From basic research to clinical practice: The impact of laminar airflow filters on surgical site infection in vascular surgery.

BACKGROUND: Laminar airflow filters have been suggested as a potential preventive factor for surgical site infections, given their ability to reduce the airborne microbiological load. However, their role is still unclear, and evidence regarding vascular surgery patients is scarce. Our aim was to assess the impact of laminar-airflow filters on surgical site infections. METHODS: This single-centre retrospective cohort study was conducted with vascular surgery patients who underwent arterial vascular intervention through a groin incision between July 2018 and July 2019 (turbulent airflow cohort) and July 2020 and July 2021 (laminar airflow cohort). Data were prospectively collected from electronic medical files. We estimated the cumulative incidence of surgical site infections and its 95% confident interval (95%CI). A propensity score matching analysis was performed. RESULTS: We included 200 patients, 78 in the turbulent airflow cohort and 122 in the laminar airflow cohort. The cumulative incidence was 15.4% (12/78; 95%CI: 9.0-25.0%) in the turbulent-airflow cohort and 14.8% (18/122; 95%CI: 9.5 -22.1%) in the laminar-airflow cohort (p-value: 1.00). The propensity score matching yielded a cumulative incidence of surgical site infection of 13.9% (10/72) with turbulent airflow and 12.5% (9/72) with laminar airflow (p-value: 1.00). Risk factors associated with infection were chronic kidney disease (OR 2.70; 95%CI: 1.14-6.21) and a greater body mass index (OR 1.47; 95%CI: 1.01-2.14). CONCLUSION: Laminar airflow filters were associated with a non-significant reduction of surgical site infections. Further research is needed to determine its usefulness and cost-effectiveness. Surgical site infection incidence was associated with chronic kidney disease and a greater body mass index. Hence, efforts should be made to optimize the body mass index before surgery and prevent chronic kidney disease in patients with known arterial disease.

Clinical Outcomes and Graft Resorption After Metal-Free Bone Block Suture Tape Cerclage Fixation for Recurrent Anterior Shoulder Instability: A Computed Tomography Analysis.

BACKGROUND: Glenoid reconstruction with a bone block for anterior glenoid bone loss (GBL) has shown excellent outcomes. However, fixation techniques that require metal implants are associated with metal-related complications and bone graft resorption. HYPOTHESIS: Arthroscopic glenoid reconstruction using a tricortical iliac crest bone graft (ICBG) and metal-free suture tape cerclage fixation can safely and effectively restore the glenoid surface area in patients with recurrent anterior shoulder instability and anterior GBL. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: Adult patients (≥18 years) of both sexes with recurrent anterior shoulder instability and anterior GBL ≥15% were enrolled. These patients underwent arthroscopic glenoid reconstruction with ICBGs and metal-free suture tape cerclage fixation. The effectiveness and clinical outcomes with this technique were evaluated at 24 months using functional scores. Resorption of the graft articular surface was assessed by computed tomography, with the graft surface divided into 6 square areas aligned in 2 columns. Descriptive analysis was conducted. RESULTS: A total of 23 consecutive patients met inclusion criteria (22 male, 1 female; mean age, 30.5 ± 7.9 years). The mean preoperative GBL was 19.7% ± 3.4%, and there were 15 allograft and 8 autograft ICBGs. All patients exhibited graft union at 3 months. The median follow-up was 38.5 months (interquartile range, 24-45 months). The Western Ontario Shoulder Instability Index, Rowe, Constant-Murley, and Subjective Shoulder Value scores improved from preoperatively (35.1%, 24.8, 83.1, and 30.9, respectively) to postoperatively (84.7%, 91.1, 96.0, and 90.9, respectively) (P < .001). No differences in clinical scores were observed between the graft types. One surgical wound infection was reported, and 2 patients (8.7% [95% CI, 2.4%-26.8%]) required a reoperation. The mean overall glenoid surface area increased from 80.3% ± 3.5% to 117.0% ± 8.3% immediately after surgery before subsequently reducing to 98.7% ± 6.2% and 95.0% ± 5.7% at 12 and 24 months, respectively (P < .001). The mean graft resorption rate was 18.1% ± 7.9% in the inner column and 80.3% ± 22.4% in the outer column. Additionally, 3 patients treated with an allograft (20.0% [95% CI, 7.1%-45.2%]), including the 2 with clinical failures, exhibited complete graft resorption at the last follow-up. CONCLUSION: Arthroscopic glenoid reconstruction using an ICBG and metal-free suture tape cerclage fixation was safe and effective, yielding excellent clinical outcomes. Resorption of the graft articular surface predominantly affected the nonloaded areas beyond the best-fit circle perimeter.

