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Intraventricular haemorrhage is a subtype of intracerebral haemorrhage, with 50% mortality and serious disability for survivors. We aimed to test whether attempting to remove intraventricular haemorrhage with alteplase versus saline irrigation improved functional outcome. In this randomised, double-blinded, placebo-controlled, multiregional trial (CLEAR III), participants with a routinely placed extraventricular drain, in the intensive care unit with stable, non-traumatic intracerebral haemorrhage volume less than 30 mL, intraventricular haemorrhage obstructing the 3rd or 4th ventricles, and no underlying pathology were adaptively randomly assigned (1:1), via a web-based system to receive up to 12 doses, 8 h apart of 1 mg of alteplase or 0·9% saline via the extraventricular drain. The treating physician, clinical research staff, and participants were masked to treatment assignment. CT scans were obtained every 24 h throughout dosing. The primary efficacy outcome was good functional outcome, defined as a modified Rankin Scale score (mRS) of 3 or less at 180 days per central adjudication by blinded evaluators. This study is registered with ClinicalTrials.gov, NCT00784134. Between Sept 18, 2009, and Jan 13, 2015, 500 patients were randomised: 249 to the alteplase group and 251 to the saline group. 180-day follow-up data were available for analysis from 246 of 249 participants in the alteplase group and 245 of 251 participants in the placebo group. The primary efficacy outcome was similar in each group (good outcome in alteplase group 48% vs saline 45%; risk ratio [RR] 1·06 [95% CI 0·88–1·28; p=0·554]). A difference of 3·5% (RR 1·08 [95% CI 0·90–1·29], p=0·420) was found after adjustment for intraventricular haemorrhage size and thalamic intracerebral haemorrhage. At 180 days, the treatment group had lower case fatality (46 [18%] vs saline 73 [29%], hazard ratio 0·60 [95% CI 0·41–0·86], p=0·006), but a greater proportion with mRS 5 (42 [17%] vs 21 [9%]; RR 1·99 [95% CI 1·22–3·26], p=0·007). Ventriculitis (17 [7%] alteplase vs 31 [12%] saline; RR 0·55 [95% CI 0·31–0·97], p=0·048) and serious adverse events (114 [46%] alteplase vs 151 [60%] saline; RR 0·76 [95% CI 0·64–0·90], p=0·002) were less frequent with alteplase treatment. Symptomatic bleeding (six [2%] in the alteplase group vs five [2%] in the saline group; RR 1·21 [95% CI 0·37–3·91], p=0·771) was similar. In patients with intraventricular haemorrhage and a routine extraventricular drain, irrigation with alteplase did not substantially improve functional outcomes at the mRS 3 cutoff compared with irrigation with saline. Protocol-based use of alteplase with extraventricular drain seems safe. Future investigation is needed to determine whether a greater frequency of complete intraventricular haemorrhage removal via alteplase produces gains in functional status. National Institute of Neurological Disorders and Stroke.

This study investigated castile soap versus normal saline irrigation delivered by means of high, low, or very low pressure for open fractures. Reoperation rates were similar, regardless of irrigation pressure; the rate was higher in the soap group than in the saline group. The initial management of open fractures requires thorough irrigation and débridement 1 – 4 to prevent infection and promote wound and bone healing. 2 , 4 Clinicians accomplish débridement by removing all visible debris and necrotic tissue and by providing copious irrigation of the wound. Controversy exists regarding the choice of irrigation pressure and solution. 4 – 13 High pressure may be more effective than low pressure in removing particulate matter and bacteria 7 – 10 but at the expense of bone damage 8 , 11 and a resultant delay in bone healing. 12 Low pressure may avoid bone damage and delayed healing but at the possible cost of less effective . . .

Background Maintaining venous access is of great clinical importance. Running a slow continuous infusion to keep the vein open (KVO) is often used in peripheral intravenous catheters (PIVCs). Previous studies have compared the effects of intermittent flushing and continuous infusion via peripherally inserted central catheters (PICCs). In this study, we applied KVO to central venous catheters (CVCs) and compared the occlusion rate of this technique with that of the intermittent flushing technique. Method This is a randomized controlled trial of 14 hospitals in China. A total of 250 patients will be recruited in this study, and they will be randomized at a 1:1 ratio. After study inclusion, patients who will undergo CVC insertion will receive intermittent flushing with prefilled saline syringes (control group) or KVO infusion with elastic pumps (test group). All the catheters will be checked for patency by scoping Catheter Injection and Aspiration (CINAS) Classification on Days 3 and 7. The primary outcome is the rate of catheter occlusion in 7 days. Patients will be followed up until 9 days after CVC insertion, catheter occlusion, or catheter removal. The secondary outcomes are the rate of catheter occlusion in 3 days, nurse satisfaction, cost-effectiveness, adverse event rate, catheter-related bloodstream infection rate, catheter-related thrombosis rate, extravasation rate, phlebitis rate, and catheter migration. Discussion We expect that the trial will generate findings that can provide an evidence-based basis for the improvement and optimization of clinical catheter flushing techniques. Trial registration Chinese Clinical Trial Registry, ChiCTR2200064007. Registered on 23 September 2022. https://www.chictr.org.cn/showproj.html?proj=177311 .

