11 research outputs found

    New tracheal stainless steel stent pilot study: twelve month follow-up in a rabbit model

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    Background Canine tracheal collapse is a complex airway pathology without promising treatment results. Currently nitinol stents are the best surgical option; however, some professionals are doubting if stent placement is the best option due to the associated complications. Objective Determine the technical feasibility, safety, and long-term follow-up after the implantation of a new tracheal stent designed for canine tracheal collapse. Methods Thirteen healthy, adult female New Zealander rabbits were involved in this pilot study.A new intra-tracheal device (Reference number 902711 patent registered as CasMin-Twine) was implanted in ten animals. Deployment was performed under general anesthesia, making a puncture incision via a 21 Gauge needle in the intra-tracheal space where the stent was introduced with a screwing process. The device was fixed to the tracheal wall with a non-absorbable suture. Computerized Tomography (CT) and an endoscopy to study structural abnormalities were performed after 30, 90 and 365 days after stent placement. Results Technical and clinical success was 100%. There was no significant change in behavior or respiratory disorders. CT studies showed no significant alterations. After the 30 days, 60% of the animals showed partial endothelization in the endoscopy study, and only one animal still presented partial endothelization after 12 months. Mucus accumulation was only present in 40% of cases and classified as low, without respiratory consequences. Only one animal presented a single granuloma at caudal stent tip. Conclusions This new tracheal stent (CasMin-Twine) is an effective and safe procedure with promising results, and also shows the possibility of removing the device after endothelization has been produced. New studies should be carried out to evaluate the effectiveness in patients with tracheomalacia. Clinical Significance/Impact This new product can give veterinarians a new option of treatment for this complicated pathology. Minimizing specific equipment for its deployment, CasMin-Twine will be more accessible for all professionals

    A new airway spiral stent designed to maintain airway architecture with an atraumatic removal after full epithelization - Research of feasibility and viability in canine patients with tracheomalacia

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    Objective: Surgical management of tracheomalacia is a challenge, with current treatments still presenting numerous complications. In the field of veterinary medicine, this same pathology is present in a significant number of dogs. For this reason, we present an experimental clinical trial performed on canines with tracheobronchomalacia, using a new atraumatic removable tracheal spiral stent (SS). Both implantation procedure and clinical improvement have been analyzed in this study.Methods: In this study, four small dogs, a mean weight of 4.89 kg and body condition scores IV‐V, were included. SS was implanted by two different surgical approaches. Image and clinical follow‐up have been performed during 90 days. Symptoms were evaluated from 1 to 10 every week. Results: This study achieved 100% technical and clinical success. Median tracheal diameters were as follows: cervical 10.85 (3.3), inlet 7.75 (2.1), and carina 7.75 (1.9) mm, and length was 77.5 (26) mm. A 12 × 10 × 100‐mm SS was implanted in all cases. Goose honk cough punctuation improved from 8 to 1; also, there were important changes in exercise intolerance, a mean weight loss of 8.76%. The values of modified Karnofsky scale varied from 50 (20) before surgery to 90 (10) after 30 days of surgery. Neither granuloma tissue nor fractures of the prosthesis was observed.Conclusion: The results in dogs are promising, and a new therapeutic alternative seems to be available for veterinarian field. The similarity of this disease between dogs and newborns suggests that this SS design can also be useful for human trials

    Antimicrobial resistance among migrants in Europe: a systematic review and meta-analysis

