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Salvage prostatic bed radiotherapy (PBRT) is a standard in case of biochemical recurrence following radical prostatectomy (RP) for prostate cancer (PC). The management of isolated prostatic bed recurrence following RP and PBRT is debated. Reirradiation within stereotactic body radiotherapy (SBRT) guided by metabolic imaging could be a relevant option in this case. In parallel, metformin, an economically viable and well-tolerated oral antidiabetic agent, has demonstrated its radiosensitising properties. This phase I/II clinical trial aims to (i) determine the optimal dose for SBRT reirradiation, (ii) conduct safety assessments and (iii) evaluate the efficacy of the metformin and SBRT combination.
We conducted a prospective, non-randomised, open-label, multicentre, dose escalation, phase I/II study involving a minimum of 44 patients. Eligible patients must have biochemical recurrence (Prostate Specific Antigen (PSA)>0.2 ng/mL and confirmed ascending trend in at least two successive assays), occurring at least 2 years after PBRT and prior RP for PC (including low, intermediate and high risk with a single risk factor) and no Common Terminology Criteria for Adverse Events (CTCAE) grade>=2 toxicity following PBRT. The recurrence should be visible on MRI and/or Positron Emission Tomography (PET) Choline and/or PET PSMA, without evidence of pelvic lymph node recurrence or metastatic disease. The primary objective of phase I is to determine the optimal SBRT dose (5x6, 6x6, or 5x5 Gy) based on dose-limiting toxicity (DLT). The dose will be chosen using a time-to-event continual reassessment method based on DLT, defined as CTCAE grade ≥3 gastrointestinal or genitourinary toxicity, or any other grade 4 adverse event. The primary outcome of the phase II is to estimate the efficacy of SBRT in combination with metformin in terms of biological relapse-free survival (bRFS) rate at 3 years. Secondary outcomes include 5-year bRFS rate, early/late genitourinary and gastrointestinal toxicities, quality of life, biochemical response rate, clinical progression-free survival and overall survival (OS).
Ethical approval has been obtained from the Ethics committee "SUD EST III Bron" Ref.CPP 2020-042B (20.05.07.72735) and the National Agency for the Safety of Medicines (ANSM) Ref. ANSM MEDAECNAT-2020-05-00009. The ethics approval obtained covers all the sites that will take part in this study. The study’s findings will be disseminated through publications and conference presentations.
NCT04536805, Registration Date: 2020-08-17
Chronic wounds decrease patients' quality of life and pose an economic burden on healthcare systems and individuals. Wound assessment tools and monitoring technologies may reduce the costs related to chronic wound management. Bioimpedance has attracted growing attention as a quantitative tool for monitoring chronic ulcers, owing to its proven ability to detect tissue changes throughout the wound healing process. The main objective of this study was to review the state-of-the-art literature on the use of bioimpedance in chronic wound monitoring. A systematic review of literature was performed on the 30th of August 2024 according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines in three electronic databases (PubMed, Scopus and Web of Science). Sixteen studies were included in the systematic review. Studies on bioimpedance measurements for chronic lower leg wound monitoring were analysed, confirming significant differences in bioimpedance between wound and healthy skin, with changes observed throughout the healing process. The variety of electrode types and setups highlights the method's complexity, with electrode configuration playing a critical role in ensuring accurate results. Several challenges remain before it can be effectively implemented in clinical practice. Our review emphasises the potential usefulness of bioimpedance-based methods in monitoring chronic wounds on the lower legs.
Intensive care units (ICUs) manage patients with or likely to have one or more life-threatening acute organ failures that might require the use of invasive supportive therapies. The use of physical restraint is frequent, with rates up to 50%, and usually initiated to maintain patient safety especially if the patient is agitated. Physical restraints have been associated with delirium, post-traumatic stress disorder and physical injuries while restricting patients’ individual freedom. Moreover, the incidence of invasive therapeutic devices’ self-removal by patients might not be decreased by physical restraint use. No recommendation is available concerning ICU patients and physical restraint management, despite being a daily practice. The main objective is to evaluate whether a strategy aimed at decreasing physical restraint use in ICU patients with that of a strategy based on routine and subjective caregivers’ decision is safe and efficient.
ARBORea is a multicentre randomised, stepped-wedge trial testing an innovative, dedicated web-based, multiprofessionally developed, experts validated, nursing management strategy in comparison with standard care. The primary outcome is physical restraint use rate (effectiveness) measured at least every 8 hours and incidents’ rate (tolerance) defined as the rate of incidents attributable to non-compliance, corresponding to the deterioration or self-removal of critical devices, a fall or self-aggressive or heteroaggressive behaviours. Planned enrolment is 4000 ICU adult participants at 20 French academic and non-academic centres. Safety and long-term outcomes will be evaluated.
