BACKGROUND: Although natural rubber latex remains dominant as the primary manufacturing material for male condoms synthetic materials first introduced in the early 1990s address many of the limitations of latex including the risk of allergies. Polyurethane elastomers allow condoms to be made significantly thinner to provide greater sensitivity and encourage greater use of condoms for contraception and STI prophylaxis. The primary objective of this Study was to evaluate the breakage, slippage and acceptability of two ultra-thin polyurethane condoms against a thin control latex male condom, designated latex C, in a randomized, cross over, masked, non-inferiority study. The condom designated Polyurethane A was designed for markets where 52/53 mm wide latex condoms are preferred whereas the condom designated Polyurethane B was designed for markets where the smaller 49 mm wide latex condom is preferred.
METHODS: The Study was designed to meet the requirements specified in ISO 29943-1: 2017 and FDA guidelines for clinical studies on synthetic condoms. It was conducted by two Essential Access Health centres, one in Northern California and the other in Southern California. Sexually active heterosexual couples (300) aged between 18 and 45 years were recruited to use three sets of five condoms in a block randomized order, recording breakage, slippage and acceptability after each use. A total of 252 couples contributed 2405 evaluable condom uses per protocol for the Condom A versus Latex C comparison (1193 Polyurethane A plus 1212 Latex C), and 247 couples provided 2335 evaluable condom uses per protocol for the Condom B versus Latex C comparison (1142 Polyurethane B plus 1193 Latex C). Only condoms used for vaginal intercourse were included in the analysis.
RESULTS: Although the total failure rates (breakage and slippage) for the polyurethane condoms were higher than for the control Latex C condom, all condoms performed extremely well with low failure rates compared to similar condom studies. Condom Polyurethane A met the noninferiority requirements specified in ISO 23409:2011 relative to Latex C, the control NR latex condom, in the full Study population. While condom Polyurethane B did not meet the noninferiority requirement for the full Study population, it did meet the noninferiority requirement when analysis was restricted to the intended population (men with penis lengths ≤ 170 mm). Trial registration The Study is registered with ClinicalTrials.gov, NCT04622306, Protocol Reference SAGCS 2, initial release date 11/02/2020.

BACKGROUND: The aim of this study was to compare the cyclic fatigue resistance (CFR) of the newly developed pediatric nickel-titanium (NiTi) rotary file systems for root canal preparation of primary teeth.
METHODS: Eighty pediatric NiTi rotary file systems files were used in this study, including 20 EasyInSmile X-Baby (25/0.04), 20 Scope miniScope (25/0.04), 20 EndoArt Pedo Gold (25/0.04), and 20 EndoArt Pedo Blue (25/0.04) files. Static CFR tests; performed on a custom-made stainless steel block with an inner diameter of 1.5 mm, an angle of curvature of 60° and a curved artificial canal with a radius of curvature of 5 mm. The test system was filled with distilled water and the temperature was kept constant at 35 ± 1 °C. The files were rotated in the simulated canal until fracture occurred. The number of cycles to failure (NCF) data was recorded, and all the fracture surfaces of the files were evaluated using scanning electron microscopy (SEM). One-way ANOVA and Tukey tests were used for statistical analysis of the data, and the significance level was set at p < 0.05.
RESULTS: EndoArt Pedo Blue showed the highest NCF values (2668.10 ± 755.26), while the miniScope showed the lowest NCF values (453.65 ± 72.51), with a statistically significant difference between all the tested file systems (p < 0.05). There was no statistical difference in terms of fractured fragment lengths among all tested files (p > 0.05).
CONCLUSIONS: The EndoArt Pedo Blue file system showed the best CFR performance among the four file systems specifically designed for primary teeth.

