Medical Devices-Evidence and Research最新文献

Purpose: Pathologic hyperkeratosis due to skin thickness increase includes corn, callous, and bunion. These conditions can cause important pain and discomfort. Treatment relies on eliminating the cause of friction and/or rubbing. Moreover, hydrocolloid occlusive dressings rehydrate hard skin, leading to maceration, facilitating removal of dead skin. Our goal was to further confirm real-life clinical performance and benefits of COMPEED^® Foot Care plasters in providing pain/discomfort relief, protection and cushioning of corns, calluses and bunions.

Patients and methods: This was a non-interventional, longitudinal, multi-center investigation, conducted from July 2021 until February 2022, during which participants were enrolled in 36 community pharmacies in France. Eligible participants were ≥18 years old at enrolment, presented painful corn, callous and/or bunion on at least one foot, accepted to buy from the participating pharmacist at least one box of targeted COMPEED^® Foot Care plasters, to be used according to their instructions for use.

Results: Overall, 417 participants gave their consent to participate in the study, and analysis was performed on 391 participants: 199 with corn, 106 with callous, 87 with bunion, whose median age was, respectively, 55.0, 59.0 and 55.0 years old (overall ranging 20.0 to 94.0 years old). Among participants with either of the 3 conditions, 21.7-37.9% reported instant pain/discomfort relief upon plaster application and an increasing number of participants with corns, calluses or bunions reported pain/discomfort elimination over the 21-days follow-up period. Significant increases in pressure relief and cushioning were also observed during follow-up in all 3 conditions. Median duration of plasters was 3 days. At study end, 66.0% of participants with calluses and up to 73.0% with corns reported their condition was removed.

Conclusion: This investigation demonstrated and confirmed COMPEED^® Foot Care plasters clinical benefits in pain/discomfort and pressure relief, cushioning against rubbing/friction of corns, calluses and bunions, and adhesion to skin, in the general population.

Objective: To evaluate the efficacy and safety of the SUPRAtube innovation device in preventing ventilator associated events and fluid accumulation in the supraglottic region in patients receiving mechanical ventilation (MV) through orotracheal tubes.

Methods: Multicenter, controlled, randomized, parallel, open-label clinical trial with a 1:1 allocation ratio of MV patients compared the use of the SUPRAtube elastomeric device with standard care and aspiration techniques. A series of computer-random numbers and centralized allocation with sealed envelopes were used.

Setting: Adult patients (n=108; mean age: 63 yrs, range: 19-85) hospitalized in intensive care units of two centers, the Cardiovascular Foundation of Colombia and the International Hospital of Colombia (Santander, Colombia), were included. All patients received MV through orotracheal tubes, were hemodynamically stable, had upper airway integrity according to fiberoptic bronchoscope findings, and had basic coagulation tests within acceptable risk criteria.

Interventions: Comprehensive standard of care, including preventive strategies, medical therapy, positive pressure MV, and routine procedures for management of oropharyngeal and pulmonary secretions (humidification, patient mobilization, and airway suctioning), was compared with the standard of care plus continuous supraglottic suction with the new SUPRAtube device.

Results: The study period reached five days before extubation (media 85±7 hours). The weight of the aspirated content was 415 g (P25;P75: 396;536) in the control group and 624 g (P25;P75: 469;824) in the SUPRAtube group (p<0.001), equivalent to a mean difference of 213 g (P₂₅;P₇₅: 55;569; +50%). The device did not induce adverse events.

Conclusion: Continuous supraglottic aspiration using SUPRAtube is complementary, effective, safe, simple, and inexpensive and reduces the accumulation of oropharyngeal secretions in mechanically ventilated patients. The relevant clinical benefit in terms of preventing and improving tracheobronchitis earlier on was demonstrated by sequential fiberoptic bronchoscopy.

Registration in clinical trials: The present study is registered at clinicaltrials.gov NCT03573609.

Purpose: The present retrospective study delivers first results after the use of a pedicle based, screw and peek rod system. Emphasis was placed on the ability of the construct to prevent adjacent segment disease at an average of 5 years follow-up by maintaining a certain degree of movement in the index segment. This was evaluated via functional X Rays before and after surgery.

