Xiuhe Zou,1,* Ting Zhang,2,* Wenxin Zhao,3 Yijun Wu,4 Wei Wei,5 Xiubo Lu,6 Changsheng Teng,7 Tao Huang,8 Meiping Shen,9 Niels-Derrek Schmitz,10 Bogdan Ilie,11 Shun Qu,12 Hao Zhang21Department of Thyroid Surgery, West China Hospital of Sichuan University, Chengdu, Sichuan, People’s Republic of China; 2Department of Thyroid Surgery, The First Hospital of China Medical University, Shenyang, Liaoning, People’s Republic of China; 3Department of Thyroid Surgery, Fujian Medical University Union Hospital, Fuzhou, Fujian, People’s Republic of China; 4Department of Thyroid Surgery, The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, People’s Republic of China; 5Department of Breast and Thyroid surgery, Peking University Shenzhen Hospital, Shenzhen, Guangdong, People’s Republic of China; 6Department of Thyroid Surgery, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, People’s Republic of China; 7Department of General Surgery, Beijing Friendship Hospital of Capital Medical University, Beijing, People’s Republic of China; 8Department of Breast and Thyroid surgery, Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, Hubei, People’s Republic of China; 9Department of General Surgery, Jiangsu Province Hospital, Nanjing, People’s Republic of China; 10Johnson and Johnson MEDICAL GmbH, Norderstedt, Germany; 11Ethicon, Inc., A Johnson and Johnson Company, Somerville, NJ, USA; 12Johnson and Johnson Medical (Shanghai) Co., Ltd., Shanghai, People’s Republic of China*These authors contributed equally to this workCorrespondence: Hao Zhang, Department of Thyroid Surgery, The First Hospital of China Medical University, No. 155, Nanjing North Street, Heping District, Shenyang, Liaoning, People’s Republic of China, Tel +86 18804039999, Email haozhang@cmu.edu.cnPurpose: This study aimed to evaluate the safety and effectiveness of two types of absorbable barbed sutures, STRATAFIXTM Spiral PDSTM Plus and STRATAFIXTM Spiral MONOCRYLTM Plus, compared with traditional sutures made of the same material in the suturing of thyroid surgery incision.Patients and Methods: This study was a multicenter, prospective, evaluator-blinded, three-arm, non-inferiority, randomized controlled design study with a planned enrollment of 501 patients undergoing open thyroid surgery. Subjects were randomized to Spiral PDS Plus group, Spiral MONOCRYL Plus group, or the control group, according to the allocation ratio of 1:1:1. The primary endpoint was the success rate of subjects achieving grade A healing of surgical incisions 5– 7 days after surgery.Results: A total of 500 subjects were randomized in this study. The PP analysis was considered the primary analysis, while the FAS analysis was considered supportive. In the PPset, which included 154 subjects in Spiral PDS Plus group, 157 subjects in Spiral MONOCRYL Plus group, and 156 subjects in the control group, the grade A wound healing success rates were 99.4%, 98.7%, and 99.4%, respectively. The differences [Wald 95% CI] in success percentage between the two investigation groups and the control group were − 0.01% [− 1.79%, 1.77%] and − 0.63% [− 2.79%, 1.52%], respectively. Both Spiral PDS Plus and Spiral MONOCRYL Plus were found to be non-inferior to control in achieving Grade A healing of surgical incision (0.05 margin, p < 0.0001 for both).Conclusion: This study demonstrated the short-term safety and efficacy outcomes of using STRATAFIXTM Spiral PDSTM Plus and STRATAFIXTM Spiral MONOCRYLTM Plus sutures in the suturing of thyroid surgery incision, with acceptable risk-benefit.Keywords: antibacterial barbed suture, multilayer wound closure, three-arm RCT, wound healing
Purpose:Experimental studies have shown that the olfactory sensory receptor neurons not only identify odors and assess odor concentrations, but also act as respiratory mechanical sensors that respond to nasal airflow during breathing. Both odor detection and mechanical sensing appear mediated by a shared cellular mechanism. This prospective, single-arm, uncontrolled, pilot study was conducted to ascertain whether olfactory nerve mechanical stimulation provided by a nasal breathing oscillation device (Goodair Nosebuds) could influence olfaction when olfaction was assessed objectively. The study was performed on participants, who felt that their olfaction could be improved. Methods:Participants wore a nasal breathing oscillation device (Goodair Nosebuds) ten minutes twice a day for four weeks. At the beginning of the study and after four weeks, the participants' olfaction was assessed. Olfactory testing was performed using Sniffin' Sticks (phenyl ethyl alcohol threshold, odor discrimination and odor identification). Results:After four weeks, participants using the nasal breathing oscillation device (Goodair Nosebuds), had an increase in olfactory function in phenyl ethyl alcohol threshold, and odor identification when compared to baseline. The global olfactory score (the sum of the three scores) increased. Conclusion:This prospective, single-arm, uncontrolled, pilot study indicates that olfactory nerve mechanical stimulation was associated with an improvement in olfactory scores. Trial Registration:The study was registered with the Australian New Zealand Clinical Trials Registry (ANZCTR; ACTRN12625001131448).
