Peripheral venous catheter colonisation after skin disinfection with 0.5% aqueous sodium hypochlorite, preceded or not by one application of 70% ethanol (DACLEAN): A single centre, randomised, open-label, pilot study

Antisepsis of the skin of children to whom a peripheral venous catheter (PVC) is to be attached is an important factor in reducing catheter related infections. No data are available on the effectiveness of sodium hypochlorite. Explorative study of children and new-born babies treated in hospital to ascertain bacterial contamination levels of PVC tips as surrogate infection indicator. In a sample of 51 children and 52 new-born babies, catheter tips were found contaminated for 7.8% of the children and 3.8% of the new-born babies. The positive results of this pilot study suggest that serious consideration should be given to assessing Amukine Med 0.05% for use with PVCs.

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Use of Sodium Hypochlorite for Skin Antisepsis Before Inserting a Peripheral Venous Catheter

Biological Research For Nursing ◽

10.1177/1099800414545509 ◽

2014 ◽

Vol 17 (3) ◽

pp. 330-333 ◽

Cited By ~ 2

Author(s):

Cristiana Forni ◽

Tania Sabattini ◽

Fabio D’Alessandro ◽

Ambra Fiorani ◽

Simonetta Gamberini ◽

...

Keyword(s):

Pilot Study ◽

Sodium Hypochlorite ◽

Povidone Iodine ◽

Experimental Studies ◽

Venous Catheter ◽

Contamination Rate ◽

Peripheral Venous Catheter ◽

Skin Antisepsis ◽

Skin Decontamination

Although it can be prevented, catheter-related bacteremia is common and dangerous. The antiseptics most widely used during insertion of peripheral venous catheters (PVCs) include povidone iodine, alcohol, and chlorhexidine. Another widely used antiseptic is a solution of 0.057 g sodium hypochlorite. This pilot study explored the contamination rate of the PVC tip inserted after skin decontamination with sodium hypochlorite. Culture analysis of the tips of the PVCs inserted into the 42 participants showed 7 (16.7%) colonized catheters. The results of this pilot study suggest taking into serious consideration the assessment of this antiseptic in randomized experimental studies.

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Efficacy of Adding 2% (w/v) Chlorhexidine Gluconate to 70% (v/v) Isopropyl Alcohol for Skin Disinfection Prior to Peripheral Venous Cannulation

Infection Control and Hospital Epidemiology ◽

10.1086/590664 ◽

2008 ◽

Vol 29 (10) ◽

pp. 963-965 ◽

Cited By ~ 30

Author(s):

Heather Small ◽

Debra Adams ◽

Anna L. Casey ◽

Cynthia T. Crosby ◽

Peter A. Lambert ◽

...

Keyword(s):

Clinical Trial ◽

Isopropyl Alcohol ◽

Venous Catheter ◽

Chlorhexidine Gluconate ◽

Venous Cannulation ◽

Catheter Colonization ◽

Peripheral Venous Catheter ◽

Skin Disinfection

We undertook a clinical trial to compare the efficacy of 2% (w/v) chlorhexidine gluconate in 70% (v/v) isopropyl alcohol with the efficacy of 70% (v/v) isopropyl alcohol alone for skin disinfection to prevent peripheral venous catheter colonization and contamination. We found that the addition of 2% chlorhexidine gluconate reduced the number of peripheral venous catheters that were colonized or contaminated.

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Safety and efficacy of 2% chlorhexidine gluconate aqueous versus 2% chlorhexidine gluconate in 70% isopropyl alcohol for skin disinfection prior to percutaneous central venous catheter insertion in preterm neonates: the ARCTIC randomised-controlled feasibility trial protocol

BMJ Open ◽

10.1136/bmjopen-2018-028022 ◽

2019 ◽

Vol 9 (2) ◽

pp. e028022 ◽

Cited By ~ 2

Author(s):

Paul Clarke ◽

Jean V Craig ◽

John Wain ◽

Catherine Tremlett ◽

Louise Linsell ◽

...

