Reproducibility and Workability of the European Test Standard EN 12791 Regarding the Effectiveness of Surgical Hand Antiseptics A Randomized, Multicenter Trial

2006 ◽  
Vol 27 (9) ◽  
pp. 935-939 ◽  
Author(s):  
Manfred Rotter ◽  
Michael Kundi ◽  
Miranda Suchomel ◽  
Hans-Peter Harke ◽  
Axel Kramer ◽  
...  
Keyword(s):  
Reduction Factor ◽  
Test Method ◽  
Test Model ◽  
Reference Formulation ◽  
In Vivo Test ◽  
Skin Flora ◽  
Hand Antisepsis ◽  
Viable Bacteria ◽  
The Mean

Objectives.To evaluate the reproducibility and workability of the in vivo test model of the European test standard EN 12791 regarding the effectiveness of surgical hand antiseptics and, as a secondary objective, to evaluate the power of the model to discriminate between the effectiveness of various formulations of surgical hand antiseptics.Design.Prospective, randomized, multicenter study with a Latin square design.Setting.Five laboratories at 2 universities, 2 disinfectant manufacturers, and 1 private testing institution.Participants.Twenty healthy adults in each laboratory.Intervention.Surgical hand antisepsis was performed by scrubbing with chlorhexidine gluconate 4% detergent (CHG) or by rubbing the hands with propan-2-OL (70% by volume; Iso 70) or ethanol 85% (E 85); rubbing the hands and forearms for 3 minutes with propan-1-OL (N 60) was used as the reference disinfection procedure. We deliberately chose to use these antiseptics at the given concentrations because they were intended to cover the range of typical antiseptics submitted for approval according to EN 12791.Methods.In once-weekly tests, the immediate effects of the 4 antiseptics were established according to the method laid down in EN 12791 by assessing the release of skin flora from the fingertips as viable bacteria counts per milliliter of sampling fluids before treatment and viable bacteria counts immediately after treatment, separately for both hands, such that after 4 weeks each volunteer had used every formulation once.Results.The mean log reduction factor (RF) for the release of bacterial skin flora (the log RF was calculated as the log count before treatment minus the log count after treatment) and corresponding standard deviations for the 4 hand antisepsis formulations were as follows: for CHG, 1.1 ± 0.3 colony-forming units (cfu) per milliliter of sampled fluid; for Iso 70, 1.7 ± 0.3 cfu/mL; for E 85, 2.1 ± 0.3 cfu/mL; and for N 60, 2.4 ± 0.4 cfu/mL. The differences between these values proved significant (P<.001) by analysis of variance and in Tukey's “honestly significantly different” (HSD) post hoc test. Although, with regard to their immediate antibacterial activity, the same ranking of these antiseptics was found at all laboratories, the levels of efficacy were significantly different across laboratories (P<.001); no statistical difference was found between left and right hands (P>.01). Relating the log RF values of the other 3 formulations to those of the reference formulation (N 60) abolished differences between laboratories (P = .16); in addition, the interclass correlation coefficient decreased from 9.1% to 4.5%. With 20 volunteers, a minimum difference of 0.47 log between the mean log RFs of the reference formulation and an inferior test formulation will be detected as significant at an α of .05 (1-sided) and a 1 — β value of .8.Conclusion.The test method described in EN 12791 yielded the same conclusion on the effectiveness of the tested formulations in every laboratory and proved, therefore, reproducible and workable.

A novel in vivo test method for evaluating the infrared radiation protection provided by sunscreen products

2019 ◽  
Author(s):  
Su Ji Kim ◽  
Jiyoun Bae ◽  
Sung Eun Lee ◽  
Jun Bae Lee ◽  
Chun Ho Park ◽  
...  
Keyword(s):  
Radiation Protection ◽  
Infrared Radiation ◽  
Test Method ◽  
In Vivo Test ◽  
Sunscreen Products

scholarly journals In Vivo Efficacies and Pharmacokinetics of DX-619, a Novel Des-Fluoro(6) Quinolone, against Streptococcus pneumoniae in a Mouse Lung Infection Model

2006 ◽  
Vol 50 (1) ◽  
pp. 121-125 ◽  
Author(s):  
Yuichi Fukuda ◽  
Katsunori Yanagihara ◽  
Hideaki Ohno ◽  
Yasuhito Higashiyama ◽  
Yoshitsugu Miyazaki ◽  
...  
Keyword(s):  
Streptococcus Pneumoniae ◽  
Mouse Lung ◽  
Infection Model ◽  
Time Curve ◽  
Concentration Time ◽  
Viable Bacteria ◽  
Effective Doses ◽  
The Mean ◽  
Lung Infections