Background:The coordination gap between the Central Sterile Supply Department (CSSD) and the Operating Room (OR) in surgical consumables management has become a bottleneck constraining surgical turnover and patient safety, yet existing digital implementations remain largely fragmented. Objective:This study aims to propose a conceptual framework for CSSD-OR consumable collaborative management based on information ecology theory, and to synthesize the integration pathways of key digital technologies. Methods:Using information ecology theory as the analytical framework (encompassing information, technology, human actors, and environment), this paper synthesizes the current literature on UDI, RFID, SPD models, data middleware, machine learning, and blockchain technologies in the CSSD-OR context. An integrated analytical framework is constructed by incorporating supply chain integration theory and socio-technical systems theory. Results:Information chain ruptures were identified at three critical nodes: distribution-receiving, usage-billing, and recycling-reprocessing. A three-tier analytical framework is proposed, comprising a foundation layer (information chain integration), an intermediate layer (technology-process adaptation), and a guarantee layer (institutional-performance synergy). The "collection-transmission-processing-feedback" closed-loop mechanism is conceptualized as the core operational logic linking material flows, risk warning, and responsibility traceability. Conclusion:The digital transformation of CSSD-OR consumable management requires systematic restoration of information ecosystem imbalances rather than isolated technology deployment. The proposed framework offers a theoretical reference for hospitals seeking to move beyond technology stacking toward ecological collaboration, particularly within the Chinese healthcare context where UDI mandates and DRG/DIP reforms are ongoing.
Background and Objective:Evaluation of new plateletpheresis devices across diverse donor populations traditionally relies on extensive multicenter clinical studies. This study proposes a physiology-based evaluation framework that integrates physiological modeling with external clinical observations to provide preliminary evidence for cross-population applicability. Methods:Physiological operating envelopes were derived from published anthropometric and hematological data together with established transfusion medicine principles. The framework was externally validated using published observations from the mature MCS+ plateletpheresis platform. The preliminary framework was subsequently applied to the NGL XF3000 by comparing its operating specifications and available clinical observations with the validated operating envelopes. Results:The predicted operating envelopes accommodated physiological variation across major ethnic populations and were consistent with the operating characteristics of both the MCS+ platform and the NGL XF3000. Published MCS+ observations supported the physiological assumptions underlying the framework, while the available NGL XF3000 data were comparable with published reference observations regarding blood component changes and remained within the validated performance envelope. Conclusion:The proposed framework provides a physiology-based, resource-efficient approach for the preliminary evaluation of plateletpheresis devices before large-scale clinical validation. By integrating mechanistic modeling with external clinical evidence, it may facilitate the regulatory assessment of new devices intended for use across diverse donor populations.
