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.

Capturing Essentials in Wound Photography Past, Present, and Future: A Proposed Algorithm for Standardization.

GENERAL PURPOSE: To discuss a standardized methodology for wound photography with a focus on aiding clinicians in capturing high-fidelity images. 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 be able to:1. Discriminate the components of high-quality wound photography.2. Identify the technological innovations that can augment clinical decision-making capacity.3. Choose strategies that can help clinicians avoid adverse medicolegal outcomes.

According to a 2018 study, chronic wounds affect more than 8 million Americans and impose a substantial economic burden, with costs of care reaching upward of US $30 billion. As demographics in the US shift toward an aging population, these numbers are likely to progressively increase annually. Care of these patients relies heavily on photographic documentation, which catalogs disease progression and informs management decisions. This article elaborates a standardized methodology for wound photography and aims to aid clinicians in capturing high-fidelity images. Technological advancements, notably digital cameras and smart phones, have exponentially improved both the rate and quality of wound photography, but their potential has yet to be fully realized. Despite the indispensable nature of wound photography, literature detailing the photography process remains sparse. The absence of a standardized methodology for wound photography leads to subpar documentation, which ultimately hinders patient care. Further, information regarding medicolegal implications of wound photography remains fragmented and opaque to many clinicians. The authors provide a comprehensive overview of best practices in wound photography, medicolegal considerations, and an overview of emerging technologies. Photographic documentation is indispensable in the management of chronic wounds. Capturing consistent, high-fidelity images requires the adoption of standardized protocols. Emerging technologies, such as three-dimensional imagery, biosensors, and artificial intelligence, are poised to profoundly alter wound photography in the future. However, standardized protocols informed by sound clinical judgment will remain of paramount importance.

Development of a Method for Clinical Evaluation of Artificial Intelligence-Based Digital Wound Assessment Tools.

Importance: Accurate assessment of wound area and percentage of granulation tissue (PGT) are important for optimizing wound care and healing outcomes. Artificial intelligence (AI)-based wound assessment tools have the potential to improve the accuracy and consistency of wound area and PGT measurement, while improving efficiency of wound care workflows. Objective: To develop a quantitative and qualitative method to evaluate AI-based wound assessment tools compared with expert human assessments. Design, Setting, and Participants: This diagnostic study was performed across 2 independent wound centers using deidentified wound photographs collected for routine care (site 1, 110 photographs taken between May 1 and 31, 2018; site 2, 89 photographs taken between January 1 and December 31, 2019). Digital wound photographs of patients were selected chronologically from the electronic medical records from the general population of patients visiting the wound centers. For inclusion in the study, the complete wound edge and a ruler were required to be visible; circumferential ulcers were specifically excluded. Four wound specialists (2 per site) and an AI-based wound assessment service independently traced wound area and granulation tissue. Main Outcomes and Measures: The quantitative performance of AI tracings was evaluated by statistically comparing error measure distributions between test AI traces and reference human traces (AI vs human) with error distributions between independent traces by 2 humans (human vs human). Quantitative outcomes included statistically significant differences in error measures of false-negative area (FNA), false-positive area (FPA), and absolute relative error (ARE) between AI vs human and human vs human comparisons of wound area and granulation tissue tracings. Six masked attending physician reviewers (3 per site) viewed randomized area tracings for AI and human annotators and qualitatively assessed them. Qualitative outcomes included statistically significant difference in the absolute difference between AI-based PGT measurements and mean reviewer visual PGT estimates compared with PGT estimate variability measures (ie, range, standard deviation) across reviewers. Results: A total of 199 photographs were selected for the study across both sites; mean (SD) patient age was 64 (18) years (range, 17-95 years) and 127 (63.8%) were women. The comparisons of AI vs human with human vs human for FPA and ARE were not statistically significant. AI vs human FNA was slightly elevated compared with human vs human FNA (median [IQR], 7.7% [2.7%-21.2%] vs 5.7% [1.6%-14.9%]; P < .001), indicating that AI traces tended to slightly underestimate the human reference wound boundaries compared with human test traces. Two of 6 reviewers had a statistically higher frequency in agreement that human tracings met the standard area definition, but overall agreement was moderate (352 yes responses of 583 total responses [60.4%] for AI and 793 yes responses of 1166 total responses [68.0%] for human tracings). AI PGT measurements fell in the typical range of variation in interreviewer visual PGT estimates; however, visual PGT estimates varied considerably (mean range, 34.8%; mean SD, 19.6%). Conclusions and Relevance: This study provides a framework for evaluating AI-based digital wound assessment tools that can be extended to automated measurements of other wound features or adapted to evaluate other AI-based digital image diagnostic tools. As AI-based wound assessment tools become more common across wound care settings, it will be important to rigorously validate their performance in helping clinicians obtain accurate wound assessments to guide clinical care.