To compare treatment effects between ultrasound guided lavage with corticosteroid injection and sham lavage with and without corticosteroid injection in patients with calcific tendinopathy of the shoulder. Pragmatic, three arm, parallel group, double blinded, sham controlled, randomised, superiority trial with repeated measurements over 24 months. Six hospitals in Norway and Sweden. 220 adults with calcific tendinopathy of the shoulder, persistent for at least three months. Ultrasound guided deposit lavage plus subacromial injection of 20 mg triamcinolone acetonide and 9 mL 1% lidocaine hydrochloride (lavage+steroid); sham lavage plus subacromial injection of 20 mg triamcinolone acetonide and 9 mL 1% lidocaine hydrochloride (sham lavage+steroid); or sham lavage plus subacromial injection of 10 mL 1% lidocaine hydrochloride (sham). All patients received a physiotherapeutic treatment regimen consisting of four home exercises. The primary outcome was the result on the 48 point scale (0=worst; 48=best) of the Oxford Shoulder Score (OSS) at four month follow-up. Secondary outcomes included measurements on the short form of the Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH) and of pain intensity up to 24 months. The influence of the size of the deposit at baseline and of the persistence or disappearance of the deposit was investigated. Data from 218 (99%) participants were included in the primary analysis. Differences between groups on the OSS at four months were not significant: lavage+steroid versus sham 0.2 (95% confidence interval -2.3 to 2.8; P=1.0); sham lavage+steroid versus sham 2.0 (-0.5 to 4.6; P=0.35); lavage+steroid versus sham lavage+steroid -1.8 (-4.3 to 0.7; P=0.47). After four months, 143 patients with insufficient treatment effect received supplementary treatment. At 24 months, none of the study procedures was superior to sham. No serious adverse events were reported. This study found no benefit for ultrasound guided lavage with a corticosteroid injection or for sham lavage with a corticosteroid injection compared with sham treatment in patients with calcific rotator cuff tendinopathy of the shoulder. NCT02419040EudraCT 2015-002343-34; Ethical committee Norway 2015-002343-34; Ethical committee Sweden 2015/79-31; Clinicaltrials.gov NCT02419040.

Chronic subdural haematoma is a common surgically treated intracranial emergency. Burr-hole drainage surgery, to evacuate chronic subdural haematoma, involves three elements: creation of a burr hole for access, irrigation of the subdural space, and insertion of a subdural drain. Although the subdural drain has been established as beneficial, the therapeutic effect of subdural irrigation has not been addressed. The FINISH trial was an investigator-initiated, pragmatic, multicentre, nationwide, randomised, controlled, parallel-group, non-inferiority trial in five neurosurgical units in Finland that enrolled adults aged 18 years or older with a chronic subdural haematoma requiring burr-hole drainage. Patients were randomly assigned (1:1) by computer-generated block randomisation with block sizes of four, six, or eight, stratified by site, to burr-hole drainage either with or without subdural irrigation. All patients and staff were masked to treatment assignment apart from the neurosurgeon and operating room staff. A burr hole was drilled at the site of maximum haematoma thickness in both groups, and the subdural space was either irrigated or not irrigated before inserting a subdural drain, which remained in place for 48 h. Reoperations, functional outcome, mortality, and adverse events were recorded for 6 months after surgery. The primary outcome was the reoperation rate within 6 months. The non-inferiority margin was set at 7·5%. Key secondary outcomes that were also required to conclude non-inferiority were the proportion of participants with unfavourable functional outcomes (ie, modified Rankin Scale score of 4–6, where 0 indicates no symptoms and 6 indicates death) and mortality rate at 6 months. The primary and key secondary analyses were done in both the intention-to-treat and per-protocol populations. The trial was registered with ClinicalTrials.gov (NCT04203550) and is completed. From Jan 1, 2020, to Aug 17, 2022, we assessed 1644 patients for eligibility and 589 (36%) patients were randomly assigned to a treatment group and treated (294 assigned to drainage with irrigation and 295 assigned to drainage without irrigation; 165 [28%] women and 424 [72%] men). The 6-month follow-up period extended until Feb 14, 2023. In the intention-to-treat analysis, 54 (18·3%) of 295 participants required reoperation in the group assigned to receive no irrigation versus 37 (12·6%) of 294 in the group assigned to receive irrigation (difference of 6·0 percentage points, 95% CI 0·2–11·7; p=0·30; adjusted for study site). There were no significant between-group differences in the proportion of people with modified Rankin Scale score of 4–6 (37 [13·1%] of 283 in the no-irrigation group vs 36 [12·6%] of 285 in the irrigation group; p=0·89) or mortality rate (18 [6·1%] of 295 in the no-irrigation group vs 21 [7·1%] of 294 in the irrigation group; p=0·58). The findings of the primary intention-to-treat analysis were not materially altered in the per-protocol analysis. There were no significant between-group differences in the number of adverse events, and the most frequent severe adverse events were systemic infections (26 [8·8%] of 295 participants who did not receive irrigation vs 22 [7·5%] of 294 participants who received irrigation), intracranial haemorrhage (13 [4·4%] vs seven [2·4%]), and epileptic seizures (five [1·7%] vs nine [3·1%]). We could not conclude non-inferiority of burr-hole drainage without irrigation. The reoperation rate was 6·0 percentage points higher after burr-hole drainage without subdural irrigation than with subdural irrigation. Considering that there were no differences in functional outcome or mortality between the groups, the trial favours the use of subdural irrigation. State Fund for University Level Health Research (Helsinki University Hospital), Finska Läkaresällskapet, Medicinska Understödsföreningen Liv och Hälsa, and Svenska Kulturfonden.