Background and Rationale:Various guidance techniques can be performed under ultrasound (US), computed tomography (CT), fluoroscopy, and magnetic resonance imaging (MRI) guidance; They pave the way for simple, intermediate, and complex minimally invasive procedures by improving visualization of the target, the access route, and device progression. Objective:This study aimed to evaluate the availability and utilization of radiological guidance tools in interventional radiology units in Kinshasa, Democratic Republic of the Congo. Materials and Methods:This descriptive study was conducted in selected medical facilities in Kinshasa. Data were collected from January 2018 to June 2024 using a structured questionnaire and medical record review. Eligible cases included patients who underwent semi-invasive diagnostic or therapeutic interventional radiology procedures performed under direct imaging guidance, with acceptable hemostatic parameters and documented informed consent. The evaluated outcomes included the type of radiological guidance used, anatomical or disease target, procedure complexity, and procedure-related incidents. Data were analyzed using descriptive statistics. Categorical variables were summarized as frequencies and percentages, and continuous variables were summarized as means and standard deviations when applicable. Results:A total of 471 image-guided interventional radiology procedures were analyzed. The evaluated cases involved a range of anatomical and disease-related targets, including liver, breast, thyroid, prostate, spinal, cervical soft-tissue, splenic, pancreatic, renal, lymph-node, and other abdominal or soft-tissue lesions. Female patients represented 55.3% of the study population. Among the 471 interventional radiology procedures analyzed, age was available for 469 cases. The mean age was 48.2 ± 17.2 years, with a range of 1 to 84 years. Ultrasound was the most frequently used guidance modality, accounting for 384 procedures (81.5%), followed by CT guidance in 63 procedures (13.4%) and fluoroscopic guidance in 24 procedures (5.1%). Cone-beam CT guidance was not used. Simple interventional radiology procedures were the most common, accounting for 327 procedures (69.4%), followed by intermediate procedures in 126 cases (26.8%) and complex procedures in 18 cases (3.8%). Conclusion:This study shows that ultrasound guidance remains the most commonly used radiological guidance method in interventional radiology settings in Kinshasa. However, MRI, fluoroscopy-CT, electromagnetic, and cone-beam CT guidance were not used in this series. These findings provide baseline local evidence on current technical capacity and unmet equipment needs, and may help guide future planning and development of interventional radiology services in the Democratic Republic of the Congo.
Frederick Tshibasu Tshienda,1 Tasnime Hamdeni,2 Jean Mukaya Tshibola,1 Antoine Molua Aundu,1 Jean-Marie Kayembe Ntumba,3 Jean Marie Mbuyi Muamba41Division of Diagnostic Imaging, University Hospital of Kinshasa, School of Medicine, University of Kinshasa, Kinshasa, Democratic Republic of the Congo; 2Statistics’ Department, Higher School of Statistics and Information Analysis (ESSAI), University of Carthage, Tunis, Tunisia; 3Department of Internal Medicine, Division of Pulmonology, University Hospital of Kinshasa, School of Medicine, University of Kinshasa, Kinshasa, Democratic Republic of the Congo; 4Department of Internal Medicine, Division of Rheumatology, University Hospital of Kinshasa, School of Medicine, University of Kinshasa, Kinshasa, Democratic Republic of the CongoCorrespondence: Frederick Tshibasu Tshienda, Division of Diagnostic Imaging, University Hospital of Kinshasa, School of Medicine, University of Kinshasa, Kinshasa, Democratic Republic of the Congo, Email fredtshibasu@gmail.comBackground and Rationale: Various guidance techniques can be performed under ultrasound (US), computed tomography (CT), fluoroscopy, and magnetic resonance imaging (MRI) guidance; They pave the way for simple, intermediate, and complex minimally invasive procedures by improving visualization of the target, the access route, and device progression.Objective: This study aimed to evaluate the availability and utilization of radiological guidance tools in interventional radiology units in Kinshasa, Democratic Republic of the Congo.Materials and Methods: This descriptive study was conducted in selected medical facilities in Kinshasa. Data were collected from January 2018 to June 2024 using a structured questionnaire and medical record review. Eligible cases included patients who underwent semi-invasive diagnostic or therapeutic interventional radiology procedures performed under direct imaging guidance, with acceptable hemostatic parameters and documented informed consent. The evaluated outcomes included the type of radiological guidance used, anatomical or disease target, procedure complexity, and procedure-related incidents. Data were analyzed using descriptive statistics. Categorical variables were summarized as frequencies and percentages, and continuous variables were summarized as means and standard deviations when applicable.Results: A total of 471 image-guided interventional radiology procedures were analyzed. The evaluated cases involved a range of anatomical and disease-related targets, including liver, breast, thyroid, prostate, spinal, cervical soft-tissue, splenic, pancreatic, renal, lymph-node, and other abdominal or soft-tissue lesions. Female