The sufficient multidisciplinary specialists under a government-led health care system associated with the downward mortality trend of Fournier's gangrene in Taiwan.

OBJECTIVES: To explore the trends in Fournier's gangrene (FG) incidence and mortality rate in Taiwan and to investigate the contributing factors to such changes. METHODS: Between 2002 and 2016, hospitalized FG patients who underwent subsequent surgical intervention were included in this retrospective study. Incidence, outcomes, age-adjusted Charlson Comorbidity Index (ACCI), hospitalization cost, surgical timing, and the number of multidisciplinary specialists involved in the first-line management of FG in each year were collected. Simple linear regression and Pearson correlation coefficient (r) were used for the subsequent analysis. RESULTS: The national cohort enrolled 2183 FG patients from 2002 to 2016 in Taiwan. The age-standardized incidence rate of FG was between 0.4 and 0.8 per 100 000 population, and overall mortality was 7.8% in these 15 years. We illustrated the downward trendline of FG mortality with a 0.62 coefficient of determination. The mortality of FG patients who underwent surgery within 24 h and after 24 h were found to be 8.3 ± 3.9% and 14.6 ± 25.2%, respectively (p = 0.02). The numbers of urologists, anesthesiologists, emergency doctors, and physicians per 100 000 population had a strong negative linear correlation with FG mortality (r = 0.8, p < 0.001). ACCI score had a moderate linear relationship with FG mortality (r = 0.57, p = 0.027). The hospitalization cost showed a weak linear correlation with FG mortality (r = -0.03, p = 0.92). CONCLUSIONS: We demonstrated the downward trend of the FG mortality rate in Taiwan from 2002 to 2016. Besides underlying comorbidities and surgical timing, sufficient multidisciplinary specialists are essential for the survival benefit of FG patients in Taiwan experience.

Understanding the Prodromal Period of Necrotizing Soft Tissue Infections of the Genitalia (Fournier's Gangrene) and the Incidence, Duration, and Risk Factors Associated With Potential Missed Opportunities for an Earlier Diagnosis: A Population-based Longitudinal Study.

PURPOSE: The purpose of this paper was to investigate patterns of health care utilization leading up to diagnosis of necrotizing soft tissue infections of the genitalia and to identify risk factors associated with potential diagnostic delay. MATERIALS AND METHODS: IBM MarketScan Research Databases (2001-2020) were used to identify index cases of necrotizing soft tissue infections of the genitalia. We identified health care visits for symptomatically similar diagnoses (eg, penile swelling, cellulitis) that occurred prior to necrotizing soft tissue infections of the genitalia diagnosis. A change-point analysis identified the window before diagnosis where diagnostic opportunities first appeared. A simulation model estimated the likelihood symptomatically similar diagnosis visits represented a missed opportunity for earlier diagnosis. Patient and provider characteristics were evaluated for their associations with delay. RESULTS: We identified 8,098 patients with necrotizing soft tissue infections of the genitalia, in which 4,032 (50%) had a symptomatically similar diagnosis visit in the 21-day diagnostic window, most commonly for "non-infectious urologic abnormalities" (eg, genital swelling; 64%): 46% received antibiotics; 16% saw a urologist. Models estimated that 5,096 of the symptomatically similar diagnosis visits (63%) represented diagnostic delay (mean duration 6.2 days; mean missed opportunities 1.8). Risk factors for delay included urinary tract infection history (OR 2.1) and morbid obesity (OR 1.6). Visits to more than 1 health care provider/location in a 24-hour period significantly decreased delay risk. CONCLUSIONS: Nearly 50% of insured patients who undergo debridement for, or die from, necrotizing soft tissue infections of the genitalia will present to a medical provider with a symptomatically similar diagnosis suggestive of early disease development. Many of these visits likely represent diagnostic delay. Efforts to minimize logistic and cognitive biases in this rare condition may lead to improved outcomes if they lead to earlier interventions.

Fournier's Gangrene under Sodium-Glucose Cotransporter-2 Inhibitors Therapy in Gynecological Patients.