Patients and methods: The cohort comprised 100 patients which received decompressive surgery in one or more segments with dynamic instrumentation for stenosis of the lumbar spinal canal and degenerative spondylolisthesis. We analyzed diagnostic imagery including functional X Rays prior and after surgery as well as cohort demographics such as reoperation rate, complications and overall patient satisfaction.

Results: The average age was 68 years, at 58 months follow-up there were 43 cases of radiological adjacent segment disease. We defined a radiological ASD as an increase of the osteoarthritis on the Wiener scale and stenosis of the spinal canal on the MRI scans. In our cohort 80 patients benefited from the surgery, either being pain free or having improved symptoms at the mean follow-up with the others either requiring renewed surgery or having developed clinically significant ASD. There was no significant statistical correlation between area of spinal canal, gender and outcome.

Conclusion: In one segment constructs the system being evaluated showed no major disadvantage when compared to similar non-fusion pedicle-based techniques nor was it able to consequently prevent ASD. Under the clinical point of view there was in our opinion no marked benefit when compared against decompressive surgery and fusion as the accepted standard. Regarding the multi segment instrumentation further larger number studies are needed to reach a conclusion.

Aim: Describe the role of dedicated ultrasound in evaluating breast implants compared to breast magnetic resonance.

Materials and methods: A prospective observational study was conducted in a single center to evaluate breast implant complications in patients referred to breast magnetic resonance (MRI) scan. All patients who had breast implants submitted to MRI scan were invited to a complementary dedicated ultrasound (US) evaluation of the breast implants. The implant changes were classified following a dedicated protocol. The classifiers used to evaluate the implant include evaluation of implant surface (shell), implant internal content homogeneity, fibrous capsule, intracapsular space, pericapsular space, and axillary extension.

Results: Preliminary results included evaluating 29 consecutive patients who underwent MRI. Twenty-nine patients with 49 implants were included in the study. The US showed a superior ability to assess the internal contents of the implants, the implant surface, and the intracapsular contents. There were no significant statistical differences in evaluating macro changes such as implant location, intracapsular collection, and radio-frequency identification (RFID) presence. MRI was superior to the US in classifying the fibrous capsule type.

Conclusion: US of silicone implants can be used as an alternative to MRI to evaluate implant complications.

Purpose: Determining the best suture for wound closure in high-tension areas by anatomical site and procedure type remains a challenge. This study assessed the cumulative incidence of clinical outcomes among patients undergoing procedures incorporating the STRATAFIX Symmetric PDS™ Plus Knotless Tissue Control Device (STRATAFIX Symmetric) for closure of high-tension areas, such as the abdominal fascia and hip and knee joint capsule, in the course of routine clinical practice.

Patients and methods: Patients undergoing open abdominal or orthopedic surgery between October 1, 2016, and October 31, 2023, using size 0 or 1 STRATAFIX Symmetric were identified from the Premier Healthcare Database. The cumulative incidences of 30-day internal wound dehiscence and 30-day surgical site infection (SSI) were measured. To contextualize the results, a targeted literature search of articles published between October 2016 and April 2024 describing the use of STRATAFIX Symmetric for wound closure in the abdominal fascia or joint capsule was performed.

Results: A total of 8156 patients undergoing open abdominal surgery and 25,807 patients undergoing open orthopedic surgery met the study criteria. In the abdominal surgery cohort, the cumulative incidences of 30-day internal wound dehiscence and SSI were 0.65% (95% CI: 0.49%, 0.85%) and 3.54% (95% CI: 3.15%, 3.97%), respectively. The overall cumulative incidences of 30-day internal wound dehiscence and SSI in the orthopedic surgery cohort were 0.07% (95% CI: 0.04%, 0.11%) and 0.58% (95% CI: 0.49%, 0.68%), respectively. These findings were within the range of clinical outcomes reported in 12 articles identified during the targeted literature search.

