葡萄糖氯己定/异丙醇(Chlorhexidine Gluconate/Isopropyl Alcohol) - 在研适应症：细菌性皮肤疾病_专利_临床

概要

基本信息

药物类型

小分子化药

别名

ChloraPrep、Soluprep

靶点-

作用机制

细胞膜功能抑制剂

治疗领域

感染皮肤和肌肉骨骼疾病

在研适应症

细菌性皮肤疾病

非在研适应症-

原研机构

Becton, Dickinson & Co.

在研机构

3M Health Care, Inc.

Becton, Dickinson & Co.

非在研机构-

最高研发阶段批准上市

首次获批日期

美国 (2000-07-14),

细菌性皮肤疾病

最高研发阶段(中国)-

特殊审评-

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结构

分子式C3H8O

InChIKeyKFZMGEQAYNKOFK-UHFFFAOYSA-N

CAS号67-63-0

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关联

29

项与葡萄糖氯己定/异丙醇相关的临床试验

NCT04756154 / Completed临床3期

Assessment of the Antimicrobial Efficacy of 3M™ SoluPrep™ Preoperative Skin Preparation Against Resident Human Skin Flora on the Inguinal Region

The purpose of this study is to determine the antimicrobial efficacy of an investigational CHG/IPA prep on skin flora of the inguinal regions of human subjects.

开始日期2020-07-06

申办/合作机构-

NCT04218110 / Completed临床3期

Preoperative Skin Preparation Study Following ASTM E1173 Methods to Evaluate the Antimicrobial Capabilities of Four Test Substances

Comparative study of antimicrobial effectiveness evaluation of of 26ml Project X, 10.5ml Project X, 5.1ml Project X and Prevantics Maxi swabstick following ASTM E1173 - Standard test method for evaluation of preoperative, precatheterization or preinjection skin preparations.

开始日期2020-02-11

申办/合作机构

Professional Disposables International, Inc.

NCT03861780 / Completed临床3期

Pilot Evaluation of Two Test Materials With a Positive Control When Used as a Patient Preoperative Skin Preparation

Comparative Study of Antimicrobial Effectiveness Evaluation of 26ml Project X, 5.1ml Project X and Prevantics Maxi Swabstick following ASTM E1173 - Standard Test Method for Evaluation of Preoperative, Precatheterization, or Preinjection Skin Preparations, ASTM International, West Conshohocken, Pennsylvania, 2015

开始日期2019-04-02

申办/合作机构

Professional Disposables International, Inc.

100 项与葡萄糖氯己定/异丙醇相关的临床结果

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100 项与葡萄糖氯己定/异丙醇相关的转化医学

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100 项与葡萄糖氯己定/异丙醇相关的专利（医药）

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58

项与葡萄糖氯己定/异丙醇相关的文献（医药）

2024-07-01·Access Microbiology

Reducing Blood Culture Contamination Rates: Introduction of a Combined Education and Skin Antisepsis Intervention

Article

作者: Mullane, Niamh ; Kelly, Deborah ; Broderick, Deirdre ; O'Callaghan, Isabelle ; Hickey, Caitriona ; Connolly, Aine ; O'Mara, Niall ; Coffey, Darragh

Background. Blood culture contamination (BCC) is an important quality concern in clinical microbiology as it can lead to unnecessary antimicrobial therapy in patients and increased workload for laboratory scientists. The Clinical Laboratory and Standards Institute recommend BCC rates to be <3 % and recently updated guidelines have set a new goal of 1 %. The aim of this project was to design and implement interventions to reduce BCC rates at our institution.Methods. We introduced a combined education and skin antisepsis intervention in a large Model 4 academic teaching hospital in the South of Ireland. BD ChloraPrep skin antisepsis applicators (2 % chlorhexidine gluconate/70 % isopropyl alcohol), licensed for use for blood culture specimen collection, were introduced, replacing Clinell (2 % chlorhexidine gluconate/70 % isopropyl alcohol) wipes. In addition, a multimodal education programme was designed and delivered. This consisted of a video demonstrating the recommended blood culture specimen collection technique using the new applicators as well as simulation training for all interns. The video was uploaded to the intranet as an educational resource available to all staff.Results. The interventions were implemented in July 2022 and BCC rates pre- and post-intervention were calculated. The average BCC rate for the 12 months preceding the intervention (July 2021 to July 2022) was 2.56 % with highest rates in the Emergency Department. This compared to an average rate of 2.2 % in the 12 months post-intervention (July 2022 to July 2023). In comparing the two rates the reduction in BCC rates between the two periods was not statistically significant (P=0.30).Conclusion. Overall BCC rates reduced but the difference between the two periods did not reach statistical significance. The resource-intensive nature of providing regular and timely feedback of contamination rates and the larger impact of in-person education and training over virtual modalities may explain the modest reduction. Further investments in these areas, particularly in the Emergency Department, will be necessary to further reduce rates in line with new recommendations.

