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Introduction: Surgical site infections (SSIs) are a significant source of postoperative morbidity. Triclosan-coated absorbable sutures, such as MITSU AB™ (Meril Endo Surgery Private Limited, Vapi, India), are designed to inhibit early microbial colonization, reducing the risk of SSIs. However, concerns about triclosan resistance highlight the need for real-world clinical evaluation. The present study aims to assess wound healing outcomes, incidence of SSIs, and triclosan resistance in patients treated with MITSU AB™ absorbable triclosan-coated sutures.Methods: A prospective, single-arm, multi-center post-marketing surveillance study was conducted involving 60 patients undergoing general surgical procedures, including laparoscopic appendectomy, episiotomy, and soft tissue repair. Patients were monitored postoperatively at discharge and days 7, 15, and 30. Primary outcomes included SSI occurrence and triclosan resistance. Secondary endpoints were wound healing grade, pain (measured by visual analogue scale (VAS)), and suture handling feedback.Results: The study population had a mean age of 38.5 ± 17.4 years, with 36 (60%) female participants. All patients (100%) achieved complete wound healing (Grade A) by day 30. No SSIs, triclosan-resistant microbial growth, or adverse events were recorded. Pain scores decreased over time, with 59 (98.3%) patients pain-free by day 15 and 100% by day 30. Suture handling was rated excellent in 51 (85%) cases. No re-interventions or re-admissions due to infection occurred during the study.Conclusion: MITSU AB™ triclosan-coated sutures demonstrated excellent infection prevention, complete healing, and favorable handling with no evidence of triclosan resistance. These findings support their safe and effective use in clinical surgery.

Abstract Background: Painful bladder syndrome (PBS) is characterized by persistent pelvic discomfort and urinary symptoms. Cystoscopy is frequently utilized to investigate bladder abnormalities in patients with PBS, particularly those presenting with persistent hematuria, refractory symptoms, or suspected bladder pathology. Objective: We aimed to evaluate the relationship between cystoscopy findings and symptom severity in patients with PBS. Materials and Methods: The study included 22 patients who underwent cystoscopy for PBS. Indications for the procedure included persistent hematuria, unrelenting symptoms, and suspected bladder pathology. Based on visual assessment, the cystoscopic findings were classified into three categories: normal, mild, and severe. Symptom severity was evaluated using a standardized symptom score questionnaire administered before treatment. Results: Of the 22 patients, 6 had normal cystoscopy findings, 14 exhibited mild changes, and 2 demonstrated severe changes. Symptom severity scores varied across the group, with no clear correlation between the severity of symptoms and cystoscopic findings. Notably, patients with severe symptoms often had normal or only mild changes on cystoscopy. Conclusion: No significant correlation was found between symptom severity and cystoscopy findings in PBS patients. This discrepancy may stem from the subjective nature of symptom scoring, the multifactorial origins of PBS symptoms, and the potential influence of functional disorders. Further research is warranted to identify additional factors influencing symptom severity in PBS.

BackgroundEarly pregnancy is characterized by the initiation of physiological and psychological changes, which places pregnant women at risk of psychological distress and poor sleep, which is known to cause adverse maternal and neonatal outcomes. This study aimed to assess the prevalence of prenatal distress and sleep quality during early pregnancy and identify factors associated with prenatal distress among pregnant women from urban and rural settings.MethodsThe study was conducted with 325 pregnant women (175 rural, 150 urban) as a baseline assessment of the MAI (Mother and Infant) cohort, a longitudinal observational study in Pune, India. Data on sociodemography, anthropometry, clinical history, prenatal distress, and sleep quality were collected between August 2020 and March 2023. Mann Whitney U test and regression were used to assess correlates of sleep quality and prenatal distress.ResultsOver one-third (37.5%) (n=122) of women experienced prenatal distress. Women from rural areas reported a higher prevalence (40%) (n=70) of distress, and poorer sleep quality than urban women (51.4% (n=90) vs 38.7% (n=58)). High prenatal distress was moderately associated with poor sleep quality (ρ = 0.308, p = 0.001). After controlling for sociodemographic and clinical factors, high prenatal distress (B=2.63, 95% CI: 1.47-4.69) predicted poor sleep quality. Rural residence (OR: 6.37, 2.46-16.51), underweight BMI status (OR: 2.21, 0.97-5.05), presence of episodes of vomiting (OR: 1.70, 0.93-3.13), and poor sleep quality (OR: 0.74, 0.40-1.38) significantly (p<0.05) contributed to prenatal distress.ConclusionPrenatal distress and poor sleep quality are significant concerns for pregnant mothers globally and require early screening and management strategies to avoid adverse maternal and fetal outcomes.

