Análisis de las notificaciones de úlceras cutáneas inducidas por medicamentos en España / Analysis of notifications of drug-induced skin ulcers in Spain

Las úlceras cutáneas son un serio problema de salud, el cual tiene repercusiones socioeconómicas y laborales muy importantes con una elevada tendencia a la cronicidad y recidiva, estimándose que hasta el 50% de ellas permanecerán activas entre 6 meses y un año. Objetivo: Estudio del papel de los medicamentos en la etiología de las úlceras cutáneas. Material y método: Estudio de todas las notificaciones espontáneas relativas a úlceras cutáneas que constan en la base de datos del Sistema Español de Farmacovigilancia de medicamentos de uso humano.Resultados: Se identificaron 292 notificaciones en las que constaban sospechas de reacción adversa a medicamentos (RAM) del tipo lesión ulcerosa relacionadas con el consumo de medicamentos. Estaban implicados 369 medicamentos que suponen 427 principios activos. Las úlceras fundamentalmente aparecían en mujeres con una media de edad de 56,6 años. Los medicamentos sospechosos más frecuentemente notificados fueron los iSGLT-2, vacunas frente al COVID-19, metotrexato, hidroxicarbamida, trimetropim-sulfametoxazol, foscarnet trisódico hexahidrato, ribavirina, docetaxel, acenocumarol e imiquimod y asociación de lidocaína Hcl-pentosano polisulfato sodio-triamcinolona acetónido. Discusión: Numerosos medicamentos tienen como reacción adversa la aparición de úlceras. No debería descartarse esta posibilidad ante la aparición de una lesión cutánea nueva tras la administración de un nuevo medicamento dado que el 25% de las RAM eran desconocidas en el momento de su notificación, como eran los casos de úlceras asociadas a los i-SGLT2 y a las vacunas contra el COVID al inicio de su comercialización; sin embargo, gracias al hecho de seguir notificando las sospechas de RAM, se crearon alertas sanitarias advirtiendo de este hecho y es por ello que aconsejamos seguir notificando cualquier sospecha de RAM a los sistemas regionales de farmacovigilancia.(AU)

Skin ulcers are a serious health problem with significant socioeconomic and labour repercussions and a high tendency to chronicity and recurrence; approximately, up to 50% remain active between six months to one year. Aim: To study the role of drugs in the aetiology of skin ulcers. Material and method: A comprehensive study of all spontaneous reports related to skin ulcers that appear in the Spanish Pharmacovigilance System of Medicines for Human Use database. Results: A total of 292 reports were identified containing suspected adverse drug reactions (ADRs) of ulcer lesion type. Three hundred sixty-nine medications with 427 active ingredients were identified. The ulcers appeared mainly in women with a mean age of 56.6 years. The most frequently reported suspected drugs were SGLT-2, vaccines against COVID-19, methotrexate, hydroxycarbamide, trimethoprim-sulfamethoxazole, foscarnet trisodium hexahydrate, ribavirin, docetaxel, acenocumarol and imiquimod, and the combination of lidocaine Hcl-pentosan polysulfate sodium-triamcinolone acetonide. Discussion: Numerous medications may cause ulcers as an adverse reaction. This possibility should not be ruled out when a new skin lesion appears after the administration of new drugs since 25% of the ADRs were unknown at the time of their notification, as were the cases of ulcers associated with i-SGLT2 and vaccines against COVID at the beginning of their commercialization. However, informative health alerts can be generated by continuously notifying suspected ADRs, so we strongly advise reporting any suspected ADRs to the regional pharmacovigilance system.(AU)

Digital Ulcers in Systemic Sclerosis.