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    BACKGROUND: Rates of antimicrobial resistance (AMR) are rising globally and there is concern that increased migration is contributing to the burden of antibiotic resistance in Europe. However, the effect of migration on the burden of AMR in Europe has not yet been comprehensively examined. Therefore, we did a systematic review and meta-analysis to identify and synthesise data for AMR carriage or infection in migrants to Europe to examine differences in patterns of AMR across migrant groups and in different settings. METHODS: For this systematic review and meta-analysis, we searched MEDLINE, Embase, PubMed, and Scopus with no language restrictions from Jan 1, 2000, to Jan 18, 2017, for primary data from observational studies reporting antibacterial resistance in common bacterial pathogens among migrants to 21 European Union-15 and European Economic Area countries. To be eligible for inclusion, studies had to report data on carriage or infection with laboratory-confirmed antibiotic-resistant organisms in migrant populations. We extracted data from eligible studies and assessed quality using piloted, standardised forms. We did not examine drug resistance in tuberculosis and excluded articles solely reporting on this parameter. We also excluded articles in which migrant status was determined by ethnicity, country of birth of participants' parents, or was not defined, and articles in which data were not disaggregated by migrant status. Outcomes were carriage of or infection with antibiotic-resistant organisms. We used random-effects models to calculate the pooled prevalence of each outcome. The study protocol is registered with PROSPERO, number CRD42016043681. FINDINGS: We identified 2274 articles, of which 23 observational studies reporting on antibiotic resistance in 2319 migrants were included. The pooled prevalence of any AMR carriage or AMR infection in migrants was 25·4% (95% CI 19·1-31·8; I2 =98%), including meticillin-resistant Staphylococcus aureus (7·8%, 4·8-10·7; I2 =92%) and antibiotic-resistant Gram-negative bacteria (27·2%, 17·6-36·8; I2 =94%). The pooled prevalence of any AMR carriage or infection was higher in refugees and asylum seekers (33·0%, 18·3-47·6; I2 =98%) than in other migrant groups (6·6%, 1·8-11·3; I2 =92%). The pooled prevalence of antibiotic-resistant organisms was slightly higher in high-migrant community settings (33·1%, 11·1-55·1; I2 =96%) than in migrants in hospitals (24·3%, 16·1-32·6; I2 =98%). We did not find evidence of high rates of transmission of AMR from migrant to host populations. INTERPRETATION: Migrants are exposed to conditions favouring the emergence of drug resistance during transit and in host countries in Europe. Increased antibiotic resistance among refugees and asylum seekers and in high-migrant community settings (such as refugee camps and detention facilities) highlights the need for improved living conditions, access to health care, and initiatives to facilitate detection of and appropriate high-quality treatment for antibiotic-resistant infections during transit and in host countries. Protocols for the prevention and control of infection and for antibiotic surveillance need to be integrated in all aspects of health care, which should be accessible for all migrant groups, and should target determinants of AMR before, during, and after migration. FUNDING: UK National Institute for Health Research Imperial Biomedical Research Centre, Imperial College Healthcare Charity, the Wellcome Trust, and UK National Institute for Health Research Health Protection Research Unit in Healthcare-associated Infections and Antimictobial Resistance at Imperial College London

    Surgical site infection after gastrointestinal surgery in high-income, middle-income, and low-income countries: a prospective, international, multicentre cohort study

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    Background: Surgical site infection (SSI) is one of the most common infections associated with health care, but its importance as a global health priority is not fully understood. We quantified the burden of SSI after gastrointestinal surgery in countries in all parts of the world. Methods: This international, prospective, multicentre cohort study included consecutive patients undergoing elective or emergency gastrointestinal resection within 2-week time periods at any health-care facility in any country. Countries with participating centres were stratified into high-income, middle-income, and low-income groups according to the UN's Human Development Index (HDI). Data variables from the GlobalSurg 1 study and other studies that have been found to affect the likelihood of SSI were entered into risk adjustment models. The primary outcome measure was the 30-day SSI incidence (defined by US Centers for Disease Control and Prevention criteria for superficial and deep incisional SSI). Relationships with explanatory variables were examined using Bayesian multilevel logistic regression models. This trial is registered with ClinicalTrials.gov, number NCT02662231. Findings: Between Jan 4, 2016, and July 31, 2016, 13 265 records were submitted for analysis. 12 539 patients from 343 hospitals in 66 countries were included. 7339 (58·5%) patient were from high-HDI countries (193 hospitals in 30 countries), 3918 (31·2%) patients were from middle-HDI countries (82 hospitals in 18 countries), and 1282 (10·2%) patients were from low-HDI countries (68 hospitals in 18 countries). In total, 1538 (12·3%) patients had SSI within 30 days of surgery. The incidence of SSI varied between countries with high (691 [9·4%] of 7339 patients), middle (549 [14·0%] of 3918 patients), and low (298 [23·2%] of 1282) HDI (p < 0·001). The highest SSI incidence in each HDI group was after dirty surgery (102 [17·8%] of 574 patients in high-HDI countries; 74 [31·4%] of 236 patients in middle-HDI countries; 72 [39·8%] of 181 patients in low-HDI countries). Following risk factor adjustment, patients in low-HDI countries were at greatest risk of SSI (adjusted odds ratio 1·60, 95% credible interval 1·05–2·37; p=0·030). 132 (21·6%) of 610 patients with an SSI and a microbiology culture result had an infection that was resistant to the prophylactic antibiotic used. Resistant infections were detected in 49 (16·6%) of 295 patients in high-HDI countries, in 37 (19·8%) of 187 patients in middle-HDI countries, and in 46 (35·9%) of 128 patients in low-HDI countries (p < 0·001). Interpretation: Countries with a low HDI carry a disproportionately greater burden of SSI than countries with a middle or high HDI and might have higher rates of antibiotic resistance. In view of WHO recommendations on SSI prevention that highlight the absence of high-quality interventional research, urgent, pragmatic, randomised trials based in LMICs are needed to assess measures aiming to reduce this preventable complication