Fournier's gangrene (FG) is a serious pathology of the soft tissues and fascia of the perineum and genital region with a high morbidity and mortality rate. In recent years, the SGLT-2 inhibitor oral antidiabetic has been related to this entity. According to the new warnings from the main drug agencies, a compilation of cases has been initiated to establish or deny a possible causal relationship. Most of these cases have been reported in men. However, it is important not to underestimate this entity in the gynecological field, since it is extremely serious and requires intense and rapid aggressive treatment based on surgery and empiric antibiotherapy. Later, some cares are needed to involve surgical reconstruction of the defects introduced by debridement. As a result of the low incidence of FG, clinical trials' data may be insufficient to robustly assess this issue because of the limited numbers of participants. Real-world evidence may help to clarify the association between SGLT2i and FG. The aim of this review is to describe and compare the reported cases of GF in diabetic women who received SGLT2 inhibitors as antiglycemic agents.

Neonatal Fournier's gangrene; pattern and predisposing factors in a tertiary health facility in Southern Nigeria.

Fournier's gangrene (FG), a necrotizing fasciitis of the genital and perineal region, is a serious and debilitating multi-infective pathological condition. More commonly seen in adults, its occurrence in neonates is uncommon. We share our experience with neonatal FG (NFG), highlighting potential factors which may predispose neonates to it.Ours is a five year retrospective review of cases of NFG in our service. Data obtained included health facility of birth, mode of delivery, symptoms and duration, investigation results, treatment and outcome. Sixteen neonates were included, comprising 13 males (M:F = 4.3:1). Fourteen were delivered outside our centre; breech vaginal delivery, hot water massaging and application of native concoctions were common. All were treated with antibiotics and wound debridement, but five (37.5%) died.NFG is not that rare in our service. Early recognition is imperative to reduce mortality. Neonates delivered by breech vaginally may be particularly at risk.

Outcome management of Fournier's gangrene cases at tertiary hospital: 7 Years experience.

OBJECTIVE: This study aims to describe the condition of Fournier's gangrene in Dr. Soetomo General Hospital from January 2014 to December 2020. MATERIAL AND METHODS: This study used a retrospective analytic design, by taking data through medical records at Dr. Soetomo General Hospital from January 2014 to December 2020. This study used total sampling with recorded data: age, gender, length of stay, outcome, location, comorbidities, causes, management, culture results, and Fournier's gangrene severity index (FGSI) score. RESULT: Of the 135 subjects collected, it was found that 55.56% were individuals over 50 years of age. About 91.11% were male patients, with some sites being in the scrotum 50.37%. Only 25.19% of patients had no comorbids, while the rest had a history of CKD, hypertension, diabetes, or a combination of these diseases. Bacterial cultures obtained were mostly caused by the Enterobacteriaceae bacteria group (32.59%). Of the subjects we studied who experienced mortality, it was found that all were from the group with FGSI >9. CONCLUSION: From the results of our descriptive study, at a glance, it appears that there is a tendency for the incidence of Fournier's gangrene in the elderly and individuals with comorbidities. And the mortality rate increases with a high FGSI value. So that FGSI could be used as a predictor of mortality in patients with FG.

Caracterización clínica de pacientes con gangrena de Fournier del Hospital General Docente "Dr. Agostinho Neto", 2008-2018 / Clinical characterization of patients with Fournier's gangrene at the Hospital General Docente "Dr. Agostinho Neto", 2008-2018 / Caracterização clínica de pacientes com gangrena de Fournier no Hospital Geral de Ensino "Dr. Agostinho Neto", 2008-2018

RESUMEN Introducción: La gangrena de Fournier se define como una forma específica de fascitis necrotizante Tipo I, que constituye una emergencia urológica, poco frecuente y de elevada mortalidad. Objetivo: Caracterizar la gangrena de Fournier en los pacientes atendidos en el servicio de Urología del Hospital General Docente "Dr. Agostinho Neto" en el periodo enero 2008 - diciembre 2018. Método: Se realizó un estudio descriptivo de variables demográficas y clínicas (edad, sexo, mortalidad, comorbilidad, causas desencadenantes, sitio primario de la infección, sitio de extensión de la infección, estadía hospitalaria) en 20 pacientes. La historia clínica fue la fuente de información primaria. Los datos fueron procesados mediante el programa estadístico SPSS versión 20.0, y se utilizó la estadística descriptiva para determinar las frecuencias absolutas y relativas (porcentajes) y media. Resultados: El 100 % correspondió a varones con un promedio de edad de 64,0 años (27-92); la mortalidad fue del 40 %. La diabetes mellitus fue la comorbilidad más frecuente en 10 pacientes (50,0 %), 12 (60,0 %) tenían más de un proceso comórbido. Las lesiones cutáneas constituyeron la causa primaria en 11 (55,0 %), y los escrotos fueron el principal sitio de origen de la infección en el 55,0 %. El promedio de estadía hospitalaria fue de 37,7 días (7-75 días). Conclusiones: La correcta evaluación de las variables demográficas y clínicas es necesaria para establecer un correcto diagnóstico y plan de tratamiento.