Digital ulcers (DU) are one of the most common complication of Systemic Sclerosis (SSc)-related vasculopathy and represent an important burden for the patients as well as for the society. Still today there is no agreement on the definition, classification and cathegorization of DU even if they are of pivotal importance in clinical practice, for treatment choice and prognostic outcomes, as well as for clinical trials. DU management requires a dedicated multidisciplinary team, that must remain ever vigilant for the development of infective complications and gangrene throughout their disease course, as well as patient education that is crucial to obtain the best compliance to assure the success of the treatment. Currently several drugs are available for DU treatment but in the future, more investigations will be needed to ameliorate the approach and the systemic and local therapies.

Prevalencia hospitalaria de lesiones relacionadasa con la dependencia de la provincia de Burgos. Estudio multicéntrico / Hospital prevalence of dependence-related lesion in the province of Burgos. Multicenter study

OBJETIVO: Determinar la prevalencia hospitalaria de lesiones relacionadas con la dependencia (LRD) en la provincia de Burgos. Determinar las características de las LRD. Identificar las valoraciones del riesgo de padecer lesión por presión (LPP) y el uso de dispositivos de prevención de LPP. Cuantificar los registros de enfermería de LRD. METODOLOGÍA: Estudio observacional, descriptivo, transversal y multicéntrico, realizado mediante observación directa y revisión de la historia clínica de adultos ingresados en unidades de hospitalización. Realizado en tres hospitales de Burgos en 2018. RESULTADOS: La población sumó 511 pacientes; presentaron LRD: 188. Se detectaron 328 LRD: 176 (53,65%) LPP, 48 (14,63%) lesiones por humedad, 81 (24,69%) lesiones por fricción, 11 (3,35%) lesiones combinadas y 12 (3,65%) lesiones multicausales. Las LPP de categoría 1 fueron las más numerosas, sumando un 35,36%. El 78,96% de las LRD se consideraron adquiridas en el hospital. La prevalencia de LRD es del 36,79%. Las prevalencias por tipos de LRD son: LPP 20,93%, lesiones por humedad 9%, fricción 12,72%, combinadas 1,76% y multicausales 1,56%. El 35,61% de los pacientes presentaba algún tipo de dispositivo preventivo; el 60,07% presentaba valoración del riesgo de padecer LPP; el 30,31% presentaba registro de la lesión, y el 18,37% contaba con plan de cuidados específico. CONCLUSIONES: La prevalencia e LRD, obtenida por inspección directa, cuadruplica los resultados nacionales, pero parece reflejar con mayor exactitud la realidad que los datos obtenidos mediante los registros de enfermería. Es aconsejable universalizar la valoración del riesgo de padecer LPP a todos los pacientes, la mejora de los registros de enfermería y reforzar los esfuerzos preventivos

AIM: To determine the hospital prevalence of dependence-related lesions (DRL) in the province of Burgos. Determine the characteristics of the DRL. Identify the risk assessments of pressure ulcer (PU) and the use of PU prevention devices. Quantify the DRL nursing records. METHODOLOGY: Observational, descriptive, cross-sectional and multicenter study, performed through direct observation and review of the health record of adults admitted to hospitalization units. RESULTS: The population totaled 511 patients, of wich 188 presented DRL. 328 DRL were detected: 176 (53.65%) PU, 48 (14.63%) moisture lesions, 81 (24,69%) friction lesions, 11 (3.35%) combined lesions, and 12 (3.65%) multifactorial lesions. The most numerous was PU category 1 totaling 35.36%. 78.96% of the DRL were determined to be hospital acquired. The prevalence of DRL is 36.79%. The prevalences for DRL types are: PU 20.93%, moisture lesions 9%, friction 12.72%, combined 1.76% and multifactorial 1.56%. 35.61% of patients had some type of preventive device, 60.07% had a risk assessment for PU, 30.31% had a record of the lesion and 18.37% had a specific care plan. CONCLUSIONS: The prevalence of DRL, obtained by direct inspection, quadruples national results, but it seems to be more accurate than the data obtained through nursing records. It is advisable to universalize the assessment of the risk of suffering PU to all patients, to improve nursing records and to reinforce preventive efforts

Validating the Italian Version of the International Skin Tear Advisory Panel Classification System.

