Evaluation of central venous catheters coated with a noble metal alloy-A randomized clinical pilot study of coating durability, performance and tolerability.

The use of Central Venous Catheters (CVCs) commonly results in complications. Coatings with silver or metal alloys can reduce the risk associated with the use of CVC. We have evaluated the durability of a noble metal coated CVC (the Bactiguard Infectious Protection, BIP CVC) and compared with an uncoated CVC for clinical tolerability (Adverse Events, AEs) and performance, in order to create a baseline for a large future study. Patients undergoing major surgery, randomised at a 2:1 ratio to BIP CVC (n = 22) or standard CVC (n = 12), were catheterized 9 - 12 days, respectively. Adverse events, microbial colonization and metal release were measured. FINDINGS: There were no AEs in the BIP CVC-group, but 5 AEs occurred in 4 patients (1 patient had 2 AEs) in the standard CVC-group, p = 0.011 (whereof 3 were catheter related). The BIP CVC showed an initial release of coating metals in blood (gold, silver and palladium), which rapidly decreased and were far below Permitted Paily Exposure (PDE) for chronical use. The levels of silver concentration were far below those needed to develop microbial resistance. The performance was equal, and there was no difference concerning microbial colonization, for the two CVCs. CONCLUSION: In this pilot study the BIP CVC had significantly lower AEs and showed a comparable performance to the standard CVC. The coating was durable throughout the study length (up to 16 days) and toxicological evaluation showed good safety margins. Larger studies are needed. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 2337-2344, 2018.

Keratins regulate colonic epithelial cell differentiation through the Notch1 signalling pathway.

Keratins (K) are intermediate filament proteins important in stress protection and mechanical support of epithelial tissues. K8, K18 and K19 are the main colonic keratins, and K8-knockout (K8-/-) mice display a keratin dose-dependent hyperproliferation of colonic crypts and a colitis-phenotype. However, the impact of the loss of K8 on intestinal cell differentiation has so far been unknown. Here we show that K8 regulates Notch1 signalling activity and differentiation in the epithelium of the large intestine. Proximity ligation and immunoprecipitation assays demonstrate that K8 and Notch1 co-localize and interact in cell cultures, and in vivo in the colonic epithelial cells. K8 with its heteropolymeric partner K18 enhance Notch1 protein levels and activity in a dose dependent manner. The levels of the full-length Notch1 receptor (FLN), the Notch1 intracellular domain (NICD) and expression of Notch1 downstream target genes are reduced in the absence of K8, and the K8-dependent loss of Notch1 activity can be rescued with re-expression of K8/K18 in K8-knockout CRISPR/Cas9 Caco-2 cells protein levels. In vivo, K8 deletion with subsequent Notch1 downregulation leads to a shift in differentiation towards a goblet cell and enteroendocrine phenotype from an enterocyte cell fate. Furthermore, the K8-/- colonic hyperproliferation results from an increased number of transit amplifying progenitor cells in these mice. K8/K18 thus interact with Notch1 and regulate Notch1 signalling activity during differentiation of the colonic epithelium.

Tolerability and performance of BIP endotracheal tubes with noble metal alloy coating--a randomized clinical evaluation study.

BACKGROUND: Hospital acquired infections worsen the outcome of patients treated in intensive care units and are costly. Coatings with silver or metal alloys may reduce or alter the formation of biofilm on invasive medical devices. An endotracheal tube (ETT) is used to connect the patient to a ventilator and coated tubes have been tested in relation to bacterial colonization and respiratory infection. In the present study, we aimed to evaluate and compare a coated and uncoated ETT for patient symptoms and local tracheal tolerability during short term clinical use. Degree of bacterial colonization was also described. METHODS: A silver-palladium-gold alloy coating ('Bactiguard®'Infection Protection, BIP) has been extensively used on urinary tract catheters and lately also on central venous catheters. We performed a randomised, single-blinded, controlled, first in man, post Conformité Européenne (EC) certification and CE marking study, focused on Bactiguard® coated ETTs (BIP ETT). Thirty patients at a tertiary university hospital scheduled for upper abdominal elective surgery with an expected duration of anaesthesia of at least 3 h were randomised; BIP ETT (n = 20) or standard ETT (n = 10). The tolerability was assessed with a modified version of Quality of Life Head and Neck Module, QLQ-H&N35 and by inspection of the tracheal mucosa with a fibre-optic bronchoscope before intubation and at extubation. Adverse Events (AE) and bacterial adherence were also studied. Statistical evaluations were carried out with the Fisher's Exact Test, the Clopper-Pearson method, as well as a Proportional Odds Model. RESULTS: Differences between groups were identified in 2 of 8 patient related symptoms with regard to tolerability by QLQ-H&N35 (cough, p = 0.022 and dry mouth, p = 0.014 in the treatment group.). No mucosal damage was identified with bronchoscopy. A low level of bacterial colonization with normal flora, equal between groups, was seen after short-term of intubation (median 5 h). No serious Adverse Events related to the use of an ETT were observed. The results should be treated with caution due to statistical confounders, a small study size and large inter-individual variability in bacterial adhesion. CONCLUSIONS: The new device BIP ETT is well tolerated and has good clinical performance during short-term intubation. Studies with larger sample sizes and longer intubation periods (>24 h) in the ICU-setting are needed and can now be planned in order to identify possible differences in clinical outcomes. TRIAL REGISTRATION: Registered in ClinicalTrials.gov, REGISTRATION NUMBER: NCT01682486 , Date of Registration: August, 30, 2012.