patients represented 55.3% of the study population. Among the 471 interventional radiology procedures analyzed, age was available for 469 cases. The mean age was 48.2 ± 17.2 years, with a range of 1 to 84 years. Ultrasound was the most frequently used guidance modality, accounting for 384 procedures (81.5%), followed by CT guidance in 63 procedures (13.4%) and fluoroscopic guidance in 24 procedures (5.1%). Cone-beam CT guidance was not used. Simple interventional radiology procedures were the most common, accounting for 327 procedures (69.4%), followed by intermediate procedures in 126 cases (26.8%) and complex procedures in 18 cases (3.8%).Conclusion: This study shows that ultrasound guidance remains the most commonly used radiological guidance method in interventional radiology settings in Kinshasa. However, MRI, fluoroscopy-CT, electromagnetic, and cone-beam CT guidance were not used in this series. These findings provide baseline local evidence on current technical capacity and unmet equipment needs, and may help guide future planning and development of interventional radiology services in the Democratic Republic of the Congo.Keywords: radiological guidance, puncture-drainage, interventional radiology – Kinshasa, DRC
Objective:Objective was to compare spring-driven mechanical and electronic infusion systems used for subcutaneous immunoglobulin (SCIg) therapy in patients with primary or secondary immunodeficiency (PID, SID) and chronic inflammatory demyelinating polyneuropathy (CIDP), with a focus on local infusion-site reactions and reliable dose delivery. Methods:A structured literature review was conducted (PubMed, Cochrane Library, Google Scholar; January 26, 2026). Eligible studies reported safety outcomes. As direct measures of dose delivery were not consistently reported, infusion system performance was evaluated using pharmacodynamic response, with immunoglobulin G (IgG) levels at the end of the study period considered an indicator of successful dose delivery. Data were extracted and descriptively aggregated across studies. Risk of bias was appraised using validated tools appropriate to study design. Results:Fourteen studies met the inclusion criteria (4 mechanical, 10 electronic). Mechanical infusion systems were associated with lower reported proportions of local infusion-site reactions, including swelling (23.1% vs 61.4%), redness (28.6% vs 44.0%), and soreness (22.9% vs 50.0%) compared with electronic infusion systems. Variability across studies was substantial, likely reflecting differences in patient populations, immunoglobulin formulations, infusion protocols, publication era, and outcome reporting methods. Across studies, both mechanical and electronic infusion systems achieved IgG levels consistent with therapeutic targets, supporting effective SCIg delivery. Conclusion:Mechanical infusion systems were associated with consistently lower reported rates of local infusion-site reactions compared with electronic infusion systems in this descriptive synthesis, while both system types effectively achieved IgG levels consistent with adequate dose delivery. Although variability across studies warrants cautious interpretation, the overall pattern suggests a favorable tolerability profile for mechanical systems. Device selection should remain individualized, and further comparative research is warranted.
Purpose:Antimicrobial resistance (AMR) complicates surgical site infections (SSI), making it important to address surgical bleeding and bacterial bioburden. Oxidized regenerated cellulose (ORC) is a topical hemostat that generates a localized acidic microenvironment hostile to the survival of microbes. The present study evaluated the intrinsic antibacterial action and wound healing results of a commercial ORC-based hemostat in an infected wound environment. Methods:In vitro and in vivo experimental designs were used to evaluate the antibacterial activity. An in vitro experiment was designed to show inhibition zones against 32 Gram-positive and Gram-negative bacterial strains, including antibiotic-resistant pathogens, compared to the negative control. In vivo efficacy was tested in a Wistar rat excisional wound model (n = 42), in which polymicrobial inoculation was performed with the same bacterial strains, and animals allocated to specific groups were monitored for hemostasis time, wound contraction, clinical observations, and histopathology over 28 days. Results:Using an agar diffusion method, ORC hemostat exhibited in vitro antibacterial activity against all the 32 tested strains. In vivo, hemostasis time was significantly reduced in the test groups compared to that in the disease control group (adjusted p < 0.001), achieving hemostasis within 42.2-54 seconds. Similarly, wound healing was statistically significant for the test specimens, achieving up to 88.5% wound closure by day 28 (adjusted p < 0.001). Histopathological analysis after 28 days revealed complete re-epithelialization of the wound bed and reduced inflammatory infiltration. Conclusion:Within the study limitations, the commercial ORC-based hemostat (Surgi-ORC®) exhibited inherent antibacterial potential against various pathogens including antimicrobial-resistant organisms and provided rapid hemostatic action. These preclinical findings suggest that ORC may help reduce microbial burden, support wound healing along with tissue regeneration. Further clinical studies are warranted to establish the relevance of these observations in surgical practice.