OBJECTIVE: To validate the International Skin Tear Advisory Panel (ISTAP) Classification System in Italian. METHODS: In collaboration with the ISTAP, the classification system was translated into Italian using a forward-back translation process. To validate the translated system, a convenience sample of 212 health professionals classified 30 photographs of skin tears originally used by ISTAP. The wound images were labeled type 1, 2, or 3 as described by the classification system. The resulting scores were compared with the ISTAP classification, and the reliability of agreement was calculated with Fleiss κ. RESULTS: Complete data were obtained from 209 healthcare professionals. When the image classifications were compared with the original ISTAP indications, 72.5% of all classifications were correct. Data indicated a moderate level of agreement (Fleiss κ = 0.466, range = 0.41-0.60). Data analysis showed similar agreement levels between nurses (n = 197, Fleiss κ = 0.466) and nonnurses (n = 12, Fleiss κ = 0.46). CONCLUSIONS: The study validates the Italian version of the ISTAP skin tear classification system. Further studies are necessary to confirm the system's usability in Italian research and clinical settings.

Correlation between capillaroscopic classifications and severity in systemic sclerosis: results from SCLEROCAP study at inclusion.

OBJECTIVES: We assessed the correlation between severity of systemic sclerosis (SSc) and current staging systems based on nailfold capillaroscopy. METHODS: SCLEROCAP is a multicenter prospective study including consecutive scleroderma patients who have a yearly routine follow-up with capillaroscopy and digital blood pressure measurement. Capillaroscopy images were read by two observers blinded from each other, then by a third one in the case of discordance. A follow-up of 3 years is planned. The present study assessed the correlation between severity of systemic sclerosis (SSc) and current staging systems based on nail fold capillaroscopy at enrollment in the SCLEROCAP study. Univariate and multivariate logistic regression analysis was performed for both the Maricq and Cutolo classifications. RESULTS: SCLEROCAP included 387 patients in one year. Maricq's active and Cutolo's late classifications were very similar. In multivariate analysis, the number of digital ulcers (OR for 2 ulcers or more, respectively 2.023 [1.074-3.81] and 2.596 [1.434-4.699]) and Rodnan's skin score >15 (OR respectively 32.007 [6.457-158.658] and 18.390 [5.380-62.865]) correlated with Maricq's active and Cutolo's late stages. Haemoglobin rate correlated with Cutolo's late stage (hemoglobin<100 vs. >120 g/dl: OR 0.223 [0.051-0.980]), and total lung capacity with Maricq's active one: increase in 10%: OR0.833 [0.717-0.969]. CONCLUSIONS: The correlations found between capillaroscopy and severity of SSc are promising before the ongoing prospective study definitively assesses whether capillaroscopy staging predicts complications of SSc. Only two capillaroscopic patterns seem useful: one involving many giant capillaries and haemorrhages and the other with severe capillary loss.

Prevalencia de lesiones por presión y otras lesiones cutáneas relacionadas con la dependencia en población adulta en hospitales españoles: resultados del 5º Estudio Nacional de 2017 / Prevalence of pressure injuries and other dependence-related skin lesions in adult patients admitted to Spanish hospitals: the fifth national study in 2017