Tofacitinib is a Janus Kinase inhibitor used for treating moderate to severe ulcerative colitis (UC), mainly after the failure of biological therapy. There is a paucity of data on the outcome of tofacitinib in biological-naïve UC patients. The present study wasaimed at analyzing the safety and efficacy of tofacitinib in biological-naïve Indian patients with UC. The present study retrospectively evaluated consecutive patients with biological-naïve moderate-to-severe active UC from six tertiary care centers in India receiving tofacitinib from September 2020 to September 2022. Clinical remission or response assessment was based on partial Mayo score (PMS) calculated at baseline and weeks eight, 16 and 24. Total 47 cases (57.4% male, median age: 32years) were included. After eightweeks of therapy, 33 (70.2%) achieved clinical remission and eight (17.0%) had a primary failure. The baseline serum albumin at treatment initiation was the only independent predictor of remission at eightweeks (Odds ratio: 11.560, 95%CI: 1.478 - 90.404), but not at 16weeks. By 24weeks, 59.6% (28/47) of the patients were in remission and 29.8% (14/47) had stopped tofacitinib either due to failure (27.6%) or adverse events (AEs) (2.1%). Among the 47 patients, 10 (21.2%) cases developed AEs during follow-up, including two tuberculosis (4.2%), one cytomegalovirus (CMV) colitis (2.1%) and one herpes zoster (2.1%). Four patients with infection required temporary drug discontinuations. One required permanent discontinuation (mania). Upfront tofacitinib is effective in biologic-naïve Indian patients with moderate-severe UC. Further randomized studies are required to validate the study findings.

This study reported a preclinical acuteand sub-acute safety profiles of Hermed plus (HP) were investigated in laboratory animals. This is a very effective formulation developed in house. We have systematically studied the effec&nbsp; in Laboratory Animals&nbsp; for its behavioral changes or mortality if any, hematological&nbsp; parameters and found&nbsp; no hepato or&nbsp; renal toxicity associated with the sub-chronic dermal&nbsp; exposure of&nbsp; investigational product&nbsp; in&nbsp; the&nbsp; animals. The study was conducted in female Swiss albino mice using OECD guidelines Number 423. HP was derived from Crataeva nurvala Buch - Ham (Varun) bark, Musa paradisiaca Linn (Kadali / Banana) stem and roots, Achyranthes aspera Linn (Aghada) whole plant and Hordeum vulgare Linn (Yav) seeds. Above materials were converted into Varun bhavi, kadali bhavit, kshars of Kadali, Aghada and Yav respectively and were mixed in certain proportions in GMP certified manufacturing facility to formulate HP capsules form.Acute and sub-acute safety profiles of HP was studied by OECD guidelines Number 423 and FDA guidelines in Swiss albino mice and Wistar rats respectively. For the acute study, HP was administered orally in a single dose of 2000mg/kg and for sub-acute study HP was &nbsp;&nbsp;administered &nbsp;orally using S90,180 and 450mg/kg doses for 90days. In the present sub-acute study at termination the weights of vital organs like adrenals, heart, kidneys, liver, spleen, lungs, testis/ ovaries were determined and were converted into relative % organ weight and these were compared with control rats.In comparison to control animals, the subacute oral therapy with 90 mg/kg, 180 mg/kg, and 450 mg/kg of HP for 90 days to several groups of rats revealed no mortality, no behavioural alterations, and no changes in blood profile, biochemistry parameters, or profiles of essential organs. Hence, the NOAEL for HP in male and female Wistar rats was determined to be &gt; 450 mg/kg when administered orally for 90 days.

