scholarly journals Antiseptic efficacy of an innovative perioperative surgical skin preparation: A confirmatory FDA phase 3 analysis

2020 ◽  
Vol 41 (6) ◽  
pp. 653-659
Author(s):  
Charles E. Edmiston ◽  
Philip Lavin ◽  
Maureen Spencer ◽  
Gwen Borlaug ◽  
Gary R. Seabrook ◽  
...  
Keyword(s):  
Skin Irritation ◽  
Phase 3 ◽  
Skin Preparation ◽  
Time Points ◽  
Efficacy Analysis ◽  
Colony Forming Units ◽  
Human Volunteers ◽  
Skin Flora ◽  
Skin Antisepsis ◽  
Antiseptic Agent

AbstractBackground:An innovative approach to perioperative antiseptic skin preparation is warranted because of potential adverse skin irritation, rare risk of serious allergic reaction, and perceived diminished clinical efficacy of current perioperative antiseptic agents. The results of a confirmatory US Food and Drug Administration (FDA) phase 3 efficacy analysis of a recently approved innovative perioperative surgical skin antiseptic agent are discussed.Methods:The microbial skin flora on abdominal and groin sites in healthy volunteers were microbiologically sampled following randomization to either ZuraGard, a 2% chlorhexidine/70% isopropyl alcohol preparation (Chloraprep), or a control vehicle (alcohol-free ZuraGard). Mean log10 reduction of colony-forming units (CFU) was assessed at 30 seconds, 10 minutes, and 6 hours.Results:For combined groin sites (1,721 paired observations) at all time points, the mean log10 CFU reductions were significantly greater in the ZuraGard group than in the Chloraprep group (P < .02). Mean log10 CFU reductions across combined abdominal and groin sites at all time points (3,277 paired observations) were significantly greater in the ZuraGard group than in the Chloraprep group (P < .02).Conclusions:A confirmatory FDA phase 3 efficacy analysis of skin antisepsis in human volunteers documented that ZuraGard was efficacious in significantly reducing the microbial burden on abdominal and groin test sites, exceeding that of Chloraprep. No significant adverse reactions were observed following the application of ZuraGard.Trial registration:ClinicalTrials.gov identifiers: NCT02831998 and NCT02831816.

scholarly journals Efficacy and safety of a novel antimicrobial preoperative skin preparation

2019 ◽  
Vol 40 (10) ◽  
pp. 1157-1163 ◽  
Author(s):  
Christopher J. Crnich ◽  
Aurora E. Pop-Vicas ◽  
Thomas G. Hedberg ◽  
Trish M. Perl
Keyword(s):  
Adverse Reactions ◽  
Skin Irritation ◽  
Negative Control ◽  
Application Time ◽  
Experimental Conditions ◽  
Skin Preparation ◽  
Colony Forming Units ◽  
Skin Flora ◽  
Skin Antisepsis ◽  
Emergence Of Resistance

AbstractObjective:Alternatives to skin preparation with conventional preoperative antiseptics are required because of adverse reactions and the potential emergence of resistance. Here, we present 2 phase 2 studies of ZuraGard (ZG), a novel formulation of isopropyl alcohol and functional excipients developed for preoperative skin antisepsis.Methods:Microbial skin flora on abdominal and inguinal sites in healthy volunteers were quantitatively assessed following application of ZG versus a negative control (ZV) and a chlorhexidine/alcohol preparation, Chloraprep (CP). In trial 1, ZG administered for both recommended and abbreviated application times was compared with CP and ZV via bacterial reductions at 10 minutes, and 6 hours, 12 hours, and 24 hours following application. In trial 2, the 10-minute postapplication responder rates (RRs) for ZG, participants with abdominal ≥2 log10 per cm2, and inguinal ≥3 log10 per cm2 reductions in colony-forming units (CFU) were compared to RRs of participants treated with CP.Results:In trial 1, ZG at the recommended application time reduced mean bacterial counts by ~3.18 log10 CFU/cm2 and ~2.98 log10 CFU/cm2 at abdominal and inguinal sites, respectively. Qualitatively similar reductions were observed for the abbreviated ZG application time and all CP applications. Application of ZV was ineffective. In trial 2, 10-minute RRs for ZG and CP exceeded 90% at abdominal sites. At inguinal sites, RRs were 83.3% for ZG and 86.7% for CP. No skin irritation or other adverse events were observed.Conclusions:ZG matched CP efficacy under these experimental conditions with immediate and persistent microbial reductions, including abbreviated application times. Further clinical studies of this novel preoperative antiseptic are merited.