Objetivo: Obtener indicadores epidemiológicos actualizados para las lesiones por presión (LPP) y otras lesiones cutáneas relacionadas con la dependencia (LCRD) en unidades de hospitalización de adultos de hospitales españoles, tanto globales como ajustados. Analizar las características demográficas y clínicas de las personas con LCRD y de las lesiones. Metodología: Estudio observacional, transversal, tipo encuesta epidemiológica (5º Estudio Nacional de Prevalencia), dirigido a todos los hospitales en España. Recogida de datos mediante formulario seguro online. Variables: características de los hospitales y de las unidades, pacientes ingresados, pacientes con cada tipo de LCRD, clasificación de cada lesión, tamaño y tiempo de evolución. Se estimó la prevalencia bruta global y ajustada por hospitales y por tipo de unidades. Resultados: Participaron 554 unidades de hospitalización de adultos pertenecientes a 70 hospitales de todo el territorio nacional. La prevalencia global de LCRD fue del 8,7%. Según tipo de lesiones, las prevalencias fueron: lesiones por presión (LPP) 7,0%; por humedad 1,4%; por fricción 0,9%; combinadas 1,5%; laceraciones 0,9%. Para las LPP, las unidades con prevalencias más altas fueron: cuidados paliativos (16,7%), UCI (14,9%) y unidades posquirúrgicas y reanimación (14,0%). La mayoría de las lesiones son de origen nosocomial (p. ej., el 72,2% de las LPP), producidas en hospitales o residencias de mayores. Se ha encontrado alta variabilidad en la prevalencia de LCRD y de LPP tanto a nivel de hospitales como de unidades de hospitalización. Conclusiones: La prevalencia de LPP es similar a la de estudios anteriores en hospitales españoles. Por primera vez se han obtenido datos de prevalencia de otros tipos de LCRD. Puesto que la mayoría de las lesiones son producidas en los propios hospitales y otras instituciones, como residencias de mayores, se evidencia la necesidad de mejorar la prevención de las LCRD en estos entornos

Aims: To obtain updated epidemiological indicators for pressure injuries (PI) and other dependence-related skin lesions (DRSL) at adult hospitalization units of Spanish hospitals, both global and adjusted. To analyse both the demographic and clinical characteristics of people with DRSL and the characteristics of the lesions. Methods: Observational, cross-sectional study, as an epidemiological survey (5th National Prevalence Study), focused to all the hospitals in Spain. Data were collected by an on-line secure form. Variables: characteristics of the hospitals and the units, number of patients admitted, number of patients with each type of DRSL, lesions classification, size and time. The crude prevalence was calculated, both overall and adjusted by hospitals and units. Results: In this study have participated 554 units from 70 Spanish hospitals. Overall, the prevalence for DRSL of any kind, was 8,7%. By type of lesion, the prevalence was: pressure injuries (PI), 7,0%; moisture associated lesions, 1,4%; friction, 0,9%; combined lesions, 1,5%; and skin tears, 0,9%. For PI, the units with highest prevalence were: palliative care (16,7%), intensive care (14,9%) and post-surgery and reanimation units (14,0%). Most of the lesions were nosocomial (e.g. 72,2% of the PI), that is, produced at hospitals or nursing homes. This study has shown a high variability in the figures of prevalence of DRSL and PI, both at hospitals and units levels. Conclusions: The prevalence of PI is similar to that of previous studies at Spanish hospitals. This is the first time that the prevalence of other types of DRSL has been calculated. Since most of the dependence-related skin lesions were produced inside the hospitals and other facilities, such nursing homes, there is a need to improve the prevention of these lesions in these settings

Classification, categorization and essential items for digital ulcer evaluation in systemic sclerosis: a DeSScipher/European Scleroderma Trials and Research group (EUSTAR) survey.

