Efficacy and safety of phospholipid nanoparticles (VBI-S) in reversing intractable hypotension in patients with septic shock: a multicentre, open-label, repeated measures, phase 2a clinical pilot trial.

Background: Since the 1990's attempts to favorably modulate nitric oxide (NO) have been unsuccessful. We hypothesized that because NO is lipophilic it would preferentially localize into intravascularly infused hydrophobic nanoparticles, thereby reducing its bioavailability and adverse effects without inhibiting its production. We aimed to determine the efficacy and safety of intravenous infusion of a fluid comprised of hydrophobic phospholipid nanoparticles (VBI-S) that reversibly absorb NO in the treatment of hypotension of patients in severe septic shock. Methods: This is a multicentre, open-label, repeated measures, phase 2a clinical pilot trial done at six hospital centers in the USA. Patients in severe septic shock were enrolled after intravenous fluid therapy had failed to raise mean arterial blood pressure (MAP) to at least the generally accepted level of 65 mmHg, requiring the use of vasopressors. The primary endpoint of this study is the proportion of patients in whom MAP increased by at least 10 mmHg. VBI-S was administered intravenously to patients as boluses of 100 ml, 200 ml, 400 ml, and 800 ml at 999 ml/min until the blood pressure goal was reached after which the infusion was stopped, and the MAP was recorded. All patients who received any volume of VBI-S were included in the primary and safety analysis. The study is registered with ClinicalTrials.gov, NCT04257136. Findings: Between February 17, 2020 and January 3, 2023, 20 eligible patients were enrolled in the study. In all 20 (100%) patients, the goal of increasing MAP by at least 10 mmHg using VBI-S was achieved (p = 0.0087, effect size = 0.654). Mean VBI-S volume required to meet the primary goal was 561.0 ± 372.3 ml. The goal of lowering vasopressor dose was also achieved (p = 0.0017). Within 48 h or less after VBI-S, there was a statistically significant improvement in oxygenation, serum creatinine, clotting variables, procalcitonin, lactic acid, and the sequential organ failure assessment (SOFA) score. At 24 h and 48 h following administration of VBI-S, 12/15 (80%) and 9/12 (75%) patients developed hyperlipidemia, respectively. No severe adverse events of VBI-S were observed, and there were no treatment-related deaths. Interpretation: These preliminary findings suggest the safety and efficacy of VBI-S in treating hypotension in patients with septic shock. However, a definitive mortality benefit cannot be demonstrated without a randomized controlled study. Funding: The Naval Medical Research Command-Naval Advanced Medical Development program via the Medical Technology Enterprise Consortium.

Reusing personal protective equipment (PPE) did not increase surgical site infection in trauma surgical patients during the COVID-19 pandemic: A retrospective cohort study in Michigan Trauma Centers.

BACKGROUND: Reuse of personal protective equipment (PPE), masks more specifically, during the COVID-19 pandemic was common. The primary objective of this study was to compare pre-pandemic surgical site infection (SSI) rates prior to reuse of PPE, to pandemic SSI rates after reuse of PPE in trauma surgical patients. METHODS: A retrospective cohort analysis collected from the Michigan Trauma Quality Improvement Program database was performed. The pre-COVID cohort was from March 1, 2019 to December 31, 2019 and post-COVID cohort was March 1, 2020 to December 31,2020. Descriptive statistics were used to assess differences between variables in each cohort. RESULTS: Nearly half (49.8%) of our cohort (n = 48,987) was in the post-COVID group. There was no significant difference in frequency of operative intervention between groups (p > .05). There was no significant increase (p > .05) between pre- and post-COVID cohorts for superficial, deep, or organ space SSI when reuse of masks was common. CONCLUSION: Reuse of PPE did not lead to an increase in SSI in surgical patients. These findings are consistent with previous studies, but the first to be described in the trauma surgical patient population. Studies such as this may help inform further discussion regarding PPE usage as we continue to emerge from the current pandemic with the continuous threat of future pandemics.

Fibroepithelioma of Pinkus with pleomorphic epithelial giant cells.

Fibroepithelioma of Pinkus is a rare, indolent variant of basal cell carcinoma (BCC). The presence of pleomorphic giant cells in such a tumor is extremely rare and to our knowledge, only one such case has been previously reported in the literature. We report another case occurring as a pedunculated, gluteal lesion in an 82-year-old man. The nodule was lightly pigmented, polypoid, and measured 1.0 cm in greatest dimension. Immunohistochemical staining confirmed that the giant cells were of epithelial origin and that the proliferative rate of these cells was low.