OBJECTIVE: The fatigue resistance of mechanical nickel-titanium files was tested by phase-locked infrared flaw detection method, in order to timely detect instrument wear, providing reference for clinical safe use and timely abandonment of nickel-titanium files.
METHODS: Twenty sets of mechanical nickel-titanium files were selected from Reciproc-Blue(RB), MTWO and S3 respectively, and resin simulated root canals with 60° and 90° bending were prepared, which were divided into 6 subgroups. The fatigue value after use, the number of uses before breaking and the length of fracture of file 25# of each group of files were recorded and compared with SPSS 26.0 software package.
RESULTS: With the increase of the times of use, the fatigue value of the three kinds of files increased gradually. Among the two types of curved root canals, the number of uses before fracture in RB group was significantly increased compared with that in MTWO group and S3 group (P＜0.05). The number of uses of the three kinds of files in the 90° curved root canal were significantly less than in the corresponding groups in the 60° curved root canal(P＜0.05). There was no significant difference in the length of fracture among the three kinds of files(P＞0.05).
CONCLUSIONS: Phase-locked infrared flaw detection method can be used for non-destructive testing and quantitative analysis of the fatigue degree of nickel-titanium files.

Nickel-titanium (NiTi) rotary files used in root canal treatments experience fatigue and shear damage due to the complex curved geometries and operating conditions encountered within the root canal. This can lead to premature file fracture, causing severe complications. A comprehensive understanding of how different factors contribute to file damage is crucial for improving their functional life. This study investigates the combined effects of root canal curvature radius, file canal curvature, and rotational speed on the fatigue life and failure modes of NiTi endodontic files through an integrated computational and experimental approach. Advanced finite element simulations precisely replicating the dynamic motion of files inside curved canal geometries were conducted. Critical stress/strain values were extracted and incorporated into empirical fatigue models to predict the functional life of endodontic files. Extensive experiments with files rotated inside artificial curved canals at various canal curvatures and speeds provided validation. Increasing the canal curvature beyond 60∘ and shorter curvature radii below 5 mm dramatically reduced the functional life of the endodontic file, especially at rotational speeds over 360 rpm. The Coffin-Manson fatigue model based on strain amplitude showed the closest agreement with experiments. Shear stresses dominated damage at low canal curvatures, while the combined shear-fatigue loading effects were prominent at higher canal curvatures. This conclusive study elucidates how operational parameters like canal curvature radii, canal curvature, and rotational speed synergistically influence the fatigue damage processes in NiTi files. The findings offer valuable guidelines to optimize these factors, significantly extending the functional life of endodontic files and reducing the risk of intra-operative failures. The validated computational approach provides a powerful tool for virtual testing and estimation of the functional life of the new file designs before manufacturing.