BACKGROUND: A consensus on digital ulcer (DU) definition in systemic sclerosis (SSc) has been recently reached (Suliman et al., J Scleroderma Relat Disord 2:115-20, 2017), while for their evaluation, classification and categorisation, it is still missing. The aims of this study were to identify a set of essential items for digital ulcer (DU) evaluation, to assess if the existing DU classification was useful and feasible in clinical practice and to investigate if the new categorisation was preferred to the simple distinction of DU in recurrent and not recurrent, in patients with systemic sclerosis (SSc). METHODS: DeSScipher is the largest European multicentre study on SSc. It consists of five observational trials (OTs), and one of them, OT1, is focused on DU management. The DeSScipher OT1 items on DU that reached ≥ 60% of completion rate were administered to EUSTAR (European Scleroderma Trials and Research group) centres via online survey. Questions about feasibility and usefulness of the existing DU classification (DU due to digital pitting scars, to loss of tissue, derived from calcinosis and gangrene) and newly proposed categorisation (episodic, recurrent and chronic) were also asked. RESULTS: A total of 84/148 (56.8%) EUSTAR centres completed the questionnaire. DeSScipher items scored by ≥ 70% of the participants as essential and feasible for DU evaluation were the number of DU defined as a loss of tissue (level of agreement 92%), recurrent DU (84%) and number of new DU (74%). For 65% of the centres, the proposed classification of DU was considered useful and feasible in clinical practice. Moreover, 80% of the centres preferred the categorisation of DU in episodic, recurrent and chronic to simple distinction in recurrent/not recurrent DU. CONCLUSIONS: For clinical practice, EUSTAR centres identified only three essential items for DU evaluation and considered the proposed classification and categorisation as useful and feasible. The set of items needs to be validated while further implementation of DU classification and categorisation is warranted. TRIAL REGISTRATION: Observational trial on DU (OT1) is one of the five trials of the DeSScipher project (ClinicalTrials.gov; OT1 Identifier: NCT01836263 , posted on April 19, 2013).

Utility of Skin Biopsy and Culture in the Diagnosis and Classification of Chronic Ulcers: A Single-Institution, Retrospective Study.

In the United States, chronic ulcers affect 6.5 million people, with a cost of ≈$20 million annually. The most common etiology of chronic ulcers in the United States is venous stasis, followed by arterial insufficiency and neuropathic ulcers. Less common causes of chronic ulcers include infection, inflammatory etiologies such as vasculitis and pyoderma gangrenosum, and neoplastic causes. Obtaining skin biopsy and tissue culture can be helpful in diagnosing unusual causes of chronic ulcers; however, there are little data on the diagnostic utility of skin biopsy in rendering a definitive diagnosis of the etiology of chronic ulcers. A retrospective study of all skin ulcers biopsied during a 10-year period at the University of Washington was undertaken. Re-excisions and surgical wounds were excluded. A total of 270 ulcer biopsy specimens were included. In 48% of cases, no specific diagnosis could be rendered histologically. 44.8% of chronic ulcers biopsied were due to atypical causes, with neoplasms (basal cell carcinoma, squamous cell carcinoma, melanoma, and cutaneous T-cell lymphoma) being the most common. Vasculitis and pyoderma gangrenosum each represented 1.5% of rendered diagnoses. Concomitant skin culture was performed in 28.9% of cases, and special stains [acid-fast bacilli, Brown and Brenn (B&B), Grocott's methenamine silver, and periodic acid-Schiff stains] were performed in 34.0%. Although more than half (49 of 78) of tissue cultures were positive, only 6.8% (12 of 175) of special stains on tissue sections were positive. We conclude that although the etiology of many ulcers cannot be determined by routine histology alone, skin biopsy of ulcers remains a critical part of the workup given that when a specific cause can be determined, atypical etiologies, including neoplasms, represent a significant proportion of chronic ulcers. Limitations of our study include referral bias. Our results also confirm the higher diagnostic yield of conventional tissue culture compared with special tissue stain biopsies of skin ulcers.

Cutaneous Lymphoproliferative Disorders: What's New in the Revised 4th Edition of the World Health Organization (WHO) Classification of Lymphoid Neoplasms.