    A new airway spiral stent designed to maintain airway architecture with an atraumatic removal after full epithelization—Research of feasibility and viability in canine patients with tracheomalacia

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    Objective: Surgical management of tracheomalacia is a challenge, with current treatments still presenting numerous complications. In the field of veterinary medicine, this same pathology is present in a significant number of dogs. For this reason, we present an experimental clinical trial performed on canines with tracheobronchomalacia, using a new atraumatic removable tracheal spiral stent (SS). Both implantation procedure and clinical improvement have been analyzed in this study.Methods: In this study, four small dogs, a mean weight of 4.89 kg and body condition scores IV‐V, were included. SS was implanted by two different surgical approaches. Image and clinical follow‐up have been performed during 90 days. Symptoms were evaluated from 1 to 10 every week. Results: This study achieved 100% technical and clinical success. Median tracheal diameters were as follows: cervical 10.85 (3.3), inlet 7.75 (2.1), and carina 7.75 (1.9) mm, and length was 77.5 (26) mm. A 12 × 10 × 100‐mm SS was implanted in all cases. Goose honk cough punctuation improved from 8 to 1; also, there were important changes in exercise intolerance, a mean weight loss of 8.76%. The values of modified Karnofsky scale varied from 50 (20) before surgery to 90 (10) after 30 days of surgery. Neither granuloma tissue nor fractures of the prosthesis was observed.Conclusion: The results in dogs are promising, and a new therapeutic alternative seems to be available for veterinarian field. The similarity of this disease between dogs and newborns suggests that this SS design can also be useful for human trials

    A New Removable Helical Metallic Stent for the Treatment of Tracheomalacia in Children: Study in Pathological Animal Model

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    Background: Congenital tracheomalacia is a pathology with no consensus of medical or surgical approach. The permanent nature and the major complications associated with metallic stents have limited their use over the years. The purpose of this study was to evaluate the feasibility of a helical stent design removal. Methods: Ten dogs diagnosed with tracheal collapse and treated with the helical stent were involved in the study. Animals were classified into three groups depending on stent indwelling time. Prior to the removal, endoscopic evaluation was performed to assess endothelization grade, mucous accumulation, and the presence of stenosis. During the removal, bleeding, fracture, or impossibility of removal were noted. After the removal, all macroscopic mucosal changes were recorded. Results: Technical success was 100%, without any complications. Complete epithelization of the stent was visualized in 7/10 animals. The removal procedure duration ranged from 2&ndash;12 min. At post-removal endoscopy, bleeding or epithelial damage, was visualized in any case. Stent fracture during removal occurred in one animal. Conclusions: The removal of a metallic stent with spiral geometry is feasible, simple, and without complications, regardless of the degree of neo-epithelialization

    Surgical site infection after gastrointestinal surgery in children : an international, multicentre, prospective cohort study

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    Introduction Surgical site infection (SSI) is one of the most common healthcare-associated infections (HAIs). However, there is a lack of data available about SSI in children worldwide, especially from low-income and middle-income countries. This study aimed to estimate the incidence of SSI in children and associations between SSI and morbidity across human development settings. Methods A multicentre, international, prospective, validated cohort study of children aged under 16 years undergoing clean-contaminated, contaminated or dirty gastrointestinal surgery. Any hospital in the world providing paediatric surgery was eligible to contribute data between January and July 2016. The primary outcome was the incidence of SSI by 30 days. Relationships between explanatory variables and SSI were examined using multilevel logistic regression. Countries were stratified into high development, middle development and low development groups using the United Nations Human Development Index (HDI). Results Of 1159 children across 181 hospitals in 51 countries, 523 (45 center dot 1%) children were from high HDI, 397 (34 center dot 2%) from middle HDI and 239 (20 center dot 6%) from low HDI countries. The 30-day SSI rate was 6.3% (33/523) in high HDI, 12 center dot 8% (51/397) in middle HDI and 24 center dot 7% (59/239) in low HDI countries. SSI was associated with higher incidence of 30-day mortality, intervention, organ-space infection and other HAIs, with the highest rates seen in low HDI countries. Median length of stay in patients who had an SSI was longer (7.0 days), compared with 3.0 days in patients who did not have an SSI. Use of laparoscopy was associated with significantly lower SSI rates, even after accounting for HDI. Conclusion The odds of SSI in children is nearly four times greater in low HDI compared with high HDI countries. Policies to reduce SSI should be prioritised as part of the wider global agenda.Peer reviewe

    Use of Telemedicine for Post-discharge Assessment of the Surgical Wound: International Cohort Study, and Systematic Review with Meta-analysis

