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.

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.

Cisgender cellular tissue-based products improve wound healing.

Neither the CTP sex effect of female CTP derived from cryopreserved human placental membranes, nor male CTP bioengineered from living human keratinocytes and foreskin fibroblasts has been described. Healing in wounds was examined to establish the CTP sex' s role in both males and females. Cisgender CTP wounds had better closure. Overall, male PC, PC-End, and CC rates over time were better than female rates. Outcomes were affected by access, etiology, and follow-up.

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.

Fetal bovine acellular dermal matrix in the management of chronic nonhealing lower extremity wounds.

BACKGROUND: The management of chronic nonhealing lower extremity wounds remains a problem that substantially affects patients and significantly burdens the health care system. Nonhealing wounds lead to increased hospitalization, decreased quality of life, minor and major amputations, and increased risk of mortality. Dermal matrices have advanced the science of wound healing. PURPOSE: To evaluate fetal bovine acellular dermal matrix (FBADM), an acellular dermal collagen repair scaffold derived from fetal bovine dermis, in the management of chronic nonhealing lower extremity wounds. METHODS: A single-center retrospective chart review was conducted to collect data on patients with chronic nonhealing lower extremity wounds treated with FBADM from January 2013 through December 2019. RESULTS: A total of 43 patients were enrolled, with a mean age of 68.5 years and a mean wound area of 27 cm2. Complete closure of the wound occurred in 53% of patients overall, with 28% of patients achieving healing within 12 weeks. CONCLUSION: Application of FBADM in the management of chronic nonhealing lower extremity wounds is safe, effective, and efficient.

Comparing U.S. and Canadian treatment patterns on venous thromboembolism outcomes in the GARFIELD-VTE registry.

BACKGROUND: Economically developed countries continue to find that venous thromboembolism (VTE) is a major cause of morbidity and mortality. OBJECTIVE: To compare baseline risk profiles and patient workflow patterns between the United States (U.S.) and Canadian management of VTE patients from 2014 to 2017. METHODS: The Global Anticoagulant Registry in the FIELD (GARFIELD-VTE) is a prospective, observational study of 10,679 patients with objectively confirmed VTE, followed for 3 years. In total 1101 patients enrolled in the U.S. and Canada were included in this analysis. RESULTS: Median age and body mass index were comparable between the U.S. (60.5; 30.2) and Canadian (59.7; 29) patients. A higher percentage of U.S. patients were black (n = 128, 24.1 %; n = 22, 3.9 %) and had a higher VTE-associated risk profile, including immobilization, hospitalization, and recent surgery. U.S. patients had a higher combined DVT and PE primary diagnoses (20.3 %) and were more likely to be treated in hospitals (77.2 %) than Canadians (13.3 %; 48.1 %). Direct oral anticoagulant therapy (DOAC) was nearly two-fold more frequent in Canadian patients (n = 218, 39.2 %) at the end of 3 years in comparison to the U.S. (n = 118, 23.0 %). Adjusted for sex, recent bleed event, heart failure, chronic immobilization, family history of VTE, history of cancer and prior VTE, and renal insufficiency, the risk of all-cause mortality was 51.9 % higher in patients from the U.S. compared to those in Canada after 3 years. Patients from the U.S. also had a higher likelihood of hospitalization, major bleeding, and recurrent VTE after controlling for prior history and comorbid conditions. CONCLUSION: Higher rates of adverse VTE-associated outcomes in the U.S. may be attributed to different baseline risk profiles, facility care, and distribution of specialists and their subsequent treatment strategies. TYPE OF RESEARCH: Global, multicentre, non-interventional, prospective registry titled Global Anticoagulant Registry in the FIELD - Venous Thromboembolism (GARFIELD-VTE). KEY FINDINGS: 531 U.S. and 557 Canadians patients included in study. DOAC use more frequent in Canadian patients after 3 years than U.S. (39.2 % vs. 23.0 %, respectively). Adjusted for sex, recent bleed event, heart failure, chronic immobilization, family history of VTE, history of cancer and prior VTE, and renal insufficiency, all-cause mortality risk remained higher in U.S. patients vs. Canadian patients after 3 years. U.S. patients had higher likelihood of hospitalization, major bleeding, and recurrent VTE. TAKE-HOME MESSAGE: Higher rates of adverse VTE-associated outcomes in the U.S. may be attributed to different baseline risk profiles, facility care, and composition of specialists and their subsequent treatment strategies. TABLE OF CONTENTS SUMMARY: Global, multicentre, non-interventional, prospective registry titled Global Anticoagulant Registry in the FIELD - Venous Thromboembolism (GARFIELD-VTE). Higher rates of adverse VTE-associated outcomes were observed in U.S. patients vs Canadian patients, which may be attributed to different baseline risk profiles, facility care, and distribution of specialists and their subsequent treatment strategies.