Background:Medical oxygen delivery systems require adaptable connection interfaces capable of supporting different clinical configurations during oxygen therapy. Integrating multifunctional connection mechanisms within a single component offers an opportunity to improve system versatility and connection management in respiratory care settings. Objective:To design and experimentally validate a novel dual-connection fitting for medical oxygen delivery, designated as the O2 Mixed Fitting, that enables simultaneous attachment of both a bubble humidifier and conventional oxygen tubing while remaining installed on the flowmeter. Methods:A comprehensive state-of-the-art review informed the conceptual development of the device. Iterative design refinement was performed using computer-aided design. The final device was manufactured by injection molding using medical-grade Acrylonitrile Butadiene Styrene. Validation included gas flow analysis, leak and pressure-holding tests, microbiological and physical stability evaluation under controlled climatic conditions, and sustainability assessment using a structured eco-design framework. Results:The integrated dual-connection mechanism enabled transition between humidified and non-humidified oxygen delivery without detachment from the flowmeter. Gas flow measurements remained within predefined accuracy tolerances, including ±0.5 L/min at low flows and ±10% at higher flows. No leakage was detected during pressure testing up to 10 psi. During the 12-month natural stability study, physical and microbiological parameters remained within predefined acceptance criteria under climatic zone IVb conditions. The eco-design assessment demonstrated favorable environmental performance. Conclusion:The O2 Mixed Fitting represents an innovative dual-connection solution for medical oxygen delivery applications. Laboratory validation confirmed structural integrity, flow stability, pressure resistance, and physical and microbiological stability under the evaluated conditions. The integrated design enhances functional versatility while maintaining full compatibility with existing clinical infrastructure. Further clinical and operational studies are warranted to evaluate its potential impact on patient care and clinical workflow.
Introduction:Silicone elastomers are widely used in maxillofacial prostheses owing to their elasticity, esthetic properties, and biocompatibility. Clean-grade silicone serves as an affordable alternative to medical-grade silicone. The addition of Cellulose Nanocrystals (CNC) and intrinsic pigments is expected to enhance the performance of clean-grade silicone. Purpose:This study aims to evaluate the effects of CNC and intrinsic pigments on the tensile strength, elongation percentage, and tear strength of clean-grade silicone as an alternative material for maxillofacial prostheses. Materials and Methods:Six groups of clean-grade silicone were evaluated: control, A (with pigment), B (with 0.5% CNC), C (with 0.5% CNC and pigment), D (with 1% CNC), and E (with 1% CNC and pigment). Scanning Electron Microscopy (SEM) and Fourier Transform Infrared Spectroscopy (FTIR) were conducted to evaluate the morphological and functional group characteristics; tensile strength, elongation percentage, and tear strength were measured to assess changes in mechanical properties and were analyzed statistically. Results:SEM analysis showed microstructure formation characterized by dispersed particles with the addition of 1% CNC and intrinsic pigments. As the filler and pigment were added, the FTIR revealed increased absorption intensities of Si-O-Si functional groups, detected at 1022-1026 cm-1. The tensile trength (3.87-4.84 MPa) was successfully increased compared to the control group (3.63 MPa), a statistically significant difference (p<0.05). Group D had the highest tensile strength, aligning closely with medical-grade silicone (approximately 2.53-8.36 MPa). Meanwhile, the lowest elongation percentage and the highest tear strength (3.84 kN/m) resulted in Group E, both of which are close to the range of maxillofacial prosthesis requirements. Conclusion:The addition of 1% CNC and intrinsic pigments successfully increased tensile and tear strength while reducing the elongation percentage of clean-grade silicone that potential as an alternative material; however, future optimization on the tear strength still required before maxillofacial prosthesis application.