Comparison of 30-day and 5-year outcomes of percutaneous coronary intervention versus coronary artery bypass grafting in patients aged≤50 years (the Coronary aRtery diseAse in younG adultS Study).

Data on the outcome of young patients after coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) are scarce. Data on 2,209 consecutive patients aged≤50 years who underwent CABG or PCI were retrospectively collected from 15 European institutions. PCI and CABG had similar 30-day mortality rates (0.8% vs 1.4%, p=0.27), late survival (at 5 years, 97.8% vs 94.9%, p=0.082), and freedom from stroke (at 5 years, 98.0% and 98.0%, p=0.731). PCI was associated with significantly lower freedom from major adverse cardiac and cerebrovascular events (at 5 years, 73.9% vs 85.0%, p<0.0001), repeat revascularization (at 5 years, 77.6% vs 92.5%, p<0.0001), and myocardial infarction (at 5 years, 89.9% vs 96.6%, p<0.0001) compared with CABG. These findings were confirmed in propensity score-adjusted and matched analyses. Freedom from major adverse cardiac and cerebrovascular events after PCI was particularly low in diabetics (at 5 years, 58.0% vs 75.9%, p<0.0001) and in patients with multivessel disease (at 5 years, 63.6% vs 85.1%, p<0.0001). PCI in patients with ST elevation myocardial infarction was associated with significantly better 5-year survival (97.5% vs 88.8%, p=0.001), which was driven by its lower 30-day mortality rate (1.5% vs 6.0%, p=0.017). In conclusion, patients aged≤50 years have an excellent immediate outcome after either PCI or CABG with similar long-term survival when used according to the current clinical practice. PCI was associated with significantly lower freedom from myocardial infarction and repeat revascularization.

Adolescent non-suicidal self-injury (NSSI) interventions.

TOPIC: Evidence-based treatment of non-suicidal self-injury (NSSI) in adolescents. PURPOSE: To review the evidence base supporting current interventions for NSSI. SOURCES USED: PubMed searches and ancestry analysis. CONCLUSIONS: All treatments studied-developmental group therapy, individual cognitive-behavioral therapy, and dialectical behavioral therapy for adolescents-were found to be comparable to the typical treatments offered in the treatment settings where the research was conducted. Additional strategies such as harm reduction have very limited evidence suggesting they may be helpful. A few common interventions including relaxation techniques have extremely limited evidence suggesting they may be perceived as harmful by clients.

Triclosan-coated sutures reduce surgical site infection after open vein harvesting in coronary artery bypass grafting patients: a randomized controlled trial.

OBJECTIVES: The incidence of surgical site infection (SSI) after open vein harvesting in coronary artery bypass grafting (CABG) patients ranges in different studies between 2 and 20%. Triclosan is an antibacterial substance that reduces the growth of bacteria by inhibiting fatty acid synthesis. We hypothesized that wound closure with triclosan-coated sutures would reduce SSI after open vein harvesting. METHODS: An investigator-initiated prospective randomized double-blind single-centre study was performed with 374 patients, randomized to subcutaneous and intracutaneous leg-wound closure with either triclosan-coated sutures (Vicryl Plus and Monocryl Plus, Ethicon, Somerville, NJ, USA) (n = 184) or identical sutures without triclosan (n = 190) from the same manufacturer. All patients were followed up after 30 days (clinical visit) and 60 days (telephone interview). Primary endpoint was SSI within 60 days after surgery according to the definition of Center for Disease Control. Predefined secondary endpoints included culture-proven and antibiotic-treated SSI. RESULTS: The primary endpoint occurred in 23 patients (12.5%) with triclosan-coated sutures and in 38 patients (20.0%) in the group without triclosan (P = 0.0497, risk ratio 0.63, (95% confidence interval 0.39-1.00). Corresponding figures for culture-proven infections were 7.6 vs 12.1%, (P = 0.15), and for antibiotic-treated infections, 10.9 vs 18.4%, (P = 0.039). Staphylococcus aureus and coagulase-negative staphylococci were the most common pathogens in both groups. Insulin-treated diabetes and vein-harvesting time were associated with SSI after vein harvesting. CONCLUSIONS: Leg-wound closure with triclosan-coated sutures in CABG patients reduces SSIs after open vein harvesting. (ClinicalTrials.gov number NCT01212315).

Sampling conditions influence multiple electrode platelet aggregometry in cardiac surgery patients.