Cutaneous lymphoproliferative disorders remain a challenging aspect of dermatopathology, in part due to the rarity of the entities and extreme variability in clinical outcomes. Although many of the entities remain unchanged, the approach to some of them has changed in the new 2016 classification scheme of the World Health Organization. Chief among these are Epstein-Barr virus-associated lymphoproliferative disorders such as Epstein-Barr virus-associated mucocutaneous ulcer and hydroa vacciniforme-like lymphoproliferative disorder, primary cutaneous CD8+ aggressive epidermotropic cytotoxic T-cell lymphoma, primary cutaneous acral CD8+ T-cell lymphoma, primary cutaneous CD4+ small/medium T-cell lymphoproliferative disorder, and breast implant-associated anaplastic large cell lymphoma. In addition, translocations and gene rearrangements such as those involving the 6p25.3 locus have started to inform diagnosis and classification of anaplastic large cell lymphoma and lymphomatoid papulosis. In this review, we will examine what is new in the diagnostic toolbox of cutaneous lymphoproliferative disorders.

French Canadian translation and the validity and inter-rater reliability of the ISTAP Skin Tear Classification System.

OBJECTIVE: To adapt the International Skin Tear Advisory Panel (ISTAP) skin tear classification system into French Canadian, and to test the content validity and inter-rater reliability of the translated version. METHOD: Phase one included the translation of the ISTAP skin tear classification system into French Canadian, using a forward-back translation method. Following this the translated version was tested for content validity and inter-rater reliability with registered nurses from a French acute care hospital in Ottawa, Canada. RESULTS: The French Canadian translation of the ISTAP skin tear classification system was evaluated by 92 nurses without in-depth wound care training. The adapted version obtained a substantial level of agreement between users, (Fleiss' Kappa = 0.69). CONCLUSION: The study tested the content validity and inter-rater reliability of the French Canadian version of the ISTAP skin tear classification system. The results support previous studies and further validate the classification system as a reliable method for classifying skin tears. The study supports ISTAP's goal of establishing a global language for describing and documenting skin tears.

Pyoderma Gangrenosum: A Critical Appraisal.

GENERAL PURPOSE: To provide information about pyoderma gangrenosum (PG), including pathophysiology, diagnostic criteria, 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 should be better able to: ABSTRACT: Pyoderma gangrenosum (PG) is an uncommon cutaneous disease, presenting with recurrent painful ulcerations most commonly on the lower extremities. The diagnosis is made according to a typical presentation, skin lesion morphology, skin biopsy, histopathology, and the exclusion of other etiologies. Classically, PG presents with painful ulcers with well-defined violaceous borders; other variants including bullous, pustular, and vegetative/granulomatous can also occur. Treatment of PG involves a combination of topical and systemic anti-inflammatory and immunosuppressive medications, wound care, antimicrobial agents for secondary infections, and treatment of the underlying etiology. This article is a continuing education review of the literature with a focus on the clinical application of the pathophysiology, diagnosis, and treatment of this challenging disease.

Prevalencia de úlceras por presión y lesiones cutáneas asociadas a la humedad en el Hospital Universitario de Burgos / Pressure ulcers and moisture associated skin damage prevalence in the Burgos University Hospital

Objetivo: Determinar la prevalencia de úlceras por presión (UPP) y lesiones cutáneas asociadas a la humedad (LESCAH) en el Hospital Universitario de Burgos. Identificar las lesiones y sus características. Identificar las valoraciones del riesgo de padecer UPP registradas en la historia clínica y el uso de dispositivos de prevención. Identificar los registros de Enfermería relacionados con las UPP y LESCAH. Metodología: Estudio observacional descriptivo transversal, mediante inspección directa de cada paciente y revisión de la historia clínica. Realizado entre el 23 de febrero y el 10 de marzo del 2015. Resultados: La población estudiada fue de 404 pacientes. Se identificaron 195 lesiones: 24 LESCAH y 171 UPP. Las prevalencias resultantes fueron 5,69% para las LESCAH y 21,53% para las UPP. El 93,56% de las UPP pertenecen a los estadios I y II. Las localizaciones anatómicas más frecuentes fueron: codo (28,07%), talón (22,8%), oreja (18,12%) y sacro (11,11%). Se encontró registro de la valoración del riesgo mediante escala de Norton en 164 (48,59%) pacientes, presentando riesgo entre medio y muy alto, 46 (28,05%) pacientes. Contaban con algún dispositivo de prevención adicional 31 (7,67%) pacientes, mientras que 29 (7,17%) pacientes, con riesgo detectado, carecían de él. Conclusiones: La prevalencia resultante de UPP es elevada debido a la mayor detección de estadios leves. Se aconseja la realización de valoración del riesgo de padecer UPP a todos los pacientes ingresados. Así mismo, se considera necesario aumentar la formación en detección y prevención de los estadios más leves