Long-term follow-up of total hip arthroplasty using polyethylene-ceramic composite (sandwich) liner.

INTRODUCTION: Ceramic-on-ceramic bearings have been widely used since their introduction in the 1970s. First-generation ceramics have very high fracture (breakage) rates. To overcome this, in the 1990s, modular cotyloid insert designs were developed, consisting of a ceramic and polyethylene composite (sandwich-type) liner; however, high implant fracture rates were observed in the medium term. We aimed to estimate the cumulative incidences of revision surgery (implant failure) and implant failure due to fractures, survival rates (time-to-revision surgery and time-to-fracture), and the long-term clinical and radiological outcomes in our series. METHODS: This was an observational, longitudinal, ambispective, single-centre study based on patients who underwent primary total hip arthroplasty (THA) using a sandwich-type liner (Cerasul), only available in our tertiary hospital between January 1999 and December 2002. Cumulative incidences were estimated and the 95% confidence interval (95% CI) was calculated. The Kaplan-Meier method was used to assess the time-to-revision surgery and time-to-fracture. RESULTS: 54 patients (49 men) were included, accounting for 59 sandwich-type linear implants. The mean (range) age was 47.4 (22-57) years. The primary THA indications were osteoarthritis (28 patients), osteonecrosis (14), childhood pathology sequelae (11), and inflammatory arthritis (6). The cumulative incidence of revision surgery by implants was 8.5% (5/59, 95% CI, 3.5-19.2%), 9.3% by patients (5/54, 95% CI, 4.0-19.9%), and 5.1% by implant fractures (3/59, 95%CI, 1.7-13.9%). The median (Interquartile Range, IQR) time-to-revision surgery was 158 (72.5-161) months, and the time to fracture was 182 (138-215) months. All primary THAs had good clinical and long-term survival outcomes. All implants had signs of solid fixation. CONCLUSIONS: After a 20-year follow-up period, the polyethylene-ceramic sandwich-type liner showed a long survival rate and low cumulative incidence of implant fracture; however, implant fractures remain the main complication. Orthopaedic surgeons should be aware that some patients still have this type of prosthesis and must be capable of responding quickly if a fracture occurs.

Radiculopathy with motor deficit: a cross-sectional study of the impact of the surgeon's experience on the indication and timing of surgical treatment.

PURPOSE: The optimal management of patients with compressive radiculopathy with motor deficit (CRMD) is controversial. Our goal was to provide evidence on the impact of the spine surgeons' experience on surgical planning and timing. METHODS: Spine surgeons were invited to participate in a 5-item online survey. A literature review was carried out. RESULTS: Of the 94 spine surgeons who responded to the survey, 70% would operate early on a patient with acute CRMD, but only 48% would do so if the radicular pain had resolved. Surgeons with more than 15 years of experience chose more conservative options. Twenty published studies were selected in the literature review. CONCLUSION: The optimal management of patients with compressive radiculopathy associated with a non-progressive motor loss remains unknown. The results of our survey show that surgeons with extensive surgical experience take a more conservative and cautious approach.

Percutaneous helical plate fixation in humeral shaft fractures with proximal extension.

BACKGROUND: Humeral shaft fractures with extension to the proximal third are increasingly frequent and technically more demanding. Surgical management of proximal metaphyseal junction humeral fractures is challenging. The aim of this study was to assess the safety, reproducibility, and possibility of early and completed rehabilitation in the percutaneous treatment with helical plates in humeral shaft fractures with proximal extension. PATIENTS AND METHODS: This was a descriptive, retrospective, single-centre cohort study based on consecutive patients with proximal metaphyseal junction humeral fractures (MIPO-helical-plate-Broggi's cohort). Surgical technique (minimally invasive approach and osteosynthesis): percutaneous treatment with a twisted plate (helical plates). STUDY VARIABLES: i): Intraoperative and postoperative (up to 1 year after surgery) safety; ii) Reproducibility of the surgical technique [number (percentage) of patients with surgical technique success]. The surgical technique success was defined as the recovering without neurovascular, implant failures and infection issues after one year follow up; and iii) Early and completed (3 months) rehabilitation [number (percentage) of patients]. A descriptive analysis was performed. RESULTS: Between April 2010 to January 2022, we received 443 humeral shaft fractures at our unit. Of these, 350 fractures were treated surgically. 157 (44.9%) were treated using the minimally invasive approach and osteosynthesis technique with extramedullary implants, of which 46 (46/157, 29.3%, 9 men and 37 women) were performed with almost orthogonally twisted Philos® helical plates. The median (range) age was 67 (51-94) years. STUDY OUTCOMES: i) Safety: None intraoperative events were gathered. No neurovascular, implant failure and infection issues were reported one year after surgery.; ii) Reproducibility of the surgical technique: only 1 failure (2%, 95%CI:0-11%), who was reoperated; and iii) Early and 3 month of rehabilitation was completed in 45 (98%, 95%CI:89-100%) patients. Forty-five (98%, 95%CI:89-100%) patients recovered their previous function the year after surgery. CONCLUSIONS: The treatment of humeral shaft fractures with proximal extension based on a minimally invasive approach and osteosynthesis: percutaneous treatment with a twisted plate (helical plates), as this is a submuscular and extraperiosteal technique, is a safe and reproducible technique, and promotes early rehabilitation. In our opinion, it is surgical technique whose main requirement is a good knowledge of topographic anatomy.