Purpose:Pulse oxygen saturation (SpO2) is widely used for continuous non-invasive oxygenation monitoring, but its accuracy can be affected by sensor design, probe placement, peripheral perfusion, skin pigmentation, motion artifacts, and device algorithms. This study evaluated the accuracy and agreement of a commercial pulse oximetry system (model M201 SpO2 module, Shenzhen Witleaf Medical Electronics Co. Ltd.) with a matched fingertip sensor during non-motion controlled hypoxemia in healthy volunteers, using arterial oxygen saturation (SaO2) measured by arterial blood gas/co-oximetry analysis as the reference standard. Material and Methods:Eighteen healthy volunteers underwent two phases of controlled hypoxemia. Each phase comprised three target SpO2 plateau ranges (90-100%, 80-89%, and 70-79%). Phase 1 was the desaturation phase, and Phase 2 was a re-oxygenation and repetition phase. After each target plateau stabilized, SpO2 values from the investigational system were recorded, and paired arterial blood samples were collected for SaO2 measurement. Measurement error was defined as SpO2-SaO2. Bias, mean absolute error (MAE), accuracy root mean square (ARMS), 95% limits of agreement (LOA), and proportions of absolute errors exceeding predefined thresholds were calculated. Results:A total of 432 paired SpO2-SaO2 observations were analyzed. SpO2 showed strong correlation with SaO2 (Pearson r = 0.990; Spearman r = 0.986; both p < 0.001). Overall bias was -0.061%, with 95% LOA from -2.65% to 2.53%. MAE and ARMS were 1.05% and 1.32%, respectively. Absolute errors exceeding ±2%, ±3%, and ±4% occurred in 11.57%, 2.55%, and 0% of observations, respectively. ARMS values were 1.03%, 1.19%, and 1.66% across the 90-100%, 80-89%, and 70-79% platform phases, respectively, with increased error dispersion and mild SaO2 underestimation in the 70-79% phase. Conclusion:The commercial pulse oximetry system showed good overall agreement with reference SaO2 during controlled hypoxemia, with an ARMS of 1.32% (well below the 4% threshold). Error dispersion increased in the 70-79% saturation range, with mild underestimation of SaO2 by SpO2. These findings support the clinical performance of this device within the tested saturation range.
Purpose:To compare post-occlusion surge pressure at various intraocular pressures using the Active Sentry handpiece. Methods:This experimental (in vitro chamber) study used the Alcon Centurion platform and Active Sentry handpiece with balanced tips. Quad preset was used with settings: vacuum 500 mmHg, aspiration flow 50 mmHg, and IOPs of 30, 50, and 70 mmHg. A rubber disk was fixed within a sealed chamber fitted with an electric pressure sensor to monitor pressure changes. The phacoemulsification tip was inserted into the water-tight port of the pressure chamber, and the foot pedal was set to position two. The tip was put in contact with the disk to replicate tip occlusion and pulled from the disk to simulate occlusion break. Ten trials were performed at each IOP; pressure changes were recorded continuously. Results:At 70 mmHg IOP, average post-occlusion surge magnitude was 5.76 mmHg ± 0.54; average surge duration was 0.45 s ± 0.10. At 50 mmHg IOP, surge magnitude was 5.76 mmHg ± 1.15; surge duration surge was 0.52 s ± 0.23. At 30 mmHg IOP, surge magnitude was 10.46 mmHg ± 2.86; surge duration was 1.27 s ± 0.51. There was a statistically significant difference between surge magnitude and duration at 30 vs. 50 mmHg IOP (P < 0.05) and at 30 vs. 70 mmHg IOP (P < 0.05). Conclusion:When utilizing the Active Sentry handpiece, an increased surge risk was not observed when operative IOP was decreased from 70 mmHg to 50 mmHg. However, our data suggest that surge risk increases when operative IOP is decreased to 30 mmHg. The Active Sentry handpiece at 50 mmHg IOP would not introduce greater surge risk than at 70 mmHg IOP.
Background:Diabetic foot ulcers (DFUs) are associated with substantial clinical and economic burden and impaired health-related quality of life (HRQoL). Although wound healing remains a core endpoint, recent consensus work identifies HRQoL as an essential outcome in DFU studies. This study describes wound healing, patient-reported outcomes, function, and safety in adults with DFU treated with silicone superabsorbent polymer (SAP) dressings. Methods:This exploratory prospective, multicenter, nonrandomized cohort study reports the DFU subgroup from a broader single-arm investigation conducted at eight specialist centers in Poland. Adults with superficial, noninfected DFUs received silicone SAP dressings for up to 6 weeks with standard offloading. Prespecified patient-reported outcome measures were the Patient Benefit Index for wounds (PBI-W) and the Wound Quality of Life questionnaire (Wound-QoL-17). Additional endpoints included wound area reduction (centralized digital planimetry), complete epithelialization, accelerometry-based activity, offloading adherence, and safety. Results:Twenty-eight participants were included (75.0% male; mean age, 63.4 years), with a median wound duration of 166 days. By the final visit, 21 (77.8%) achieved at least 20% wound area reduction before cleansing/debridement and 24 (85.7%) after cleansing/debridement; 6 (22.2%) achieved complete epithelialization. Mean global Wound-QoL improved from 2.4 ± 0.6 to 1.5 ± 1.0 (mean change, -1.0 ± 0.8; P < 0.001), with greatest improvements in psyche and everyday-life domains. Mean PBI-W increased from 2.44 ± 0.94 to 2.94 ± 0.87 (mean change, 0.45 ± 1.10; P = 0.043). Activity intensity remained stable, offloading adherence exceeded 95%, and no device-related adverse events were reported. Conclusion:In this prospective DFU cohort, use of silicone SAP dressings within a structured care setting was associated with improvements in wound area reduction and wound-related quality of life over 6 weeks. These results highlight the feasibility of integrating patient-reported outcomes in DFU studies and provide a clinically relevant platform for future comparative and health-economic evaluations.