Keyword(s):

Large Scale ◽

Controlled Trial ◽

Venous Catheter ◽

Chlorhexidine Gluconate ◽

Feasibility Trial ◽

Preterm Neonates ◽

Central Venous ◽

Skin Disinfection ◽

Randomised Controlled ◽

Catheter Colonisation

IntroductionCatheter-related sepsis is one of the most dangerous complications of neonatal intensive care and is associated with significant morbidity and mortality. Use of catheter-care ‘bundles’ has reduced the incidence of catheter-related sepsis, although individual components have not been well studied. Better evidence is needed to guide selection of the most appropriate antiseptic solution for skin disinfection in preterm neonates. This study will inform the feasibility and design of the first randomised controlled trial to examine the safety and efficacy of alcohol-based versus aqueous-based chlorhexidine antiseptic formulations for skin disinfection prior to percutaneous central venous catheterisation in preterm neonates. The antiseptics to be compared are 2% chlorhexidine gluconate (CHG) aqueous and 2% CHG in 70% isopropyl alcohol.Methods and analysisThe Antiseptic Randomised Controlled Trial for Insertion of Catheters (ARCTIC) is a two-centre randomised-controlled feasibility trial. At least 100 preterm infants born at <34 weeks’ gestation and due to undergo percutaneous insertion of a central venous catheter will be randomly allocated to receive prior skin disinfection with one of the two antiseptic solutions. Outcomes include: i) recruitment and retention rates; ii) completeness of data collection; iii) numbers of enrolled infants meeting case definitions for definite catheter-related sepsis, catheter-associated sepsis and catheter colonisation and iv) safety outcomes of skin morbidity scores recorded daily from catheter insertion until 48 hours post removal. The key feasibility metrics will be reported as proportions with 95% CIs. Estimated prevalence of catheter colonisation will allow calculation of sample size for the large-scale trial. The data will inform whether it will be feasible to progress to a large-scale trial.Ethics and disseminationARCTIC has been approved by the National Health Service Health Research Authority National Research Ethics Service Committee East of England (Cambridge South) (IRAS ID 163868), was adopted onto the National Institute of Health Research Clinical Research Network portfolio (CPMS ID 19899) and is registered with an International Standard Randomised Control Trials Number (ISRCTN: 82571474; Pre-results) and European Clinical Trials Database number 2015-000874-36. Dissemination plans include presentations at scientific conferences, scientific publications and sharing of the findings with parents via the support of Bliss baby charity.Trial registration numberISRCTN82571474; Pre-results.

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Sodium Hypochlorite/Salicylic Acid Shampoo for Treatment of Canine Staphylococcal Pyoderma

Journal of the American Animal Hospital Association ◽

10.5326/jaaha-ms-6628 ◽

2019 ◽

Vol 55 (3) ◽

pp. 117-123 ◽

Cited By ~ 2

Author(s):

Valerie A. Fadok ◽

Katherine Irwin

Keyword(s):

Salicylic Acid ◽

Pilot Study ◽

Sodium Hypochlorite ◽

Topical Therapy ◽

Positive Culture ◽

Open Label ◽

Methicillin Resistant ◽

Clinical Assessments ◽

Resistant Strains ◽

Household Bleach

ABSTRACTThe emergence of methicillin-resistant Staphylococcus pseudintermedius has increased the interest in topical therapy for treating canine pyoderma. Shampooing with chlorhexidine followed by dilute bleach rinses are often recommended, but household bleach can dry the skin and is unpleasant to use. A shampoo formulated with sodium hypochlorite and salicylic acid was evaluated as sole therapy for dogs with superficial pyoderma associated with S. pseudintermedius, including methicillin-resistant strains. Client-owned dogs were recruited based on positive culture for methicillin-resistant staphylococci or prior failure of pyoderma to respond to antibiotics. This prospective, open-label pilot study assessed the efficacy of the shampoo when used three times weekly for 4 wk. Dogs were evaluated at baseline and at 2 and 4 wk by cytology, clinical examination, and owner assessment. Digital images were also obtained. Baseline bacterial counts, clinical assessments and owner scores were significantly improved at 2 and 4 wk. Clients completing the study reported excellent lathering and dispersion, reduction in odor, and brightening of white and light coats. No owners reported skin dryness or other adverse events during the study. We conclude that this shampoo containing sodium hypochlorite in a vehicle that avoids skin drying is an effective treatment for canine pyoderma.

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Prevention of Acute Radiation-Induced Skin Reaction with NPE® Camellia Sinensis Nonfermentatum Extract in Female Breast Cancer Patients Undergoing Postoperative Radiotherapy: A Single Centre, Prospective, Open-Label Pilot Study

International Journal of Breast Cancer ◽

10.1155/2018/2479274 ◽

2018 ◽

Vol 2018 ◽

pp. 1-8

Author(s):

Gabriela Näf ◽

Urs E. Gasser ◽

Hans E. Holzgang ◽

Sandra Schafroth ◽

Christoph Oehler ◽

...