2024-03-01·Journal of Shoulder and Elbow Surgery

Does hydrogen peroxide application to the dermis following surgical incision affect Cutibacterium acnes cultures in total shoulder arthroplasty in male patients? A randomized controlled trial

Article

作者: Hao, Kevin A ; Wright, Thomas W ; Wright, Jonathan O ; Vasilopoulos, Terrie ; King, Joseph J ; Struk, Aimee M ; Schoch, Bradley S ; Ritter, Alaina S ; Sutton, Christopher D ; Farmer, Kevin W

BACKGROUNDPeriprosthetic joint infections occur in 1%-4% of primary total shoulder arthroplasties (TSAs). Cutibacterium acnes is the most commonly implicated organism and has been shown to persist in the dermis despite use of preoperative antibiotics and standard skin preparations. Studies have shown decreased rates of cultures positive for C acnes with use of preoperative benzoyl peroxide or hydrogen peroxide (H₂O₂), but even with this positive deep cultures remain common. We sought to determine whether an additional application of H₂O₂ directly to the dermis following skin incision would further decrease deep culture positivity rates.METHODSWe performed a randomized controlled trial comparing tissue culture results in primary TSA in patients who received a standard skin preparation with H₂O₂, ethanol, and ChloraPrep (CareFusion, Leawood, KS, USA) vs. an additional application of H₂O₂ to the dermis immediately after skin incision. Given the sexual dimorphism seen in the shoulder microbiome regarding C acnes colonization rates, only male patients were included. Bivariable and multivariable analyses were performed to compare rates of positive cultures based on demographic and surgical factors.RESULTSDermal cultures were found to be positive for C acnes at similar rates between the experimental and control cohorts for the initial (22% vs. 28%, P = .600) and final (61% vs. 50%, P > .999) dermal swabs. On bivariable analysis, the rate of positive deep cultures for C acnes was lower in the experimental group, but this difference was not statistically significant (28% vs. 44%, P = .130). However, patients who underwent anatomic TSA were found to have a significantly greater rate of deep cultures positive for C acnes (57% vs. 28%, P = .048); when controlling for this on multivariable analysis, the experimental cohort was found to be associated with significantly lower odds of having positive deep cultures (odds ratio, 0.37 [95% confidence interval, 0.16-0.90], P = .023). There were no wound complications in either cohort.CONCLUSIONSAn additional H₂O₂ application directly to the dermis following skin incision resulted in a small but statistically significant decrease in the odds of having deep cultures positive for C acnes without any obvious adverse effects on wound healing. Given its cost-effectiveness, use of a post-incisional dermal decontamination protocol may be considered as an adjuvant to preoperative use of benzoyl peroxide or H₂O₂ to decrease C acnes contamination.

2024-01-01·Current Microbiology

Fungal Diseases Caused by Serious Contamination of Pharmaceuticals and Medical Devices, and Rapid Fungal Detection Using Nano-Diagnostic Tools: A Critical Review

Review

作者: Ahmed, Mohamed Abd El-Gawad El-Sayed ; Abbas, Heba S ; Kotakonda, Muddukrishnaiah

AbstractFungal-contaminated compounded pharmaceuticals and medical devices pose a public health problem. This review aimed to provide an organized overview of the literature on that critical issue. Firstly, it was found that compounding pharmacies can produce drugs that are contaminated with fungi, leading to outbreaks of severe fungal diseases. Secondly, inadequate sterile compounding techniques or storage conditions, or exceeding the limit of a fungal count, can result in fungal contamination. Lastly, nanotools can be used to rapidly detect fungi, thus improving fungal diagnostic procedures. To achieve this goal, we have reviewed the published data on PubMed, the CDC, and FDA Web sites, and a literature search was undertaken to identify severe fungal infections associated with compounding pharmacies outside of hospitals, limited by the dates 2003 to 2021. The “Preferred Reporting Items for Critical Reviews” were followed in searching, including, and excluding papers. Fungal outbreaks have been documented due to contaminated pharmaceuticals and medical devices. In 2013, 55 people died from fungal meningitis caused by contaminated steroid injections containing methylprednisolone acetate. Additionally, in 2021, Aspergillus penicillioides contamination was reported in ChloraPrep drugs, which was attributed to the storage conditions that were conducive to the growth of this fungus. These incidents have resulted in severe infectious diseases, such as invasive mycoses, cornea infections, Endophthalmitis, and intestinal and gastric mycosis. By implementing preventive measures and policies, it is possible to avoid these outbreaks. Creating Nano-diagnostics presents a major challenge, where promptly diagnosing fungal infections is required to determine the proper corrective and preventive measures.

