Single-center, prospective, and observational study on the management and treatment of impetigo in a pediatric population.

OBJECTIVE: Ozenoxacin is a new antibiotic used to treat non-bullous impetigo. The aim of this study is to evaluate the microbiological and clinical efficacy of topical ozenoxacin 1% cream after 5-day twice-daily treatment, in pediatric patients with impetigo. PATIENTS AND METHODS: This observational and prospective study included patients aged 6 months to 18 years, with non-bullous impetigo. Efficacy was measured using the Skin Infection Rating Scale (SIRS) and microbiological culture at the first visit (T0), at the second visit after 72 hours (T1) and after 5 days (T2). Safety and tolerability were also evaluated. RESULTS: A total of 50 patients was enrolled. A reduction of SIRS score >10% after 72 hours of treatment was noticed in all patients, while a complete reduction was assessed after 5 days in all the population. Microbiologic success rates for ozenoxacin at T1 was 92% (four patients had original pathogens in the specimen culture from the skin area), whereas at T2, it was 100%. CONCLUSIONS: Topical ozenoxacin has strong efficacy in treating impetigo in pediatric patients. Ozenoxacin's clinical and microbiological rapid onset of response led to consider this antibiotic a novel efficacy option for the treatment of impetigo.

Analysis of the Trend Over Time of High-Urgency Liver Transplantation Requests in Italy in the 4-Year Period 2014-2017.

BACKGROUND: The national protocol for the handling of high-urgency (HU) liver organ procurement for transplant is administered by the Italian National Transplant Center. In recent years, we have witnessed a change in requests to access the program. We have therefore evaluated their temporal trend, the need to change the access criteria, the percentage of transplants performed, the time of request satisfaction, and the follow-up. METHODS: We analyzed all the liver requests for the HU program received during the 4-year period of 2014 to 2017 for adult recipients (≥18 years of age): all the variables linked to the recipient or to the donor and the organ transplants are registered in the Informative Transplant System as established by the law 91/99. In addition, intention to treat (ITT) survival rates were compared among 4 different groups: (1) patients on standard waiting lists vs (2) patients on urgency waiting lists, and (3) patients with a history of transplant in urgency vs (4) patients with a history of transplant not in urgency. RESULTS: Out of the 370 requests included in the study, 291 (78.7%) were satisfied with liver transplantation. Seventy-nine requests (21.3%) have not been processed, but if we consider only the real failures, this percentage falls to 13.1% and the percentage of satisfied requests rises to 86.9%. The average waiting period for liver transplantation (LT) is 1.7 days and most requests (74%) are met in less than 24 hours, if we consider the hours between the registration of the request and the donor reporting . The percentage of late retransplantations is 2.1%. The clinical indication for HU-LT that appears to improve over time is hepatic artery thrombosis (82.5%). The overall 1-year patient survival is 68.3%. The overall 1-year graft survival, performed on all the patients, is 89% and all the indications for HU-LT appear to go well over time with an average survival rate greater than 85%. CONCLUSIONS: The indications for HU-LT are changing according to the changes in the hepatologic field in recent years. The centralized management of requests has proven to be successful in optimizing responses. Urgent LT is confirmed to be lifesaving in its timeliness.

Transport of Human Organs in Italy: Location, Time, and Performances.