ABSTRACT Introduction: Fournier's gangrene is defined as a specific form of Type I necrotizing fasciitis, which constitutes a rare urological emergency with high mortality. Objective: To characterize Fournier's gangrene in patients treated in the Urology service of the Hospital General Docente "Dr. Agostinho Neto" in the period from January 2008 to December 2018. Method: A descriptive study of demographic and clinical variables (age, gender, mortality, comorbidity, triggering causes, primary site of infection, site of extension of the infection, hospital stay) was carried out in 20 patients. The medical history was the primary source of information. The data were processed using the statistical program SPSS, version 20.0, and descriptive statistics were used to determine the absolute and relative frequencies (percentages) and mean. Results: 100% corresponded to men with an average age of 64.0 years (27-92); mortality made a 40%. Diabetes mellitus was the most frequent comorbidity, in 10 of the patients (50.0%); 12 patients (60.0%) had more than one comorbid process. Skin lesions were the primary cause in 11 (55.0%), and the scrotum was the main site of origin of infection in 55.0%. The mean hospital stay was 37.7 days (7-75 days). Conclusions: The correct evaluation of the demographic and clinical variables is necessary to establish a correct diagnosis and treatment plan.

RESUMO Introdução: A gangrena de Fournier é definida como uma forma específica de fasceíte necrosante tipo I, que se constitui em uma rara emergência urológica com alta mortalidade. Objetivo: Caracterizar a gangrena de Fournier em pacientes atendidos no serviço de Urologia do Hospital Geral Universitário "Dr. Agostinho Neto" no período de janeiro de 2008 a dezembro de 2018. Método: Estudo descritivo de variáveis demográficas e clínicas (idade, sexo, mortalidade, comorbidade, causas desencadeantes, sítio primário de infecção, extensão do sítio de infecção, internação) em 20 pacientes. O histórico médico foi a principal fonte de informação. Os dados foram processados no programa estatístico SPSS versão 20.0, e a estatística descritiva foi utilizada para determinar as frequências absolutas e relativas (percentuais) e a média. Resultados: 100% corresponderam a homens com idade média de 64,0 anos (27-92); a mortalidade foi de 40%. Diabetes mellitus foi a comorbidade mais frequente em 10 pacientes (50,0%), 12 (60,0%) apresentaram mais de um processo comórbido. Lesões cutâneas foram a causa primária em 11 (55,0%), e o escroto foi o principal sítio de origem da infecção em 55,0%. O tempo médio de internação foi de 37,7 dias (7-75 dias). Conclusões: A correta avaliação das variáveis demográficas e clínicas é necessária para estabelecer um correto diagnóstico e plano de tratamento.

A prospective case series of Fournier's gangrene at a tertiary centre involving adjacent organs.

BACKGROUND: Recent studies of patients with Fournier's gangrene (FG) highlight the importance of early surgical intervention in improving mortality rates. We prospectively determined subgroups of patients with FG at high risk of severe local morbidity. METHODS: We prospectively evaluated all patients diagnosed with FG at a tertiary hospital (1 January 2018 to 1 January 2021). Data were collated on demographics, comorbidity, infection source, treatment and clinical outcomes. RESULTS: We identified 14 consecutive male patients with a median (interquartile range) age of 57 (50-64) years. Most common risk factors were diabetes (n = 10, 71%) and obesity (n = 10, 71%). Median (range) HbA1c was 11.20 (7.5-15.3), and body mass index of 41.25 (23.7-70.0). Seven patients had adjacent organ involvement (AOI), involving the corporal bodies (57%) and testes (43%). The most common suspected source was dermatological (50%), followed by genitourinary (29%) and gastrointestinal (GI) (21%). Median (interquartile range) hospital length of stay (LOS) was 32 (8.5-30.75) days. Patients with AOI were more likely to have a suspected GI source, need mechanical ventilation (p = 0.023), a significantly longer LOS (p = 0.015) and time to wound closure (p = 0.04). Patients with suspected dermatological origin of infection, had a significantly lower rate of AOI (p = 0.029), mechanical ventilation (p = 0.029) and a shorter LOS (p = 0.035). CONCLUSION: In our prospective series, FG is associated with a high rate of AOI and suspected non-dermatological origin of infection, which confers significant perioperative morbidity including the need for mechanical ventilation, LOS and longer time from initial debridement to wound closure.