UNASSIGNED: Catheter dislodgement is a common complication for children with tunneled or peripherally inserted noncuffed central venous catheters (CVCs). A subcutaneous anchor securement system (SASS) may reduce this risk compared with traditional adhesive securement.
UNASSIGNED: To compare dislodgement of noncuffed CVCs secured with SASS with dislodgement of noncuffed CVCs secured with sutureless securement devices (SSDs).
UNASSIGNED: The SECURED (Securing Central Venous Catheters to Prevent Dislodegment) trial was a pragmatic, multicenter, superiority randomized clinical trial with an internal pilot and was conducted from August 5, 2020, to August 30, 2022, at 2 Australian quaternary pediatric hospitals. Data analysis was performed in January 2023. Patients aged 0 to 18 years requiring a noncuffed CVC (≥3F catheter) were eligible for inclusion. Follow-up duration was 8 weeks or until device removal.
UNASSIGNED: Patients were randomly assigned 1:1 to receive an SASS or SSD, stratified by hospital and catheter type. Only 1 catheter was studied per patient.
UNASSIGNED: The primary outcome was dislodgement (partial or total), defined as movement of the catheter tip by greater than 1 cm (change in external catheter length) at any point during catheter dwell. Dislodgement, reported as a risk ratio (RR), was estimated using a generalized linear model with binomial family and log link. Secondary outcomes were reported as incidence rate ratios and were analyzed using Poission regression. Outcomes reported as mean differences (MDs) were analyzed using linear regression.
UNASSIGNED: Of 310 randomized patients, 175 patients (56.5%) were male and median (IQR) patient age was 48 (16-120) months. A total of 307 patients had a catheter device inserted, of which 153 (49.8%) were SASS and 154 (50.2%) were SSD, and were included in the intention-to-treat (ITT) analysis. Device dislodgement was lower with SASS (8 dislodgements in 153 patients [5.2%]) compared with SSD (35 dislodgements in 154 patients [22.7%]) (RR, 0.23; 95% CI, 0.11-0.48; P < .001). The per-protocol analysis was consistent with the ITT analysis. Partial dislodgement accounted for most dislodgement events, including 6 partial dislodgements in the SASS group (3.9%) and 30 partial dislodgements in the SSD group (19.5%) (RR, 0.18; 95% CI, 0.08-0.42). This contributed to fewer complications during dwell in the SASS group (37 reported complications [24.2%]) vs the SSD group (60 reported complications [39.0%]) (RR, 0.62; 95% CI, 0.44-0.87). Staff reported greater difficulty removing devices anchored with SASS vs SSD (mean [SD], 29.1 [31.3] vs 5.3 [17.0], respectively; MD, 23.8; 95% CI, 16.7-31.0). However, use of SASS resulted in reduced per-participant health care costs of A$36.60 (95% credible interval, 4.25-68.95; US $24.36; 95% credible interval, 2.83-45.89).
UNASSIGNED: In the SECURED trial, noncuffed CVCs secured with SASS had fewer dislodgements compared with SSDs, with a lower cost per patient and an acceptable safety profile. Future efforts should be directed at SASS implementation at the health service level.
UNASSIGNED: anzctr.org.au Identifier: ACTRN12620000783921.

UNASSIGNED: Over the past decade, the adoption of virtual wards has surged. Virtual wards aim to prevent unnecessary hospital admissions, expedite home discharge, and enhance patient satisfaction, which are particularly beneficial for the older adult population who faces risks associated with hospitalization. Consequently, substantial investments are being made in virtual rehabilitation wards (VRWs), despite evidence of varying levels of success in their implementation. However, the facilitators and barriers experienced by virtual ward staff for the rapid implementation of these innovative care models remain poorly understood.
UNASSIGNED: This paper presents insights from hospital staff working on an Australian VRW in response to the growing demand for programs aimed at preventing hospital admissions. We explore staff\'s perspectives on the facilitators and barriers of the VRW, shedding light on service setup and delivery.
UNASSIGNED: Qualitative interviews were conducted with 21 VRW staff using the Nonadoption, Abandonment, Scale-up, Spread, and Sustainability (NASSS) framework. The analysis of data was performed using framework analysis and the 7 domains of the NASSS framework.
UNASSIGNED: The results were mapped onto the 7 domains of the NASSS framework. (1) Condition: Managing certain conditions, especially those involving comorbidities and sociocultural factors, can be challenging. (2) Technology: The VRW demonstrated suitability for technologically engaged patients without cognitive impairment, offering advantages in clinical decision-making through remote monitoring and video calls. However, interoperability issues and equipment malfunctions caused staff frustration, highlighting the importance of promptly addressing technical challenges. (3) Value proposition: The VRW empowered patients to choose their care location, extending access to care for rural communities and enabling home-based treatment for older adults. (4) Adopters and (5) organizations: Despite these benefits, the cultural shift from in-person to remote treatment introduced uncertainties in workflows, professional responsibilities, resource allocation, and intake processes. (6) Wider system and (7) embedding: As the service continues to develop to address gaps in hospital capacity, it is imperative to prioritize ongoing adaptation. This includes refining the process of smoothly transferring patients back to the hospital, addressing technical aspects, ensuring seamless continuity of care, and thoughtfully considering how the burden of care may shift to patients and their families.
UNASSIGNED: In this qualitative study exploring health care staff\'s experience of an innovative VRW, we identified several drivers and challenges to implementation and acceptability. The findings have implications for future services considering implementing VRWs for older adults in terms of service setup and delivery. Future work will focus on assessing patient and carer experiences of the VRW.