INTRODUCTION: The outcome of transplantation activities depends on a variety of unpredictable factors. Up-to-date criteria on organ allocation foresee an efficient transport chain along with compliant performance parameters. METHODS AND OBJECTIVES: The Centro Nazionale Trapianti and the Department of Civil, Chemical, Environmental, and Materials Engineering of the University of Bologna (respectively, CNT and DICAM) have been updating a national database of organ transplantation activities to investigate performance parameters and the main causes of disruption. RESULTS: Between June 2015 and July 2016, 617 of 1061 organs have been shipped by air (making for 486 flight events), of which 407 were accompanied by medical equipment. Origin/destination and distance matrixes have been drawn for both road and air transport. Each airport node is ranked based on the n° of organs ingoing/outgoing and each route link on its frequency. Performance parameters such as average speed, distance covered, and time have been computed and compared with each organ's cold ischemia time (CIT). Average distance frontiers are rather homogeneous, but much effort is necessary to reduce the number of events performed with approximately 90% or more of CIT spent. CONCLUSIONS: The monitoring of organ transplantation activities' performance is a standalone action within Europe to support strategic policies to optimize the system. Thus, a clearer awareness on performances and issues related to organ transport has been made possible: analyses show that the higher uncertainty associated with total time of displacement by air is due to the steps which take place by road (length and paths must be optimized) and lung transports generally perform weaker than heart transports due to longer average distances travelled and smaller average speeds, often resulting in a total displacement time greater than 90% of CIT.

Analysis of the Organ Offers Received From European Union Countries Before and After the Introduction of a Dedicated Information Technology Portal: The COORENOR/FOEDUS Portal.

INTRODUCTION: To optimize the use of nontransplantable organs in their own territory, the European Commission, as part of a project led by Italy, has promoted the use of an information technology (IT) portal, the COORENOR portal, developed by the Czech Republic in 2012, which evolved to become FOEDUS in 2015. METHODS: To evaluate the impact of the portal on our reality, we analyzed the number and type of offers received and organs imported in the previous 48 months (period A) as well as the 48 months after the introduction of the portal (period B). We also examined the origin and the offer mode. RESULTS: The offers received were 404 and 753, respectively, in the two periods, with 315 (41.8%) organs received through the portal. The organs transplanted were 53 and 64, respectively, in the two periods; 20 (31.2%) were sent through the portal. The most commonly offered organs are lungs (36.7% and 29.3% of offers in periods A and B, respectively). The most transplanted organ is the liver (59.4% and 45% of transplants in periods A and B, respectively). The use of the portal has gradually increased, growing from 16.4% of the offer mode in 2012 to 84.7% in 2016. CONCLUSIONS: The increase of offers related to the increase of donations and the attitude to the sharing of resources has determined an increase of 19.2% of total transplants, especially for certain types such as pediatric transplants. The portal, ensuring speed and simultaneity of offer, real time sharing of information and transparency of allocation, is also used for trade in the International Partnership Agreements. Therefore, transplants have been conditioned by the existing agreements with Greece, Malta, and the countries of the South Transplant Alliance.

Liver Allocation in Urgent MELD Score ≥30: The Italian Experience.

INTRODUCTION: Patients with an urgent MELD score ≥30 are managed by the Italian Operative National Transplant Center on the basis of a division of Italy into 2 main areas, the northern macro area (NMA) and the southern macro area (SMA). The object of this study was to evaluate the possibility and the need to transform the MELD score ≥30 macro area-based program into a nationwide one. PATIENTS AND METHODS: When a region reports the presence of a patient with a MELD score ≥30, the same macro area-compatible donors, in the absence of urgent national and 1B status, are offered primarily to this recipient. RESULTS: From August 2014 to August 2015, 132 requests for patients with urgent MELD score ≥30, 98 from the NMA and 34 from the SMA, were handled. The average waiting list in the NMA was significantly different from that of the SMA (2.74 ± 2.29 vs 4.5 ± 3.98, P < .05). A total of 73.7% of the received requests (n = 97) were satisfied: the NMA met 80.4% of the requests (n = 77), whereas the SMA met 55.5% (n = 20). A total of 35 requests (26.5%), 21 from the NMA (60%) and 14 (40%) from the SMA, were not met. The average waiting time of these recipients for a liver was significantly different between the NMA and the SMA (3.14 ± 3.21 vs 5.78 ± 4.59; P < .05). CONCLUSIONS: The MELD score is a priority allocation, and the longer the waiting time to transplantation for these recipients, the more their mortality increases. Given the differences in waiting times between the NMA and SMA, we should start thinking about transforming the macro area program into a national one.