scholarly journals Povidone-iodine-alcohol is superior to chlorhexidine-alcohol in its antimicrobial efficacy on the anaerobic microbial flora in surgical skin preparation of the shoulder region

2019 ◽  
Author(s):  
Dorothea Dörfel ◽  
Georg Daeschlein ◽  
Matthias Maiwald ◽  
Gerald Müller ◽  
Robert Hudek ◽  
...  
Keyword(s):  
Povidone Iodine ◽  
Surgical Site Infections ◽  
Shoulder Surgery ◽  
Skin Microbiome ◽  
Negative Effects ◽  
Skin Preparation ◽  
Prolonged Contact ◽  
Skin Flora ◽  
Cutibacterium Acnes ◽  
Skin Antisepsis

Abstract Background: Cutibacterium acnes is part of the anaerobic skin microbiome and resides in deeper skin layers. The organism is an important agent of surgical site infections (SSI), particularly in shoulder surgery, and is difficult to target with skin antisepsis. We hypothesized that prolonged preparation with an agent that penetrates deeper into the skin is more effective in shoulder surgery. Thus, we compared two different classes of antiseptics, each combined with alcohol, and each applied with two different contact times. Methods: Shoulders of 16 healthy volunteers were treated for 2.5 min (standard) or 30 min (prolonged) with alcohol-based chlorhexidine (CHG-ALC; 2% w/v CHG, 55% w/v [70% v/v] 2-propanol) or alcohol-based povidone iodine (PVP-I-ALC; 3.24% w/v PVP-I, 38.9% w/v 2-propanol, 37.3% w/v ethanol). Skin sites were sampled before, immediately after, and 3 h after treatment. Results: Aerobic skin flora was reduced more effectively by PVP-I-ALC than by CHG-ALC after 2.5 min and immediate sampling, but not after prolonged contact times and 3-h sampling. Anaerobic flora was reduced more effectively by PVP-I-ALC than by CHG-ALC after standard and prolonged contact times and immediate sampling, but not after 3-h sampling. None of the volunteers reported negative effects from skin antisepsis. Conclusions: PVP-I-ALC is more efficacious than CHG-ALC for topical skin antisepsis regarding the anaerobic flora on the skin of the shoulder. Standard and prolonged contact times demonstrated superiority for PVP-I-ALC for samples taken immediately, but missed significance 3 h after application. The clinical relevance of these findings should be studied with SSI as an endpoint.

scholarly journals Povidone-iodine-alcohol is superior to chlorhexidine-alcohol in its antimicrobial efficacy on the anaerobic microbial flora in surgical skin preparation of the shoulder Region

2020 ◽  
Author(s):  
Dorothea Dörfel ◽  
Georg Daeschlein ◽  
Matthias Maiwald ◽  
Gerald Müller ◽  
Robert Hudek ◽  
...  
Keyword(s):  
Povidone Iodine ◽  
Shoulder Surgery ◽  
Skin Microbiome ◽  
Coagulase Negative Staphylococci ◽  
Skin Preparation ◽  
Prolonged Contact ◽  
Skin Flora ◽  
Significant Difference ◽  
Cutibacterium Acnes ◽  
Skin Antisepsis