Measurement of apixaban concentrations in different human biological fluids by UHPLC-MS/MS. Clinical pharmacokinetic application in a subject with chronic kidney disease and nonvalvular atrial fibrillation on haemodialysis.

BACKGROUND: Apixaban's technical sheet does not recommend its use in clinical practice for patients with chronic kidney disease undergoing haemodialysis. However, recent studies indicate that apixaban could be a safe oral anticoagulant in these kinds of patients who do not present valvular atrial fibrillation. We developed and validated ultra-high-performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS) procedures for measuring apixaban concentrations in plasma, dialysate liquid, and urine. MATERIAL AND METHODS: Simple protein precipitation was implemented to prepare samples. Chromatographic separations were achieved on an Acquity®-UPLC®-BEHTM (2.1x100 mm id, 1.7 µm) reverse-phase C18 column using a water/acetonitrile non-linear gradient containing 0.1 % formic acid at a 0.4 mL/min flow rate. Apixaban and its internal standard (apixaban-d3) were detected by electrospray ionisation mass spectrometry in positive and multiple reaction monitoring modes, using transitions of 460.3 â†’ 199.0/443.2 and 463.3 â†’ 202.0, respectively. RESULTS: No significant interferences and carry-overs were observed. Precisions, absolute relative biases, normalised-matrix factors, and normalised recoveries were ≤ 12.2%, ≤8.0%, 94.3-105.1%, and 93.9-105.4%, respectively. Linearity was observed between 5 and 500 µg/L for plasma/dialysate liquid and 5-1000 µg/L for urine. CONCLUSIONS: The validated UHPLC-MS/MS procedures could help support a pharmacokinetic study in non-valvular atrial fibrillation subjects with chronic kidney disease undergoing haemodialysis and apixaban-based anticoagulant therapy.

Effect and safety of listening to music or audiobooks as a coadjuvant treatment for chronic pain patients under opioid treatment: a study protocol for an open-label, parallel-group, randomised, controlled, proof-of-concept clinical trial in a tertiary hospital in the Barcelona South Metropolitan area.

BACKGROUND: Chronic non-cancer pain (CNCP) treatment's primary goal is to maintain physical and mental functioning while improving quality of life. Opioid use in CNCP patients has increased in recent years, and non-pharmacological interventions such as music listening have been proposed to counter it. Unlike other auditive stimuli, music can activate emotional-regulating and reward-regulating circuits, making it a potential tool to modulate attentional processes and regulate mood. This study's primary objective is to provide the first evidence on the distinct (separate) effects of music listening as a coadjuvant maintenance analgesic treatment in CNCP patients undergoing opioid analgesia. METHODS AND ANALYSIS: This will be a single-centre, phase II, open-label, parallel-group, proof-of-concept randomised clinical trial with CNCP patients under a minimum 4-week regular opioid treatment. We plan to include 70 consecutive patients, which will be randomised (1:1) to either the experimental group (active music listening) or the control group (active audiobooks listening). During 28 days, both groups will listen daily (for at least 30 min and up to 1 hour) to preset playlists tailored to individual preferences.Pain intensity scores at each visit, the changes (differences) from baseline and the proportions of responders according to various definitions based on pain intensity differences will be described and compared between study arms. We will apply longitudinal data assessment methods (mixed generalised linear models) taking the patient as a cluster to assess and compare the endpoints' evolution. We will also use the mediation analysis framework to adjust for the effects of additional therapeutic measures and obtain estimates of effect with a causal interpretation. ETHICS AND DISSEMINATION: The study protocol has been reviewed, and ethics approval has been obtained from the Bellvitge University Hospital Institutional Review Board, L'Hospitalet de Llobregat, Barcelona, Spain. The results from this study will be actively disseminated through manuscript publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT05726266.

Feasibility of a multidisciplinary group videoconferencing approach for chronic low back pain: a randomized, open-label, controlled, pilot clinical trial (EN-FORMA).