Keyword(s):

Pilot Study ◽

Skin Reaction ◽

Camellia Sinensis ◽

Acute Radiation ◽

Control Group ◽

Data Sets ◽

Single Centre ◽

Open Label ◽

Whole Breast Radiotherapy ◽

Radiation Induced

Background. To assess effectiveness of NPE, a proprietary Camellia sinensis nonfermentatum (CSNF) extract, in prevention and recovery of acute radiation-induced skin reaction (ARSR) and skin care during postoperative whole breast radiotherapy (RT). Methods. Twenty patients were enrolled in this single centre, prospective, open-label pilot study. The outcomes of 20 prospective data sets were compared with 100 retrospectively collected matched data sets derived from hospital records. The preventive CSNF gel (2.5%) was administered 1 to 2 hours before each session on the irradiated fields. The care CSNF lotion (0.4%) was administered as 7-day pretreatment after each RT session, twice daily between RT sessions, and 4 to 8 weeks thereafter. The control group was treated according to the hospital care guidelines. The primary endpoint was time to ARSR ≥ Grade 2 (CTCAE v4.03); secondary endpoints were frequencies of ARSR grades 1, 2, 3, and 4, recovery of ARSR, frequencies of interruption and RT stop, complications and required rescue interventions, and tolerability of CSNF. Results. Time to ARSR ≥ G2 (censoring) was significantly longer (p = 0.014) in the CSNF group. The hazard ratio was 2.33 (95% CI: 1.15–4.72), demonstrating a 50% decrease in the risk of developing ARSR ≥ G2. There was a trend to faster recovery from ARSR G2 in the CSNF group (100% versus 47%; p = 0.078). The proportion of patients requiring rescue treatment during RT and follow-up was markedly higher in the control compared to the CSNF group (1% to 51% versus 0% to 15%). CSNF gel and lotion were well tolerated both during and after RT. Conclusions. This pilot study provides the first evidence on the potential pharmacological effectiveness of CSNF extract in prevention of RT-induced ARSR and recovery of skin irritation in patients undergoing postoperative whole breast RT and may reflect a novel concept for prevention of RT-induced ARSR and care of irritated skin.

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Heparinized saline versus normal saline for maintaining peripheral venous catheter patency in China: An open-label, randomized controlled study

Journal of International Medical Research ◽

10.1177/0300060516685203 ◽

2017 ◽

Vol 45 (2) ◽

pp. 471-480 ◽

Cited By ~ 3

Author(s):

Lichun Xu ◽

Yan Hu ◽

Xiaojin Huang ◽

Jianguo Fu ◽

Jinhui Zhang

Keyword(s):

Normal Saline ◽

Venous Catheter ◽

Saline Group ◽

Randomized Controlled Study ◽

Chinese Patients ◽

Controlled Study ◽

Tertiary Referral Hospital ◽

Open Label ◽

Peripheral Venous Catheter ◽

Randomized Controlled

Objective To evaluate the effects of heparin saline versus normal saline as locking solution for maintaining patency in peripheral venous catheters in Chinese patients. Methods This open-label, randomized controlled study was conducted in two hepatobiliary surgery wards, where patients received identical treatments, at a tertiary referral hospital. Patients were randomly divided into a normal saline group (NS, 3 ml) or a heparin saline group (HS, 50 IU/ml, 3 ml) for catheter sealing. Results The study enrolled 286 patients and 609 peripheral venous catheters were included in the analysis. The patients in the two groups had no local infections or catheter-related bloodstream infections. There were no significant differences between the two groups in terms of the rate of catheter obstruction, duration time, or the rates of phlebitis, infiltration, and accidental catheter removal. Conclusions No significant differences in the peripheral venous catheter sealing effects were observed between normal saline and heparin saline usage in Chinese patients.