Abstract Background Cutibacterium acnes is part of the anaerobic skin microbiome and resides in deeper skin layers. The organism is an agent of surgical site infections (SSI) in shoulder surgery and is difficult to target with skin antisepsis. We hypothesized that prolonged preparation with an agent that penetrates more deeply into the skin is more effective in shoulder surgery. Thus, we compared two different classes of antiseptics, each combined with alcohol, and each applied with two different contact times. Methods Using a cross-over study design, shoulders of 16 healthy volunteers were treated for 2.5 min (standard) or 30 min (prolonged) with alcohol-based chlorhexidine (CHG-ALC; 2% w/v CHG, 55% w/v [70% v/v] 2-propanol) or alcohol-based povidone-iodine (PVP-I-ALC; 3.24% w/v PVP-I, 38.9% w/v 2-propanol, 37.3% w/v ethanol). Skin sites were sampled before, immediately after, and 3 h after treatment, using a standardized cup-scrub technique. Results Aerobic skin flora was reduced more effectively by PVP-I-ALC than by CHG-ALC after 2.5 min application and immediate sampling (reduction factor [RF] 2.55±0.75 vs. 1.94±0.91, p = 0.04), but not after prolonged contact times and 3-h sampling. Coagulase-negative staphylococci were completely eliminated after PVP-I-ALC application, but still recovered from 3 of 16 and 1 of 16 samples after 2.5-min and 30-min CHG-ALC application and immediate sampling, respectively. Anaerobic flora, mostly consisting of C. acnes, was reduced more effectively by PVP-I-ALC than by CHG-ALC after standard (RF 3.96±1.46 vs. 1.74±1.24, p < 0.01) and prolonged (RF 3.14±1.20 vs. 1.38±1.16, p < 0.01) contact times. Sampling 3 h after treatment did not show any significant difference. None of the volunteers reported adverse events. Conclusions PVP-I-ALC is more efficacious than CHG-ALC for topical skin antisepsis concerning the anaerobic flora on the skin of the shoulder. Standard and prolonged contact times demonstrated superiority for PVP-I-ALC for samples taken immediately, but missed significance 3 h after application. The results underscore the need for protection against C. acnes and coagulase-negative staphylococci in orthopaedic surgery and the need to prevent infections caused by these organisms. The clinical relevance of these findings, however, should be studied with SSI as an endpoint.

Synthetic Nanoclay Gels Do Not Cause Skin Irritation in Healthy Human Volunteers

2021 ◽  
Author(s):  
Luciana E. Bostan ◽  
Claire E. Clarkin ◽  
Mohamed Mousa ◽  
Peter R. Worsley ◽  
Daniel L. Bader ◽  
...  
Keyword(s):  
Skin Irritation ◽  
Healthy Human ◽  
Human Volunteers

scholarly journals Ligusticum sinense Nanoemulsion Gel as Potential Repellent against Aedes aegypti, Anopheles minimus, and Culex quinquefasciatus (Diptera: Culicidae)

Insects ◽  
2021 ◽  
Vol 12 (7) ◽  
pp. 596
Author(s):  
Anuluck Junkum ◽  
Wanchai Maleewong ◽  
Atiporn Saeung ◽  
Danita Champakaew ◽  
Arpaporn Chansang ◽  
...  
Keyword(s):  
Aedes Aegypti ◽  
Culex Quinquefasciatus ◽  
Disease Transmission ◽  
Skin Irritation ◽  
Mosquito Vectors ◽  
Plant Family ◽  
Anopheles Minimus ◽  
Human Volunteers ◽  
Nanoemulsion Gel ◽  
Fresh Preparation