OBJECTIVE: To compare catheter-related outcomes of individuals who received a tunnelled femorally inserted central catheter (tFICC) with those who received a peripherally inserted central catheter (PICC) in the upper extremities.
METHODS: A propensity-score matched cohort study.
METHODS: A 980-bed tertiary referral hospital in South West Sydney, Australia.
METHODS: In-patients referred to the hospital central venous access service for the insertion of a central venous access device.
METHODS: The primary outcome of interest was the incidence of all-cause catheter failure. Secondary outcomes included the rates of catheters removed because of suspected or confirmed catheter-associated infection, catheter dwell and confirmed upper or lower extremity deep vein thrombosis (DVT).
RESULTS: The overall rate of all-cause catheter failure in the matched tFICC and PICC cohort was 2.4/1000 catheter days (95% CI 1.1 to 4.4) and 3.0/1000 catheter days (95% CI 2.3 to 3.9), respectively, and when compared, no difference was observed (difference -0.63/1000 catheter days, 95% CI -2.32 to 1.06). We found no differences in catheter dwell (mean difference of 14.2 days, 95% CI -6.6 to 35.0, p=0.910); or in the cumulative probability of failure between the two groups within the first month of dwell (p=0.358). No significant differences were observed in the rate of catheters requiring removal for confirmed central line-associated bloodstream infection (difference 0.13/1000 catheter day, 95% CI -0.36 to 0.63, p=0.896). Similarly, no significant differences were found between the groups for confirmed catheter-related DVT (difference -0.11 per 1000 catheter days, 95% CI -0.26 to 0.04, p=1.00).
CONCLUSIONS: There were no differences in catheter-related outcomes between the matched cohort of tFICC and PICC patients, suggesting that tFICCs are a possible alternative for vascular access when the veins of the upper extremities or thoracic region are not viable for catheterisation.

BACKGROUND: Short peripheral intravenous catheter (PIVC) failure is a common complication that is generally underdiagnosed. Some studies have evaluated the factors associated with these complications, but the impact of care complexity individual factors and nurse staffing levels on PIVC failure is still to be assessed. The aim of this study was to determine the incidence and risk factors of PIVC failure in the public hospital system of the Southern Barcelona Metropolitan Area.
METHODS: A retrospective multicentre observational cohort study of hospitalised adult patients was conducted in two public hospitals in Barcelona from 1st January 2016 to 31st December 2017. All adult patients admitted to the hospitalisation ward were included until the day of discharge. Patients were classified according to presence or absence of PIVC failure. The main outcomes were nurse staffing coverage (ATIC patient classification system) and 27-care complexity individual factors. Data were obtained from electronic health records in 2022.
RESULTS: Of the 44,661 patients with a PIVC, catheter failure was recorded in 2,624 (5.9%) patients (2,577 [5.8%] phlebitis and 55 [0.1%] extravasation). PIVC failure was more frequent in female patients (42%), admitted to medical wards, unscheduled admissions, longer catheter dwell time (median 7.3 vs 2.2 days) and those with lower levels of nurse staffing coverage (mean 60.2 vs 71.5). Multivariate logistic regression analysis revealed that the female gender, medical ward admission, catheter dwell time, haemodynamic instability, uncontrolled pain, communication disorders, a high risk of haemorrhage, mental impairments, and a lack of caregiver support were independent factors associated with PIVC failure. Moreover, higher nurse staffing were a protective factor against PIVC failure (AUC, 0.73; 95% confidence interval [CI]: 0.72-0.74).
CONCLUSIONS: About 6% of patients presented PIVC failure during hospitalisation. Several complexity factors were associated with PIVC failure and lower nurse staffing levels were identified in patients with PIVC failure. Institutions should consider that prior identification of care complexity individual factors and nurse staffing coverage could be associated with a reduced risk of PIVC failure.