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.

National survey results on effect of COVID-19 pandemic on female surgeons: A new normal work environment.

BACKGROUND: The impact of COVID-19 reaches the overall well-being of women surgeons. We aimed to describe the impact of transitioning to a new challenging environment. METHODS: A survey of 60 quantitative questions using a Likert-like scale was distributed electronically via email across 1200 members of the Association of Women Surgeons in 2021. Family lifestyle factors including care for children, elderly family members, extent of household chores, and impact of COVID-19 pandemic were queried. RESULTS: A total of 139 members responded. Fifty one percent of these respondents had children at home and 31.2% indicated they needed additional help at home during that time. Eighteen percent of those in practice cared for their elderly family members. Of the survey participants, 71.2% felt the COVID pandemic resulted in a worsened clinical practice, with 30.9% noting a decrease in income. CONCLUSIONS: Women surgeons faced crucial challenges during and post pandemic. An awareness of the changing needs of women surgeons is essential.

Effectiveness of a purified type I collagen matrix plus the antimicrobial polyhexamethylene biguanide for use in cutaneous wounds: analysis of a population of three combined registries.

INTRODUCTION: Chronic wounds represent a significant burden to the health care system and patients. OBJECTIVE: This study determined the effectiveness of a wound scaffold comprised of PCMP for use in nonhealing, cutaneous wounds; this study analyzes pooled data from the population of 3 combined registries. MATERIALS AND METHODS: A total of 3 combined registry populations were pooled from a single-center study of 41 patients, a single-center study of 86 patients, and the RESPOND Registry of 307 patients treated at 28 centers. All 434 patients received PCMP and were followed for up to 48 weeks. Male and female patients 18 years or older with wounds between 0.2 cm2 and 200 cm2 were included. RESULTS: In total, there were 95 VLUs, 78 DFUs, 90 PIs, 73 PSWs, and 98 wounds of other etiologies analyzed. The mean baseline area, depth, and volume of all 434 wounds was 15.1 cm2, 4.9 mm, and 7.2 cm3, respectively. K-M median time to wound closure for all wounds was 19 weeks. At weeks 20, 24, 28, and 48, the frequency of wound closure for all wounds was 51%, 56%, 62%, and 72%, respectively. The median time to closure by wound type was 22 weeks for VLUs, 24 weeks for DFUs, 23 weeks for PIs, 12 weeks for PSWs, and 14 weeks for other wounds. The proportion of wounds closed were 72% (VLUs), 52% (DFUs), 63% (PIs), 95% (PSWs), and 67% (other etiologies). CONCLUSIONS: This 434-patient PCMP cohort analysis showed 72% wound closure and median time to wound closure of 19 weeks. PCMP demonstrated effectiveness for use in multiple wound types.

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.

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.

Lessons Learned: A Disruption in Care Leads to Increased Rates of Proximal Amputations.