Conclusion: The cumulative incidence of 30-day internal wound dehiscence and SSI among patients undergoing abdominal and orthopedic procedures incorporating STRATAFIX Symmetric for wound closure of high-tension areas was low and comparable to prior literature.

Purpose: The new Medical Device Regulations (MDR) in Europe represent unprecedented challenges for researchers in academic environments. Adherence to regulatory frameworks, like the Medical Device Directive (MDD), was mostly relevant for projects nearing commercialization. However, the MDR now extends its reach into the preliminary phases of pre-clinical research, imposing new challenges and necessitating compliance for any clinical investigation involving medical device safety or performance.

Methods: We have systematically engineered and implemented a Quality Management System (QMS) tailored to meet the distinct needs of academic institutions. Our objective was to establish a comprehensive framework that enable our research group to comply with MDR without hindering innovation and discovery. Specifically, we engineered a traditional commercial QMS aligned with ISO13485 to fulfill academic needs. We ensured the QMS focused on requirements relevant to pre-market clinical investigations and considered appropriate roles for an academic setting.

Results: We present an optimized QMS implementation to satisfy the urgent need for research institutions to align with the MDR. Notably, our efforts yielded demonstrable results, culminating in the successful approval of research projects by the Swedish Medical Product Agency (MPA). This achievement stands as a testament to the impact of our work within the regulatory landscape.

Conclusion: Here, we share the insights and challenges we encountered during the implementation of an appropriate and efficient QMS for academic research, which we believe can serve as a guiding example for other academic research groups. By presenting our QMS implementation validated by an MPA clinical investigation approval, we aim to raise awareness about the pivotal importance of MDR compliance among researchers in Europe. Our contribution seeks to provide a roadmap for fellow research groups in navigating the evolving regulatory landscape while sustaining their focus on groundbreaking research and innovation in the field of biomedical engineering.

Background: The clinical methods of diagnosing pneumonia have been for many years chest X-rays (CXR) and computed tomography (CT) scans. However, a relatively new modality that is promising, efficient, and cheap is the lung ultrasound (LUS). The scope of this systematic review focuses on evaluating the diagnostic performance of LUS, CXR, and CT for diagnosing pneumonia.

Objective: The first aim of this review is to assess the diagnostic accuracy of lung ultrasound in comparison with chest X-rays and CT scans.

Methods: PubMed, Cochrane, Embase, and Scopus were electronically searched without date and language limitations were set. Inclusion criteria covered only those diagnostic studies that involved comparing lung ultrasound, chest X-ray, and CT scans in human beings with suspected pneumonia. Both abstraction and quality of studies were assessed by two researchers and the quality was assessed using PRISMA and QUADAS-2 checklists.

Results: There were 13 empirical studies included in the review which referred to different patients and contexts. Although none of the imaging techniques could achieve both high sensitivity and high specificity, CT scans produced the highest sensitivity, with values higher than 95% on all occasions, and specificities ranging between 80% and 90%. Lung US was most helpful in pediatric and acute care populations, whereas CT was preferred when there was uncertainty regarding the presentation.

Conclusion: Lung ultrasound is a very sensitive, specific, practical method of subsequent lung examination; it is useful in environments that need fast bedside assessment and for patients particularly vulnerable to radiation exposure, such as children. Even though chest X-ray remains valuable in excluding pneumonia in outpatient practices, it lacks sensitivity and is therefore less useful in diagnosing early disease. Computed tomography scans are the most accurate type of scans but should only be used in the more severe interventions due to cost and radiation exposure.

Purpose: Laser surgery can use photo-chemical, photo-thermal, photo-ablative, and photo-mechanical effects to treat various tissues in the human body, and has unique advantages of extremely high precision, non-invasive penetration, and fast operation speed. However, at present, the effective penetration depth of directly illuminating light in the body is only several millimeters. Therefore, increasing the safe operating depth for non-invasive laser surgery will have important, widespread, and irreplaceable applications in the future.

