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Pilonidal sinus disease (PSD) is associated with substantial morbidity because of wound complications and recurrence after surgery. Adjunct laser hair removal (LHR) has been incorporated into postoperative management in some settings, but real-world outcomes in cohorts treated uniformly with LHR remain incompletely described. This study aimed to characterize postoperative outcomes after PSD surgery in a large integrated healthcare system in which adjunctive LHR was standard practice and to compare outcomes by surgical approach. We performed a retrospective descriptive cohort study of patients aged 14–89 years who underwent operative treatment of PSD with adjunctive LHR at Kaiser Permanente Northern California between 2012 and 2024. Outcomes included repeat procedures, 30-day surgical site infection (SSI), and unplanned clinic visits. Outcomes were summarized as proportions overall and by surgical approach. Exploratory bivariable logistic regression examined associations between sex or body mass index (BMI) and outcomes. Multivariable modeling was not performed because of low event counts and sparse covariate distributions, which resulted in unstable models. Among 168 patients, the overall repeat procedure rate was 16.7%, the 30-day SSI rate was 14.4%, and 39.3% had at least one unplanned clinic visit. Patients treated with Bascom flap closure had fewer repeat procedures (10.4% vs. 20.8%) and fewer unplanned visits (33.8% vs. 43.6%) than those undergoing pilocystectomy, with similar SSI rates (14.9% vs. 14.0%). In exploratory analyses, sex and BMI were not significantly associated with outcomes in either surgical group. In this real-world cohort managed uniformly with adjunctive LHR, postoperative outcomes appeared to vary more by surgical approach than by sex or BMI. These findings are descriptive and do not estimate the independent effect of LHR. Controlled comparative studies are needed to determine the contribution of LHR to PSD outcomes.
Multimorbidity or multiple long-term conditions (MLTCs) are defined as the coexistence of two or more chronic conditions in an individual. With increased longevity and the rising burden of chronic non-communicable diseases (NCDs), multimorbidity is becoming the norm. Although more prevalent in older populations and people with low socio-economic status, multimorbidity is rapidly rising in the younger age groups. Accurate data on its incidence and health and economic impacts, ie, disability-adjusted life years (DALY) lost and quality-adjusted life year (QALY) are not available for the Indian population. The objective of this study is to determine the incidence and predictors of multimorbidity, the longitudinal trends, the common clusters of conditions and the health and economic impact of multimorbidity among adult Indians aged ≥40 years.
12 229 participants (≥40 years) from the population-based cohort, titled the Centre for cArdiometabolic Risk Reduction in South-Asia (CARRS) cohort, from Delhi and Chennai will be recruited. CARRS is an existing adult urban cohort which is well characterised, deeply phenotyped and geocoded with bio-banked samples. They will be followed up longitudinally twice during 2023–2025. Information will be collected on common NCD risk factors (physical inactivity, tobacco and alcohol use), disability, frailty and treatment costs. We will also perform anthropometric and blood pressure measurements on all participants as well as biomarker assessments on a sub-sample of 2300.
Ethics approval has been obtained from the ethics committees of the Centre for Chronic Disease Control (CCDC) (Institutional Review Board (IRB) 00006330) and the Madras Diabetes Research Foundation (IRB no. IRB00002640). Key findings from the study will be published in national and international peer-reviewed journals. Results will also be presented at various academic conferences to engage with the broader research community. A final report will be submitted to the funding agency upon completion of the fellowship. De-identified data will be securely stored at the CCDC. Access to the data will be available upon request to the principal investigator.
Patients receiving haemodialysis are at very high risk of fragility fracture, yet there are no proven treatments for fracture prevention. We will advance a pilot study on the feasibility of a large, pragmatic, randomised controlled trial (RCT) of denosumab for fragility fracture prevention in haemodialysis.
PRevEnting FracturEs in REnal Disease-1 is a pragmatic, open-label, pilot study of an RCT of a denosumab care pathway embedded in routine care haemodialysis centres.
We will recruit at least 60 participants at high risk of fracture from at least 6 haemodialysis centres in Ontario, Canada. They must be aged 40 years or older, have access to provincial drug coverage, have appropriate baseline calcium and parathyroid hormone levels and be deemed suitable for denosumab by their kidney care provider. Participants will be randomised 1:1 to denosumab (with supports to mitigate hypocalcaemia) versus usual care using block randomisation by a central statistician (computer-generated sequence). Primary outcomes include recruitment feasibility and adherence. Secondary outcomes include safety (hypocalcaemia) and participant satisfaction with our protocol and processes. Study investigators and data analysts will be blind to treatment allocation.
We will present results descriptively. The trial was approved by Clinical Trials Ontario and local research ethics boards across study sites.
Primary and secondary outcomes will be published on trial completion.
This pilot will inform the feasibility of conducting a large-scale, efficiently run, pragmatic RCT to test whether a denosumab care pathway safely reduces the risk of fragility fracture in patients receiving haemodialysis. Results have the potential to transform fracture care in real-world patients with kidney and metabolic bone disease.
Neonatal death and later disability remain common sequelae of hypoxic-ischaemic encephalopathy (HIE) despite the now standard use of therapeutic hypothermia (HT). New therapeutic approaches to brain protection are required. Melatonin is an indolamine hormone with free-radical scavenging, antiapoptotic, anti-inflammatory and gene regulatory neuroprotective properties, which has extensive preclinical evidence of safety and efficacy. Pharmacokinetic (PK) data suggest it is necessary to reach melatonin levels of 15–30 mg/L within 6–8 hours of hypoxia-ischaemia for brain protection. We developed a novel Good Manufacturing Practice (GMP) grade melatonin in ethanol 50 mg/mL solution for intravenous use. In preclinical studies, ethanol is an adjuvant excipient with additional neuroprotective benefit; optimised dosing protocols can achieve therapeutic melatonin levels while limiting blood alcohol concentrations (BACs).
The Acute High Dose Melatonin for Encephalopathy of the Newborn (ACUMEN) Study is a first-in-human, international, multicentre, phase 1 safety study of intravenous melatonin in babies with moderate/severe HIE receiving HT. Sixty babies will be studied over two phases: a dose escalation study including four dose levels to establish the recommended phase 2 dose (RP2D), followed by a 6-month cohort expansion study of RP2D to further characterise PKs and affirm safety. Participants will receive a 2-hour intravenous infusion of melatonin within 6 hours of birth, followed by five maintenance doses every 12 hours to cover the period of HT. Plasma melatonin and BACs will be monitored. The RP2D will be based on the attainment of therapeutic melatonin levels while limiting BACs and the frequency of dose-limiting events (DLEs). A Bayesian Escalation with Overdose Control approach will be used to estimate the risk of DLE per dose level, with a target level of
Approval has been given by the London Central National Health Service Health Research Authority Ethics Committee (25/LO/0170) and UK Clinical Trials Authorisation from the Medicines and Healthcare products Regulatory Agency. Separate approvals have been sought in Ireland and Australia. Dissemination will be via peer-reviewed journals, conference presentations, public registries and plain language summaries for parent/legal guardian(s), in accordance with national requirements.
ISRCTN61218504. EU CT: 2025-520538-49-00.
Publication based on the UK protocol V.3.0, 08 May 2025
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