Percutaneous liver biopsy is the gold standard test for the assessment of liver disease. In patients with coagulopathy, ascites, post-transplantation, and hypervascular tumors, biopsy is associated with increased risk of adverse events (AEs). Transjugular liver biopsy (TJLB) is recommended in these conditions but is expensive and unavailable at many centers. Plugged liver biopsy (PLB) provides an alternate diagnostic modality in these high-risk cases. To analyze the pooled diagnostic outcome and safety of PLB in high-risk cases. A literature search of various databases from January 1990 to July 2022 was conducted for studies evaluating the outcome of PLB in high-risk cases. The primary outcomes were pooled sample adequacy and AEs. Pooled event rates across studies were expressed with summative statistics. A total of 17 studies (2329 patients) were included in the meta-analysis. The pooled proportion of sample adequacy was 98.9% (95% confidence interval [CI]=98.2-99.6). Severe AEs, major bleeding, and minor AEs were seen in 0.7% (95% CI=0.1-1.3), 0.4% (95% CI=0.1-0.8), and 11.5% (95% CI=2.4-20.6) of the patients. There was only one reported mortality, giving a pooled incidence of 0.0002% (95% CI=0.0-0.0038). Compared to TJLB (5 studies, n = 336), there was no difference in either sample adequacy (odds ratio [OR]=2.34, 95% CI=0.83-6.58) or risk of serious AEs (OR=0.47, 95% CI=0.173-1.31). PLB can be safely performed on patients with coagulopathy and/or ascites with high sample adequacy rates and low incidence of AEs and mortality.

Journal of Obstetrics and Gynaecology ResearchVolume 48, Issue 2 p. 515-515 Letter to the Editor Letter to “Clinical effects and safety of ferric carboxymaltose in pregnancy: An Indian real-life experience” Sanjay A. Gupte, Corresponding Author Sanjay A. Gupte guptehospital@gmail.com Department of Obstetrics and Gynecology, Gupte Hospital and Centre for Research in Reproduction, Pune, IndiaSearch for more papers by this authorGayatri Venkataraman, Gayatri Venkataraman Department of Obstetrics and Gynecology, Gupte Hospital and Centre for Research in Reproduction, Pune, IndiaSearch for more papers by this authorAarti S. Shah, Aarti S. Shah Department of Reproductive Medicine, Pulse Clinic, Ahmedabad, IndiaSearch for more papers by this author Sanjay A. Gupte, Corresponding Author Sanjay A. Gupte guptehospital@gmail.com Department of Obstetrics and Gynecology, Gupte Hospital and Centre for Research in Reproduction, Pune, IndiaSearch for more papers by this authorGayatri Venkataraman, Gayatri Venkataraman Department of Obstetrics and Gynecology, Gupte Hospital and Centre for Research in Reproduction, Pune, IndiaSearch for more papers by this authorAarti S. Shah, Aarti S. Shah Department of Reproductive Medicine, Pulse Clinic, Ahmedabad, IndiaSearch for more papers by this author First published: 21 November 2021 https://doi.org/10.1111/jog.15106Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat No abstract is available for this article. Volume48, Issue2February 2022Pages 515-515 RelatedInformation

BackgroundThe coronavirus disease 2019 (COVID‐19) pandemic has resulted in millions of deaths and overburdened healthcare systems worldwide. Systemic low‐dose corticosteroids have proven clinical benefit in patients with severe COVID‐19. Higher doses of corticosteroids are used in other inflammatory lung diseases and may offer additional clinical benefits in COVID‐19. At present, the balance between benefits and harms of higher vs. lower doses of corticosteroids for patients with COVID‐19 is unclear.MethodsThe COVID STEROID 2 trial is an investigator‐initiated, international, parallel‐grouped, blinded, centrally randomised and stratified clinical trial assessing higher (12 mg) vs. lower (6 mg) doses of dexamethasone for adults with COVID‐19 and severe hypoxia. We plan to enrol 1,000 patients in Denmark, Sweden, Switzerland and India. The primary outcome is days alive without life support (invasive mechanical ventilation, circulatory support or renal replacement therapy) at day 28. Secondary outcomes include serious adverse reactions at day 28; all‐cause mortality at day 28, 90 and 180; days alive without life support at day 90; days alive and out of hospital at day 90; and health‐related quality of life at day 180. The primary outcome will be analysed using the Kryger Jensen and Lange test adjusted for stratification variables and reported as adjusted mean differences and median differences. The full statistical analysis plan is outlined in this protocol.DiscussionThe COVID STEROID 2 trial will provide evidence on the optimal dosing of systemic corticosteroids for COVID‐19 patients with severe hypoxia with important implications for patients, their relatives and society.