Hyperbaric oxygen therapy for COVID-19 patients with respiratory distress: treated cases versus propensity-matched controls.

Objective: Given the high mortality and prolonged duration of mechanical ventilation of COVID-19 patients, we evaluated the safety and efficacy of hyperbaric oxygen for COVID-19 patients with respiratory distress. Methods: This is a single-center clinical trial of COVID-19 patients at NYU Winthrop Hospital from March 31 to April 28, 2020. Patients in this trial received hyperbaric oxygen therapy at 2.0 atmospheres of pressure in monoplace hyperbaric chambers for 90 minutes daily for a maximum of five total treatments. Controls were identified using propensity score matching among COVID-19 patients admitted during the same time period. Using competing-risks survival regression, we analyzed our primary outcome of inpatient mortality and secondary outcome of mechanical ventilation. Results: We treated 20 COVID-19 patients with hyperbaric oxygen. Ages ranged from 30 to 79 years with an oxygen requirement ranging from 2 to 15 liters on hospital days 0 to 14. Of these 20 patients, two (10%) were intubated and died, and none remain hospitalized. Among 60 propensity-matched controls based on age, sex, body mass index, coronary artery disease, troponin, D-dimer, hospital day, and oxygen requirement, 18 (30%) were intubated, 13 (22%) have died, and three (5%) remain hospitalized (with one still requiring mechanical ventilation). Assuming no further deaths among controls, we estimate that the adjusted subdistribution hazard ratios were 0.37 for inpatient mortality (p=0.14) and 0.26 for mechanical ventilation (p=0.046). Conclusion: Though limited by its study design, our results demonstrate the safety of hyperbaric oxygen among COVID-19 patients and strongly suggests the need for a well-designed, multicenter randomized control trial.

Regenerative Wound Surgery: Practical Application of Regenerative Medicine in the OR.

Chronic nonhealing wounds cause significant morbidity and mortality and remain a challenging condition to treat. Regenerative wound surgery involves operative debridement of wounds to remove dead and healing-impaired tissue and bacterial contamination and, subsequently, the application of regenerative medicine treatments to accelerate healing. Regenerative treatments aim to restore native tissue structure and function by targeting biological mechanisms underlying impaired healing. A wide range of regenerative modalities are used for treating chronic and complex wounds, including decellularized scaffolds, living engineered donor tissues, autologous stem cells, and recombinant growth factors. Each of these modalities has specific and sometimes complex requirements for implementation. The advanced wound care team, including OR staff members, should be aware of how these products are used and regulated. This article highlights some of the common and emerging regenerative treatments that are applied in wound surgery and focuses on how the products are used practically in the OR.

Necrotizing Myositis: A Rare Necrotizing Soft Tissue Infection Involving Muscle.

INTRODUCTION: Necrotizing myositis (NM) is an extremely rare necrotizing soft tissue infection involving muscle. Unlike similar infections (eg, necrotizing fasciitis, clostridial myonecrosis) that can be more readily diagnosed, NM can have a benign presentation then rapidly progress into a life-threatening condition with a mortality rate of 100% without surgical intervention. CASE REPORT: A 74-year-old man with a history of prostate cancer with radiation therapy, seed implants, and 2 transurethral resection procedures presented to the emergency department after a fall. He was initially diagnosed and treated for urosepsis. Sixteen hours after presentation, he complained of pain and swelling of his right groin. Computed tomography of the abdomen and pelvis showed gas findings suspicious for necrotizing infection of the bilateral thighs. Surgical exploration revealed NM. Separate cultures from the left thigh and bladder grew Streptococcus intermedius, Clostridium clostridioforme, and Peptostreptococcus, suggesting a possible common source of infection from the prostate gland or the osteomyelitic pubic symphysis, which subsequently spread to the bilateral thighs. CONCLUSIONS: To the best of the authors' knowledge, this is the first reported case of S intermedius and C clostridioforme causing NM. A high index of suspicion is required for extremely rare conditions like NM, because early diagnosis and surgical intervention significantly reduce mortality.