Objectives Simplifying interdental space cleaning is a constantly discussed topic. The present study aimed to compare the cleansing efficacy of an oral irrigator with that of dental flossing in adolescent patients with fixed braces after four weeks of home-use. Materials and methods The study design is a randomized, single-blinded cross-over study. Following a twenty-eight-day period of product utilization in a home setting, a comparative analysis was conducted on hygiene indices, the Rustogi Modified Navy Plaque Index (RMNPI) and the Gingival Bleeding Index (GBI), between the test group (oral irrigator) and the control group (dental floss). Results Seventeen adolescent individuals completed the study. After 28 days of cleaning with the oral irrigator, RMNPI was 58.81% (55.31–66.47) compared to 59.46% (52.68–68.67) with dental floss ( p  = 0.070). Subgroup analyses did not indicate the superiority of either method. GBI after the test phase with the oral irrigator was 28.93% (23.21–33.97) and insignificantly higher compared to 26.40% (21.01–31.41) achieved with dental floss ( p  = 0.1585). Conclusions Neither of the two products demonstrated statistically significant superiority in terms of cleaning efficacy. Therefore, no recommendation can be made in favor of one over the other. It was found that the high initial hygiene indices for fixed orthodontic appliances could be improved through increased awareness and precise instruction. Clinical relevance For adolescent patients who struggle to use interdental brushes an oral irrigator may be suggested as a simple alternative in hard-to-reach areas, such as those around a fixed dental appliance.

Background Perforated diverticulitis is a condition associated with substantial morbidity. Recently published reports suggest that laparoscopic lavage has fewer complications and shorter hospital stay. So far no randomised study has published any results. Methods DILALA is a Scandinavian, randomised trial, comparing laparoscopic lavage (LL) to the traditional Hartmann's Procedure (HP). Primary endpoint is the number of re-operations within 12 months. Secondary endpoints consist of mortality, quality of life (QoL), re-admission, health economy assessment and permanent stoma. Patients are included when surgery is required. A laparoscopy is performed and if Hinchey grade III is diagnosed the patient is included and randomised 1:1, to either LL or HP. Patients undergoing LL receive > 3L of saline intraperitoneally, placement of pelvic drain and continued antibiotics. Follow-up is scheduled 6-12 weeks, 6 months and 12 months. A QoL-form is filled out on discharge, 6- and 12 months. Inclusion is set to 80 patients (40+40). Discussion HP is associated with a high rate of complication. Not only does the primary operation entail complications, but also subsequent surgery is associated with a high morbidity. Thus the combined risk of treatment for the patient is high. The aim of the DILALA trial is to evaluate if laparoscopic lavage is a safe, minimally invasive method for patients with perforated diverticulitis Hinchey grade III, resulting in fewer re-operations, decreased morbidity, mortality, costs and increased quality of life. Trial registration British registry (ISRCTN) for clinical trials ISRCTN82208287 http://www.controlled-trials.com/ISRCTN82208287