Tratamiento quirúrgico de la gangrena de Fournier / Surgical management of Fournier's gangrene

Resumen Objetivo: Describir el manejo quirúrgico realizado para la reconstrucción genitoperineal (RGP) en pacientes con secuelas de Gangrena de Fournier (GF). Materiales y Método: Corresponde a una serie de casos retrospectiva de pacientes con secuelas de GF a los que se les realizó RGP entre los años 2011 y 2019. Se realizó un análisis descriptivo con las variables de técnica quirúrgica, edad, sexo, comorbilidades, subunidades anatómicas afectadas, origen anatómico de la gangrena de Fournier, número de procedimientos quirúrgicos, procedimiento de colostomía, terapia de presión negativa, Flexi-Seal®, bacterias aisladas, duración de estancia hospitalaria, tipo de procedimientos reconstructivos y complicaciones. Resultados: Se realizó RGP a 43 pacientes (81,1% hombres), con un promedio de edad de 59,1 (17-86 años), 72,7% eran diabéticos. El número de subunidades involucradas se asocia directamente y significativamente en relación al número de intervenciones quirúrgicas. Las técnicas utilizadas para la reconstrucción en orden de frecuencia fueron: colgajos (23%), cierre parcial más injerto dermoepidérmico de grosor parcial (IPP) (20%), cierre parcial (16%) e IPP (16%), cierre por segunda intención (10%), colgajo más IPP (7%) y cierre parcial para cierre por segunda intención de zona restante (5%). Discusión: La elección de reconstrucción se basa en las características del defecto, es decir, el tamaño, la ubicación y profundidad, así como la disponibilidad de tejido local. De preferencia optar por cierres primarios sin tensión, seguido de colgajos y de IPP. Conclusión: La RGP es un desafío para el cirujano plástico. Las técnicas descritas han demostrado ser seguras y reproducibles para el tratamiento quirúrgico de la gangrena de Fournier.

Aim: To describe the surgical management performed for genital-perineal reconstruction (GPR) in patients with sequelae of Fournier gangrene (FG). Materials and Method: It is based on a retroactive series of cases of patients with effects of FG who were given GPR between 2011 and 2019. We performed a descriptive analysis using the variables surgical technique, age, sex, comorbidities, anatomical subunits affected, anatomic origin of the Fournier's gangrene, number of surgical procedures, colostomy procedure, negative pressure therapy, Flexi-Seal®, bacteria isolated, hospital stay, type of reconstructive procedures and complications. We performed GPR on 43 patients (81.1% male), with a mean age of 59.1 (17-86 years); 72% were diabetic. The number of subunits involved was directly and significantly associated with the number of surgical interventions. Results: The reconstruction techniques most used were, in descending order: flaps (23.2%), wound closure and split-thickness skin graft (STSG) (23.2%), primary closure (16.2%), STSG (16.2%), secondary closure (9.3%), flap and STSG (6.9%) and partial wound closure for healing of the remaining area for a second intention (4.6%). Discussion: The reconstruction choice is based on the characteristics of the defect, that is, the size, location and depth, as well as the availability of local tissue. Preferably opt for primary closures without tension, followed by flaps and IPP. Conclusion: The RGP is a challenge for the plastic surgeon. The techniques described have proven safe and reproducible for the surgical treatment of Fournier Gangrene.

Analyzing Outcomes Among Older Adults With Necrotizing Soft-Tissue Infections in the United States.