Purpose:Treatment of pediatric growth hormone deficiency (pGHD) with daily somatropin (human growth hormone [hGH]) injections is associated with challenges including needle anxiety, which may lead to poor adherence and ultimately result in suboptimal growth outcomes. The lonapegsomatropin (TransCon hGH, SKYTROFA®) Auto-Injector, designed to deliver once-weekly lonapegsomatropin for the treatment of pGHD while minimizing injection challenges, was validated in usability studies in pGHD. Patients and Methods:The Auto-Injector was evaluated in a usability validation study conducted under simulated-use conditions in accordance with FDA guidance, involving simulated injections performed by injection-naive or injection-experienced patients with pGHD or proxy medical conditions, caregivers, and health care providers (HCPs) responsible for injections or training patients/caregivers. Half of the patient and caregiver participants received training by a Nurse Trainer. Results:All participants (60 children, 60 caregivers, and 15 HCPs) were able to complete an injection successfully. All participants reported that they could follow the instructions as written, and 98% felt they could use the device as intended on their own or, for pediatric patients, with supervision. Use deviations observed for injection tasks for all participant groups were low: patients (3.2% of tasks), caregivers (2.4%), and HCPs (2.8%). Conclusion:The user-centric design of the lonapegsomatropin Auto-Injector enables successful and confident use to deliver an injection as intended, with the potential to overcome known barriers associated with GH injections and facilitate adherence, which may improve treatment outcomes.
Purpose:Uncontrolled bleeding remains a major surgical challenge, increasing morbidity, operative time, and costs, highlighting the need for effective adjunctive hemostats. Veriset is a synthetic, absorbable patch that promotes clotting and provides mechanical hemostasis. While early studies show efficacy, real-world evidence across diverse settings is needed. This post-market, multicenter study evaluated the safety and effectiveness of Veriset in various surgical procedures. Methods:This observational, single-arm, prospective study was nested within Medtronic's product surveillance registry. Sites were selected for procedural diversity (cardiovascular, soft-tissue, solid-organ), high Veriset use, and clinical study experience. Patients treated with Veriset as part of usual care were followed for 30 days post-procedure to monitor adverse events (AEs). The primary safety and effectiveness endpoints were device-related AEs within 30 days and hemostasis within 5 minutes, respectively. Secondary outcomes included time to hemostasis, length of hospital stay, and bleeding-site severity. Results were summarized using descriptive statistics and exact (Clopper-Pearson) confidence intervals. Results:Veriset was used on-label in 100 patients in cardiovascular (56), soft-tissue (18), solid-organ (18), and other (8) procedures. Most were performed via open surgery (90.0%), with 34% involving anastomoses. Median blood loss was 600 mL (interquartile range 200-1500), with transfusions in 24 patients. Of the 120 bleeding sites treated, pre-Veriset methods included sutures (55.8%, 67/120) and pressure (29.2%, 35/120). Bleeding was mostly mild/moderate (82.5%, 99/120). Device-related AEs occurred in 1 patient, with no deaths. Hemostasis within 5 minutes was achieved at 91.7% (110/120) of sites and in 96.0% (96/100) of patients. Median time to hemostasis was 2.0 minutes; median hospital stay was 7 days. Conclusion:This study provides real-world evidence that Veriset is safe and suggests that it may be an efficacious and rapid adjunct for surgical hemostasis, including in high-risk cardiovascular and solid-organ procedures, supporting and extending prior trial data for routine clinical use. Clinicaltrialsgov Identifier:NCT01524276, Dec 24, 2025.
