Pragmatic randomized clinical trial comparing Iodine Povacrylex based on alcohol to Chlorhexidine also based on alcohol in efficacy and security to diminish frequency of surgical site infections in major abdominal elective clean contaminated wounds. Will be held in a third level university, high volume national public hospital in San Salvador, El Salvador.

开始日期2019-04-05

申办/合作机构

Universidad del Salvador

NCT03523962

/ Completed临床4期IIT

PREPARE: A Pragmatic Randomized Trial Evaluating Pre-operative Alcohol Skin Solutions in FRactured Extremites

The prevention of infection is an important goal influencing peri-operative care of extremity fracture patients. Standard practice in the operative management of extremity fractures includes sterile technique and pre-operative skin preparation with an antiseptic solution. The available solutions kill bacteria and decrease the quantity of native skin flora, thereby decreasing surgical site infection (SSI). While there is extensive guidance on specific procedures for prophylactic antibiotic use and standards for sterile technique, the evidence regarding the choice of antiseptic skin preparation solution is very limited for extremity fracture surgery.

开始日期2018-08-21

申办/合作机构

University of Maryland Baltimore

[+2]

NCT03393819

/ CompletedN/AIIT

Efficacy of Surgical Skin Preparation Solutions in Hip Arthroplasty Surgery

This study will assess the efficacy of two of the most commonly used surgical skin-preparation solutions: Chloraprep (chlorhexidine-alcohol) and Duraprep (iodine-alcohol) at eliminating bacteria from the hip site by evaluating the residual bacteria present following surgical skin-preparation.

开始日期2014-10-29

申办/合作机构

University of Lakehead

[+1]

100 项与 Iodine Povacrylex/Isopropyl Alcohol 相关的临床结果

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100 项与 Iodine Povacrylex/Isopropyl Alcohol 相关的转化医学

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100 项与 Iodine Povacrylex/Isopropyl Alcohol 相关的专利（医药）

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项与 Iodine Povacrylex/Isopropyl Alcohol 相关的文献（医药）

2024-02-01·New England Journal of Medicine1区 · 医学

Skin Antisepsis before Surgical Fixation of Extremity Fractures

1区 · 医学

Article

作者: Della Rocca, Gregory J ; Van Demark, Robert E ; Wood, Amber ; Pierrie, Sarah N ; Chang, Gerard ; Marchand, Lucas S ; Scott, Alesha N ; Heng, Marilyn ; Donegan, Derek J ; Natoli, Roman M ; Apostle, Kelly L ; Domes, Christopher M ; Carroll, Eben A ; Kuhn, Gabrielle R ; Scolaro, John A ; D'Alleyrand, Jean-Claude G ; Szatkowski, Jan ; Gallant, Jodi L ; Shannon, Steven F ; Kempton, Laurence B ; Hymes, Robert A ; Patterson, Joseph T ; Morellato, John ; Karunakar, Madhav ; Rivera, Jessica C ; Bhandari, Mohit ; Zura, Robert D ; Gitajn, I Leah ; Potter, G David ; Thabane, Lehana ; Tanner, Stephanie L ; Wells, Jeffrey L ; Lin, Carol A ; Sprague, Sheila ; Weaver, Michael J ; von Keudell, Arvind G ; Demyanovich, Haley K ; O'Toole, Robert V ; Slobogean, Gerard ; Bergin, Patrick F ; Devereaux, P J ; Romeo, Nicholas M ; Hebden, Joan N ; Pogorzelski, David ; Gaski, Greg E ; Higgins, Thomas F ; Lee, Christopher ; Halvorson, Jason J ; Mossuto, Franca ; Marmor, Meir T ; Gage, Mark J ; Reilly, Rachel M ; Marvel, Debra ; Joshi, Manjari ; Leonard, Jordan ; Amirhekmat, Arya ; McTague, Michael F ; Alnasser, Ahmad ; Guyatt, Gordon ; Viskontas, Darius ; Jaeblon, Todd ; Schrank, Gregory M ; Bzovsky, Sofia ; O'Hara, Lyndsay M ; Al-Asiri, Jamal ; Palmer, Jana E ; Phelps, Kevin D ; Thomson, Cameron G ; O'Hara, Nathan N ; Jeray, Kyle J ; Mullins, C Daniel ; Beltran, Michael J ; Friedrich, Jeff ; Johal, Herman ; Moon, Charles N ; Heels-Ansdell, Diane ; Fowler, Justin T ; Matityahu, Amir ; Szasz, Olivia P ; Babcock, Sharon ; Pilson, Holly T ; Matson, Christopher A ; Harris, Anthony D ; Mehta, Samir

