RESUMO
Chronic wounds (ie, wounds that fail to progress through a normal, orderly, timely sequence of repair) continue to pose significant clinical and economic burdens. A prospective, descriptive, 3-week post-marketing surveillance study was conducted across 3 wound care centers in the United States to evaluate the effectiveness of a collagen calcium alginate dressing on chronic wounds in conjunction with standard care (SC) practices (eg, offloading, debridement, compression) to support healing. Eligible participants had to be >18 years of age, have at least 1 chronic wound, and no known sensitivity to collagen. Demographic characteristics were recorded at the screening visit on case report forms. At each visit, wound-related pain was assessed using the Visual Analog Scale along with wound characteristics including size (using digital planimetry), wound exudate (minimal, moderate, heavy), and odor (none, mild). Participants were monitored for adverse events as well as infection based on signs and symptoms in and around the local wound bed, the deeper structures, and the surrounding skin. An intention-to-treat approach was used for all analyses. If an observation was missing, the last observation carried forward principle was used. For wounds that healed, pain and exudate were set to 0 (no pain/exudate) at visit 4. Descriptive, paired t tests and the Wilcoxon signed rank test were used to analyze the data. Of the 31 participants (15 men, 16 women, mean age 66.6 years), most (13, 42%) had a diabetic foot ulcer or venous leg ulcer (10, 32%); median duration of all wounds was 148 days. Thirty (30) patients completed the study. The mean number of comorbidities was 10.6 ± 6.3, and patients used a mean of 9.3 ± 5.64 prescription or over-the-counter medications. For all wounds combined, mean wound area was 4.8 ± 8.38 cm2 at baseline. At week 3, a decrease in wound area of 38.1% was noted (median: 45% ± 42.54; P = .006); 3 wounds healed completely. The change in wound exudate level from visit 1 to visit 4 was statistically significant (P = .006). No adverse events or infections occurred. In this population, the use of etiology-appropriate SC and a collagen calcium alginate dressing resulted in a decrease in wound area after 3 weeks of care. Longer-term studies to confirm these observations and controlled clinical studies to compare the effects of this dressing to other nongauze dressing treatments are needed.
Assuntos
Alginatos/farmacologia , Bandagens/normas , Doença Crônica/terapia , Cicatrização/efeitos dos fármacos , Idoso , Idoso de 80 Anos ou mais , Alginatos/uso terapêutico , Bandagens/estatística & dados numéricos , Doença Crônica/enfermagem , Colágeno/farmacologia , Colágeno/uso terapêutico , Angiopatias Diabéticas/complicações , Angiopatias Diabéticas/fisiopatologia , Feminino , Humanos , Masculino , Marketing de Serviços de Saúde/métodos , Pessoa de Meia-Idade , Vigilância da População/métodos , Estudos Prospectivos , Estados Unidos , Úlcera Varicosa/complicações , Úlcera Varicosa/fisiopatologia , Escala Visual AnalógicaRESUMO
The disparity between ideal evidence from randomized controlled trials and real-world evidence in medical research has prompted the United States Food and Drug Administration to consider the use of real-world data to better understand safety and effectiveness of new devices for a broader patient population and to prioritize real-world data in regulatory decision making. As the healthcare system transitions from volume- to value-based care, there is a growing need to harness the power of real-world data to change the paradigm for wound care clinical research and enable more generalizable clinical trials. This paper describes the implementation of a network-based learning healthcare system by a for-profit consortium of wound care clinics that integrates wound care management, quality improvement, and comparative effectiveness research, by harnessing structured real-world data within a purpose-built electronic health record at the point of care. Centers participating in the consortium submit their clinical data and quality measures to a qualified clinical data registry for wound care, enabling benchmarking of their data across this national network. The common definitional framework of the purpose-built electronic health record and the 21 wound-specific quality measures help to standardize the potential sources of bias in real-world data, making the consortium data useful for comparative effectiveness research. This consortium can transform wound care clinical research and raise the standards of care, while helping physicians achieve success with the Merit-Based Incentive Payment System.