BACKGROUND: Low back pain is a common condition that becomes even more prevalent with aging. A non-pharmacological multidisciplinary approach for chronic non-specific low back pain (CNSLBP) has been recommended, but integrating different healthcare professionals is challenging. A multidisciplinary group videoconferencing approach (MGVA) can be helpful. Our aim was to provide evidence on MGVA's feasibility in managing CNSLBP and its impact on clinical practice. METHODS: We conducted an open-label, randomized, controlled, parallel-group pilot clinical trial with CNSLBP patients irresponsive to conservative treatment. Patients between 18 and 67 years of age were randomly assigned (1:1) to either Standard-of-Care + MGVA (experimental group) or Standard-of-Care alone (control group). MGVA consisted of integrated sessions for physical rehabilitation/physiotherapy, psychology, and social work treatments. The control group received standard clinical practice treatment. The feasibility was assessed by the number of study procedures completed to at least 80% as planned. The impact on clinical practice was evaluated by the number of patients who changed their status from "candidate" to "non-candidate" to low back surgery as the treatment of choice for CNSLBP. The SF-36, Oswestry Disability Index, and TMMS-24 questionnaires were used. We performed a whole population-based descriptive analysis. RESULTS: We included 20 patients, but only 18 were randomized (2 withdrew consent before randomization). The mean (SD) age was 53.1 (5.9) years, and mostly women (13/18); 7 were actively employed. In the experimental group, 6/9 (67%, 95%CI:35-88%) patients attended at least 80% of the scheduled procedures, while in the control group, 8/9 (89%, 95%CI:57-98%) did. Additionally, 1 out of 4 (25%) patients in the experimental group changed their status from "candidate" for low back surgery to "non-candidate". None of the 2 patients in the control group did so. We found differences between groups in the SF-36 mental health component (p-value:0.061), Oswestry Disability Index (p-value:0.032), and TMMS-24 Repair component (p-value:0.014) at the end of the trial favoring MGVA. CONCLUSIONS: The multidisciplinary group videoconferencing approach to managing chronic non-specific low back pain was feasible, suggesting overall beneficial effects on patients' health and could play a role in changing a patient's status from "candidate" to "non-candidate" for surgery. TRIAL REGISTRATION: NCT05093543 (ClinicalTrials.gov), first registered in 26/10/2021.

Are iodophor-impregnated drapes associated with lower intraoperative contamination compared to no adhesive drape?: A protocol for systematic review and meta analysis.

BACKGROUND: Surgical site infection (SSI) is one of the most frightening complications after surgery. Adhesive drapes (AD) are widely used as an infection prevention tool. They can be non-impregnated or iodophor-impregnated, although non-impregnated are less used as they might be related to higher number of infections. One of the most common ways to study their efficacy is by analyzing the intraoperative contamination, which is a useful primary endpoint as it does not need follow-up and it has been strongly associated with infections. Therefore, we believe a systematic review (SR) and meta-analysis is needed to determine which is the literature available about this topic and to explore their results. METHODS: All randomized controlled trials (RCT) published since 1984 through to January 15, 2023 will be included. Non-human and experimental studies will be excluded. We will only include studies written in English. We will conduct searches in the following electronic databases: MEDLINE (via PubMed), SCOPUS and Web Of Science. The protocol of the SR was registered in PROSPERO under the number CRD42023391651 and was written according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocol guidelines. DISCUSSION: The evidence regarding the benefits of using iodophor-impregnated adhesive drapes (IIAD) is scarce. Therefore, this SR and meta-analysis is required to determine if they are related with a lower intraoperative contamination incidence, compared to no AD.

Indocyanine green angiography-guided thyroidectomy versus conventional thyroidectomy for preserving parathyroid function: study protocol for a randomized single-blind controlled trial.

Introduction: Angiography with indocyanine green (ICG) fluorescence performed before thyroidectomy would allow identification of the vascularization of parathyroid glands, maximizing efforts for preserving functioning glands intraoperatively. The rationale of the study was based on the hypothesis that showing the vascular pattern of the parathyroid glands by means of ICG angiography before performing the thyroidectomy could prevent permanent hypoparathyroidism. Methods and analysis: We propose a randomized single-blind controlled and multicenter clinical trial to assess the efficacy and safety of ICG angiography-guided thyroidectomy to identify the vascular pattern of the parathyroid glands versus conventional thyroidectomy in patients scheduled for elective total thyroidectomy. Patients will be randomized 1:1 to ICG angiography-guided thyroidectomy (experimental group) or conventional thyroidectomy (control group). Patients in the experimental group will undergo ICG angiography before thyroidectomy to identify the feeding vessels of the parathyroid glands and then, post-thyroidectomy ICG angiography to predict immediate parathyroid gland function by scoring the degree of fluorescence of the glands. Patients in the control group will undergo post-thyroidectomy ICG angiography only. The primary outcome measure will be the rate of patients with permanent hypoparathyroidism. Secondary outcome measures will be rate of postoperative hypoparathyroidism, the percentage of well vascularized parathyroid glands remaining in situ, the levels of iPTH and serum calcium after surgery and the influence of the type of vascular pattern of the parathyroid glands over these outcomes, as well as the safety profile of ICG angiography. Discussion: The results will contribute to adopt a new surgical strategy based on intraoperative ICG angiography before performing total thyroidectomy, according to which the rate of permanent hypoparathyroidism could be substantially reduced. Clinical trial registration: ClinicalTrials.gov. identifier NCT05573828.