Ligusticum sinense Oliv. cv. is a species of Umbelliferae (Apiaceae), a large plant family in the order Apiales. In this study, L. sinense hexane extract nanoemulsion gel (LHE-NEG) was investigated for mosquito repellency and compared to the standard chemical, N,N-diethyl-3-methylbenzamide (DEET), with the goal of developing a natural alternative to synthetic repellents in protecting against mosquito vectors. The results demonstrated that LHE-NEG afforded remarkable repellency against Aedes aegypti, Anopheles minimus, and Culex quinquefasciatus, with median protection times (MPTs) of 5.5 (4.5–6.0), 11.5 (8.5–12.5), and 11.25 (8.5–12.5) h, respectively, which was comparable to those of DEET-nanoemulsion gel (DEET-NEG: 8.5 (7.0–9.0), 12.0 (10.0–12.5), and 12.5 (10.0–13.5) h, respectively). Evaluation of skin irritation in 30 human volunteers revealed no potential irritant from LHE-NEG. The physical and biological stability of LHE-NEG were determined after being kept under heating/cooling cycle conditions. The stored samples of LHE-NEG exhibited some changes in appearance and differing degrees of repellency between those kept for 3 and 6 heating/cooling cycles, thus providing slightly shorter MPTs of 4.25 (4.0–4.5) and 3.25 (2.5–3.5) h, respectively, when compared to those of 5.0 (4.5–6.0) h in fresh preparation. These findings encourage commercially developed LHE-based products as an alternative to conventional synthetic repellents in preventing mosquito bites and helping to interrupt mosquito-borne disease transmission.

scholarly journals The impact of a ‘milking the COW’ campaign in a regional hospital in Singapore

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Surinder Kaur M. S. Pada ◽  
Poh Lishi ◽  
Kim Sim Ng ◽  
Sarathamani Rethenam ◽  
Lilibeth Silagan Alenton ◽  
...  
Keyword(s):  
Hand Hygiene ◽  
Pathogenic Bacteria ◽  
Mixed Model ◽  
Mixed Model Analysis ◽  
Colony Forming Units ◽  
Skin Flora ◽  
Before And After ◽  
The Difference ◽  
And Control ◽  
The Impact

Abstract Background Computerisation of various processes in hospitals and reliance on electronic devices raises the concern of contamination of these devices from the patient environment. We undertook this study to determine if an attached hand hygiene device that unlocks the screen of a computer on wheels (COW) on usage can be effective in decreasing the microbiological burden on computer keyboards. Methods An electronic hand sanitizer was integrated onto the COW. A prospective cohort study with a crossover design involving 2 control and 2 intervention wards was used. The study end point was the number of colony forming units found on the keyboards. Bacteria were classified into 4 main groups; pathogenic, skin flora, from the environment or those thought to be commensals in healthy individuals. We then used a mixed effects model for the statistical analysis to determine if there were any differences before and after the intervention. Results Thirty-nine keyboards were swabbed at baseline, day 7 and 14, with 234 keyboards cultured, colony forming units (CFUs) counted and organisms isolated. By mixed model analysis, the difference of mean bacteria count between intervention and control for week 1 was 32.74 (− 32.74, CI − 94.29 to 28.75, p = 0.29), for week 2 by 155.86 (− 155.86, CI − 227.45 to − 83.53, p < 0.0001), and after the 2-week period by 157.04 (− 157.04, CI − 231.53 to − 82.67, p < 0.0001). In the sub-analysis, there were significant differences of pathogenic bacteria counts for the Intervention as compared to the Control in contrast with commensal counts. Conclusion A hand hygiene device attached to a COW may be effective in decreasing the microbiological burden on computer keyboards.

scholarly journals 354 Lenvatinib and pembrolizumab in advanced endometrial carcinoma (EC): long-term efficacy and safety update from a phase 1b/2 study

2021 ◽  
Vol 9 (Suppl 3) ◽  
pp. A381-A381
Author(s):  
Vicky Makker ◽  
Carol Aghajanian ◽  
Allen Cohn ◽  
Margarita Romeo ◽  
Raquel Bratos ◽  
...  
Keyword(s):  
Endometrial Cancer ◽  
Cancer Center ◽  
Efficacy And Safety ◽  
Open Label ◽  
Phase 3 ◽  
Efficacy Analysis ◽  
Phase 1B ◽  
Grade 3 ◽  
Cutoff Date