BACKGROUNDStudies evaluating surgical-site infection have had conflicting results with respect to the use of alcohol solutions containing iodine povacrylex or chlorhexidine gluconate as skin antisepsis before surgery to repair a fractured limb (i.e., an extremity fracture).METHODSIn a cluster-randomized, crossover trial at 25 hospitals in the United States and Canada, we randomly assigned hospitals to use a solution of 0.7% iodine povacrylex in 74% isopropyl alcohol (iodine group) or 2% chlorhexidine gluconate in 70% isopropyl alcohol (chlorhexidine group) as preoperative antisepsis for surgical procedures to repair extremity fractures. Every 2 months, the hospitals alternated interventions. Separate populations of patients with either open or closed fractures were enrolled and included in the analysis. The primary outcome was surgical-site infection, which included superficial incisional infection within 30 days or deep incisional or organ-space infection within 90 days. The secondary outcome was unplanned reoperation for fracture-healing complications.RESULTSA total of 6785 patients with a closed fracture and 1700 patients with an open fracture were included in the trial. In the closed-fracture population, surgical-site infection occurred in 77 patients (2.4%) in the iodine group and in 108 patients (3.3%) in the chlorhexidine group (odds ratio, 0.74; 95% confidence interval [CI], 0.55 to 1.00; P = 0.049). In the open-fracture population, surgical-site infection occurred in 54 patients (6.5%) in the iodine group and in 60 patients (7.3%) in the chlorhexidine group (odd ratio, 0.86; 95% CI, 0.58 to 1.27; P = 0.45). The frequencies of unplanned reoperation, 1-year outcomes, and serious adverse events were similar in the two groups.CONCLUSIONSAmong patients with closed extremity fractures, skin antisepsis with iodine povacrylex in alcohol resulted in fewer surgical-site infections than antisepsis with chlorhexidine gluconate in alcohol. In patients with open fractures, the results were similar in the two groups. (Funded by the Patient-Centered Outcomes Research Institute and the Canadian Institutes of Health Research; PREPARE ClinicalTrials.gov number, NCT03523962.).

2024-02-01·Journal of Neurosurgery: Pediatrics

Shunt infection prevention practices in Hydrocephalus Clinical Research Network–Quality: a new quality improvement network for hydrocephalus management

Article

作者: Smith, Jodi ; Ravindra, Vijay ; Gonda, David ; Wait, Scott ; Souster, Jenny ; Lujan, Aaron ; Bhattacharya, Sudeshna ; Wilbrand, Stephanie ; Kestle, John R. W. ; Alvarez, Aida ; Partington, Michael ; Kim, Irene ; Clawson, Jason ; Venteicher, Emma ; Spader, Heather ; Mahaney, Kelly ; Niazi, Toba ; Walling, Simon ; Hersh, David ; Brown, Jaquelyn ; Oimoen, Maggie ; Endres, McKenzie ; Bock, Jenna ; Botros, James ; Nunn, Nichol ; Romero, Bianca ; Muhonen, Michael ; Bet, Anthony ; Tamber, Mandeep S. ; Martin, Jonathan ; Szego, Sarah ; Omini, Michael ; Cero, Heather ; Castillo, Ashley ; Nguyen, Victoria ; Souweidane, Mark ; Gnenz, Sydney ; Delaney, Erin ; Vestal, Matty ; McNeely, Daniel ; Jensen, Hailey ; Melo, Leslie ; Tailor, Jignesh ; Papadakis, Joanna ; Clerkin, Patricia ; Kyle, Dante ; Dziugan, Klaudia ; Mosher, Amanda ; Lopez, Lina ; Maugans, Todd ; Warf, Benjamin ; Ahmad, Samuel ; Morgenstern, Peter ; Vance, Emily ; Morton, Gabriella ; Gupta, Nalin ; Williamson, Alice ; Beaudoin, Wendy ; _, _ ; Valladrez, Adrian ; Stoltz, Petronella ; Ingram, Katherine ; Kann, Leah ; Madura, Casey ; Bowman, Robin ; Gaiser, Jeremy ; Ritter, Ann ; Whittemore, Brett ; Nader, Amy ; Villamater, Francis ; Shirrell, Mariah ; Ahmed, Raheel ; Elbabaa, Samer ; Olavarria, Greg ; Bollerman, Kari ; Salgado, Amayrani Salvario ; Hamilton, Kimberly ; Westenbroek, Sarah ; Reynolds, Renee ; Martin, Jonathan E. ; Dekeseredy, Patricia ; Benitez-Rosas, Hazani ; Gernsback, Joanna ; Wellons, John C. ; Wiersema, Sarah ; Shears, Danielle ; Lowe, Marissa ; Mehta, Vivek ; Halvorson, Kyle ; Parrimon, Yazandra ; Foy, Andrew ; Gonzales, Allison ; Kobets, Andrew ; Burton, Heather ; Meltzer, Hal ; Elliott, Cameron ; Sandoval-Garcia, Carolina ; Benitez, Jonathan ; Pen, Catalina ; Raskin, Jeffrey ; Perry, Beth ; Weber, Daniel ; Mahuvakar, Shivani ; Northam, Weston ; Porter, Adam ; Heuer, Gregory ; Bristol, Ruth ; Piatt, Joseph