A Framework to Assist Providers in the Management of Patients with Chronic, Nonhealing Wounds.

GENERAL PURPOSE: To describe the development of an evidence-based wound electronic medical record (WEMR) framework for providers to execute timely, protocol-based, best-practice care for patients with chronic, nonhealing wounds. 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 completing this continuing education activity, you should be better able to: ABSTRACT: The care of patients with nonhealing wounds involves a host of treatment modalities. The authors developed a wound-specific framework to enhance provider management of these wounds and a summary sheet to involve patients and caregivers in their own healthcare to improve treatment adherence and outcomes. Implementing evidence-based practice for chronic wounds enables corrective actions to optimize care.

An unusual presentation of Merkel cell carcinoma: a case report.

Merkel cell carcinoma (MCC) is a rare, aggressive carcinoma that usually arises in sun-exposed regions. MCC is a primary neuroendocrine tumor that arises in the skin. This report describes an unusual case of MCC on the buttocks that was treated with excision, radiation and chemotherapy. Physicians should consider MCC as a differential diagnosis when encountering a rapidly growing, painless lesion. Early diagnosis and treatment may improve patient survival rates.

A Wolf in Sheep's Clothing: An Unusual Presentation of Diabetic Myonecrosis.

GENERAL PURPOSE: To provide information about the diagnosis and treatment of diabetic myonecrosis (DMN).This continuing education activity is intended for physicians, physician assistants, nurse practitioners, and nurses with an interest in skin and wound care.After participating in this educational activity, the participant should be better able to:1. Cite the incidence and symptomatology of diabetic myonecrosis.2. Identify the diagnostic tests associated with DMN.3. Summarize the evidence-based treatments for DMN.Diabetic myonecrosis is a rare complication of poorly controlled diabetes mellitus that presents similarly to many common conditions such as cellulitis, abscess, and fasciitis. Therefore, a high index of suspicion is required for diagnosis. Magnetic resonance imaging is the investigative test of choice. Treatment includes antiplatelet therapy, nonsteroidal anti-inflammatory agents, and glycemic control.

Practical Application of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Patients with Wounds.

Rapidly evolving advances in wound-care technologies and treatment modalities, including locally injectable granulocyte-macrophage colony-stimulating factor (GM-CSF), are increasingly being used. Based on its role in the stimulation and recruitment of key contributors to wound healing, such as keratinocytes, macrophages, and fibroblasts, GM-CSF is considered to play an essential role in the wound-healing cascade. Synthetic GM-CSF has been shown to have a positive effect on the healing of chronic wounds when given as a local injection in a small number of patients. Subsequent randomized, controlled trials demonstrated that GM-CSF accelerated the healing of chronic wounds. This paper reviews the proposed mechanism of action of GM-CSF in wound healing. We also describe its method of application in the operating room at a tertiary care center for patients with wounds. Key Messages: Many types of chronic wounds have an altered keratinocyte and macrophage function that can be potentially assuaged by the addition of locally injected growth factor therapy to standard-of-care treatment. Granulocyte-macrophage colony-stimulating factor (GM-CSF) has been shown to be beneficial for the treatment of chronic, non-healing wounds. This article reviews the data on GM-CSF, reports a proposed mechanism of action, and describes its use by a team of wound surgeons.

Wound Care Center of Excellence: A Process for Continuous Monitoring and Improvement of Wound Care Quality.

GENERAL PURPOSE: To provide information about a study using a new process for continuous monitoring to improve chronic wound care quality.This continuing education activity is intended for physicians, physician assistants, nurse practitioners, and nurses with an interest in skin and wound care.After completing this continuing education activity, you should be better able to:1. Recognize problems associated with chronic wound care.2. Identify methods used in this project to improve care.3. Illustrate the findings from this and similar projects and implications for providing improved wound care.Patients with chronic wounds require complex care because of comorbidities that can affect healing. Therefore, the goal of this project was to develop a system of reviewing all hospitalized patients seen by the study authors' wound care service on a weekly basis to decrease readmissions, morbidity, and mortality. Weekly multidisciplinary conferences were conducted to evaluate patient data and systematically assess for adherence to wound care protocols, as well as to create and modify patient care plans. This review of pathology and the performance of root-cause analyses often led to improved patient care.

