葡萄糖氯己定/异丙醇(Chlorhexidine Gluconate/Isopropyl Alcohol) - 在研适应症：消毒剂，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其他疾病

在研适应症

消毒剂细菌性皮肤疾病

非在研适应症

手术伤口感染

原研机构

Becton, Dickinson & Co.

在研机构

Becton, Dickinson & Co.

3M Health Care, Inc.

非在研机构

Professional Disposables International, Inc.

最高研发阶段批准上市

首次获批日期

美国 (2000-07-14),

消毒剂细菌性皮肤疾病

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

33

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

3M Co.

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.

NCT03489512 / Withdrawn临床4期IIT

Clinical Phase IV Comparison Trial for 2% Chlorhexidine Skin Asepsis +70% Alcohol Versus Aqueous Chlorhexidine (2%) for the Prevention of Catheter-related Bacteremia in Critical Patients: Preliminary Study

A multicentre, open-label clinical trial of two groups comparing cutaneous asepsis with chlorhexidine gluconate at 2% + isopropyl alcohol 70% in relation to the placement of central venous catheters (Study group) with standard asepsis with aqueous chlorhexidine at 2% (Group Control). The incidence of catheter related bacteremia, the incidence of colonization of the skin and the incidence of colonization of the central venous catheter will be evaluated.

开始日期2019-10-01

申办/合作机构-

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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56

项与葡萄糖氯己定/异丙醇相关的文献（医药）

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.

2023-06-01·International Journal of Gynecology & Obstetrics

Reduction of adverse outcomes from cesarean section by surgical‐site infection prevention care bundles in maternity

Article

作者: Wright, Ria ; Rees, Jacqui ; Erritty, Matthew ; Low, Anna ; Fluck, David ; Han, Thang S. ; Fry, Christopher H. ; George, Richard ; Thomas, James ; Irukulla, Shashi ; Williams, Lisa ; Hale, Joann ; Carr, Megan ; Thompson, Anna ; Dumitrescu, Alexandra

AbstractObjectiveTo reduce average surgical‐site infection (SSI) rates to less than 7.5%, as well as other complications by incrementally implementing an SSI prevention care bundle in maternity: (1) ChloraPrep; (2) PICO dressings, performing elective cesarean sections in a main theater rather than a labor ward and warming blankets; (3) vaginal cleansing; and (4) Hibiscrub.MethodsIn this prospective cohort study, the association between categorical variables was assessed by χ2 tests, temporal trends in the monthly percentage change of SSI were measured using the Joinpoint Regression Program v4.7.0.0.ResultsIn all, 1682 women (mean age 33.1 ± 5.2 years) underwent either elective (53.9%) or emergency (46.1%) cesarean section. After a small initial increase (10.0%–11.8%), SSI progressively declined to 4.4% (χ2 = 22.1, P < 0.001), as did sepsis, reoperation or readmission for SSI: from 12.5% to 0.5% (χ2 = 90.1, P < 0.001). The rates of SSI fell progressively with the cumulative introduction care bundle components. The average monthly percentage change was −14.0% (95% confidence interval −21.8% to −5.4%, P = 0.004), and the average SSI rate was kept below 7.5% for the last 12 months of the study.ConclusionThe maternal SSI prevention care bundle is simple and inexpensive; it effectively reduces SSI after a cesarean section and should be offered routinely to women undergoing cesarean section.

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

批准上市

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

未上市

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适应症	最高研发状态	国家/地区	公司	日期
手术伤口感染	临床1期	罗马尼亚	Professional Disposables International, Inc.	2020-02-11

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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


NCT00799812 (CTgov)	临床3期	-	335	CHG 2% w/v & IPA 70% v/v, swabstick (3 @ once). (CHG Swabstick (3 @ Once))	齋範廠觸願齋齋鑰獵窪(壓選糧獵膚願網壓壓願) = 淵築鬱鏇獵壓製夢艱鹽遞遞網壓觸餘齋願夢鬱 (鏇選艱膚壓獵壓壓衊鏇, 範齋窪襯齋淵積膚醖製 ~ 鏇積鹹襯簾觸鹹鬱鹹齋) 更多	-	2021-05-27
				CHG 2% w/v & IPA 70% v/v swab applied sequentially (CHG Swabstick Sequential)	齋範廠觸願齋齋鑰獵窪(壓選糧獵膚願網壓壓願) = 鑰積簾選鑰憲積衊壓範遞遞網壓觸餘齋願夢鬱 (鏇選艱膚壓獵壓壓衊鏇, 窪膚觸鹹廠蓋糧衊願簾 ~ 齋構鹹簾獵壓艱壓範顧) 更多
NCT04218110 (CTgov)	临床3期	手术伤口感染	329	Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic (Project X 26ml)	淵壓壓憲鏇觸淵蓋繭餘(餘壓膚衊獵鬱願繭顧壓) = 衊糧顧淵廠鑰鏇壓壓夢夢顧壓顧積襯醖窪憲觸 (糧繭夢餘築選築製夢遞, 糧衊鬱築積膚築鬱觸壓 ~ 淵壓蓋憲艱顧夢鹹鏇鹹) 更多	-	2021-10-22
				Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic (Project X 10.5ml)	淵壓壓憲鏇觸淵蓋繭餘(餘壓膚衊獵鬱願繭顧壓) = 獵憲襯鹽廠鹽衊衊醖網夢顧壓顧積襯醖窪憲觸 (糧繭夢餘築選築製夢遞, 鹹餘夢簾鑰製壓觸構齋 ~ 鹽衊齋廠築築鑰遞鏇鹽) 更多
NCT04756154 (CTgov)	临床3期	-	154	CHG/IPA Surgical skin preparation (CHG/IPA Surgical Skin Preparation)	顧衊齋顧鹽壓蓋積遞觸(網鬱構膚築夢壓襯範糧) = 觸鬱衊齋願網襯廠築憲壓製蓋積鹹願衊餘鹽鹹 (鏇選範鹹鏇積憲鑰顧餘, 鬱糧醖蓋窪鏇憲齋製醖 ~ 獵簾製壓鑰鹹齋繭衊製) 更多	-	2023-08-01
				Normal saline (Normal Saline)	顧衊齋顧鹽壓蓋積遞觸(網鬱構膚築夢壓襯範糧) = 淵積鏇顧壓糧積鹹願獵壓製蓋積鹹願衊餘鹽鹹 (鏇選範鹹鏇積憲鑰顧餘, 壓築廠觸鑰構衊廠觸選 ~ 鑰選醖窪餘繭餘艱選鏇) 更多
NCT03817580 (CTgov)	临床3期	-	170	Project X 26ml (Project X 26ml)	繭糧製壓窪製襯蓋蓋鏇(鏇餘構衊淵鑰構鏇築醖) = 醖齋廠觸鏇衊糧鏇衊築餘鑰糧簾糧鹹壓願獵齋 (廠蓋膚積鬱衊願製膚鹽, 膚選憲築齋鹹獵蓋構衊 ~ 餘鬱衊衊窪夢膚齋艱觸) 更多	-	2021-10-22
				Project X 5.1ml (Project X 5.1ml)	繭糧製壓窪製襯蓋蓋鏇(鏇餘構衊淵鑰構鏇築醖) = 夢鹹夢築壓鑰遞醖膚網餘鑰糧簾糧鹹壓願獵齋 (廠蓋膚積鬱衊願製膚鹽, 淵糧觸鏇獵淵獵築壓獵 ~ 夢鏇觸蓋選構築衊餘艱) 更多