ABSTRACT DX-619 is a novel des-fluoro(6) quinolone with potent activity against gram-positive pathogens. The in vivo activity of DX-619 against Streptococcus pneumoniae was compared with those of fluoro(6) quinolones, sitafloxacin, and ciprofloxacin in a mouse model. Two strains of S. pneumoniae were used: a penicillin-sensitive S. pneumoniae (PSSP) strain and a penicillin-resistant S. pneumoniae (PRSP) strain. Furthermore, these strains showed intermediate susceptibilities to ciprofloxacin. In murine lung infections caused by PSSP, the 50% effective doses (ED50s) of DX-619, sitafloxacin, and ciprofloxacin were 9.15, 11.1, and 127.6 mg/kg of body weight, respectively. Against PRSP-mediated pneumonia in mice, the ED50s of DX-619, sitafloxacin, and ciprofloxacin were 0.69, 4.84, and 38.75 mg/kg, respectively. The mean ± standard error of the mean viable bacterial counts in murine lungs infected with PSSP and treated with DX-619, sitafloxacin, ciprofloxacin (10 mg/kg twice daily), and saline (twice daily) were 1.75 ± 0.06, 1.92 ± 0.23, 6.48 ± 0.28, and 7.57 ± 0.13 log10 CFU/ml, respectively. Furthermore, the numbers of viable bacteria in lungs infected with PRSP and treated with the three agents and not treated (control) were 1.73 ± 0.04, 2.28 ± 0.17, 4.61 ± 0.59, and 5.54 ± 0.72 log10 CFU/ml, respectively. DX-619 and sitafloxacin significantly decreased the numbers of viable bacteria in the lungs compared to the numbers in the lungs of ciprofloxacin-treated and untreated mice. The pharmacokinetic parameter of the area under the concentration-time curve (AUC)/MIC ratio in the lungs for DX-619, sitafloxacin, and ciprofloxacin were 171.0, 21.92, and 1.22, respectively. The AUC/MIC ratio in the lungs was significantly higher for DX-619 than for sitafloxacin and ciprofloxacin. Our results suggest that DX-619 and sitafloxacin are potent against both PSSP and PRSP in our mouse pneumonia model.

Water protective effect of barrier creams and moisturizing creams: a new in vivo test method

1996 ◽  
Vol 35 (4) ◽  
pp. 219-225 ◽  
Author(s):  
Frederik de Fine Olivarius ◽  
Alice Brinch Hansen ◽  
Tonny Karlsmark ◽  
Hans Christian Wolf
Keyword(s):  
Protective Effect ◽  
Test Method ◽  
In Vivo Test

Adhesion of Polycarboxylate-based Dental Cements to Enamel: An in vivo Study

1986 ◽  
Vol 65 (6) ◽  
pp. 885-887 ◽  
Author(s):  
T. Jemt ◽  
P.A. Stålblad ◽  
G. Øilo
Keyword(s):  
Bond Strength ◽  
Tensile Force ◽  
Test Method ◽  
Glass Ionomer Cements ◽  
Glass Ionomer ◽  
Adhesive Failure ◽  
Cohesive Failure ◽  
The Mean

The bond strength of two polycarboxylate and two glass ionomer cements to enamel in vivo has been measured by a tensile test method. The four cements were used to cement small stainless steel cylinders onto the facial surfaces of 11 and 21. The cylinders were removed by a tensile force applied by a handpiece containing a semi-conductor sensory unit. The results showed that all cements gave two sets of bond strength values, either a good bond corresponding to a cohesive failure, or a weak bond corresponding to an adhesive failure. The mean bond strength values were lower than those recorded in vitro, and differences among the cements were limited.

scholarly journals Use of microporous hydroxyapatite material in regenerative treatment of periodontal tissues in dogs: a clinical study

2018 ◽  
Vol 74 (1) ◽  
pp. 5985-2018
Author(s):  
IZABELA POLKOWSKA ◽  
ANNA ŚLÓSARCZYK ◽  
ALEKSANDRA SOBCZYŃSKA-RAK ◽  
MAGDALENA GOŁYŃSKA ◽  
TOMASZ SZPONDER ◽  
...  
Keyword(s):  
Periodontal Diseases ◽  
Healing Process ◽  
Study Groups ◽  
Control Group ◽  
Control Groups ◽  
In Vivo Test ◽  
Periodontal Tissues ◽  
Respective Control Group ◽  
The Mean