A Perioperative Approach to Increase Limb Salvage When Treating Foot Ulcers in Patients With Diabetes.

Foot ulceration in patients with diabetes increases the risk of lower extremity amputation. Major amputations produce substantial adverse consequences, increase length of hospital stay, diminish quality of life, and increase mortality. In this article, we describe approaches that decrease amputations and improve the quality of life for patients with diabetes and foot ulcers. We highlight the role of the perioperative nurse, who is essential to providing optimal patient care in the perioperative period. Perioperative care of patients with diabetes involves providing optimal surveillance for a break in the skin of the foot, screening for neuropathy, following guidelines for foot ulcer infections, preparing for pathophysiology-based debridement, using adjuvant therapies, and offloading the patient's affected foot. Nurses should understand the disease process and pathophysiology and how to use these approaches in the perioperative setting to assist in curtailing the morbidity and mortality associated with foot ulcers in patients with diabetes.

The Future of Data-Driven Wound Care.

Care for patients with chronic wounds can be complex, and the chances of poor outcomes are high if wound care is not optimized through evidence-based protocols. Tracking and managing every variable and comorbidity in patients with wounds is difficult despite the increasing use of wound-specific electronic medical records. Harnessing the power of big data analytics to help nurses and physicians provide optimized care based on the care provided to millions of patients can result in better outcomes. Numerous applications of machine learning toward workflow improvements, inpatient monitoring, outpatient communication, and hospital operations can improve overall efficiency and efficacy of care delivery in and out of the hospital, while reducing adverse events and complications. This article provides an overview of the application of big data analytics and machine learning in health care, highlights important recent advances, and discusses how these technologies may revolutionize advanced wound care.

Protocol for Psychopharmacologic Management of Behavioral Health Comorbidity in Adult Patients with Diabetes and Soft Tissue Infections in a Tertiary Care Hospital Setting.

GENERAL PURPOSE: To provide information about the effect of psychiatric comorbidities on wound healing in patients with diabetes mellitus (DM). 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 should be better able to:1. Discuss the connection between DM and the development of psychiatric comorbidities.2. Identify the drugs recommended in the treatment of these psychiatric comorbidities.3. List cautions and contraindications related to the drugs discussed. ABSTRACT: In patients with diabetes mellitus type 2, psychiatric comorbidities such as depressive and anxiety disorders are 60% or more prevalent than in the general population. The severity of mental illness and the duration of diabetes have been shown to correlate with worsening glycemic control, thus impeding wound healing. A retrospective chart review was conducted in all patients with diabetes mellitus admitted to the wound service with prior or current psychiatric symptoms of anxiety, depression, or cognitive impairment. A psychopharmacologic protocol was developed based on the clinical data collected and treatment parameters used by the behavioral health consultation liaison service.

Major Histopathologic Diagnoses of Chronic Wounds.

PURPOSE: To clarify the histopathology of acute osteomyelitis, chronic osteomyelitis, primary vasculitis, and secondary-type vasculitis. TARGET AUDIENCE: This continuing education activity is intended for physicians and nurses with an interest in skin and wound care. OBJECTIVES/OUTCOMES: After participating in this educational activity, the participant should be better able to:1. Describe the parameters and significance of this study.2. Identify chronic wound diagnosis and treatment.3. Differentiate the histopathology of osteomyelitis and vasculitis. OBJECTIVE: The presence of a chronic wound can result in significant morbidity/mortality. Understanding the pathological alterations of wound tissue that are refractory to standard wound therapy is essential for effective wound management and healing. The authors describe 4 wound etiologies, specifically, acute osteomyelitis, chronic osteomyelitis, primary vasculitis, and secondary-type vasculitis. SETTING: A tertiary care hospital. DESIGN: A retrospective review of 1392 wound operations performed during a 24-month period at a tertiary care hospital was conducted. Tissue specimens reviewed included soft tissue infections of the lower extremity, sacrum, hip/pelvis, trunk, perineum, and buttocks. MAIN RESULTS: Acute osteomyelitis is defined as bone tissue with a predominance of polymorphonuclear leukocytes, evidence of osteoclast bone resorption with scalloping of the cortical bone edges, and bone detritus. Chronic osteomyelitis is defined as bone tissue with a significant amount of fibrosis surrounding devitalized tissue and heavy infiltration of lymphocytes and plasma cells. Primary-type vasculitis is defined primarily as inflammation and necrosis of blood vessel walls. In cutaneous lesions of granulomatosis with polyangiitis, ulceration with numerous inflammatory granulomas is seen in the papillary dermis. Secondary vasculitis is defined by vessel wall infiltration by inflammatory cells and fibrinoid necrosis of the small vessel wall. CONCLUSIONS: Pathologies of these 4 types of wounds can complicate standard algorithms designed for diagnosis and treatment, and accurate diagnosis through histopathologic analysis can help tailor targeted treatment.