Patients on liver transplantation waiting list with Model for End-Stage Liver Disease score ≥ 30: experience in the Organizzazione Centro Sud Trapianti macro area.

INTRODUCTION: From 2011 a program was developed for liver transplant recipients with Model for End-Stage Liver Disease (MELD) score ≥30. We examined its effectiveness and impact on the other subjects on the waiting list. MATERIALS AND METHODS: We analyzed requests received between January 2011 and May 2012 for the primary pathology, the outcome, the average waiting time, and the origin of the organ. We examined the ordinary waiting list for mortality rates and numbers of transplantations over this period (group A) versus a comparable preceding period (group B). RESULTS: There were 38 requests for 33 patients. Their primary pathologies were cirrhosis associated with viral infection (n = 15), delayed graft failure (DGF; n = 5), biliary cirrhosis (n = 4), hepatocellular carcinoma (HCC; n = 3 including 2 with cirrhosis), cryptogenic cirrhosis (n = 3), postalcoholic cirrhosis (n = 2), metabolic disease (n = 2), and iatrogenic disease (n = 1). Of the requests, 25 were successfully dealt with, whereas 5 requests were temporarily suspended and 2 were permanently suspended because of better or worse patient conditions. There were 6 deceased patients. Transplanted organs came from the inter-regional area in 64% of cases. The average waiting time was 5.9 days. Within group A were a 311 transplantations among 723 waiting list patients on with a 13.7% mortality rate. Within group B were 305 transplantations among 871 wait-listed patients with a 14% mortality rate. DISCUSSION: The liver transplantation program for recipients with MELD scores ≥ 30 allowed recipients in critical condition to receive grafts without altering substantially the opportunities for recipients on the elective waiting list.

Research for optimization in organ donation in a macro-area after federal reform of the Italian health system.

Law number 91, dated April 1, 1999, established an organizational model for the activities of donation, retrieval, and transplantation of organs consisting of 4 levels: national, interregional, regional, and local. After 12 years this organizational project, called the "National Transplant Network," has reached an excellent level of effectiveness and efficiency. Since 2001 regional administrative districts have been entrusted increasingly with responsibilities concerning health. In 2008 health federalism was approved and in 2010 the federal health fiscal system entered in force. In a country with a federal organization, where regional districts are completely autonomous, is there a reason to still have a national transplant center and 3 interregional transplantation centers? We have developed a hypothesis on the function of Interregional Transplant Centers (CIR). The risk of federalism is the fragmentation of the National Healthcare System. To adequately meet the needs of citizens, smaller regions should sign agreements with larger regions regarding transplantation programs that require a large pool of donors whereas they could retain management of patients during the presurgery and postsurgery phases. The CIR should be committed to increase organ donation, to establish shared protocols and procedures, to disseminate knowledge, and to ensure equal access to health care. In conclusion, the adoption of health and fiscal federalism provides an opportunity to build healthcare systems to optimize resources. The network model should be kept but it is necessary to overcome localism and create positive federalism.

Living organ donation, a therapeutic possibility, is still poorly used in Italy: a national analysis.

Validity of living donor kidney transplantation is universally accepted. In contrast, after enthusiastic adoption in the 1990s, living donor liver transplantation has decreased in recent years. The aim of the present study was to evaluate retrospectively the current use of this form of donation in Italy by comparing liver and kidney cadaveric and living donations from 2002 to 2010. The number of liver transplantations from living donors has decreased from 34 in 2002 (3.9% of total) to 13 in 2010 (1.3% of total). In contrast, kidney transplantation from living donors increased from 126 (7.9% of total) to 186 (11% of total). We observed that living donations for kidney transplantation are still underused, especially with unrelated donors. Living donor liver transplantation has decreased in recent years; this procedure should be reserved to centers with particular expertise. It would be appropriate to implement programs to increase the attention of health professionals and the general population and to integrate living donations into programs of deceased organ donation.