BACKGROUND: In March 2020, due to the COVID-19 pandemic, hospitalizations in New York state were restricted to emergency purposes. Non-COVID related cases involving lower extremity wounds were only admitted for acute infections and limb salvage. Patients with these conditions were placed at higher risk for eventual limb loss. PURPOSE: To understand the impact of COVID-19 on amputation rates. METHODS: A retrospective review of lower limb institution-wide amputations was conducted at Northwell Health from January 2020 to January 2021. The amputation rates during the COVID-19 shutdown period were compared to the pre-pandemic, post-shutdown, and reopening period. RESULTS: The pre-pandemic period had 179 amputations, of which 8.38 % were proximal. 86 amputations were performed during shutdown, with a greater proportion being proximal (25.58 %, p=0.0009). Following the shutdown period, amputations returned to baseline. The proportion of proximal amputations during post-shutdown was 18.5 % and during reopening was 12.06 %. Patients had 4.89 times higher odds of undergoing a proximal amputation during the shutdown period. CONCLUSIONS: The effect of COVID-19 on amputation rates demonstrates an increase in proximal amputation during the initial shutdown. This study suggests an indirect negative effect of COVID-19 hospital restrictions on surgeries during the initial shutdown period.

Efficacy of Topical Wound Oxygen Therapy in Healing Chronic Diabetic Foot Ulcers: Systematic Review and Meta-Analysis.

Objective: To conduct a systematic review and meta-analysis of recently published randomized controlled trials (RCTs) that employed the use of topical oxygen therapy (TOT) as an adjunct therapy in the treatment of Wagner 1 and 2 diabetic foot ulcers. Approach: Following a literature search of eligible studies from 2010 onward, four RCTs were included. Studies were analyzed for patient and wound characteristics, outcomes, risk of bias, and quality of the evidence assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology. A random-effects meta-analysis for complete wound healing was carried out due to statistical heterogeneity of included studies. Results: Risk of bias judgment (RoB2 analysis) resulted in one low-risk trial and three trials with some risk. One study was determined to be the origin of the statistical heterogeneity. Pooled results showed statistical significance with a risk ratio (RR) of 1.59 (95% confidence interval [CI]: 1.07-2.37; p = 0.021). Sensitivity analysis, based on imputed values for missing outcomes, demonstrated that both the RR and 95% CIs changed little. The GRADE ratings for each domain were as follows: (a) risk of bias: moderate (3); (b) imprecision: moderate (2), high (1); (c) inconsistency: low (2), high (1); (d) indirectness: moderate (2), high (1); and (e) publication bias: moderate (1), high (2). Overall, the evidence was moderate. Innovation: Our study shows that TOT is a viable diabetic foot ulcer therapy. Conclusions: These data support the use of TOT for the treatment of chronic Wagner 1 or 2 diabetic foot ulcers in the absence of infection and ischemia.

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.

Virtual Events in the Era of COVID-19: Perspectives From a Virtual Interdisciplinary Wound Care Symposium.

BACKGROUND: The coronavirus disease-19 pandemic has created changes in the way medicine is practiced. The move to virtual conferencing to avoid mass gatherings is a significant change to how health care professionals meet, discuss current trends, and share research. METHODS: Data from exit polls conducted after annual wound care symposiums were reviewed. Physicians, nurses, podiatrists, and other health care professionals attended. Respondents were asked to comment and reflect on their experiences of attending a virtual conference. RESULTS: Over 60% of all (N = 283) respondents stated the virtual conference was better than or on par with a live event. Many respondents had attended this live event in person in previous years. Of all respondents, 83% stated that they planned to access conference materials for the 30 days they remained posted after the event. More than 50% of respondents stated they favored the ability to communicate effectively with colleagues via the instant messaging feature offered by the conference. Approximately 80% of respondents stated that they would like to attend this and other conferences virtually in the future. CONCLUSIONS: The shift from in-person to virtual conferences has the potential to remain a significant method of attending health care conferences. Conference organizers are encouraged to consider how they can implement virtual components, including postconference access to materials, to enhance the conference experience. Additional work needs to be done to understand the impact of the virtual format on knowledge retention.