100 项与葡萄糖氯己定/异丙醇相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	D08AC52	-

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
细菌性皮肤疾病	美国	Becton, Dickinson & Co.	2000-07-14

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04756154 (CTgov)	临床3期	-	154	CHG/IPA Surgical skin preparation (CHG/IPA Surgical Skin Preparation)	衊衊鏇廠鹹願齋壓遞襯(艱獵鹹築顧積廠簾膚遞) = 淵網壓製鬱鏇衊廠鬱衊膚壓鹹艱鏇願襯願範範 (觸繭襯觸觸鏇襯廠鏇獵, 顧淵繭襯餘淵網膚積製 ~ 鹽範蓋淵壓糧鏇艱構鬱) 更多	-	2023-08-01
				Normal saline (Normal Saline)	衊衊鏇廠鹹願齋壓遞襯(艱獵鹹築顧積廠簾膚遞) = 憲鑰餘繭艱蓋衊遞鹹廠膚壓鹹艱鏇願襯願範範 (觸繭襯觸觸鏇襯廠鏇獵, 築艱餘餘範壓膚觸壓壓 ~ 襯衊鹽淵蓋顧獵網艱衊) 更多
NCT03681990 (CTgov)	临床2期	-	28	3M CHG/IPA Prep (3M CHG/IPA Prep / Center)	艱鏇蓋憲積積衊蓋鏇憲(網觸願襯鏇糧簾壓網鑰) = 顧齋構鹹觸鹹鹹鏇壓顧夢憲選顧繭鹽鹹窪衊壓 (齋糧餘鑰簾艱壓衊網醖, 鹹繭淵夢範鹹簾衊網觸 ~ 選齋淵製襯觸獵膚顧襯) 更多	-	2023-06-27
				3M CHG/IPA Prep (3M CHG/IPA Prep / Mid-peripheral)	淵襯鬱衊鑰鹹願鬱築築(廠願廠願鹹壓獵繭鑰鏇) = 網窪糧艱糧蓋繭窪構淵鹹壓遞廠獵廠遞衊積網 (窪構醖廠鬱襯選鬱構壓, 製製壓糧築製鬱壓鹹遞 ~ 積製鬱醖觸醖齋積淵遞) 更多
NCT03861780 (CTgov)	临床3期	-	152	Project X 26ml (Project X 26ml)	範憲糧觸鏇製鑰觸蓋鬱(顧廠蓋顧鹽顧壓範壓願) = 廠餘簾鏇觸鑰製艱簾簾糧夢範鹹獵簾構遞艱繭 (積鑰遞獵餘鑰齋顧衊壓, 鑰築齋築廠鹽鑰簾繭選 ~ 蓋鹹製餘鏇膚網顧淵範) 更多	-	2021-10-22
				Project X 5.1ml (Project X 5.1ml)	範憲糧觸鏇製鑰觸蓋鬱(顧廠蓋顧鹽顧壓範壓願) = 齋膚簾積餘願鬱顧獵糧糧夢範鹹獵簾構遞艱繭 (積鑰遞獵餘鑰齋顧衊壓, 糧淵獵構鹽鹹鑰願醖簾 ~ 糧艱鹹鹽艱壓艱願鏇壓) 更多
NCT03817580 (CTgov)	临床3期	-	170	Project X 26ml (Project X 26ml)	鬱顧齋顧遞鏇憲鏇築鑰(齋獵範範艱衊製製遞願) = 壓鏇蓋廠遞齋顧壓艱選憲築艱獵衊鑰餘獵積蓋 (齋網壓窪鑰遞構膚膚艱, 襯顧遞獵網鑰衊簾淵艱 ~ 窪艱繭築夢網觸憲淵窪) 更多	-	2021-10-22
				Project X 5.1ml (Project X 5.1ml)	鬱顧齋顧遞鏇憲鏇築鑰(齋獵範範艱衊製製遞願) = 鬱壓衊製顧廠鏇夢膚鏇憲築艱獵衊鑰餘獵積蓋 (齋網壓窪鑰遞構膚膚艱, 構積餘廠衊繭鏇壓鏇鏇 ~ 夢鏇獵鑰鑰積鹹糧遞蓋) 更多
NCT04218110 (CTgov)	临床3期	手术伤口感染	329	Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic (Project X 26ml)	鹹顧鹽願鹹衊衊觸願齋(窪憲範窪膚憲蓋網觸糧) = 範繭蓋遞選鏇餘構壓夢艱獵簾構築遞顧簾遞繭 (夢築顧醖夢鬱積築夢鬱, 製積願獵遞築淵衊簾廠 ~ 齋膚顧憲繭齋顧衊壓觸) 更多	-	2021-10-22
				Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic (Project X 10.5ml)	鹹顧鹽願鹹衊衊觸願齋(窪憲範窪膚憲蓋網觸糧) = 窪鹹遞繭齋夢憲鏇憲願艱獵簾構築遞顧簾遞繭 (夢築顧醖夢鬱積築夢鬱, 製壓齋獵壓夢憲憲範窪 ~ 壓蓋淵觸觸餘廠觸簾淵) 更多