Methods: The method is based on improving a recently emerged technique. Its principle involves using a negative dispersion device to broaden the width of the short light pulse first. Then, after the pulse enters the body, as its peak intensity is reduced, the skin and healthy tissues in the laser propagation path cannot be injured. Meanwhile, since body tissues have positive dispersion, the broadened width of the laser pulse will be shortened back. When the broadened pulse is completely shortened, a thin inner light layer with high intensity will be formed in the body and used as a scalpel to treat target tissue.

Results: The theoretical calculation results have shown that the designed apparatus has excellent performance. Its safe non-invasive operating depth can be more than 70 millimeters with the possibility of up to 130 millimeters. Surgery precisions are around 1 micron transversely and about 1 millimeter longitudinally in theory.

Conclusion: An improved method of non-invasive laser surgery with deep operation depth has been investigated theoretically. The calculations show that the designed apparatus has excellent performance. The proposed method depends on two well-known physical phenomena: light pulse broadening and shortening caused by optical negative and positive dispersions, and thus has solid basis. The developed method will have important, widespread and irreplaceable applications in the medical surgery field.

Background: The burden of neurological disorders in low- and middle-income countries (LMICs) may be underestimated due to the limited number of diagnostic imaging devices and trained specialists to operate and interpret scans. Recent advancements in low-field (<100 milliteslas) magnetic resonance imaging (LFMRI) hold significant promise for improving access to pediatric neuroimaging due to the technology's lower costs, portability, and reduced infrastructure and training requirements.

Purpose: Explore user needs and experiences on the training and use of a portable LFMRI for pediatric neuroimaging in LMICs.

Methods: We conducted qualitative interviews with end users of the LFMRI systems across 11 sites in Bangladesh, Ethiopia, Ghana, Malawi, Pakistan, South Africa, Uganda, and Zambia. A semi-structured questionnaire with open-ended questions on usability and feasibility was used to encourage participants to share their experiences and opinions on ease of use, user satisfaction, and integration into local health systems.

Results: Among 46 participants, key challenges were reported in infant positioning, power stability, and internet connectivity. Suggestions included developing reference materials with content and format tailored to local needs and contexts, conducting refresher trainings, and providing education that includes technical and maintenance support crucial for appropriate utilization and implementation sustainability.

Conclusion: This study underscores the importance of incorporating human-centered design principles and user feedback into identifying and resolving usability issues, sharing insights for successful integration of LFMRI within existing health care infrastructures in LMICs, and optimizing LFMRI use for pediatric populations.

Introduction: Sedatives and anesthetics can modify airway tone and induce respiratory depression, exacerbating the gas exchange impairments associated with obesity. In obese patients undergoing gastrointestinal endoscopy, upper airway obstruction and hypoventilation are prevalent, leading to frequent occurrences of hypoxemia during the procedure. This study aims to investigate the effects of the nasopharyngeal airway in mitigating hypoxemia via alleviating upper airway obstruction in obese outpatients during painless gastrointestinal endoscopy procedure.

Methods: This is a prospective single-center randomized controlled study. After signing the written informed consent, eligible outpatients scheduled for painless gastrointestinal endoscopy will be randomly allocated into the nasopharyngeal airway group (group N) and control group (group C), with 88 patients in each group. Patients in group N will undergo intubation of the nasopharyngeal airway prior to examination, whereas patients in group C will receive oxygen therapy through an endoscopic respiratory mask at a flow rate of 10 L/min during the procedure. All patients in two groups will receive propofol and opioids for procedural sedation. The primary outcome will be the incidence of hypoxemia. The secondary outcomes will be the incidence of epistaxis, suspended examination due to hypoxemia, manual ventilation, the times of attempt to nasopharynx airway insertion, duration of insertion of nasopharyngeal airway, tracheal/laryngeal mask intubation, adverse cardiovascular events, gastrointestinal complications, VAS score of nasopharynx pain after removing the nasopharyngeal airway, satisfaction score of patients, endoscopist and anesthesiologists.

Discussion: This study evaluates the effects of nasopharyngeal airway insertion on hypoxemia caused by procedural sedation in obese patients undergoing gastrointestinal endoscopy. The results of this study are expected to provide evidence for the use of nasopharyngeal airway in obese outpatients.

Trial registration number: ChiCTR2300078892.