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Comparison of alcohol, povidone-iodine and octenidine dihydrochloride as skin disinfectants to reduce bacterial count prior to peripheral venous catheter insertions in newborn infants

Paediatrica Indonesiana ◽

10.14238/pi51.5.2011.277-81 ◽

2011 ◽

Vol 51 (5) ◽

pp. 277 ◽

Cited By ~ 2

Author(s):

Lily Rundjan ◽

Rinawati Rohsiswatmo ◽

Sarah Rafika ◽

Enty Enty ◽

Lucky H. Moehario

Keyword(s):

Povidone Iodine ◽

Newborn Infants ◽

Bloodstream Infections ◽

Venous Catheter ◽

Bacterial Count ◽

Peripheral Venous Catheter ◽

Skin Bacteria ◽

Skin Disinfection ◽

Octenidine Dihydrochloride ◽

Before And After

AbstractBackground Vascular access may increase the risk of bloodstream infections, especially in newborn infants with weak immune systems and requiring invasive supportive care. Skin disinfection prior to peripheral venous catheter insertion lowers the risk of infection. However, antiseptics chosen for this task should be effective and safe for newborn infants.Objective To compare the effectiveness of 70% alcohol (BD alcohol swabs ®), 10% povidone-iodine (Pharma-RSUPNCM), and octenidine (Octenisept ®) as antiseptics for reducing skin bacteria for pre-invasive procedures in neonates.Methods Infants aged less than 28 days, regardless of gestational age, at the Neonatal Unit of Cipto Mangunkusumo Hospital (RSUPNCM) were included in our study. Infants were divided into three groups, each tested with different skin antiseptics (alcohol, povidone-iodine or octenidine). Skin swabs were performed before and after application of skin antiseptic, followed by inoculation onto blood agar plates. Colony-forming units were counted after 18 hours of incubation at 37ºC.Results Ninety subjects were divided into 3 groups of 30, each group using either 70% alcohol swabs, 10% povidone-iodine, or octenidine as skin antiseptic. Skin swabs were taken before and after antiseptic application and drying, as well as 5 minutes after application. The mean reductions in CFU/cm2 (%) after antiseptic application (and fully dried) were 97.54% for povidone-iodine, 97.52% for octenidine, and 89.07% for alcohol. There were no significant differences in mean CFU reductions among the three antiseptics groups (P=0.299). Furthermore, 5 minutes after application, there were still no significant differences in the three antiseptic groups (P=0.289).Conclusions Although octenidine showed a significant bacterial count reduction after application, it was not significantly different from those of alcohol or povidone-iodine. [Paediatr Indones. 2011;51:277-81].

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FLUID study: study protocol for an open-label, single-centre pilot study to investigate the efFect of Lemborexant on sleep management in Japanese sUbjects aged 50 years and older with Insomnia Disorder

BMJ Open ◽

10.1136/bmjopen-2021-054885 ◽

2021 ◽

Vol 11 (11) ◽

pp. e054885

Author(s):

Ippei Okada ◽

Kunihiro Iwamoto ◽

Seiko Miyata ◽

Akihiro Fujimoto ◽

Masaki Tanaka ◽

...

Keyword(s):

Pilot Study ◽

Sleep Quality ◽

Sleep Disturbance ◽

Study Protocol ◽

Single Centre ◽

Open Label ◽

Glymphatic System ◽

Insomnia Disorder ◽

Sleep Parameters ◽

The Alps

IntroductionBidirectional associations have been reported between sleep disturbance and both cognitive impairment, including Alzheimer’s disease and amyloid beta-peptide (Aβ) accumulation. These relationships can be explained by the glymphatic system, which acts as a garbage drainage system in the brain. As interstitial fluid dynamics are suggested to increase during sleep, clearance of Aβ can be influenced by sleep disturbance or deprivation. We hypothesised that using lemborexant, an orexin receptor antagonist, to improve sleep quality would also improve the function of the glymphatic system. We plan to examine the effect of lemborexant on sleep quality and the glymphatic system among patients with insomnia disorder.Methods and analysisThis pilot study is designed as an open-label, single-arm, single-centre trial. Thirty patients aged 50 years and over with insomnia will be recruited. The participants will take lemborexant (5 mg) at bedtime for 12 weeks and undergo a home-based sleep study at baseline and weeks 4 and 12, as well as MRI examinations to evaluate the glymphatic system at baseline and week 12. The primary outcome will be changes in objective sleep parameters as evaluated using a sleep monitoring system. The secondary outcomes will be changes in subjective sleep parameters. The relationships between changes in sleep parameters and the glymphatic system will be evaluated using diffusion tensor image analysis along the perivascular space, which is called the ALPS-index. Sleep parameters and the ALPS-index will be analysed using a paired t-test or Pearson’s correlation coefficient.Ethics and disseminationThe study protocol was approved by Nagoya University Certified Review Board. The findings from this research will be published in peer-reviewed journals and be presented at local, national and international conferences.Trial registration numberjRCTs041210024.

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