BACKGROUND: Necrotizing soft-tissue infections (NSTIs) encompass a group of severe, life-threatening diseases with high morbidity and mortality. Evidence suggests advanced age is associated with worse outcomes. To date, no large data sets exist describing outcomes in older individuals, and risk factor identification is lacking. METHODS: Retrospective data were obtained from the 2015 Medicare 100% sample. Included in the analysis were those aged ≥65 y with a primary diagnosis of an NSTI (gas gangrene, necrotizing fasciitis, cutaneous gangrene, or Fournier's gangrene). Risk factors for in-hospital mortality and discharge disposition were examined. Continuous variables were assessed using central tendency, t-tests, and Wilcoxon rank-sum tests. Categorical variables were assessed using the chi-squared and Fisher's exact tests. Statistical significance was defined as P < 0.05. RESULTS: 1427 patient records were reviewed. 59% of patients were male, and the overall mean age was 75.4±8.6 y. 1385 (97.0%) patients required emergency surgery for their NSTI diagnosis. The overall mortality was 5.3%. Several underlying comorbidities were associated with higher rates of mortality including cancer (OR: 3.50, P = 0.0009), liver disease (OR: 2.97, P = 0.03), and kidney disease (OR: 2.15, P = 0.01). While associated with high in-hospital mortality, these diagnoses were not associated with a difference in the rate of discharge to home compared with skilled nursing or rehab. Overall, patients discharged to skilled nursing facilities or rehab had higher rates of underlying comorbidities than patients who were discharged home (3 or more comorbid illness 84.3% versus 68.6%, P < 0.0001); however, no individual comorbid illness was associated with discharge location. CONCLUSIONS: In our Medicare data set, we identified several medical comorbidities that are associated with increased rates of in-hospital mortality. Patients with underlying cancers had the highest odds of increased mortality. The effect on outcomes of the potentially immunosuppressive cancer treatments in these patients is unknown. These data suggest that patients with underlying illnesses, especially cancer, kidney disease, or liver disease have higher mortalities and are more likely to be discharged to skilled nursing facilities or rehab. It is unclear why these illnesses were associated with these worse outcomes while others including diabetes and heart disease were not. These data suggest that these particular comorbid illnesses may have special prognostic implications, although further analysis is necessary to identify the causative factors.

Monomicrobial Fournier's Gangrene Caused by Panton-Valentine Leukocidin-negative Methicillin-susceptible Staphylococcus aureus ST8 in Japan.

Methicillin-resistant Staphylococcus aureus USA300, belonging to sequence type (ST) 8, is a rare cause of necrotizing fasciitis in the USA. We herein report a case of monomicrobial Fournier's gangrene caused by an ST8, methicillin-susceptible Staphylococcus aureus (designated ksw1). Whole-genome sequencing and analyses for virulence determinants revealed that, unlike USA300, ksw1 lacked virulence genes, such as Panton-Valentine leukocidin and SCCmec, while harboring the toxic shock syndrome toxin-1 gene. These genomic features correlate with ST8 CA-MRSA/J, which is the major genotype of ST8 in Japan.

Fournier's gangrene: Five years' experience from a single center in Turkey.

BACKGROUND: Is the present study aims to analyze demographic, clinical and surgical data of all patients with FG (Fournier's gangrene) admitted to a tertiary healthcare hospital in the largest city of Turkey. METHODS: This study included 35 patients with Fournier's gangrene, who were followed by the General Surgery, Plastic Surgery, and Urology Departments of Istanbul University Cerrahpasa Faculty of Medicine from January 2010 to January 2015. Demographic and clinical data, including gender, age, length of stay at the hospital, the underlying cause(s), number of debridement, predisposing factors, and surgical reconstructive data over 10 years were assessed and analyzed retrospectively. RESULTS: The mean age of the 35 patients was 58.14±12.71 years. Diabetes mellitus was present in 20 of the 35 (57.1%) patients. Twelve of the patients (34.2%) were hospitalized in the intensive care unit (ICU). Length of stay in the ICU was found to be significantly influenced by age, hematocrit level, FGSI and UFGSI (p=0.013, p=0.030 p=0.025 and p=0.002, respectively). CONCLUSION: Fournier's gangrene is a fulminant infection with a high mortality rate. Physical examination and anamnesis are quite important for the diagnosis of FG. DM is the most common comorbidity. Age, hematocrit level, FGSI and UFGSI scores affect the patients' length of stay in the ICU.