One of the biomaterials used in veterinary dentistry is hydroxyapatite (HAp). It aids the biological process of bone reconstruction and provides the basis on which damaged tissues can be rebuilt. It is also exceptionally osteoconductive and bioactive towards bone and other tissues. The aim of the present study was to verify the usefulness of hydroxyapatite microporus ceramics for the treatment of periodontal diseases and post-extraction defects. The study was performed on 40 dogs. Dogs were qualified for the in vivo test: 2 study groups and 2 control groups (K1, K2) were created. Group G1 comprised 10 dogs diagnosed with periodontitis with 4-8 mm gingival pockets and mobility of mandibular/maxillary incisors. In order to avoid extraction, hydroxyapatite implantation into the bone pockets was performed. Group G2 comprised 10 dogs that required the extraction of maxillary canines, following which biomaterial was introduced into the post-extraction cavities. Control groups were performed without using of microporous hydroxyapatite. In group G1, animals displayed significant shallowing of gingival pockets. The mean depth of pockets was significantly reduced in those dogs and considerably better reconstruction of periodontal tissues was observed when compared to the control group K1. In group G2, significantly faster healing of bone cavities was stated when compared to the respective control group K2. The study confirmed the validity of using microporous hydroxyapatite granules and shaped blocks in reconstructive periodontal treatment as well as prevention of oronasal fistulas after canines extraction and facilitation of the post-extraction healing process..

scholarly journals Evaluation of Two Methods of Determining the Efficacies of Two Alcohol-Based Hand Rubs for Surgical Hand Antisepsis

2006 ◽  
Vol 72 (6) ◽  
pp. 3856-3861 ◽  
Author(s):  
G�nter Kampf ◽  
Christiane Ostermeyer ◽  
Peter Heeg ◽  
Daryl Paulson
Keyword(s):  
Sampling Methods ◽  
Reduction Factor ◽  
Test Method ◽  
The Other ◽  
Bacterial Reduction ◽  
Bacterial Counts ◽  
Drug Products ◽  
Application Mode ◽  
Hand Antisepsis ◽  
Sampling Times

ABSTRACT The antimicrobial efficacies of preparations for surgical hand antisepsis can be determined according to a European standard (prEN 12791 [EN]) and a U.S. standard (tentative final monograph for health care antiseptic drug products [TFM]). The U.S. method differs in the product application mode (hands and lower forearms, versus hands only in EN), the number of applications (11 over 5 days, versus a single application in EN), the sampling times (0, 3, and 6 h after application, versus 0 and 3 h in EN), the sampling methods (glove juice versus fingertip sampling in EN), and the outcome requirements (absolute bacterial reduction factor [RF], versus noninferiority to reference treatment in EN). We have studied the efficacies of two hand rubs according to both methods. One hand rub was based on 80% ethanol and applied for 2 min, and the other one was based on 45% propan-2-ol, 30% propan-1-ol, and 0.2% mecetronium etilsulfate and applied for 1.5 min. The ethanol-based hand rub was equally effective as the 3-min reference disinfection of prEN 12791 in both the immediate (RFs, 2.97 � 0.89 versus 2.92 � 1.03, respectively) and sustained (RFs, 2.20 � 1.07 versus 2.47 � 1.25, respectively) effects. According to TFM, the immediate effects were 2.99 log10 (day 1), 3.00 log10 (day 2), and 3.43 log10 (day 5), and bacterial counts were still below baseline after 6 h. The propanol-based hand rub was even more effective than the reference disinfection of prEN 12791 in both the immediate (RFs, 2.35 � 0.99 versus 1.86 � 0.87, respectively) and sustained (RFs, 2.17 � 1.00 versus 1.50 � 1.26, respectively) effects. According to TFM, the immediate effects were 2.82 log10 (day 1), 3.29 log10 (day 2), and 3.25 log10 (day 5), and bacterial counts were still below baseline after 6 h. Some formulations have been reported to meet the efficacy requirements of one of the methods but not those of the other. That is why we conclude that, despite our results, meeting the efficacy requirements of one test method does not allow the claim that the requirements of the other test method are also met.

scholarly journals Towards a New, Pre-Clinical, Subject-Independent Test Model for Kinematic Analysis after Total Knee Arthroplasty—Influence of the Proximo-Distal Patella Position and Patellar Tendon Stiffness

2021 ◽  
Vol 11 (21) ◽  
pp. 10322
Author(s):  
Adrian Sauer ◽  
Allan Maas ◽  
Svenja Ottawa ◽  
Alexander Giurea ◽  
Thomas M. Grupp
Keyword(s):  
Patellar Tendon ◽  
Test Method ◽  
Clinical Test ◽  
Research Approach ◽  
Fe Model ◽  
Test Model ◽  
Knee Prostheses ◽  
Tendon Stiffness ◽  
Patella Position