BackgroundLenvatinib is a multikinase inhibitor of VEGFR 1–3, FGFR 1–4, PDGFRα, RET, and KIT. Pembrolizumab is an anti-programmed death-1 monoclonal antibody. We previously reported results from a cohort of 108 patients with metastatic EC (data cutoff date, January 10, 2019) who received lenvatinib + pembrolizumab as part of an ongoing multicenter, open-label, phase 1b/2 study evaluating the combination treatment in patients with selected solid tumors (NCT02501096). Lenvatinib + pembrolizumab showed a tolerable safety profile and promising antitumor activity per immune-related (ir) Response Evaluation Criteria In Solid Tumors (RECIST) by investigator assessment, including an objective response rate (ORR) of 38.9% (95% confidence interval [CI], 29.7–48.7), median progression-free survival (PFS) of 7.4 months (95% CI, 5.3–8.7), and median overall survival (OS) of 16.7 months (95% CI, 15.0-not estimable).1 Here we present updated efficacy and safety data (data cutoff date: August 18, 2020).MethodsPatients included in the EC cohort had histologically confirmed, measurable metastatic EC and had received ≤2 prior chemotherapies (unless discussed with the sponsor). Patients received lenvatinib (20 mg orally once daily) and pembrolizumab (200 mg intravenously once every 3 weeks). The phase 2 efficacy endpoints included ORR, PFS, OS, and duration of response. Tumor assessments for primary and secondary endpoints were evaluated by investigators per irRECIST.ResultsThe 108 patients from the key efficacy analysis set for the previously reported results were all included in these updated analyses. Median follow-up duration for the study was 34.7 months. Efficacy outcomes are summarized in table 1. Treatment-related adverse events (TRAEs) occurred in 104 (96%) patients (94 [87%] grade ≤3, 10 [9%] grade ≥4). TRAEs led to study-drug interruption of 1 or both drugs in 80 (74.1%) patients and dose reductions of lenvatinib in 73 (67.6%) patients; 23 (21.3%) patients discontinued 1 or both drugs due to a TRAE. The most common grade ≥3 TRAEs were hypertension (33.3%), lipase increased (9.3%), fatigue (8.3%), and diarrhea (7.4%).Abstract 354 Table 1ConclusionsWith extended follow-up, our updated efficacy analysis continued to show clinical benefit in patients with metastatic EC who received lenvatinib + pembrolizumab. Moreover, the combination had a manageable safety profile that was generally consistent with the established safety profiles of the individual monotherapies. No new safety signals were detected. A phase 3 study of lenvatinib + pembrolizumab versus treatment of physician’s choice in advanced endometrial cancer further supports the lasting clinical benefits observed in our study.2Trial Registration www.clinicaltrials.gov NCT02501096ReferencesMakker V, Taylor MH, Aghajanian C, et al. Lenvatinib plus pembrolizumab in patients with advanced endometrial cancer. J Clin Oncol 2020;38(26):2981–2992.Makker V, Colombo N, Casado Herráez A, et al. A multicenter, open-label, randomized, phase 3 study to compare Ethics ApprovalThis study was approved by the following ethics committees/institutional review boards (IRBs): Oregon Health & Sciences University IRB, IntegReview IRB, Memorial Sloan Kettering Cancer Center IRB, University of Pennsylvania Office of Regulatory Affairs IRB, Dana-Farber Cancer Institute IRB, The University of Chicago Biological Sciences Division IRB, University of Texas MD Anderson Cancer Center IRB, Western IRB, Quorum Review IRB, US Oncology, Inc. IRB, CEIm - Comité de Ética de la Investigación con Medicamentos, Regional Komite for Medisinsk og Helsefagli Forskningsetikk, and REC - Regional Committees for Medical and Health Research Ethics. All participants gave informed consent before taking part in this study.ConsentNo identifying information is contained in this abstract so no permission from participants is considered necessary.