Purpose:To advance minimally invasive surgical techniques, we developed the sutureless ELANA® End-to-End anastomotic technique. This preclinical study aimed to evaluate the technical feasibility, hemostatic performance, and short-term patency of the new approach in a porcine model. Methods:Six pigs underwent implantation of the ELANA End-to-End device in a divided in situ right internal mammary artery (RIMA) via partial sternotomy. The pigs were followed-up for either 35 days (N=3) or 90 (N=3) days. Feasibility was evaluated based on technical success, achievement of hemostasis, and anastomotic construction time. Patency was assessed at the end of follow-up through angiography and histological analysis. Results:The anastomosis was successfully constructed in four of six animals. Among these, hemostasis was achieved in three cases without additional intervention; one required a single hemostatic stitch. The median anastomotic construction time was 18 (15-45) minutes. Technical failure in two animals was due to difficulty maintaining vessel alignment during deployment. All four successfully constructed anastomoses were patent at the end of follow-up (N=2, 35 days; N=2, 90 days), with no evidence of stenosis on angiography or histology. Conclusion:The ELANA End-to-End technique demonstrated promising patency outcomes. However, the current procedure is technically demanding. Design improvements aimed at stabilizing vessel positioning are warranted to enhance feasibility and reduce construction time.
Purpose: The evaluation of Coronary Artery Disease (CAD) using stress ECG and Myocardial Perfusion SPECT (MPS) frequently reveals discrepancies, particularly in patients with a positive ECG and a negative MPS (MPS-/ECG+). This paradoxical group poses a diagnostic challenge, often unexplained by classic statistical analyses. Our study aims to characterize this profile using interpretable Artificial Intelligence (AI). Patients and Methods: A cohort of 86 patients with negative MPS was stratified into a "discordant" group (MPS-/ECG+, n=19) and a "concordant" group (MPS-/ECG-, n=67). A two-pronged analytical approach was used: (1) bivariate statistical analysis and (2) machine learning modelling. Two algorithms, Random Forest and XGBoost, were trained on a dataset rebalanced using SMOTE. Performance was assessed by AUC, and interpretability was ensured by SHAP analysis. Results: Conventional univariate statistical analysis did not identify any variable significantly associated with discordance (all p> 0.05). In contrast, the XGBoost model, exploiting multivariate interactions, surpassed Random Forest, achieving a moderate but informative performance (AUC = 0.78), with a Sensitivity (Recall) of 67%, a Precision (Positive Predictive Value) of 50% for the discordant class (Class 1), and an overall Accuracy of 76%. SHAP analysis revealed that the most important predictors of discordance were female gender, advanced age, and the presence of diabetes, indicating that the prediction was influenced by the combination of these factors rather than a single one. Conclusion: This exploratory study demonstrates the potential value of explainable AI for deciphering complex clinical problems such as MPS/ECG discordance. Our multivariate models identified a potential patient profile associated with of MPS-/ECG+ discordance, characterized by the synergy of clinical factors. These preliminary results suggest that ECG abnormalities in the absence of a perfusion deficit might reflect an underlying pathology (e.g. microvascular disease) rather than a simple false positive, warranting further prospective validation.
Background: Home medical equipment is extensively utilized in Japan; however, its management is typically overseen by visiting nurses or medical equipment manufacturers rather than by clinical engineers (CEs), who are specialized professionals. Visiting nurses often lack expertise in medical equipment, and manufacturers face legal limitations regarding equipment management. Improper operation or maintenance threatens patient safety. This study aims to elucidate the relationship between equipment malfunctions and management practices at visiting nursing stations (stations), as well as to assess the perceived need for CEs. Methods: A nationwide cross-sectional questionnaire survey was conducted, in which a stratified random sample of 500 stations was selected nationwide by region, with 76 stations providing valid responses. A questionnaire survey was conducted to assess the incidence and management of malfunctions across six types of medical equipment: infusion pumps, syringe pumps, electric suction units, oxygen concentrators, non-invasive positive pressure ventilation devices, and tracheostomy positive pressure ventilation devices. The survey also evaluated the perceived necessity for CEs. Associations between equipment malfunctions and management practices were analyzed using the chi-square or Fisher's exact tests. Results: Among the 76 stations, device abnormalities were the most frequently reported cause of malfunctions across all six equipment types, accounting for over half of the cases. In more than half of the incidents, responses were managed by visiting nurses and manufacturers. Significant associations were identified between infusion pump malfunctions and hospital affiliation, as well as between syringe pump malfunctions and the presence of operation manuals and safety information collection. Notably, 81.6% of stations recognized the need for CEs in home medical care. Conclusion: This study elucidated the relationship between equipment malfunctions, management practices at stations, and the perceived need for CEs. Our findings highlight the importance of establishing a collaborative framework between stations and CEs.