Association of biological sex with clinical outcomes and biomarkers of Alzheimer's disease in adults with Down syndrome.

The study of sex differences in Alzheimer's disease is increasingly recognized as a key priority in research and clinical development. People with Down syndrome represent the largest population with a genetic link to Alzheimer's disease (>90% in the 7th decade). Yet, sex differences in Alzheimer's disease manifestations have not been fully investigated in these individuals, who are key candidates for preventive clinical trials. In this double-centre, cross-sectional study of 628 adults with Down syndrome [46% female, 44.4 (34.6; 50.7) years], we compared Alzheimer's disease prevalence, as well as cognitive outcomes and AT(N) biomarkers across age and sex. Participants were recruited from a population-based health plan in Barcelona, Spain, and from a convenience sample recruited via services for people with intellectual disabilities in England and Scotland. They underwent assessment with the Cambridge Cognitive Examination for Older Adults with Down Syndrome, modified cued recall test and determinations of brain amyloidosis (CSF amyloid-ß 42 / 40 and amyloid-PET), tau pathology (CSF and plasma phosphorylated-tau181) and neurodegeneration biomarkers (CSF and plasma neurofilament light, total-tau, fluorodeoxyglucose-PET and MRI). We used within-group locally estimated scatterplot smoothing models to compare the trajectory of biomarker changes with age in females versus males, as well as by apolipoprotein ɛ4 carriership. Our work revealed similar prevalence, age at diagnosis and Cambridge Cognitive Examination for Older Adults with Down Syndrome scores by sex, but males showed lower modified cued recall test scores from age 45 compared with females. AT(N) biomarkers were comparable in males and females. When considering apolipoprotein ɛ4, female ɛ4 carriers showed a 3-year earlier age at diagnosis compared with female non-carriers (50.5 versus 53.2 years, P = 0.01). This difference was not seen in males (52.2 versus 52.5 years, P = 0.76). Our exploratory analyses considering sex, apolipoprotein ɛ4 and biomarkers showed that female ɛ4 carriers tended to exhibit lower CSF amyloid-ß 42/amyloid-ß 40 ratios and lower hippocampal volume compared with females without this allele, in line with the clinical difference. This work showed that biological sex did not influence clinical and biomarker profiles of Alzheimer's disease in adults with Down syndrome. Consideration of apolipoprotein ɛ4 haplotype, particularly in females, may be important for clinical research and clinical trials that consider this population. Accounting for, reporting and publishing sex-stratified data, even when no sex differences are found, is central to helping advance precision medicine.

Usefulness of ICG Angiography-Guided Thyroidectomy for Preserving Parathyroid Function.

INTRODUCTION: Hypoparathyroidism is the most frequent complication after total thyroidectomy and, when permanent, it becomes a severe chronic disease. We assessed the usefulness of indocyanine green (ICG) angiography-guided thyroidectomy to reduce the postoperative hypocalcemia. METHODS: Prospective study with two consecutive cohorts of patients who underwent total thyroidectomy: historical control group (CG) and angiography-guided thyroidectomy group (AG). In all patients, ICG-angiography was performed at the end of the surgery to predict immediate parathyroid gland (PG) function. In the AG, ICG-angiography was also done after PG identification to show their vascular supply. We compared the rate of postoperative hypocalcemia (calcium supplementation needed due to hypocalcemia symptoms or calcium levels < 1.8 mmol/L on the first postoperative day) and permanent hypocalcemia (need of calcium ± vitamin D supplementation 12 months after thyroidectomy). RESULTS: We included 120 consecutive patients (84 CG; 36 AG). Thyroid cancer was the most common diagnostic (63.1% CG-69.4% AG; p = 0.646) and central neck dissection was also frequent (54.8% CG-64.3% AG; p = 0.468). The AG developed a lower rate of postoperative (26.2-5.6%; p = 0.011) and permanent hypocalcemia (11.9-0%; p = 0.032). The OR for permanent hypocalcemia was 0.673 (95% CI 0.591-0.766). A significant higher rate of well vascularized PG at the end of the surgery (score 2) in the AG (39.2-52.9%; p = 0.018) was also seen. CONCLUSION: ICG angiography-guided thyroidectomy is a useful tool to identify PG vascularization, allowing a better PG preservation and a significant decrease in hypocalcemia rates.