scholarly journals FC 022AN OPEN-LABEL, MULTICENTER STUDY TO EVALUATE THE SAFETY AND EFFECTIVENESS OF INTRAVENOUS DIFELIKEFALIN IN PATIENTS WITH MODERATE-TO-SEVERE CKD–ASSOCIATED PRURITUS UNDERGOING HEMODIALYSIS

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Daniel Weiner ◽  
Frederique Menzaghi ◽  
Warren Wen ◽  
Jenny Qian ◽  
Catherine Munera ◽  
...  
Keyword(s):  
Sleep Quality ◽  
Safety Profile ◽  
Complete Resolution ◽  
Skin Irritation ◽  
Quality Score ◽  
Open Label ◽  
Phase 3 ◽  
Open Label Study ◽  
Label Study ◽  
Self Confidence

Abstract Background and Aims Chronic kidney disease–associated pruritus (CKD-aP) is a common and highly distressing condition in patients undergoing hemodialysis (HD). CKD-aP is associated with sleep disturbances, significant quality-of-life (QoL) impairment, and increased morbidity and mortality. Difelikefalin (DFK) is a selective kappa opioid receptor agonist in development for CKD-aP that has minimal central nervous system penetration. In placebo-controlled phase 3 trials of patients with moderate to severe CKD-aP undergoing HD, intravenous (IV) DFK had an acceptable safety profile and demonstrated significant reductions vs placebo in itch intensity. We report safety and effectiveness outcomes, including itch-related QoL and sleep measures, from a phase 3 open-label study of DFK in patients with moderate to severe CKD-aP. Method This multicenter, open-label study conducted in the United States and Europe enrolled patients with moderate to severe CKD-aP (mean baseline 24-hour Worst Itching Intensity Numerical Rating Scale [WI-NRS] score ≥5) undergoing HD for ≥3 months. Patients received IV DFK 0.5 mcg/kg 3 times/week at the end of each HD session for up to 12 weeks. Predefined effectiveness endpoints at week 12 included ≥3-point and ≥4-point improvement in the weekly mean of the 24-hour WI-NRS score (range from 0 [no itching] to 10 [worst itching imaginable]). Change from baseline in QoL at week 12 was assessed using the 5-D itch and Skindex-10, multidimensional itch-related questionnaires validated in CKD-aP (higher scores indicate worse QoL). The proportion of patients with no problems (score of 1) on the skin irritation and self-confidence domains of the EQ-PSO questionnaire was evaluated. Post hoc endpoints included complete resolution in WI-NRS (≥75% of week 12 scores 0 or 1) and Sleep Quality Questionnaire total score assessments (range of possible scores, 0 [did not interfere] to 10 [completely interfered]), including ≥3-point and ≥4-point improvement in weekly mean score and complete resolution (all scores of 0) at week 12. Safety assessments and adverse events (AEs) were evaluated. Data were summarized descriptively. Results Among 222 patients who received DFK, 197 (88.7%) completed the study. At baseline, mean ±SD age was 58.1 ±12.8 years and 54.5% of patients were male. Baseline mean ±SD WI-NRS score was 7.6 ±1.3, Sleep Quality score was 6.6 ±2.2, 5-D itch score was 17.1 ±3.5, and Skindex-10 score was 32.9 ±14.3. At week 12, the majority of patients achieved ≥3-point and ≥4-point improvement in WI-NRS (73.7% and 59.3%) and Sleep Quality score (66.0% and 56.7%). Complete resolution of WI-NRS and Sleep Quality score was observed in 29.4% and 19.1% of patients, respectively (Figure). DFK was associated with improvements in mean 5-D itch (−7.1 ±4.3) and Skindex-10 (−21.0 ±15.6) scores at week 12. The proportion of patients reporting no problems in the skin irritation EQ-PSO domain increased from 1.4% at baseline to 28.9% at week 12, and self-confidence EQ-PSO domain scores increased from 63.5% at baseline to 73.2% at week 12. Overall, 64.4% (143/222) of patients reported ≥1 treatment-emergent AE (TEAE). The most commonly reported TEAEs (≥4% of patients) were diarrhea (5.0% [11/222]), nausea (4.5% [10/222]), and hyperkalemia (4.1% [9/222]). Serious TEAEs were reported by 20.3% (45/222) of patients; no serious TEAEs were related to study drug. Conclusion In this phase 3 open-label study in patients with moderate to severe CKD-aP undergoing HD, DFK was generally well tolerated with an acceptable safety profile. DFK demonstrated effectiveness based on reduction of itch intensity, and improvements in sleep quality and itch-related QoL at week 12. The majority of patients reported ≥3-point or ≥4-point improvement in WI-NRS and Sleep Quality scores, with some reporting complete resolution. Findings from this open-label study provide insight into the potential real-world effectiveness of DFK in moderate to severe CKD-aP.

