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Evaluation of ethanol-chlorhexidine gluconate scrub surgical, Artykuły z zakresu dezynfekcji, Dezynfekcja - ...
[ Pobierz całość w formacie PDF ]//-->Evaluation of a Waterless,Scrubless ChlorhexidineGluconate/Ethanol SurgicalScrub for Antimicrobial EfficacybyG. Mulberry1A. Snyder2J. Stahl,J. Heilman and J. Pyrek3Hill Top Research, Inc., Cincinnati, OH2ViroMed Laboratories (VML), Inc., Minneapolis, MN33M Health Care, St. Paul, MN1This study was supported by a grant from 3M Health Care, St. Paul, Minnesota.Evaluation of a Waterless, Scrubless ChlorhexidineGluconate/Ethanol Surgical Scrub for Antimicrobial EfficacyAbstractA new waterless surgical hand scrub product containing1% chlorhexidine gluconate (CHG) and 61% ethyl alcohol inan emollient-rich lotion base (CHG/ethanol-emollient handpreparation) was evaluated. Clinical studies were based onthe Tentative Final Monograph for Health Care AntisepticDrug Products (TFM)1; Proposed Rule and ASTM E1115-912,Standard Test Method for Evaluation of Surgical HandScrub Formulations.Two randomized, blinded well-controlled clinical studiesinvolving over 100 healthy subjects evaluated the antimicrobialeffectiveness of CHG/ethanol-emollient hand preparationin producing an immediate and persistent reduction in thenormal bacterial flora of the hands. CHG/ethanol-emollienthand preparation was applied without scrubbing or theuse of water, while a 4% CHG reference product wasapplied using scrub brushes in two traditional 3-minutesurgical scrubs.Over a 5-day period, each subject performed a series of11 surgical scrubs using one of the products. After the firsttreatment on Days 1, 2 and 5, surgical gloves were wornfor 3 and/or 6 hours. Bacterial samples were taken usingthe glove juice technique at 1 minute, 3 hours and/or6 hours after treatment. The immediate bactericidal effectof CHG/ethanol-emollient hand preparation after a singleapplication resulted in a 2.5 log reduction in normal flora.This bactericidal effect persisted throughout the study, andeventually increased to a 3.5 log reduction after the eleventhscrub on Day 5. The log reductions of CHG/ethanol-emollienthand preparation proved to be significantly better (p<0.05)than that of the 4% CHG product at each sampling intervalon Days 1 and 2, and at the 6 hour sampling on Day 5,exceeding the TFM requirements. Use of this new waterlessproduct as a surgical hand scrub lowers bacterial flora onthe hands.• To assess bacterial reductions achieved within 1 minuteand at 3 and 6 hours post-treatment, comparing theCHG/ethanol-emollient hand preparation productversus Hibiclens.• To compare the skin condition of the hands as assessed bysubjects receiving the CHG/ethanol-emollient handpreparation product to that of subjects receiving Hibiclens.MethodsStudy designTwo prospective, randomized, partially-blinded, parallel-group trials (the design was identical for Studies A and B):• 14-day pretreatment washout period for stabilization ofhand bacterial flora, during which subjects refrained fromusing any topical antimicrobials, systemic antibiotics, ormedicated soaps, lotions, shampoos, etc.• 5 to 7 days of baseline bacterial evaluations where threebaseline samples of hand bacterial flora were taken.Subjects with baseline bacterial populations≥1.0 x 105colony forming units (CFU) per hand at the first and secondbaseline samplings were eligible to be enrolled in thetreatment period.• 5-day treatment period during which subjects performed aseries of 11 simulated surgical hand scrubs using one of thetest products:- once daily on Treatment Days 1 and 5, and- three times daily on Treatment Days 2, 3, and 4.TreatmentsSubjects were randomized to receive one of the followingtwo* treatments during each hand wash procedure:• CHG/ethanol-emollient hand preparation (6 mL,3 x 2 mL), or• Hibiclens (10 mL, 2 x 5 mL).* Note: In one of the two studies, some subjects were alsorandomized to receive a vehicle control formulation.Those data are not presented here.IntroductionThis white paper describes the results of two clinical studiesdesigned to determine the antimicrobial effectiveness ofCHG/ethanol-emollient hand preparation using the logreduction criteria for bacterial counts on the hands definedby the Food & Drug Administration’s (FDA) TentativeFinal Monograph for Health-Care Antiseptic Drug Products(TFM). In these trials, CHG/ethanol-emollient handpreparation is compared with Hibiclens®(StuartPharmaceuticals, Wilmington, DE), a currently marketedpresurgical antimicrobial hand-wash product containing 4%CHG in a detergent base. Changes in baseline skin conditionwere also measured based on results of subject self-assessment questionnaires.Bacterial samples• Samples were collected following scrubs on TreatmentDays 1, 2 and 5.