Oxy-Mat™ Mattress System Development Utilizing Simultaneous Measurement of Interface Pressure and Deep Tissue Oxygen Saturation.

The development and management of pressure ulcers (PUs) among hospital and nursing home patients is one of the greatest preventable challenges to healthcare worldwide. For over 50 years, pressure mapping and subjective comfort has been the primary indicators for mattress selection. Our research demonstrates that mattress/patient interface pressure and relative blood/oxygen perfusion do not inversely correlate and pressure is not a meaningful, real-time indicator of tissue ischemia and risk of pressure ulcer development. Developed in our research is a real-time sensor system to simultaneously measure and record these parameters over the anatomical sites at risk for PUs. Measurements focused on the heel, sacrum, trochanter, ischium, scapula and occipital. A modified pressure mapping system is used for interface pressure measurements and integrated with multiple near-infrared sensors to measure specific deep tissue hemoglobin saturated oxygen or rSO2. Testing and mattress design development was done during the period of 2008 to present. Over 200 human tests of commercially available mattresses were conducted in supine, 30 degree, and 70 degree positions, ranging in times of up to four hours. During this time period, we utilized 20 test subjects-eight female and 12 male-with ages ranging from 18 to 65 years. The result of this proprietary off-loading device evaluation and design system shows that the new Oxy-Mat™ (Off-Loading Technologies, Tarrytown, NY) Non-Powered Mattress System consistently provides optimized tissue perfusion as measured by natural deep tissue oxygen saturation levels. In extensive laboratory and clinical evaluations, the Oxy-Mat™ was shown to be functionally superior to CMS Group 2 powered mattresses. Another outcome of our research was that a powered mattress system may not be appropriate for most sensate and semi-ambulatory patients. Further research is underway.

Protective effects of hyperbaric oxygen therapy (HBO2) in cardiac care--A proposal to conduct a study into the effects of hyperbaric pre-conditioning in elective coronary artery bypass graft surgery (CABG).

We review and report on accumulated data showing the benefits offered by hyperbaric oxygen (HBO2) therapy as an adjunct in the treatment of coronary artery bypass graft (CABG) patients. It has been shown that ischemia-reperfusion injury is deleterious to the myocardium, causing left ventricular dysfunction, structural damage to the myocytes and endothelial cells, myocardial stunning, reperfusion arrhythmias and potentially irreversible injury. There is a substantial body of evidence pointing to the role of HBO2 in mitigating the harmful effects of ischemia-reperfusion injury. Specifically, we review evidence from a number of studies which clearly point to both clinical and cost benefits HBO2 offers when used to precondition non-emergent patients having on-pump coronary arterial bypass graft surgery. Study data show that adding adjunctive HBO2 into the plan of care leads to improved myocardial function, reduces length of stay in the ICU, and limits post-surgical complications. Further, it has only minimal impact on the presurgical preparation, i.e., time must be allowed for the hyperbaric treatment(s), and no role in the surgery or post-surgical care of the patient. The studies pointing to clinical and cost benefit of preconditioning have been conducted outside the United States. Given the pressure on costs in all areas of health care, it seems that a therapeutic approach, which has been shown to be of benefit in both animal and human trials over the course of many years, should attract funding for a properly structured study designed to test whether significant and simultaneous improvements in clinical outcomes and cost reductions can be achieved within the framework of a U.S. healthcare facility.