Strategies to increase heart transplantation in centre-sud transplant organization.

The 21 heart transplantations in Centre-Sud Transplant Organization (OCST) is a stable number despite increasing donations, especially among subjects aged 50 to 60 years. The aim of the present study was to evaluate the possibility to increase the usage of marginal hearts through dipyridamole ecostress. From 2008 to 2010 we analyzed OCST donors at 74 donation sites for echocardiography (31 yes versus 43 no) and heart utilization: (1) principal sites (n > 13) versus (2) minor sites (n < 13). Among 2145 signaled donors, there were 900 (42%) effective donors, including 816 (38%) utilized organs from 387 subjects of age <50 years; 189, 50 to 60 years and 240, >60 years with 217 (90%); 24 (10%), and 3 (1%) utilized hearts respectively to the analyzed sites, the utilized donors with echocardiography were 373: 259 (69.4%) versus 114 (30.5%) from those without such a service. Utilized donors between 50 and 60 years came from principal sites (n = 50), minor sites (n = 7) or those without an echocardiagram (n = 16). Utilized heart donors in each type of site were eight, one, and six, respectively. We believe that it may be possible to increase the total number of heart transplantations using dipyridamole stress-test echocardiography at the sites with major retrieval activity to increase heart transplantation among donors in the age range of 50 to 60 years.

Italy-Greece cooperation for transplantation of medically urgent Greek patients: is it an effective, efficient model?

INTRODUCTION: In 2005 the Italian National Transplant Centre (CNT) signed a cooperation agreement with the Hellenic Transplant Organization (HTO) fostering the transfer and transplantation of urgent Greek liver patients at Italian transplantation centers. So as to not reduce access to transplantation for Italian patients, the agreement provided compensation for organs allocated to Greek transplant recipients. The aim of this study was to analyze the flow of patients from Greece to Italy and the number of received livers to consider the possibility to extend this kind of agreement to other countries, so that this should not penalize Italian recipients. MATERIALS AND METHODS: The agreement provides the possibility for Greek patients affected by acute disease to be transferred to Italian transplantation centers participating in the agreement. Until 2008 livers transplanted into Greek recipients were returned through a preferential offer of surplus Greek organs, whereas from 2009 an obligation of payback was introduced. RESULTS: During the reviewed period requests for transfer, transferred patients, and number of patients who later underwent transplantation in Italy were 56, 26, and 23, respectively. Livers offered by the Greek organization that were accepted, transferred, and transplanted in Italy have been 82, 50, and 44, respectively. DISCUSSION AND CONCLUSIONS: According to our analysis, the cooperation has had as positive impact for both Greece, which has difficulties transplanting urgent recipient because of the low number of donors, and for Italy, which is not penalized by the use of an organ in a Greek recipients, but is also rewarded for helpfulness.

The use of neoplastic donors to increase the donor pool.