Aim: Determine the prevalence of pressure ulcers (PU) and moisture associated skin damage (MASD) at Burgos University Hospital. Identify lesions and their characteristics. Identify the risk assessment surveys of PU recorded in the health record and the use of prevention devices. Identify nursing records related to PU and MASD. Methods: Transversal descriptive observational study, by direct observation of each patient and review of their health record. Conducted between February 23rd and March 10th, 2015. Results: The study population was 404 patients. 195 lesions were identified: 24 MASD and 171 PU. The resulting prevalences were 5.69% for MASD and 21.53% for PU. 93,56% of PU were stages I and II. The most common anatomic sites were: elbow (28,07%), heel (22,8%), ear (18,12%) and sacrum (11,11%). Using the Norton scale, PU risk was assessed in 164 patients (48.59%), with 46 patients (28.05%) exhibiting medium to high risk levels. 31 patients had additional prevention devices (7.67%), while 29 patients (7.17%) with identified risk had no device. Conclusions: The resulting prevalence of PU is high due to increased detection of mild stages. Conducting risk assessment of PU to all hospitalized patients is advised. Likewise it is pertinent to increase training in detection and prevention of the milder stages

Clinical study on single-organ cutaneous small vessels vasculitis (SoCSVV).

Leukocytoclastic vasculitis (LCV) is a heterogenous group of disorders that may manifest as a mild disease isolated to the skin or be a part of life-threatening systemic vasculitis. According to the 2012 Chapel Hill Consensus Conference nomenclature, patients presenting symptoms of LCV confined only to the skin should be defined as suffering from a single-organ cutaneous small vessel vasculitis (SoCSVV). SoCSVV is a benign disease with a good clinical outcome but with a significant risk of relapse and skin ulcer formation.The aim of the current study was to characterize SoCSVV and to identify factors that may be associated with the risk of recurrence and skin ulcers.Medical records of patients with LCV hospitalized at the Department of Dermatology at University Hospital in Cracow in the years 2010 to 2015 were analyzed.A total of 24 patients fulfilled criteria of SoCSVV. Drugs and preceding infections were identified as precipitating factors in 40% and 20% of cases, respectively. Skin lesions other than palpable purpura (i.e., macules, urticarial vasculitis, or ulcers) were identified in almost half of the patients. Interestingly, the presence of macules independently increased the risk of skin ulcer formation (odds ratio = 16; 95% confidence interval: 1.5-176.6; P = 0.0075) in the multivariate logistic regression analysis. One-quarter of patients with SoCSVV experienced relapse during the 6-month follow-up. The greater number of affected skin areas was an independent risk factor of recurrence (odds ratio = 5; 95% confidence interval: 2-45; P = 0.02).SoCSVV was usually associated with drugs and preceding infections. The disease relapses in approximately one-quarter of the patients. The more severe the skin involvement in the course of SoCSVV, the higher is the risk of recurrence.

Elucidating the burden of recurrent and chronic digital ulcers in systemic sclerosis: long-term results from the DUO Registry.