scholarly journals Evaluation of 3 Alcohol-based Agents for Presurgical Skin Preparation in Mice

2020 ◽  
Vol 59 (1) ◽  
pp. 67-73
Author(s):  
Monika K Huss ◽  
Kerriann M Casey ◽  
Jing Hu ◽  
Roberta C Moorhead ◽  
Helen H Chum
Keyword(s):  
Space Constraint ◽  
Surgical Procedure ◽  
Povidone Iodine ◽  
Skin Irritation ◽  
Histopathologic Examination ◽  
Bacterial Identification ◽  
Aseptic Technique ◽  
Skin Preparation ◽  
Bacterial Populations ◽  
Crucial Component

Appropriate aseptic technique is a crucial component of rodent survival surgery. Ease of technique, surgical space constraint, batch surgery, and cost are factors that may affect researcher compliance with appropriate aseptic technique. The first part of this study compared 3 antiseptic preparation agents with the standard triplicate application of povidone-iodine and alcohol. Euthanized mice (n = 40) were shaved on the dorsum, and culture swabs were taken for RODAC plating and bacterial identification. Shaved sites were prepared by using one of the 4 antiseptic preparation agents. Culture samples were obtained immediately and at 20 min after antiseptic preparation. In the 2nd part of the study, 8 mice (n = 2 per group) were prepared for a survival surgical procedure by using one of the 4 antiseptic preparation agents to evaluate whether the antiseptic preparation agents caused skin irritation or impaired healing. Results from this study indicated that all 3 of the antiseptic agents evaluated were equally effective at reducing bacterial populations immediately and at 20 min after preparation. Histopathologic examination of the incision sites revealed signs of normal healing without lesions adjacent to the incision site. We conclude that all 3 of the products evaluated are comparable to traditional povidone–iodine and alcohol as agents for aseptic preparation of surgical sites.

scholarly journals EDITORIAL: FAILURE AFTER FAILURE. WHAT NEXT IN AD DRUG DEVELOPMENT?

2019 ◽  
pp. 1-1 ◽  
Author(s):  
P.S. Aisen
Keyword(s):  
Drug Development ◽  
Phase 3 ◽  
Efficacy Analysis ◽  
Amyloid Hypothesis ◽  
Disease Modifying ◽  
Disease Modifying Agents

The Phase 3 aducanumab program in early AD has been stopped based on a futility efficacy analysis. This huge disappointment follows exciting preliminary studies that had raised expectations (1). Now this frustrating result joins the long series of negative and interrupted trials of potential disease-modifying agents, going back to tarenflurbil (2), tramiprosate (3), and bapineuzumab (4), among many others. Is the amyloid hypothesis wrong? Where do we go from here?

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