Predictive factors for resection and survival in type A borderline resectable pancreatic ductal adenocarcinoma patients after neoadjuvant therapy: A retrospective cohort study.

INTRODUCTION: Pancreatic cancer is the seventh leading cause of cancer-related death worldwide, and surgical resection with radical intent remains the only potentially curative treatment option today. However, borderline resectable pancreatic ductal adenocarcinomas (BR-PDAC) stand in the gray area between the resectable and unresectable disease since they are technically resectable but have a high probability of incomplete exeresis. Neoadjuvant treatment (NAT) plays an important role in ensuring resection success.Different survival prognostic factors for BR-PDAC have been well described, but evidence on the predictive factors associated with resection after NAT is scarce. This study aims to study if CA 19-9 plasmatic levels and the tumor anatomical relationship with neighboring vascular structures are prognostic factors for resection and survival (both Overall Survival and Progression-Free Survival) in patients with type A BR-PDAC. METHODS: This will be a retrospective cohort study using data from type A BR-PDAC patients who received NAT in the Bellvitge University Hospital. The observation period is from January 2010 until December 2019; patients must have a minimum 12-month follow-up. Patients will be classified according to the MD Anderson Cancer Center criteria for BR-PDAC. DISCUSSION: Patients with BR-PDAC have a high risk for a margin-positive resection. Serum Carbohydrate Antigen 19-9 plasmatic levels and vascular involvement stand out as disease-related prognostic factors.This study will provide valuable information on the prognostic factors associated with resection. We will exclude locally advanced tumors and expect this approach to provide more realistic resection rates without selecting those patients that undergo surgical exploration. However, focusing on an anatomical definition may limit the results' generalizability.

Groin surgical site infection incidence in vascular surgery with intradermal suture versus metallic stapling skin closure: A study protocol for a pragmatic open-label parallel-group randomized clinical trial (VASC-INF trial).

BACKGROUND: Surgical site infection is 1 of the most frightening complications in vascular surgery due to its high morbimortality. The use of intradermal sutures for skin closure might be associated with a reduction in infections incidence. However, the data available in the literature is scarce and primarily built on low-evidence studies. To our knowledge, no multicenter clinical trial has been published to assess if the intradermal suture is associated with a lower surgical site infection incidence than metallic staples in patients who will undergo revascularization surgery requiring a femoral approach. METHODS: VASC-INF is a pragmatic, multicenter, multistate (Spain, Italy, and Greece), randomized, open-label, clinical trial assessing the surgical site infection incidence in patients undergoing revascularization surgery requiring a femoral approach. Patients will be randomized on a 1:1 ratio to intradermal suture closure (experimental group) or to metallic staples closure (control group).The primary outcome is the number (percentage) of patients with surgical site infection (superficial and/or deep) associated with a femoral approach up to 28 (±2) days after surgery. Among the secondary outcomes are the number (percentage) of patients with other surgical wound complications; the number (percentage) of patients with surgical site infections who develop sepsis; type of antibiotic therapy used; type of microorganisms' species isolated and to describe the surgical site infection risk factors. DISCUSSION: Intradermal suture closure may be beneficial in patients undergoing revascularization surgery requiring a femoral approach. Our working hypothesis is that intradermal suture closure reduces the incidence of surgical site infection respect to metallic staples closure.

A pilot randomized controlled trial on the utility of gastric conditioning in the prevention of esophagogastric anastomotic leak after Ivor Lewis esophagectomy. The APIL_2013 Trial.