Trial results will be reported according to the Consolidated Standards of Reporting Trials 2010 guidelines. Findings will be published in peer-reviewed journals and presented at local, national and international meetings and conferences to publicise and explain the research to clinicians, commissioners and service users. The trial is funded by the French Ministry of Health and has been approved by the French local ethics committee (Comité de Protection des Personnes Sud-Ouest et Outre-Mer 2, Toulouse, France with registration number: 2020-A02904-35).
(ClinicalTrials.gov) NCT04957238 on 12 July 2021 before first inclusion in study.
Open incision negative pressure wound therapy (NPWT) combines delayed closure with negative pressure to prevent surgical site infection (SSI). Its effectiveness in preventing SSI remains unclear, complicating its risk–benefit assessment. PubMed and Web of Science databases were searched for relevant English studies. Two reviewers independently screened titles and abstracts using the ASReviewer tool. Full-text articles were assessed for eligibility. Eight studies were included in the systematic review and five were pooled in the meta-analysis. Data extraction followed the PRISMA guidelines, and the risk of bias was assessed. A meta-analysis was performed using a random-effects model for SSI occurrence. Eight studies (three RCTs and five cohort studies) with 1655 patients were included. Studies were pooled based on control interventions: primary closure (PC) or delayed primary closure (DPC). Pooled odds ratio (OR) estimates favoured NPWT over PC for SSI reduction (OR, 0.15; 95% CI, 0.02–0.87). No significant SSI risk difference was found between the NPWT and DPC groups (OR, 0.28; 95% CI, 0.06–1.27). Preventive NPWT is associated with a reduced risk of SSI in abdominal surgery compared to PC. Our findings indicate that standardising treatment and reporting protocols could improve future evaluations of NPWT effectiveness.
Trial Registration: PROSPERO identifier: CRD42024401669
In an ageing society, the incidence of hard-to-heal wounds is rising. Chronic wound healing is a complex process, which requires specialised treatment. Clinical assessment of the wound is essential to establish care approaches but is usually based on visual evaluation and it remains challenging. Therefore, innovative quantitative methods for the assessment of chronic wounds are needed. We conducted a single-centre observational study designed to assess the feasibility of a bioimpedance measurement method conducted with a multielectrode sensor array to monitor the wound healing process in patients with chronic wounds of venous, mixed venous–arterial and diabetic aetiology. In total, 104 measurements of bioimpedance were conducted in 18 ulcers during the study. Across all 7 patients analysed, the bioimpedance of the ulcers was consistently increasing as the wound surface was decreasing. The variables had significant (p < 0.001) and strong negative correlation (r = −0.86). We validated the feasibility of the bioimpedance measurement method for the monitoring of the wound healing process on the lower legs. It may be a promising quantitative method for monitoring the status of the wounds. However, long-term measurements are needed to show the usability of the electrode dressing and bioimpedance measurement in the assessment of chronic wounds.
by Kamila Roszczyc-Owsiejczuk, Monika Imierska, Emilia Sokołowska, Mariusz Kuźmicki, Karolina Pogodzińska, Agnieszka Błachnio-Zabielska, Piotr Zabielski
Prolonged consumption of diet rich in fats is regarded as the major factor leading to the insulin resistance (IR) and type 2 diabetes (T2D). Emerging evidence link excessive accumulation of bioactive lipids such as diacylglycerol (DAG) and ceramide (Cer), with impairment of insulin signaling in skeletal muscle. Until recently, little has been known about the involvement of long-chain acyl-CoAs synthetases in the above mechanism. To examine possible role of long-chain acyl-coenzyme A synthetase 1 (Acsl1) (a major muscular ACSL isoform) in mediating HFD-induced IR we locally silenced Acsl1 in gastrocnemius of high-fat diet (HFD)-fed C57BL/6J mice through electroporation-delivered shRNA and compared it to non-silenced tissue within the same animal. Acsl1 down-regulation decreased the content of muscular long-chain acyl-CoA (LCACoA) and both the Cer (C18:1-Cer and C24:1-Cer) and DAG (C16:0/18:0-DAG, C16:0/18:2-DAG, C18:0/18:0-DAG) and simultaneously improved insulin sensitivity and glucose uptake as compared with non-silenced tissue. Acsl1 down-regulation decreased expression of mitochondrial β-oxidation enzymes, and the content of both the short-chain acylcarnitine (SCA-Car) and short-chain acyl-CoA (SCACoA) in muscle, pointing towards reduction of mitochondrial FA oxidation. The results indicate, that beneficial effects of Acsl1 partial ablation on muscular insulin sensitivity are connected with inhibition of Cer and DAG accumulation, and outweigh detrimental impact of decreased mitochondrial fatty acids metabolism in skeletal muscle of obese HFD-fed mice.
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