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    Objective: This study aimed to determine whether remote wound reviews using telemedicine can be safely upscaled, and if standardised assessment tools are needed. Summary background data: Surgical site infection is the most common complication of surgery worldwide, and frequently occurs after hospital discharge. Evidence to support implementation of telemedicine during postoperative recovery will be an essential component of pandemic recovery. Methods: The primary outcome of this study was surgical site infection reported up to 30-days after surgery (SSI), comparing rates reported using telemedicine (telephone and/or video assessment) to those with in-person review. The first part of this study analysed primary data from an international cohort study of adult patients undergoing abdominal surgery who were discharged from hospital before 30-days after surgery. The second part combined this data with the results of a systematic review to perform a meta-analysis of all available data conducted in accordance with PRIMSA guidelines (PROSPERO:192596). Results: The cohort study included 15,358 patients from 66 countries (8069 high, 4448 middle, 1744 low income). Of these, 6907 (45.0%) were followed up using telemedicine. The SSI rate reported using telemedicine was slightly lower than with in-person follow-up (13.4% vs. 11.1%, P&lt;0.001), which persisted after risk adjustment in a mixed-effects model (adjusted odds ratio: 0.73, 95% confidence interval 0.63-0.84, P&lt;0.001). This association was consistent across sensitivity and subgroup analyses, including a propensity-score matched model. In nine eligible non-randomised studies identified, a pooled mean of 64% of patients underwent telemedicine follow-up. Upon meta-analysis, the SSI rate reported was lower with telemedicine (odds ratio: 0.67, 0.47-0.94) than in-person (reference) follow-up (I2=0.45, P=0.12), although there a high risk of bias in included studies. Conclusions: Use of telemedicine to assess the surgical wound post-discharge is feasible, but risks underreporting of SSI. Standardised tools for remote assessment of SSI must be evaluated and adopted as telemedicine is upscaled globally

    Global economic burden of unmet surgical need for appendicitis

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    Background There is a substantial gap in provision of adequate surgical care in many low- and middle-income countries. This study aimed to identify the economic burden of unmet surgical need for the common condition of appendicitis. Methods Data on the incidence of appendicitis from 170 countries and two different approaches were used to estimate numbers of patients who do not receive surgery: as a fixed proportion of the total unmet surgical need per country (approach 1); and based on country income status (approach 2). Indirect costs with current levels of access and local quality, and those if quality were at the standards of high-income countries, were estimated. A human capital approach was applied, focusing on the economic burden resulting from premature death and absenteeism. Results Excess mortality was 4185 per 100 000 cases of appendicitis using approach 1 and 3448 per 100 000 using approach 2. The economic burden of continuing current levels of access and local quality was US 92492millionusingapproach1and92 492 million using approach 1 and 73 141 million using approach 2. The economic burden of not providing surgical care to the standards of high-income countries was 95004millionusingapproach1and95 004 million using approach 1 and 75 666 million using approach 2. The largest share of these costs resulted from premature death (97.7 per cent) and lack of access (97.0 per cent) in contrast to lack of quality. Conclusion For a comparatively non-complex emergency condition such as appendicitis, increasing access to care should be prioritized. Although improving quality of care should not be neglected, increasing provision of care at current standards could reduce societal costs substantially

    Global economic burden of unmet surgical need for appendicitis

    No full text
    Background There is a substantial gap in provision of adequate surgical care in many low- and middle-income countries. This study aimed to identify the economic burden of unmet surgical need for the common condition of appendicitis. Methods Data on the incidence of appendicitis from 170 countries and two different approaches were used to estimate numbers of patients who do not receive surgery: as a fixed proportion of the total unmet surgical need per country (approach 1); and based on country income status (approach 2). Indirect costs with current levels of access and local quality, and those if quality were at the standards of high-income countries, were estimated. A human capital approach was applied, focusing on the economic burden resulting from premature death and absenteeism. Results Excess mortality was 4185 per 100 000 cases of appendicitis using approach 1 and 3448 per 100 000 using approach 2. The economic burden of continuing current levels of access and local quality was US 92492millionusingapproach1and92 492 million using approach 1 and 73 141 million using approach 2. The economic burden of not providing surgical care to the standards of high-income countries was 95004millionusingapproach1and95 004 million using approach 1 and 75 666 million using approach 2. The largest share of these costs resulted from premature death (97.7 per cent) and lack of access (97.0 per cent) in contrast to lack of quality. Conclusion For a comparatively non-complex emergency condition such as appendicitis, increasing access to care should be prioritized. Although improving quality of care should not be neglected, increasing provision of care at current standards could reduce societal costs substantially
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