OBJECTIVES: Digital ulcers (DUs) occur in up to half of patients with systemic sclerosis (SSc) and may lead to infection, gangrene and amputation with functional disability and reduced quality of life. This study has elucidated the burden of SSc-associated DUs through identification of four patient categories based on the pattern of DU recurrence over a 2-year observation period. METHODS: Patients with SSc-associated DUs enrolled in the Digital Ulcers Outcome Registry between 1 April 2008 and 19 November 2013, and with ≥2 years of observation and ≥3 follow-up visits during the observation period were analysed. Incident DU-associated complications were recorded during follow-up. Work and daily activity impairment were measured using a functional assessment questionnaire completed by patients after the observation period. Potential factors that could predict incident complications were identified in patients with chronic DUs. RESULTS: From 1459 patients, four DU occurrence categories were identified: 33.2% no-DU; 9.4% episodic; 46.2% recurrent; 11.2% chronic. During the observation period, patients from the chronic category had the highest rate of incident complications, highest work impairment and greatest need for help compared with the other categories. Independent factors associated with incident complications included gastrointestinal manifestations (OR 3.73, p=0.03) and previous soft tissue infection (OR 5.86, p=0.01). CONCLUSIONS: This proposed novel categorisation of patients with SSc-associated DUs based on the occurrence of DUs over time may help to identify patients in the clinic with a heavier DU burden who could benefit from more complex management to improve their functioning and quality of life.

Grading of shoulder ulcerations in sows by biopsies.

Shoulder ulcerations can be graded postmortem from 0 to 4 on a pathoanatomical scale. However, veterinarians and farmers express difficulties evaluating the grade of the lesions antemortem. Accurate grading is needed in order to comply with veterinary instruction in relation to the Danish legislation, stating that sows with shoulder ulcers grade 3 or 4 must be kept loose and have access to soft bedding. Thus, the aim of the present study was to evaluate if biopsies from the center of a shoulder ulcer can be used to point out animals for which an intervention must be initiated. Postmortem, a punch biopsy was sampled from the center of the ulceration or from the tissue overlaying the tuber spina scapula. Afterward, the shoulders were cross-sectioned and evaluated grossly and histologically ("gold standard"). In total, 121 shoulders were included in the study, and the diagnostic value of a punch biopsy in grading shoulder ulcerations was evaluated. The results showed a sensitivity of 0.78, a specificity of 0.98, a positive likelihood ratio of 38.36, and a negative likelihood ratio of 0.22. The agreement between the cross-section evaluation and the punch biopsy was found to be 0.90 by calculating the Cohen kappa value. In conclusion, a single punch biopsy from the center of an ulcer is useful for determining the grade of a shoulder ulcer and can be used to facilitate the identification of sows with ulcers requiring an intervention.

Consensus opinion of a North American Working Group regarding the classification of digital ulcers in systemic sclerosis.

The objectives of this study were to develop a standard classification of digital ulcers (DUs) in systemic sclerosis (SSc) for use in observational or therapeutic studies and to assess the reliability of these definitions as well as of the measurement of ulcer area. Ten North American rheumatologists with expertise in SSc reviewed multiple photos of DUs, examined four SSc subjects with DUs, and came to a consensus on the definitions for digital, active, healed, and indeterminate ulcers. These ten raters then examined the right hand of ten SSc subjects twice and the left hand once to classify ulcers and to measure ulcer area. Weighted and Fleiss kappa were used to calculate intra- and interrater agreement on classification of ulcers, and intraclass correlation coefficient (ICC) was used to assess agreement on ulcer area. Because the traditional ICC calculations relied on a small number of ulcers, ICCs were recalculated using the results of linear mixed models to evaluate the variance components of observations on all the data. Intrarater kappa for classifying DU as not an ulcer/healed ulcer versus active/indeterminate ulcer was substantial (0.76), and interrater kappa was moderate (0.53). The ICC for ulcer area using the linear mixed models was moderate both for intrarater (0.57) and interrater (0.48) measurements. A consensus for the classification of DUs in SSc was developed, and after a training session, rheumatologists with expertise in SSc are able to reliably classify DUs and to measure ulcer area.