BACKGROUND: Anastomotic leakage (AL) after Ivor Lewis esophagectomy is associated with high morbidity and mortality. Preoperative gastric conditioning (GC) improves blood perfusion of the gastroplasty, one of the most important factors for anastomotic viability. This pilot randomized controlled trial aimed to evaluate the feasibility of GC before oesophageal surgery in patients with oesophageal cancer or Siewert I-II esophagogastric junction cancer, who required an Ivor Lewis esophagectomy. MATERIALS AND METHODS: This was a randomized (1:1), open-label, single-centre, controlled, parallel-group, pilot clinical trial. Two study groups: 1) GC-group: patients who underwent an Ivor Lewis esophagectomy and GC before surgery; 2) Surgery alone (SA)-group: patients who underwent only Ivor Lewis esophagectomy. Feasibility was assessed by means of the number of patients in whom a GC was performed, and the cumulative incidence of postoperative AL. Secondary endpoints were conduit necrosis (CN), hospital stay, morbidity, mortality, and anastomotic stricture. RESULTS: Between 2015 and 2018, 38 patients were randomized and analysed: 20 to GC-group and 18 to SA-group. 17 GCs (85%) were successfully performed, right gastric artery occlusion failed in three patients. Morbidity after GC occurred in 5/22 patients (all Clavien-Dindo ≤ IIIa). The cumulative incidence of AL was 15.0% (3/20, 95%CI: 5.2-36.0%) in GC-group and 33.3% (6/18, 95%CI: 16.3-56.3%) in SA-group, p-value: 0.184. CN: 0/20 vs. 1/18 (p-value: 0.474); surgical morbidity (Clavien-Dindo III-V): 7/20 vs. 12/18 (p-value: 0.070); hospital stay (median [range] days): 12 [9-45] vs. 27.5 [10-166] (p-value: 0.067). When only successful GCs (three arteries) were included for analysis, ischemia-related gastric conduit failure (AL and CN) was lower in the GC group (p-value: 0.041). CONCLUSIONS: Preoperative arteriographic GC before Ivor Lewis esophagectomy is a feasible and safe procedure and seems it may reduce AL in patients with oesophageal cancer or Siewert I-II esophagogastric junction cancer.

Use of failure-to-rescue after emergency surgery as a dynamic indicator of hospital resilience during the COVID-19 pandemic. A multicenter retrospective propensity score-matched cohort study.

BACKGROUND: Surgical failure-to-rescue (FTR, death rate following complications) is a reliable cross-sectional quality of care marker, but has not been evaluated dynamically. We aimed to study changes in FTR following emergency surgery during the COVID-19 pandemic. MATERIAL AND METHODS: Matched cohort study including all COVID-19-non-infected adult patients undergoing emergency general surgery in 25 Spanish hospitals during COVID-19 pandemic peak (March-April 2020), non-peak (May-June 2020), and 2019 control periods. A propensity score-matched comparative analysis was conducted using a logistic regression model, in which period was regressed on observed baseline characteristics. Subsequently, a mixed effects logistic regression model was constructed for each variable of interest. Main variable was FTR. Secondary variables were post-operative complications, readmissions, reinterventions, and length of stay. RESULTS: 5003 patients were included (948, 1108, and 2947 in the pandemic peak, non-peak, and control periods), with comparable clinical characteristics, prognostic scores, complications, reintervention, rehospitalization rates, and length of stay across periods. FTR was greater during the pandemic peak than during non-peak and pre-pandemic periods (22.5% vs. 17.2% and 12.7%), being this difference confirmed in adjusted analysis (odds ratio [OR] 2.13, 95% confidence interval [95% CI] 1.27-3.66). There was sensible inter-hospital variability in FTR changes during the pandemic peak (median FTR change +8.77%, IQR 0-29.17%) not observed during the pandemic non-peak period (median FTR change 0%, IQR -6.01-6.72%). Greater FTR increase was associated with higher COVID-19 incidence (OR 2.31, 95% CI 1.31-4.16) and some hospital characteristics, including tertiary level (OR 3.07, 95% CI 1.27-8.00), medium-volume (OR 2.79, 95% CI 1.14-7.34), and high basal-adjusted complication risk (OR 2.21, 95% CI 1.07-4.72). CONCLUSION: FTR following emergency surgery experienced a heterogeneous increase during different periods of the COVID-19 pandemic, suggesting it to behave as an indicator of hospital resilience. FTR monitoring could facilitate identification of centres in special needs during ongoing health care challenges.

Prevalence of HPV-DNA and E6 mRNA in lung cancer of HIV-infected patients.

HIV-infected individuals could be at a greater risk for developing lung cancer than the general population due to the higher prevalence in the former of human papillomavirus (HPV) in the oral cavity and higher smoking rates. Our aim was to assess HPV prevalence and E6 viral oncogene transcription in lung cancer samples from HIV-infected individuals. This was a single-center, retrospective study of a cohort of HIV-1-infected patients diagnosed with and treated for lung cancer. Pathological lung samples archived as smears or formalin-fixed paraffin-embedded blocks were subjected to HPV genotyping, detection of human p16 protein and assessment for HPV E6 mRNA expression. Lung cancer samples from 41 patients were studied, including squamous cell carcinoma (32%), adenocarcinoma (34%), non-small cell cancer (27%), and small cell cancer (7%). HPV DNA was detected in 23 out of 41 (56%, 95% CI 41-70%) of samples and high-risk (HR)-HPV types were detected in 16 out of 41 (39%, 95% CI 26-54%), HPV-16 being the most prevalent [13/16 (81.3%, 95% CI 57.0-93%]. In samples with sufficient material left: expression of p16 was detected in 3 out of 10 (30%) of HR-HPV DNA-positive tumors and in 3 out of 7 (43%) of the negative ones; and E6 mRNA was detected in 2 out of 10 (20%) of HPV-16-positive samples (squamous lung cancers). These two patients had a background of a previous HPV-related neoplasia and smoking. HR-HPV DNA detection was prevalent in lung cancers in HIV-infected patients. However, viral oncogene expression was limited to patients with previous HPV-related cancers.