Objective This study investigated the associations among endodontic instruments, ultrasonic tips and various final irrigation protocols for removing intracanal and intratubular biofilms in long oval canals. Methodology One hundred mandibular premolars inoculated with Enterococcus faecalis were divided into two groups: the control group (CG: n  = 10), which received no treatment; and the test groups ( n  = 30), which included saline (SS), sodium hypochlorite (2.5% NaOCl) and chlorhexidine (2% CHX). The samples were prepared with Reciproc ® Blue 25/0.08, Flatsonic, Clearsonic and Reciproc Blue 40/0.06. Each test group was divided into three subgroups ( n  = 10): conventional irrigation (CI) with syringes and needles, passive ultrasonic irrigation (PUI) and continuous ultrasonic irrigation (CUI) with an Irrisonic tip. The root canals were examined using confocal laser scanning microscopy. Mann‒Whitney and Kruskal‒Wallis tests followed by Dunn post hoc tests ( p  < 0.05) were used for statistical analysis. Results NaOCl and CHX were effective for intracanal and intratubular decontamination. Saline showed significant decontamination in the intratubular areas when CUI was used. The CI method was the least effective for intracanal decontamination. Conclusion The use of Flatsonic and Clearsonic ultrasonic tips is promising for root canal disinfection. Clinical relevance The disinfection techniques in endodontic treatment focus on the removal of biofilms from long oval canals, which is crucial for effective cleaning during root canal procedures.

Background The research objectives of the Femoroacetabular Impingement Randomised controlled Trial (FIRST) are to assess whether surgical correction of the hip impingement morphology (arthroscopic osteochondroplasty) with or without labral repair, in adults aged 18–50 years diagnosed with non-arthritic femoroacetabular impingement (FAI), provides decreased pain and improved health-related quality of life at 12 months compared to arthroscopic lavage of the hip joint. This article describes the statistical analysis plan for the FIRST trial. Methods/design FIRST is an ongoing multi-centre, blinded randomised controlled trial of 220 patients who have been diagnosed with FAI and are optimized for surgical intervention. This article describes the overall analysis principles, including how participants will be included in each analysis, the presentation of the results, adjustments for covariates, the primary and secondary outcomes and their respective analyses. In addition, we will present the planned sensitivity and subgroup analyses. Discussion Our rationale for FIRST is based upon (1) an epidemic of FAI surgery with resultant increased healthcare costs over that last decade, (2) worldwide disparity in perceptions about its utility, and (3) consensus that definitive evidence for or against surgical approaches is lacking. Trial registration ClinicalTrials.gov, NCT01623843 . Registered on 20 June 2012.

Background Intraventricular haemorrhage (IVH) is a common and severe complication of preterm birth, affecting nearly 500 neonates annually in the UK. Over 50% of infants with IVH develop post-haemorrhagic ventricular dilatation (PHVD), which is associated with significant long-term neurodevelopmental impairment. Current treatment strategies involve the use of temporary CSF diversion, through options such as ventricular access devices (VADs) or ventricular subgaleal shunts (VSGS). Neuroendoscopic lavage (NEL) is an emerging technique that aims to directly reduce the load of intraventricular blood and its breakdown products, potentially reducing the risk of secondary brain injury. The ENLIVEN-UK trial aims to assess whether the addition of NEL to standard temporising device placement improves neurodevelopmental outcomes at 2 years of corrected age compared to temporising device placement alone. Methods ENLIVEN-UK is a national, multicentre, parallel-group, assessor-blinded, superiority randomised controlled trial (RCT) that aims to enrol 100 preterm infants with severe IVH and PHVD across UK paediatric neurosurgical centres. Infants will be randomised in a 1:1 ratio to receive either standard temporising device placement or NEL in addition to temporising device placement. Randomisation will be performed using a secure online system (Sealed Envelope), with outcome assessors and statisticians blinded to treatment allocation. The primary outcome measure will be cognitive quotient (CQ) at 2 years of corrected age, assessed using the Bayley Scales of Infant and Toddler Development (4th edition, Bayley-IV). Secondary outcomes will include motor and language development, the requirement for permanent CSF diversion with a ventriculoperitoneal (VP) shunt, surgical complications, health-related quality of life (EQ-5D-5L, TAPQOL), and healthcare costs. Discussion This study aims to provide level 1 evidence regarding the efficacy and safety of NEL in preterm infants with IVH and PHVD. If successful, this trial has the potential to change the standard of care and improve long-term neurodevelopmental outcomes in this cohort of patients. Trial registration ISRCTN Trial Registration: ISRCTN14018410.