Assuntos
Pesquisa Biomédica , Pesquisa Comparativa da Efetividade , Planos de Incentivos Médicos/tendências , Melhoria de Qualidade/tendências , Qualidade da Assistência à Saúde/normas , Cicatrização , Pesquisa Biomédica/economia , Pesquisa Biomédica/tendências , Medicina Baseada em Evidências , Humanos , Garantia da Qualidade dos Cuidados de Saúde , Melhoria de Qualidade/normas , Ensaios Clínicos Controlados Aleatórios como Assunto , Reembolso de Incentivo , Estados UnidosRESUMO
It is widely accepted that elevated protease activity (EPA) in chronic wounds impedes healing. However, little progress has occurred in quantifying the level of protease activity that is detrimental for healing. The aim of this study was to determine the relationship between inflammatory protease activity and wound healing status, and to establish the level of EPA above which human neutrophil-derived elastase (HNE) and matrix metalloproteases (MMP) activities correlate with nonhealing wounds. Chronic wound swab samples (n = 290) were collected from four wound centers across the USA to measure HNE and MMP activity. Healing status was determined according to percentage reduction in wound area over the previous 2-4 weeks; this was available for 211 wounds. Association between protease activity and nonhealing wounds was determined by receiver operating characteristic analysis (ROC), a statistical technique used for visualizing and analyzing the performance of diagnostic tests. ROC analysis showed that area under the curve (AUC) for HNE were 0.69 for all wounds and 0.78 for wounds with the most reliable wound trajectory information, respectively. For MMP, the corresponding AUC values were 0.70 and 0.82. Analysis suggested that chronic wounds having values of HNE >5 and/or MMP ≥13, should be considered wound healing impaired. EPA is indicative of nonhealing wounds. Use of a diagnostic test to detect EPA in clinical practice could enable clinicians to identify wounds that are nonhealing, thus enabling targeted treatment with protease modulating therapies.
Assuntos
Inibidores Enzimáticos/uso terapêutico , Peptídeo Hidrolases/metabolismo , Cicatrização , Ferimentos e Lesões/diagnóstico , Ferimentos e Lesões/terapia , Área Sob a Curva , Pé Diabético/diagnóstico , Pé Diabético/enzimologia , Pé Diabético/fisiopatologia , Pé Diabético/terapia , Ativação Enzimática/efeitos dos fármacos , Inibidores Enzimáticos/farmacologia , Humanos , Metaloproteinases da Matriz/metabolismo , Úlcera por Pressão/diagnóstico , Úlcera por Pressão/enzimologia , Úlcera por Pressão/fisiopatologia , Úlcera por Pressão/terapia , Curva ROC , Resultado do Tratamento , Úlcera Varicosa/enzimologia , Úlcera Varicosa/fisiopatologia , Úlcera Varicosa/terapia , Cicatrização/efeitos dos fármacos , Ferimentos e Lesões/enzimologia , Ferimentos e Lesões/fisiopatologiaRESUMO
The prevalence of chronic wounds is sharply rising throughout the world due to an aging population and increases in the incidence of obesity, diabetes, and cardiovascular diseases. People with diabetes, hypertension, and hyperlipidemia are at increased risk for developing peripheral arterial disease (PAD). PAD affects 8 to 12 million people over the age of 40 years in the United States and it is a major contributing factor to the development of lower extremity ulcers. Although a number of noninvasive diagnostic tests are available to detect PAD in lower extremities, they have several clinical limitations. In this review, current understanding of the pathophysiology of commonly seen lower extremity ulcers is described and vascular assessments typically used in practice are evaluated. In addition, application of the LUNA Fluorescence Angiography System (Novadaq, Bonita Springs, FL) for the screening and treatment of complex nonhealing wounds in patients with PAD is discussed.