OBJECTIVES: To investigate the importance of blood sampling conditions for multiple electrode platelet aggregometry (MEA) in cardiac surgery patients. DESIGN: Eighty-one patients undergoing first time CABG surgery were included in three prospective, observational studies. MEA was used to analyze platelet aggregability after addition of adenosine-diphosphate (ADP) or thrombin activating peptide 6 (TRAP). In substudy 1, hirudin and citrate tubes were compared. In substudy 2, samples from peripheral vein, central venous catheter, and radial artery were compared and in substudy 3, the effect of surgery was investigated by analyzing pre- and postoperative samples. RESULTS: Platelet aggregability values were 30% higher in hirudin tubes than in citrate tubes. There was a significant correlation between hirudin and citrate tubes in TRAP-induced aggregability (r = 0.84, p < 0.001) but not in ADP-induced aggregability (r = 0.25, p = 0.13). The blood sampling site did not influence platelet aggregability. Surgery reduced ADP-induced aggregability by 31% (p < 0.001) and TRAP-induced aggregability by 30% (p < 0.001) with large intraindividual variations. CONCLUSIONS: MEA results in cardiac surgery patients should not be compared between samples collected in test tubes with different anticoagulants. The choice of blood sampling site does not affect the results. The operation in itself reduces markedly mean platelet aggregability.

Pregnancy and multiple sclerosis.

Multiple sclerosis (MS) is often diagnosed among women of childbearing age. This article reviews how MS affects pregnancy and provides information for health care providers who care for women with this disorder. Women with MS need to be informed regarding how the disease will affect their reproductive health. The disease itself does not usually have a negative impact on fertility or pregnancy, although some studies indicate that women with MS have a slightly increased risk for having small-for-gestational-age newborns. Some of the common MS symptoms such as fatigue, urinary frequency, constipation, and mood changes are similar to pregnancy-related symptoms. Mode of birth and anesthesia choices are similar to those for women without MS. Immunomodulatory therapy for MS needs to be discontinued before conception because most of the medications are still under investigation with regard to safety during pregnancy or have adverse effects on pregnancy. Relapse rates are increased for up to 6 months in the postpartum period. Breast feeding does not appear to increase the risk of postpartum relapses. All hormonal contraception can be used by women with MS. Some studies suggest that estrogen may have protective effects against disease progression.

How caregivers manage pain and distress in second-stage labor.

Innovative care interactions are needed when helping a woman who exhibits severe pain or distress during the second stage of labor. We describe how caregivers and laboring women interacted during second-stage labor, with particular attention to how caregivers managed pain and distress. We used observational methods to perform a microanalysis of behaviors from video-recorded data. Pain occurred during labor contractions, and distress (an emotional response to pain) manifested primarily between contractions. Four patterns of women's behavior were identified: 1) no pain or distress, 2) low-level pain and/or distress, 3) focused working, and 4) severe pain and/or distress. Successful care was identified as enabling the woman to maintain herself in any state other than severe pain and/or distress. Particular modes of speech used by the caregiver enabled the attainment of successful care when the woman was not in severe pain or distress. When severe pain or distress existed, innovative caregiving transitioned the woman to another state. Successful intervention strategies included 1) giving innovative directions and 2) "talking down." Ordinary modes of "birth talk" can be used when severe pain or distress is not manifested and when the primary care problem is to assist women with bearing down. Innovative care interactions are needed when faced with severe pain or distress. Managing labor pain is an ongoing focus of clinicians who provide care to women in labor. In addition to pain, women might also experience distress, an emotional response to the labor experience. Whether from choice or necessity, caregivers for laboring women need nonpharmacologic interventions and interpersonal skills that can help women endure labor and give birth. Labor is hard work, and even in precipitous labors most women require assistance. Care given to a laboring woman consists of employing comforting strategies that help her cope with the pain of uterine contractions. The purpose of these comfort strategies is to help the woman find needed resilience during labor. Most cultures have mechanisms for providing this kind of support. In this article, we identify patterns of behavior used by laboring women and describe successful and unsuccessful strategies used by caregivers to help these women deal with pain and distress during the second stage of labor.

Birth talk in second stage labor.

In this secondary analysis of videotape data, we describe birth talk demonstrated by caregivers to women during the second stage of labor. Birth talk is a distinctive verbal register or a set of linguistic features that are used with particular behaviors during specific situations, has a particular communication purpose, and is characterized by distinctive language features. Birth talk is found cross-culturally among speakers of diverse languages. Our findings show that birth talk occurred mainly during contractions and co-occurred with two general styles of caregiving: "directed toward forced bearing down" and "supportive of physiologic bearing down." We also describe talk that occurred during rest periods, which was similar across the two styles. Caregivers' use of language tended to be either procedural (giving directions, instructions) or comfort related (encouraging and supporting). Linguistic features of the talk consisted of utterances of short duration, level pitch patterns with no sudden pitch shifts, and a restricted pitch range.