The aim of the study was to evaluate the experience of the Centre-Sud Transplant Organization (OCST) area using cadaveric donor with neoplastic diseases to evaluate the possibility of transmission to recipients. From January 1, 2003, to December 31, 2010, the neoplastic risk has been reported to be 5.4% (377/4654 referred donors). In 2003, the number of donors with a tumor and their mean age were respectively: 60 (10.3%) and 59.6 ± 19.9; 2004: 33 (5.2%) and 61.4 ± 15.9; 2005: 32 (6%) and 62.8 ± 15.5; 2006: 46 (7%) and 60.7 ± 19.1; 2007: 51 (7%) and 58.9 ± 16; in 2008: 58 (7%) and 59.7 ± 19.6; 2009: 47 (7%) and 57 ± 26; 2010: 49 (7%) and 64 ± 16. The organ most affected by tumor has been the central nervous system (18%). The tumor was diagnosed before in 325 (86%) cases, versus during organ retrieval in 48 (12.7%) donor operations but before, which four cases (1%) occured after transplantation. According to the histological types and grades, 28 evaluated donors (8.2%) were suitable for transplantation. The histological types were: thyroid carcinoma (n = 3); prostate carcinoma (n = 8), renal clear cell carcinoma (n = 7), oncocytoma (n = 1), meningiomas (n = 2), dermofibrosarcoma (n = 1); verrucous carcinoma of the vulva (n = 1), colon adenocarcinoma (n = 1), grade II astrocytoma (n = 1), adrenal gland tumor (n = 1), gastric GIST (n = 1), oligodendroglioma (n = 1). Forty-five organs were retrieved (22 livers, 19 kidneys, 3 hearts, and 1 pancreas) and transplanted into 44 recipients with 1 liver-kidney combined transplantation. Four recipients died due to causes not related to the tumor. No donor-transmitted tumor was detected among the recipients. Donation is absolutely not indicated in cases of tumors with high metastatic potential and high grades. Performing an accurate evaluation of the donor, taking into account the histological grade, currently can allow, organ retrieval and transplantation with an acceptable risk.

Risk management systems for health care and safety development on transplantation: a review and a proposal.

UNLABELLED: Starting from the report on medical errors published in 1999 by the US Institute of Medicine, a number of different approaches to risk management have been developed for maximum risk reduction in health care activities. The health care authorities in many countries have focused attention on patient safety, employing action research programs that are based on quite different principles. MATERIALS AND METHODS: We performed a systematic Medline research of the literature since 1999. The following key words were used, also combining boolean operators and medical subheading terms: "adverse event," "risk management," "error," and "governance." Studies published in the last 5 years were particularly classified in various groups: risk management in health care systems; safety in specific hospital activities; and health care institutions' official documents. Methods of action researches have been analysed and their characteristics compared. Their suitability for safety development in donation, retrieval, and transplantation processes were discussed in the reality of the Italian transplant network. DISCUSSION: Some action researches and studies were dedicated to entire national healthcare systems, whereas others focused on specific risks. Many research programs have undergone critical review in the literature. Retrospective analysis has centered on so-called sentinel events to particularly analyze only a minor portion of the organizational phenomena, which can be the origin of an adverse event, an incident, or an error. Sentinel events give useful information if they are studied in highly engineered and standardized organizations like laboratories or tissue establishments, but they show several limits in the analysis of organ donation, retrieval, and transplantation processes, which are characterized by prevailing human factors, with high intrinsic risk and variability. Thus, they are poorly effective to deliver sure elements to base safety management improvement programs, especially regarding multidisciplinary systems with high complexity. CONCLUSION: In organ transplantation, the possibility to increase safety seems greater using proactive research, mainly centred on organizational processes together with retrospective analyses but not limited to sentinel event reports.

Incidence of neoplastic donors in Organizzazione Centro Sud Trapianti area during the 2003-2005 period.

The aim of this study is to evaluate the incidence of malignant tumors in cadaver donors and the possibility of neoplastic disease transmission to the recipients in the Organizzazione Centro Sud Trapianti (OCST) area. Among 1744 potential donors identified from 2003 to 2005, 125 (7.1%) showed an elevated malignant neoplastic risk. In 2003 a malignant tumor was diagnosed in 60 donors of mean age 59.6 +/- 19.9 years (median 62.5, M:36 F:24); in 2004, 33 donors of mean age, 61.4 +/- 15.9 years (median 63, M:19 F:14); in 2005, 32 donors of mean age of 62.8 +/- 15.5 years (median 65.5, M:20 F:12). Prostatic cancer was the most common tumor (23.2%). In 101 of 125 cases (80.8%) the tumor was diagnosed before organ retrieval, in 23 (18.4%) cases, during the donor operation but before the transplant, and in one case (0.8%) after transplantation. Each tumor was evaluated according to the histologic types and grades. From 12 of those donors with neoplasia, 24 organs were retrieved (10 livers, 11 kidneys, 3 hearts) transplanted in 23 recipients (one liver-kidney combined transplant). Three recipients died during the perisurgical period due to causes unrelated to the tumor and therefore were not considered in the follow-up evaluation. Among the remaining nine recipients who had a mean follow-up of 38.83 months (range 9-42), no donor-transmitted disease has become apparent by imaging control. A careful donor evaluation including histologic grading and strict application of Centro Nazionale Trapianti guidelines allowed us to use donors with malignant tumors in selected cases with an apparently reduced risk of transmitted neoplastic disease.