Although simulation models are heavily used in biomechanical research and testing of TKA implants, pre-clinical tools for a holistic estimation of implant performance under dynamic loading conditions are rare. The objective of this study was the development of an efficient pre-clinical test method for analyzing knee contact mechanics and kinematics based on a dynamic FE model and to evaluate the effects of the proximo-distal patella position and the patellar tendon stiffness on the patellar kinematics. A finite element-based workflow for knee prostheses designs was developed based on standardized in vivo load data, which included the tibial forces and moments. In a new research approach, the tibial forces are used as input for the model, whereas the tibial moments were used to validate the results. For the standardized sit down, stand up, and knee bend load cycles, the calculated tibial moments show only small deviations from the reference values—especially for high flexion angles. For the knee bend cycle, the maximum absolute value of patellar flexion decreases for higher patellar tendon stiffness and more distally placed patellar components. Therefore, patella-related clinical problems caused by patella baja may also arise if the patellar tendon is too weak for high tibiofemoral flexion angles.

scholarly journals Anxiety Therapeutic Interventions of β-Caryophyllene: A Laboratory-Based Study

2020 ◽  
Vol 15 (10) ◽  
pp. 1934578X2096222
Author(s):  
Keylla da Conceição Machado ◽  
Márcia Fernanda Correia Jardim Paz ◽  
José Victor de Oliveira Santos ◽  
Felipe Cavalcanti Carneiro da Silva ◽  
Jana Dimitrova Tchekalarova ◽  
...  
Keyword(s):  
Biological Activities ◽  
Neurological Diseases ◽  
Radical Scavenging ◽  
Artemia Salina ◽  
Therapeutic Interventions ◽  
Test Model ◽  
Protective Effects ◽  
In Vivo Test

The bicyclic sesquiterpene β-caryophyllene (BCP) has diverse biological activities, including antioxidant, anti-inflammatory, antidiabetic, and analgesic effects. This study evaluates anxiolytic, toxicity, and antioxidant effects of BCP using in vitro and in vivo test models. The anxiolytic effects were tested in Swiss albino mice ( Mus musculus) by applying the elevated plus-maze, rota-rod, light and dark, and hiding sphere models, while the toxicity was evaluated by brine shrimp ( Artemia salina) lethality bioassay. Additionally, the antioxidant capacity was tested by using 2,2-diphenyl-1-picrylhydrazyl radical, 2,2′-azinobis-3-ethylbenzothiazoline-6-sulfonic acid hydroxyl radical scavenging, and the Saccharomyces cerevisiae test model. The results suggest that BCP exerted a dose-dependent anxiolytic-like effect on the experimental animals. It did not show toxicity in A. salina at 24 hours. BCP showed a concentration-dependent free-radical-scavenging capacity, similar to the standard antioxidant Trolox. It also showed protective and repair capacities against hydrogen peroxide-induced damaging effects in isogenic and wild-type S. cerevisiae strains. Taken together, BCP exerted antioxidant and protective effects, which can be targeted to treat neurological diseases and disorders such as anxiety.

scholarly journals The Research of Toxicity and Sensitization Potential of PEGylated Silver and Gold Nanomaterials

Toxics ◽  
2021 ◽  
Vol 9 (12) ◽  
pp. 355
Author(s):  
Dong-Han Lee ◽  
Seo-Yoon Choi ◽  
Ki-Kyung Jung ◽  
Jun-Young Yang ◽  
Ja-young Jeong ◽  
...  
Keyword(s):  
Immune Response ◽  
The Body ◽  
Test Method ◽  
In Vitro Test ◽  
Skin Sensitization ◽  
In Vivo Test ◽  
Gold Silver ◽  
Original Group

Polyethylene glycol (PEG) is a polymer used for surface modification of important substances in the modern pharmaceutical industry and biopharmaceutical fields. Despite the many benefits of PEGylation, there is also the possibility that the application and exposure of the substance may cause adverse effects in the body, such as an immune response. Therefore, we aimed to evaluate the sensitization responses that could be induced through the intercomparison of nanomaterials of the PEG-coated group with the original group. We selected gold/silver nanomaterials (NMs) for original group and PEGylated silver/gold NMs in this study. First, we measured the physicochemical properties of the four NMs, such as size and zeta potential under various conditions. Additionally, we performed the test of the NM’s sensitization potential using the KeratinoSens™ assay for in vitro test method and the LLNA: 5-bromo-2-deoxyuridine (BrdU)-FCM for in vivo test method. The results showed that PEGylated-NMs did not lead to skin sensitization according to OECD TG 442 (alternative test for skin sensitization). In addition, gold nanomaterial showed that cytotoxicity of PEGylated-AuNMs was lower than AuNMs. These results suggest the possibility that PEG coating does not induce an immune response in the skin tissue and can lower the cytotoxicity of nanomaterials.

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