A Randomized Controlled Trial Comparing Effectiveness of Different Fibrinogen Preparations in Restoring Clot Firmness.

BACKGROUND: Different preparations of fibrinogen concentrate are currently available. Two in vitro studies demonstrated the superiority of FibCLOT (LFB) in increasing clot firmness with respect to RiaSTAP (CSL Behring). The present trial involved a clinical model to test the hypothesis of superiority, with the increase in clot firmness as the primary end point. METHODS: Forty cardiac surgery patients were randomly allocated to receive a dose of 30 mg/kg FibCLOT or RiaSTAP after protamine administration in the presence of microvascular bleeding and a FIBTEM maximum clot firmness (MCF) <10 mm. Viscoelastic parameters were measured before and after fibrinogen supplementation: FIBTEM MCF, EXTEM MCF, and EXTEM clotting time (CT). RESULTS: The mean increase in FIBTEM MCF was 4 ± 1.2 mm (mean and standard deviation) in the FibCLOT group and 4 ± 1.6 mm in the RiaSTAP group (P = 1.000); the mean decrease in CT was 11. 2 ± 12.2 (mean and standard deviation) seconds in the FibCLOT group and 14. 8 ± 13 seconds in the RiaSTAP group (P = .372). In both groups, fibrinogen supplementation induced a significant (P = .001) increase in the FIBTEM MCF and EXTEM CT. The proportions of patients who did not experience an increase of 4 mm in the RiaSTAP group and the FibCLOT group were not statistically significantly higher (35% vs 20%, respectively, relative risk 2.15, 95% confidence interval 0.52-9.00, P = .288). CONCLUSIONS: In contrast to previous in vitro studies, we found that the effect of FibCLOT on MCF and CT was not significantly greater than that of RiaSTAP in cardiac surgery patients. Further studies in other clinical settings are warranted.

Efficacy of Polyhexamethylene Biguanide in Reducing Post-Operative Infections: A Systematic Review and Meta-Analysis.

Background: Post-operative infections are a substantial cause of morbidity and mortality worldwide. Polyhexamethylene biguanide (PHMB) is an antimicrobial agent that has been used in various surgical settings to prevent infections. However, the literature on its efficacy in reducing post-operative infections remains unclear. Materials and Methods: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to evaluate the efficacy of PHMB in reducing post-operative infections. The risk of bias and methodologic quality of the included studies were also assessed. Results: The systematic review included nine RCTs, and eight were included in the meta-analysis that showed that the use of PHMB was associated with a reduction in the rate of post-operative infections. The overall effect size was statistically significant, with moderate heterogeneity across the included studies (log Peto's odds ratio [OR], -0.890; 95% confidence interval [CI], -1.411 to -0.369; I2 = 41.89%). However, the diversity in the application of PHMB and the potential influence of other factors, such as adherence to infection prevention protocols and organizational-level variables, underscore the need for further primary studies. Conclusions: Polyhexamethylene biguanide appears to be a promising intervention for reducing post-operative infections. However, more high-quality, well-designed RCTs are needed to confirm these findings and to explore the most effective ways to use PHMB within specific infection prevention bundles. Future research should also aim to control for potential confounding factors to provide a more comprehensive understanding of the efficacy of PHMB in reducing post-operative infections.

Vascular access and clinical competency: Which elements matter? The development of three bottom-up and evidence-grounded self-assessment tools.

BACKGROUND: Assessing competency in the speciality of vascular access is still limited, and few valid and reliable tools are available. Therefore, this study aimed to develop and validate three different tools for assessing competency in managing the care of short peripheral cannulas (SPCs), midlines, peripherally inserted central catheters (PICCs), centrally inserted central catheters (CICCs), and arterial catheters (ACs) (tool one), placing SPCs (tool two), placing PICCs and midlines (tool three). METHODS: A two-phase and multi-method design was adopted. Phase one was implemented to develop the initial pool of items for each tool, starting from a literature overview. Panel discussions were adopted for developing the items. In phase two, the developed items were tested for content and face validity, involving a panel of 10 experts. Once obtained adequate content validity, a cross-sectional data collection was implemented to enroll three samples of healthcare workers who had to assess their competency through the developed tools. Dimensionality was assessed by performing a principal component analysis (PCA) and assessing internal consistency (Cronbach's α). RESULTS: Tool one had 26 items, and the dimensionality was given by placement, risk assessment, procedure conformity and traceability, and patient education to self-care. Tool two had 35 items; its principal components were: risk evaluation, identification, clinical assessment and orientation to self-care, placement, and procedure registration shaped the competency of placing SPCs. Tool three had 31 items; its principal components were: risk assessment, placement, conformity to standards and procedure traceability, education, and orientation to self-care were the essential elements for adequately placing midlines and PICCs. Cronbach's α values ranged between 0.806 and 0.959. CONCLUSIONS: The three developed tools reflected the core elements of competency in each application area, representing an initial framework that could be useful in future research and educational projects. Cross-national investigations are required to corroborate the described results.

Evaluating safety, efficacy, and cost-effectiveness of PICC securement by subcutaneously anchored stabilization device.

PURPOSE: In recent years, a large variety of medical devices has become available. Every device must be efficient, safe and cost effective, but it is not enough to use it properly without considering the environment in which it will be employed. We applied this kind of analysis to subcutaneously anchored sutureless devices (SAS). METHODS: This is a one-center prospective observational study on safety, effectiveness and cost effectiveness of an SAS device (SecurAcath, Interrad) for securement of peripherally inserted central catheter (PICC) in 30 adult cancer patients with treatment expected to be >60 days. RESULTS: During 4963 catheter days and after 709 dressing changes (documented by 373 pictures), the use of SAS was associated with no episode of PICC dislodgement and a lower incidence of complications if compared to traditional securement devices. Insertion, management and removal of SAS were not associated with an increased pain perception by the patients. Cost effectiveness was particularly evident for long dwelling PICCs. CONCLUSIONS: Our study suggests that SAS is a highly effective and cost-effective method for securement of medium- to long-term PICCs with expected duration longer than 30 days. The introduction of SAS had a positive impact on our healthcare organization.