• Hands were randomized to bacterial sampling times.The first hand was sampled at 1 minute or 3 hours afterscrubbing. The second hand of each subject was thensampled at either 3 or 6 hours after scrubbing.• Sampling technique:- Loosely fitting sterile surgical gloves were placedover the hands to be sampled, then 75 mL of samplingsolutions was aseptically added to the gloves.- Gloves were occluded above the wrist and the glovedhand was uniformly massaged for 1 minute.Objectives• To evaluate the effectiveness of the CHG/ethanol-emollienthand preparation formulation as a surgical hand scrub inmeeting the TFM criteria for immediate and persistentreductions in the number of bacteria on the hands.- After massaging, an aliquot of the fluid in the glovewas aseptically transferred to a serial dilution tubecontaining suitable antimicrobial neutralizers toachieve a 1:10 dilution.- Solutions were plated using Trypticase Soy Agar andincubated for 48 to 72 hours at 30°C ± 2°C. Colonieswere counted and viable cells in the undiluted samplewere calculated by standard methods.• Log reductions in bacterial counts were measured after1 minute, 3 hours, and at 6 hours on Days 1, 2, and 5.• Reductions in bacterial counts achieved with CHG/ethanol-emollient hand preparation were compared with those of areference control treatment (Hibiclens).• Log reductions were calculated by subtracting the post-treatment log count from the average baseline log count onthe same hand.• The differences between groups in log reductions at eachtime period were analyzed using a t-test, with significanceat p≤ 0.05 (2-tailed).Skin condition:• Change from baseline at Day 4 was calculated for each itemon the subject self-assessment questionnaire.• A one-way analysis of variance (ANOVA) on the rank-transformed change scores was used to test the effect of theformulation on each aspect of skin condition.SubjectsHealthy, male or female volunteer subjects, ages 18 to 65years old, inclusive, with 1st and 2nd baseline counts≥1.0 x 105 CFU per hand.Demographic and baseline characteristics of the studypopulation were similar across test groups. (Table 1)Table 1. Demographic characteristicsParameterStudy A (HTR)CHG/ethanol-emollienthand preparation(N=27)Hibiclens(N=25)ResultsDisposition of subjects is displayed in Table 2.Table 2. Disposition of subjectsCategoryStudy ACHG/ethanol-emollienthand preparationHibiclensStudy BCHG/ethanol-emollienthand preparationHibiclensEnrolledCompleted study2724252434312019Study B (VML)CHG/ethanol-emollienthand preparation(N=33)Hibiclens(N=20)Reasons fordiscontinuation*Adverse eventPersonal reasonsLack of compliance22-11-1-2--1-Age yearsMean (SD)Gender N (%)MaleFemaleRace N (%)WhiteBlackHispanic51.3 (10.3)4 (15)23 (85)27 (100)--54.8 (7.8)7 (28)18 (72)22 (88)3 (12)-30.1 (7.3)11 (32)23 (68)31 (91)-3 (9)27.9 (7.5)7 (35)13 (65)20 (100)-Lost to follow-up*More than one reason for discontinuing could be provided.Evaluation criteriaEfficacy:Efficacy evaluations were based on the immediateand persistent activity of CHG/ethanol-emollient handpreparation as measured by the log reductions frombaseline counts per hand at the following post-scrubsampling time points:• Treatment Day 1 at 1 minute, 3 hours, and 6 hours.• Treatment Day 2 (after the 1st scrub) at 1 minute, 3 hours,and 6 hours.• Treatment Day 5 at 1 minute, 3 hours, and 6 hours.Skin condition:Based on subject self-assessment questionnaires, changefrom baseline skin condition at Day 4 was calculated forseveral skin characteristics (appearance, intactness, moisturecontent, and sensation), based on a seven-point scale(1=abnormal, red, dry itchy, etc., to 7=normal).In Study A, both the CHG/ethanol-emollient handpreparation and Hibiclens groups showed statisticallysignificant reductions from baseline bacterial counts at alltime points. The log reductions from baseline bacterialcounts on Days 1, 2, and 5 exceeded the TFM criteria at thespecified time points for both groups (Table 3). In comparingCHG/ethanol-emollient hand preparation and Hibiclens,CHG/ethanol-emollient hand preparation had significantlygreater log reduction at 1 minute and 3 hours on Day 1 and6 hours on Day 2. In Study B, the log reductions frombaseline bacterial counts were statistically significant andexceeded the TFM criteria at the specified time points forboth CHG/ethanol-emollient hand preparation and Hibiclens.In comparing CHG/ethanol-emollient hand preparationand Hibiclens, CHG/ethanol-emollient