Epidemiological study on Fournier syndrome in a tertiary hospital in Jundiaí-SP from October 2016 to October 2018 / Estudo epidemiológico sobre síndrome de Fournier em um hospital terciario de Jundiaí-SP de Outubro de 2016 a Outubro de 2018

Abstract Introduction: Fournier's gangrene is a polymicrobial infection caused by aerobic and anaerobic microorganisms, which determine a fast and progressive necrotizing fasciitis, compromising mainly the perineal region and the genital region, being able to evolve to sepsis, multiple organ failure and death. Treatment consists of early surgical diagnosis and debridement, associated with broad-spectrum antibiotic therapy and hyperbaric oxygen therapy. Objective: Compare the most prevalent epidemiological data of patients with Fournier's Syndrome with the data examined in the literature in order to evaluate the incidence in the analyzed service, treatment form and evolution of the patients with the disease. Materials and methods: Observational transversal study from the medical records of patients diagnosed with the disease at the São Vicente de Paulo Charity Hospital in Jundiaí, SP, from October 2016 to October 2018. Results: 23 patients with Fournier's Syndrome, all included in the study, and were analyzed. The most prevalent epidemiological data on the disease, such as age, sex, association with other comorbidities, treatment performed, mortality and early surgical procedure, had obtained a similar data as compared as the medical literature that was in studied. Conclusion: Despite the recognized severity of Fournier's Syndrome, early diagnosis combined with extensive surgical debridement, broad-spectrum antibiotic therapy and measures and oxygen therapy when available are important measures to contain the rapid progression of the disease, thus decreasing its levels of mortality.

Resumo Introdução: A Gangrena de Fournier é uma infecção polimicrobiana ocasionada por microrganismos aeróbios e anaeróbios, que determinam uma fascite necrosante rápida e progressiva, comprometendo principalmente a região do períneo e a região genital, podendo evoluir para sepse, falência de múltiplos órgãos e óbito. O tratamento consiste no diagnóstico e desbridamento cirúrgico precoce, associado à antibioticoterapia de largo espectro e oxigenoterapia hiperbárica. Objetivo: Comparar dados epidemiológicos mais prevalentes dos pacientes diagnosticados com Síndrome de Fournier com os dados já descritos na literatura a fim de avaliar a incidência no serviço em questão analisado, forma de tratamento e evolução dos pacientes com a doença. Materiais e métodos: Estudo transversal observacional a partir da análise de prontuários de pacientes diagnosticados com a doença no Hospital de Caridade São Vicente de Paulo de Jundiaí-SP, no período entre Outubro de 2016 a Outubro de 2018. Resultados: Foram analisados 23 pacientes com diagnóstico de Síndrome de Fournier, todos incluídos na pesquisa. Avaliado os dados epidemiológicos mais prevalentes na doença, como faixa etária, sexo, associação com outras comorbidades, tratamento realizado, mortalidade decorrente da doença, período médio de internação, uso de antibioticoterapia e necessidade de procedimento cirúrgico, obtendo-se dados semelhantes com os já descritos na literatura médica. Conclusão: Apesar da reconhecida gravidade da Síndrome de Fournier, o diagnóstico precoce aliado ao desbridamento cirúrgico extenso, antibioticoterapia de amplo espectro e medidas e oxigenioterapia quando disponível são medidas importantes na contenção da rápida progressão da doença, diminuindo assim seus níveis de mortalidade.

Real-world evidence on sodium-glucose cotransporter-2 inhibitor use and risk of Fournier's gangrene.