[Chemotherapy in the elderly patient]. / I trattamenti chemioterapici nel paziente anziano.

In the past, the clinical approach in elderly cancer patients was different than in younger ones; the natural history of neoplastic disease and the chemotherapy-related toxicity were the main reasons for this behaviour, and frequently over 65 years patients were excluded from chemotherapeutic treatments and from clinical trials. In the last years, according to clinical data, this approach changed and now there is evidence that also old patients (70-80 ys) can be treated with full dose chemotherapy, on condition that no poor performance status and no severe associated disease are present. Nevertheless, because of the increasing number of cancer patients with advanced age, in future it will be necessary to optimize the antineoplastic treatments individualizing chemotherapy and improving the clinical surveillance in this subset of patients. Moreover it will be strategic to identify optimal schedules of treatment in elderly cancer patients.

[Chemotherapy in gastroenterologic neuroendocrine tumors]. / Chemioterapia nei tumori neuroendocrini gastroenterici.

Gastrointestinal neuroendocrine tumors (carcinoids tumors and endocrine islet cell tumors) are a family of rare malignancies with many typical characteristics by a biologic, epidemiologic and clinical point of view. In this category of neoplasia an integrated clinical and therapeutic approach is mandatory, whereas for too many years these tumors were investigated and treated in an empirical way without considering an integrated approach. The singular features of this class of malignancies, with different and complex symptomatology, with enigmatic clinical presentation and outcome and with conflicting therapeutic options, oblige the clinicians to give different treatment to the patients. Chemotherapy has a marginal role in gastrointestinal neuroendocrine tumors mostly because it is used in patients with advanced disease not suitable for other therapeutic approach (surgery, thermoablation, chemoembolization, biotherapy). Unfortunately in the past it was not possible to establish the efficacy of chemotherapy in these malignancies because most of the studies pooled without distinction carcinoids, pancreatic tumors and hepatic metastases from unknown primary. The most extensively studied drugs have been streptozotocin, doxorubicin, mitoxantrone, dacarbazine, used alone or in combination; the gold standard today is considered the association of streptozotocin with doxorubicin or 5-fluorouracil, but there is strong evidence that the disappointing results in the treatment of these rare malignancies could be improved in a multidisciplinary fashion; in this field the combination of new drugs with aggressive surgery, radionuclide therapy, biotherapy and local therapeutic approach will give new opportunities to better control the symptoms and the clinical course of gastrointestinal neuroendocrine tumors.

Determination of antibodies to Borrelia burgdorferi in the serum of patients living in Calabria, southern Italy.

The aim of our work was to determine the sero-prevalence of antibodies to B. burgdorferi in 300 patients living in Calabria, a region of southern Italy. The research of antibodies to B. burgdorferi was conducted by ELISA as a screening method and Western Blot as a confirmatory test. Out of the 300 patients we found a rate of positivity of 7.3% with ELISA and 4.5% with Western Blot. This data allows us to classify Calabria, among the regions where Lyme borreliosis is non-endemic and where sero-epidemiological research has been carried out on patients, as having a degree of positivity second to that of Campania (9.1%) and higher than Lombardy (3.2%) and Umbria (2.8%). Considering all the demographic and clinical data, only that of the higher IgG positivity of males over females is statistically significant.