hand preparationhad statistically significantly greater log reductions inbacteria at 3 and 6 hours on Day 1 and at all time pointson Day 2 (Table 3).Table 3: Log reductions in bacterial counts(CFU/Hand)from baselineStudy ACHG/ethanol-emollienthand preparationHibiclensStudy BCHG/ethanol-emollienthand preparationHibiclensBaselinePeriod MeanDay 1 Log Reduction1 Minute3 Hours6 Hours6.32.5*2.6*2.23.03.13.3*3.73.63.86.41.81.81.92.62.72.33.73.73.56.12.53.1*2.8*3.2*3.7*3.6*3.53.93.56.01.61.81.42.42.32.33.63.63.0Safety:Assessments based on observed and reported adverse events.Statistical MethodsEfficacy:• Raw data on microbial counts from each baselinedetermination on each hand (CFU/hand) were converted tobase 10 logarithms, then were averaged to determine eachhand’s baseline count.Day 2 Log Reduction1 Minute3 Hours6 HoursDay 5 Log Reduction1 Minute3 Hours6 Hours*Statistically significantly higher for CHG/ethanol-emollient hand preparation than for Hibiclens.Figure 1. Combined AnalysisLog Reduction of Normal Flora on the HandsLines Represent FDA Performance Criteria4sCHG/ethanol-emollient hand preparationsHibiclens3Log Reduction of Bacteria*******211 min.*Statistically significant difference.3 hr.6 hr.1 min.3 hr.6 hr.1 min.3 hr.6 hr.Day 1Day 2Day 5When data from the two studies were combined,CHG/ethanol-emollient hand preparation had statisticallysignificantly greater log reductions in bacteria at all timepoints on Days 1 and 2 and at the 6-hour sampling onDay 5 compared to Hibiclens (Figure 1).Skin assessmentsIn Study A, at the end of Day 4, CHG/ethanol-emollienthand preparation was statistically significantly superiorto Hibiclens with respect to change from baselinemoisture content (p=0.0091), although no statisticallysignificant differences were found for appearance,intactness, or sensation.In Study B, a statistically significant treatment effect wasdemonstrated for all skin assessments, indicating thatCHG/ethanol-emollient hand preparation was associatedwith better skin condition than Hibiclens. Pairwisecomparisons of CHG/ethanol-emollient hand preparationand Hibiclens yielded statistically significant results forall skin condition assessments (appearance, intactness,moisture content, and sensation) in favor ofCHG/ethanol-emollient hand preparation.Two adverse events were reported with the use ofHibiclens:• One subject experienced an allergic reaction considered“possibly related” to use of the product.• One subject experienced an erythematous rashconsidered “probably not related” to use of the product.Conclusions• CHG/ethanol-emollient hand preparation met orexceeded TFM criteria for antimicrobial effectiveness.• CHG/ethanol-emollient hand preparation was equal orsuperior to Hibiclens in antimicrobial effectiveness, asassessed by log reductions in counts of hand bacteria.• CHG/ethanol-emollient hand preparation wasassociated with less drying of the skin than Hibiclens,as assessed by subject evaluations of Moisture Contentat the end of Day 4 in Study A, and with statisticallysignificantly better skin condition scores forappearance, intactness, moisture content, and sensationscores than Hibiclens in Study B.• CHG/ethanol-emollient hand preparation was welltolerated in both studies.SafetyNo serious or severe adverse events occurred duringeither study.Two subjects reported three adverse events in theCHG/ethanol-emollient hand preparation groups, whichwere “probably related” to the study formulation:• One subject reported a maculopapular rash on thedorsal surface of both wrists where the gloves hadbeen secured.• One subject experienced two adverse events—conjunctivitis and abnormal vision—after rubbing hiseyes after application.Four other reported adverse events which were “probablynot related” to study formulation included: a viral infection,menorrhagia, an upper respiratory infection, and aninflicted injury of cuts to the knuckles of one hand.References1. Federal Register Part III, Tentative Final Monograph for Health-Care Antiseptic Drug Products; Proposed Rule. Vol. 59, No 116(Friday, June 17, 1994). Code of Federal Regulations, Title 21CFR Parts 333 and 369.2. ASTM Standard 1115-91. Standard Test Method for Evaluation ofSurgical Hand Scrub Formulations. Annual Book of ASTMStandards, Vol. 11.05., p. 447-450, 1996.3Health Care3M Center, Building 275-4E-01St. Paul, MN 55144-1000USA1 800 228-3957healthcare@3M.comwww.3M.com/healthcareHibiclens is a registered trademark ofAstraZeneca PLC.H.I. 4509Printed in U.S.A.Copyright © 3M (IPC) 2000.All rights reserved.70-2009-3173-4 WG40% Pre-consumer waste paper10% Post-consumer waste paper [ Pobierz całość w formacie PDF ]