BACKGROUND: Sodium-glucose cotransporter-2 inhibitors (SGLT2i) have been associated with increased occurrence of Fournier's gangrene (FG), a rare but serious form of necrotizing fasciitis, leading to a warning from the Food and Drug Administration. Real-world evidence on FG is needed to validate this warning. METHODS: We used data from IBM MarketScan (2013-2017) to compare the incidence of FG among adult patients who initiated either SGLT2i, a dipeptidyl peptidase-4 inhibitor (DPP4i), or any non-SGLT2i antihyperglycemic medication. FG was defined using inpatient International Classification of Diseases, Ninth Edition and Tenth Edition diagnosis codes 608.83 and N49.3, respectively, combined with procedure codes for debridement, surgery, or systemic antibiotics. We estimated crude incidence rates (IRs) using Poisson regression, and crude and adjusted HRs (aHR) and 95% CIs using standardized mortality ratio-weighted Cox proportional hazards models. Sensitivity analyses examined the impact of alternative outcome definitions. RESULTS: We identified 211 671 initiators of SGLT2i (n=93 197) and DPP4i (n=118 474), and 305 329 initiators of SGLT2i (n=32 868) and non-SGLT2i (n=272 461). Crude FG IR ranged from 3.2 to 3.8 cases per 100 000 person-years during a median follow-up of 0.51-0.58 years. Compared with DPP4i, SGLT2i initiation was not associated with increased risk of FG for any outcome definition, with aHR estimates ranging from 0.25 (0.04-1.74) to 1.14 (0.86-1.51). In the non-SGLT2i comparison, we observed an increased risk of FG for SGLT2i initiators when using FG diagnosis codes alone, using all diagnosis settings (aHR 1.80; 0.53-6.11) and inpatient diagnoses only (aHR 4.58; 0.99-21.21). CONCLUSIONS: No evidence of increased risk of FG associated with SGLT2i was observed compared with DPP4i, arguably the most relevant clinical comparison. However, uncertainty remains based on potentially higher risk in the broader comparison with all non-SGLT2i antihyperglycemic agents and the rarity of FG. TRIAL REGISTRATION NUMBER: EUPAS Register Number 30018.

Fournier's gangrene mortality: A 17-year systematic review and meta-analysis.

BACKGROUND: To provide better management of Fournier's gangrene, mortality-associated comorbidities and common etiologies were identified. METHODS: A systematic search was conducted using 12 databases, followed by meticulous screening to select relevant articles. Meta-analysis and meta-regression (for possible cofounders) were both done for all possible outcomes. RESULTS: Out of 1186 reports screened, 38 studies were finally included in the systematic review and meta-analysis. A higher risk of mortality was detected in patients with diabetes, heart disease, renal failure, and kidney disease, with risk ratios (RR) and 95% confidence intervals (95% CI) of 0.72 (0.59-0.89), 0.39 (0.24-0.62), 0.41 (0.27-0.63), and 0.34 (95% CI 0.16-0.73), respectively. However, there was no association between mortality rates and comorbid hypertension, lung disease, liver disease, or malignant disease (p > 0.05). The highest mortality rates were due to sepsis (76%) and multiple organ failure (66%), followed by respiratory (19.4%), renal (18%), cardiovascular (15.7%), and hepatic (5%) mortality. CONCLUSIONS: Modifications to the Fournier's Gangrene Severity Index (FGSI) are recommended, in order to include comorbidities as an important prognostic tool for FG mortality. Close monitoring of the patients, with special interest given to the main causes of mortality, is an essential element of the management process.

Fournier's gangrene in patients with type 2 diabetes using second-line antidiabetic medications.

Cases of a rare but serious infection called Fournier's gangrene have been reported with sodium-glucose co-transporter-2 inhibitors (SGLT-2i). To evaluate the safety signal in a population of patients with type 2 diabetes, we used administrative claims data from Horizon Blue Cross Blue Shield of New Jersey from 2014 through 2017 to estimate incidence rates of Fournier's gangrene or necrotizing fasciitis of the perineum among patients treated with a second-line antidiabetic drug. We found very low incidence rates of Fournier's gangrene or necrotizing fasciitis. While we found no indication of an increased risk among SGLT-2i users compared with similar patients treated with other second-line antidiabetic medications, the small number of events yielded wide confidence intervals.

Fournier's gangrene and sodium-glucose co-transporter-2 inhibitors: A meta-analysis of randomized controlled trials.