A multicenter, open-label, randomized, proof-of-concept phase II clinical trial to assess the efficacy and safety of icatibant in patients infected with SARS-CoV-2 (COVID-19) and admitted to hospital units without invasive mechanical ventilation: study protocol (ICAT-COVID).

BACKGROUND: COVID-19 has quickly become a global pandemic with a substantial number of deaths and is a considerable burden for healthcare systems worldwide. Although most cases are paucisymptomatic and limited to the viral infection-related symptoms, some patients evolve to a second phase, with an impaired inflammatory response (cytokine storm) that may lead to acute respiratory distress syndrome and death. This is thought to be caused by increased bradykinin synthesis. METHODS: ICAT-COVID is a multicenter, randomized, open-label, proof-of-concept phase II clinical trial assessing the clinical efficacy and safety of adding icatibant to the standard of care in patients hospitalized with COVID-19 without invasive mechanical ventilation. Patients hospitalized with a confirmed COVID-19 pneumonia diagnosis (RT-PCR or antigen test ≤ 10 days prior to randomization, and radiographic evidence of pulmonary infiltrates), rated "4" or "5" on the WHO's clinical status scale, are eligible. Patients will be randomized on a 1:1 ratio to either standard of care-plus-icatibant (experimental group) or to standard of care alone (control group). The experimental group will receive 30 mg of icatibant subcutaneously 3 times a day for 3 days (for a total of 9 doses). The expected sample size is 120 patients (60 per group) from 2 sites in Spain. Primary outcomes are the efficacy and safety of Icatibant. The main efficacy outcome is the number of patients reaching grades "2" or "1" on the WHO scale within 10 days of starting treatment. Secondary outcomes include "long-term efficacy": number of patients discharged who do not present COVID-19-related relapse or comorbidity up until 28 days after discharge, and mortality. DISCUSSION: Icatibant, a bradykinin type 2 receptor antagonist with proven effectiveness and safety against hereditary angioedema attacks, may be beneficial for COVID-19 patients by inhibiting bradykinin's action on endothelial cells and by inhibiting the SARS-CoV-2 M protease. Our working hypothesis is that treatment with standard of care-plus-icatibant is effective and safe to treat patients infected with SARS-CoV-2 admitted to hospital for pneumonia without invasive mechanical ventilation. TRIAL REGISTRATION: EudraCT 2020-002166-13. CLINICALTRIALS: gov NCT04978051.

SPECT-CT metabolic and morphological study of 2 types of cemented hip stem prostheses in primary total hip arthroplasty patients: A protocol for a randomized controlled clinical trial (SPECT-PROTMA).

BACKGROUND: Cemented hip arthroplasty requires applying a layer of polymethylmethacrylate (cement) in the space between the bone and the prosthetic stem. This can be achieved using 2 techniques: the thick-layer technique (requires a layer of at least 2 mm to surround an undersized prosthetic stem), and the thin-layer technique (requires a thin layer of cement, so that the prosthetic stem fills the femoral medullary canal). Both approaches have excellent long-term clinical and radiological outcomes, although an implant's insertion into the bone generates inevitable bone mass and bone metabolic changes around it. Combination of single photon emission computed tomography and computed tomography scan (SPECT-CT) imaging combines the single photon emission computed tomography's ability to provide detailed bone metabolism assessment with the computed tomography scan's capacity to provide a meticulous anatomical study. METHODS: This is a single center, open label, randomized clinical trial, performed in the premises of the Bellvitge University Hospital. Participants will be randomly assigned to the Thick-layer technique group (Exeter V40 Cemented Femoral Stem) or to the French paradox technique group (Müller Straight Stem). All participants will have a SPECT-CT scan study at 3, 6, 12, and 24 months after the surgery. DISCUSSION: Surgical distress itself and the implant's insertion into the bone may cause microvascular changes that alter periprosthetic bone mass and bone metabolism. To the best of our knowledge, there are no studies using SPECT-CT to compare bone metabolism evolution in the postoperative period between these 2 surgical cementation techniques. We aim to provide information in this regard that could help decision making in complicated implant cases and, maybe, pave the way for larger, and methodologically improved studies. TRIAL REGISTRATION: NCT05010733 (August 18, 2021).