UNASSIGNED: The mechanical qualities of Ni-Ti is crucial because they give the files their flexibility and enable us to prepare curved and double-curved canals with more ease. It happens frequently for instruments to separate during canal preparation, and cyclic fatigue (metal fatigue) is a frequent cause.This study aimed to assess how irrigation affected the two rotary endodontic instruments\' cyclic fatigue resistance.
UNASSIGNED: The Edge File and Fanta File rotary endodontic instrument groups were chosen. Each group (n = 42) was split into 3 subgroups (n = 14 each), one receiving NaOH, one Glycine, and one EDTA treatment. The number of cycles to failure (NCF) was determined after each subgroup underwent testing for cyclic fatigue resistance.
UNASSIGNED: The result appeared different significant between the two group and sub-group with the different materials that used with it with the length of fractures and time that recorded in each group.
UNASSIGNED: NaOCl, glycine, and EDTA as chemical materials appeared to have considerably varied cycle fatigue resistance for various lengths of fractures and durations, according to the comparison between the two evaluated instruments.

UNASSIGNED: Peripheral intravenous catheters (PIVCs) facilitate essential treatment. Failure of these essential devices is frequent and new securement strategies may reduce failure and improve patient outcomes.
UNASSIGNED: To evaluate clinical effectiveness of novel PIVC securement technologies for children to reduce catheter failure.
UNASSIGNED: A 3-arm, parallel group, superiority randomized clinical trial was conducted at 2 regional Australian hospitals from February 5, 2020, to January 14, 2022. Children aged 6 months to 8 years who were anticipated to require admission with a PIVC for at least 24 hours of in hospital treatment were eligible. Data were analyzed from May 25, 2022, to February 20, 2024.
UNASSIGNED: Participants were randomly allocated in a 1:1:1 ratio to standard care, bordered polyurethane (Tegaderm [3M]), integrated securement dressing (SorbaView SHIELD [Medline]), and integrated securement dressing with tissue adhesive (Secureport IV). One catheter was studied per patient.
UNASSIGNED: Primary outcome was PIVC failure, defined as premature cessation of PIVC function for any reason prior to completion of planned treatment. Secondary outcomes were PIVC complications (any time dislodgement, occlusion, infiltration, partial dislodgement, extravasation, device leaking, phlebitis, pain), PIVC longevity, intervention acceptability (clinicians, participants, caregivers; 0-10 scale), and pain on removal (participants and caregivers; 0-10 scale relevant to age), adverse events, and health care costs.
UNASSIGNED: A total of 383 patients (51% female; median age 36 [25th-75th percentiles, 22-72] months) were randomized 134 to standard care, 118 to integrated securement dressing, and 131 to integrated securement dressing with tissue adhesive. PIVC failure was lowest in integrated securement dressing with tissue adhesive (15 [12%]; adjusted hazard ratio [aHR], 0.47; 95% CI, 0.26-0.84) compared with integrated securement dressing (24 [21%]; aHR, 0.78; 95% CI, 0.47-1.28) and standard care (43 [34%]). Direct costs were significantly lower for integrated securement dressing with tissue adhesive (median, Australian dollars [A$], 312 [A$1 is equal to $0.65 US dollars]; IQR, A$302-A$380) and integrated securement dressing (median, A$303; IQR, A$294-A$465) compared with standard care (median, A$341; IQR, A$297-A$592; P ≤ .002) when considering the economic burden related to failure of devices. PIVC longevity and intervention acceptability were similar across all groups.
UNASSIGNED: In this study, PIVCs secured with integrated securement dressings and tissue adhesive, in comparison with standard care, bordered polyurethane dressings, were associated with significantly reduced PIVC failure, for children admitted to hospital via the emergency department. Further research should focus on implementation in inpatient units where prolonged dwell and reliable intravenous access is most needed.
UNASSIGNED: Australian New Zealand Clinical Trials Registry Identifier: ACTRN12619001026112.