Fournier's gangrene (FG) is a rare, life-threatening necrotizing fasciitis of the perineum. The US Food and Drug Administration (FDA) released a Drug Safety Communication regarding the risk of FG associated with sodium-glucose co-transporter-2 inhibitors (SGLT2i), relying on the FDA Adverse Event Reporting System. To verify this association, we performed a meta-analysis of all randomized controlled trials enrolling patients with type 2 diabetes, comparing SGLT2i with placebo or different therapies, collecting cases of FG reported as a serious adverse event. Risk of abscess, cellulitis and erysipela were secondary outcomes. We retrieved 84 trials enrolling 42 415 patients in the SGLT2i group and 27 158 patients in comparator groups. No difference was observed between SGLT2i and comparators in the risk of FG (Mantel-Haenzel odds ratio [MH-OR] 0.41 [0.09, 1.82]), abscess (MH-OR 0.94 [0.54, 1.65]), cellulitis (MH-OR 0.90 [0.71, 1.13] or erysipela (MH-OR 0.89 [0.45, 1.77]). The number of events was small, leading to a wide confidence interval that does not allow ruling out an increase in FG or skin and subcutaneous tissue infections.

Fournier Gangrene: A Review for Emergency Clinicians.

BACKGROUND: Fournier gangrene (FG) is a rare, life-threatening infection that can result in significant morbidity and mortality, with many patients requiring emergency department (ED) management for complications and stabilization. OBJECTIVE: This narrative review provides an evidence-based summary of the current data for the emergency medicine evaluation and management of FG. DISCUSSION: Although originally thought to be an idiopathic process, FG has been shown to have a strong association for male patients with advanced age and comorbidities affecting microvascular circulation and immune system function, most commonly those with diabetes or alcohol use disorder. However, it can also affect patients without risk factors. The initial infectious nidus is usually located in the genitourinary tract, gastrointestinal tract, or perineum. FG is a mixed infection of aerobic and anaerobic bacterial flora. The development and progression of gangrene is often fulminant and can rapidly cause multiple organ failure and death, although patients may present subacutely with findings similar to cellulitis. Laboratory studies, as well as imaging including point-of-care ultrasound, conventional radiography, and computed tomography are important diagnostic adjuncts, though negative results cannot exclude diagnosis. Treatment includes emergent surgical debridement of all necrotic tissue, broad-spectrum antibiotics, and resuscitation with intravenous fluids and vasoactive medications. CONCLUSIONS: FG requires a high clinical level of suspicion, combined with knowledge of anatomy, risk factors, and etiology for an accurate diagnosis. Although FG remains a clinical diagnosis, relevant laboratory and radiography investigations can serve as useful adjuncts to expedite surgical management, hemodynamic resuscitation, and antibiotic administration.

A contemporary case series of Fournier's gangrene at a Swiss tertiary care center-can scoring systems accurately predict mortality and morbidity?

Background: Fournier's gangrene (FG) is a life-threatening infection of the genital, perineal, and perianal regions with a morbidity range between 3 and 67%. Our aim is to report our experience in treatment of FG and to assess whether three different scoring systems can accurately predict mortality and morbidity in FG patients. Methods: All patients that were treated for FG at the Department of Urology of the University Hospital Basel between June 2012 and March 2017 were included and assessed retrospectively by chart review. Furthermore, we calculated Fournier's Gangrene Severity Index (FGSI), the Laboratory Risk Indicator for Necrotizing Fasciitis (LRINEC), and the neutrophil-lymphocyte ratio (NLR) in every patient and assessed whether those scores correlate with the patients' morbidity and mortality. Results: Twenty patients were included, with a median (IQR) age of 66 (46-73) years. Fifteen of twenty (75%) patients required treatment on an intensive care unit, and three died (mortality rate: 15%). The mean FGSI, LRINEC, and NLR scores were 13.0, 9.3, and 45.3 for non-survivors and 7.7, 6.5, and 26 for survivors, respectively. None of the risk scores correlated significantly with mortality; however, all three significantly correlated with infection- and surgically-induced morbidity. Conclusions: In our series, Fournier's gangrene was associated with a mortality rate of 15% despite maximum multidisciplinary therapy at a specialized center. All risk scores were able to predict the morbidity of the disease in terms of local extent and the required surgical measures.

Presentation and Diagnosis of Fournier Gangrene.

Necrotizing fasciitis is a severe type of necrotizing soft tissue infection involving the superficial fascia and subcutaneous tissues. Fournier gangrene, a type of necrotizing fasciitis, affects the genitalia or perineum. Although a rare health condition, Fournier gangrene can result in significant morbidity and unnecessary mortality following delay in diagnosis and management. We provide a review of relevant presenting features to aid diagnosis and allow timely surgical management of this serious infectious condition.