SYNTHESIS: Human amnion chorion membrane allografts in the treatment of chronic DFUs have led to a reduction in healing time and increased the overall percentage of healing, making them more effective in treating DFUs compared with standard of care. These products are offered in multiple sizes with various shelf lives and methods of storage, making them accessible, easy to use, less wasteful, and lower in cost compared with other commercially available products. Promising evidence demonstrates that HACMAs are beneficial in treating complex, high-grade DFUs with exposed tendon or bone. CONCLUSIONS: Human amnion chorion membrane allografts are effective in treating chronic DFUs with a greater percentage of complete wound closure and a reduction in healing time versus standard of care.

Current Concepts in the Diagnosis and Management of Lymphedema.

GENERAL PURPOSE: To present a comprehensive review of lymphedema, including its pathophysiology, assessment, diagnosis, and treatment. TARGET AUDIENCE: This continuing education activity is intended for physicians, physician assistants, nurse practitioners, and nurses with an interest in skin and wound care. LEARNING OBJECTIVES/OUTCOMES: After participating in this educational activity, the participant will:1. Summarize the etiology, pathophysiology, and clinical manifestations of lymphedema.2. Describe the diagnostic and treatment approaches for patients who have lymphedema. ABSTRACT: Lymphedema is a condition characterized by localized protein-rich swelling caused by damaged or malfunctioning lymphatics. Patients with lymphedema have an increased risk of infection because of the lymphostatic nature of the disease. Chronic ulceration of the skin can make individuals vulnerable to infection leading to serious, sometimes fatal, complications. Proper diagnosis and treatment modalities can aid in the prevention of these complications and ensure better outcomes for the patient.

Lymphedema is a condition characterized by localized protein-rich swelling caused by damaged or malfunctioning lymphatics. Patients with lymphedema have an increased risk of infection because of the lymphostatic nature of the disease. Chronic ulceration of the skin can make individuals vulnerable to infection leading to serious, sometimes fatal, complications. Proper diagnosis and treatment modalities can aid in the prevention of these complications and ensure better outcomes for the patient.

The use of indocyanine green fluorescence angiography to assess perfusion of chronic wounds undergoing hyperbaric oxygen therapy.

OBJECTIVE: The purpose of this study is to determine the utility of using indocyanine green fluorescence angiography (IGFA) in assessing perfusion of chronic wounds after hyperbaric oxygen (HBO2) therapy. METHODS: From May 2016 to January 2018, 26 patients underwent both HBO2 and IGFA. A near-infrared charge-coupled camera measured the flow of intravenous indocyanine green into the wound. IGFA was done pre-HBO2, after approximately 10 HBO2 sessions, and upon completion of HBO2. The ingress rate at baseline, mid-therapy and post-HBO2 values were compared using descriptive statistics. RESULTS: A total of 26 chronic wounds were identified. Baseline median ingress rate was 0.90 units/second (IQR: 0.28 to 6.10). Median ingress rate after approximately of 10 HBO2 sessions was 2.45 units/sec (IQR: 0.48 to 6.35). Six of 11 patients, however, exhibited a decrease in ingress rate from baseline to mid-therapy. Finally, median ingress rate post-HBO2 was 3.70 units/second (IQR: 0.30 to 9.90). Median increase in ingress and rate from baseline to mid-HBO2 treatment 0.30 units/second (IQR: -0.25 to 3.10) and from mid- to post-HBO2 was -0.40 units/second (IQR: -1.50 to 2.60). CONCLUSIONS: This preliminary study shows capability of IGFA to detect changes in blood flow to wounds following HBO2 therapy. Results support the use of IGFA to evaluate the changes in perfusion of patients undergoing HBO2 for chronic wounds. A larger sample size may help clarify the benefit of IGFA to predict potential for wound healing.

Pressure and stiffness of a new air-inflated compression wrap.

OBJECTIVE: To report pressure and stiffness, in healthy volunteers, of a new compression device with an air bladder inflated by a pump to regulate pressure. METHODS: The device was applied to 60 legs of 30 volunteers and set to exert different pressures of 20-50 mmHg. The exerted pressure was measured in supine and standing positions and during simple physical exercises; static stiffness index, dynamic stiffness index, and walking pressure amplitudes were calculated. RESULTS: The exerted pressure showed a good correlation with the expected pressure at each pressure range. The stiffness indices were >10 mmHg in the range of inelastic materials. The device was considered very easy to apply and use by the testing researchers. CONCLUSIONS: The device stiffness is in the same range as the inelastic bandages. Consequently, similar hemodynamic effectiveness could be expected but must be proved. Unlike inelastic bandages, this device was easy to apply and use.

Revisiting Heinz-Lippman disease as a complication of chronic venous insufficiency.

Chronic venous insufficiency with and without ulceration is a common complication of varicose veins. Heinz-Lippmann disease is a potentially underreported complication of chronic venous insufficiency that involves heterotopic ossification of the peri-wound that might contribute to the chronicity of venous leg ulcers. Most commonly, heterotopic ossification is associated with traumatic injury. We report the cases of three patients with chronic venous insufficiency and no history of trauma who were found to have subcutaneous calcifications consistent with Heinz-Lippmann disease. Osteomyelitis was confirmed in two patients. Physical examination and diagnostic imaging can be helpful in determining the diagnosis. Interventions can include biopsy to rule out osteomyelitis, with subsequent treatment, if needed.

Skin Pigmentation Impacts the Clinical Diagnosis of Wound Infection: Imaging of Bacterial Burden to Overcome Diagnostic Limitations.

Underrepresentation of diverse skin tones in medical education and providers' implicit racial bias drives inequities in wound care, such as disproportionally poor outcomes for Black patients. Diagnostic indicators (e.g., erythema) can present differently depending on skin pigmentation. This post hoc analysis of 350 chronic wounds from a prospective 14-site clinical trial aimed to determine how the perception of clinical signs and symptoms of infection (CSS) differs by patient skin tone and if fluorescence-imaging can offer a more objective diagnostic solution. Participants were grouped by skin tone (low, medium, high) as measured by the Fitzpatrick Skin Phototype Classification (FSPC) scale. CSS and total bacterial load (TBL) were compared across FSPC groups, along with sensitivity to detect TBL >104 CFU/g using CSS alone and combined with fluorescence-imaging. Erythema was reported less often with increasing FSPC score (p = 0.05), from 13.4% (low), to 7.2% (medium), to 2.3% (high), despite comparable bacterial loads (median = 1.8 × 106 CFU/g). CSS sensitivity in the high group (2.9%) was 4.8-fold to 8.4-fold lower than the low (p = 0.003) and medium groups (p = 0.04). Fluorescence-imaging significantly improved the detection of high bacterial load in each group, peaking in the high group at 12-fold over CSS alone. These findings underscore the threat of pervasive racialized health inequities in wound care, where missed diagnosis of pathogenic bacteria and infection could delay treatment, increasing the risk of complications and poor outcomes. Fluorescence-imaging is poised to fill this gap, at least in part, serving as a more objective and equitable indicator of wound bacteria. Clinicaltrials.gov #NCT03540004 registered 16-05-2018.