OBJECTIVEKnowledge-based tools used to standardize perioperative care, such as the shunt infection prevention protocol of the Hydrocephalus Clinical Research Network (HCRN), have demonstrated their ability to reduce surgeon-based and center-based variations in outcomes and improve patient care. The mere presence of high-quality evidence, however, does not necessarily translate into improved patient outcomes owing to the implementation gap. To advance understanding of how knowledge-based tools are being utilized in the routine clinical care of children with hydrocephalus, the HCRN-Quality (HCRNq) network was started in 2019. With a focus on CSF shunt infection, the authors present baseline data regarding CSF shunt infection rates and current shunt infection prevention practices in use at HCRNq sites.METHODSBaseline shunt surgery practices, infection rate, and risk factor data were prospectively collected within HCRNq. No standard infection protocol was recommended, but site use of a protocol was implied if at least 3 of 6 common shunt infection prevention practices were used in > 80% of shunt surgical procedures. Univariable and multivariable analyses of shunt infection risk factors were performed.RESULTSThirty sites accrued data on 2437 procedures between November 2019 and June 2021. The unadjusted infection rate across all sites was 3.9% (range 0%–13%) and did not differ among shunt insertion, shunt revision, or shunt insertion after infection. Protocol use was implied for only 15/30 centers and 60% of shunt operations. On univariable analysis, iodine/DuraPrep (OR 0.57, 95% CI 0.37–0.88, p = 0.02) and the use of an antibiotic-impregnated catheter in any segment of the shunt (or both) decreased infection risk (OR 0.53, 95% CI 0.34–0.82, p = 0.01). Iodine-based prep solutions (OR 0.56, 95% 0.36–0.86, p = 0.02) and the use of antibiotic-impregnated catheters (OR 0.52, 95% CI 0.34–0.81, p = 0.01) retained significance in the multivariable model, but no relationship between protocol use and infection risk was demonstrated in this baseline analysis.CONCLUSIONSThe authors have demonstrated that children undergoing CSF shunt surgery at HCRNq sites share similar demographic characteristics with other large North American multicenter cohorts, with similar observed baseline infection rates and risk factors. Many centers have implemented standardized shunt infection prevention practices, but considerable practice variation remains. As such, there is an opportunity to decrease shunt infection rates in these centers through continued standardization of care.

2022-11-16·Canadian Journal of Surgery

Efficacy of surgical skin preparation solutions in hip arthroplasty: a prospective randomized trial

Article

作者: Cullinan, Claude ; Droll, Kurt P ; Puskas, David ; Dubois, Sacha ; Abouassaly, Marcel

BACKGROUNDThe use of an effective antimicrobial preoperative skin preparation solution is essential in preventing infections after surgery, but the findings in the literature regarding efficacy are not necessarily applicable to surgery involving the hip. The purpose of the present study was twofold: 1) to examine the native bacteria on the skin at the hip and 2) to determine the efficacy of 2 surgical skin preparation solutions at eliminating bacteria from the hip site in patients undergoing total hip arthroplasty.METHODSWe conducted a prospective randomized controlled trial in consecutive adult patients who underwent primary total hip arthroplasty at a single institution from October 2014 to December 2015. Each patient was randomly allocated to be treated with 1 of 2 commonly used surgical skin preparation solutions: ChloraPrep (2% chlorhexidine gluconate and 70% isopropyl alcohol) or DuraPrep (0.7% iodophor and 74% isopropyl alcohol). Aerobic and anaerobic samples were obtained for culture before skin preparation, immediately after skin preparation and after skin closure.RESULTSFull data were obtained for 105 patients: 54 in the ChloraPrep group and 51 in the DuraPrep group. Staphylococcus epidermidis, Corynebacterium and Micrococcus luteus were the organisms most commonly isolated from the hip before skin preparation. Positive bacterial culture results were obtained in 50 patients (93%) in the ChloraPrep group and 48 patients (94%) in the DuraPrep group. Immediately after skin preparation, the overall proportion of positive culture results was significantly lower in the DuraPrep group than the ChloraPrep group (14% v. 35%, adjusted relative risk 0.40, 95% confidence interval 0.18-0.85). After wound closure, there was no significant difference in the rate of positive culture results between the 2 groups.CONCLUSIONDuraPrep was more effective than ChloraPrep at eliminating skin flora at the hip initially on application, but the 2 solutions were equally effective at the time of closure. Further study with larger samples is required to identify any influence of skin preparation solution on the incidence of prosthetic joint infection.

100 项与 Iodine Povacrylex/Isopropyl Alcohol 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	D08AX	DB09537

研发状态

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消毒剂	美国	3M Health Care, Inc.	2006-09-29

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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


NCT03523962 (PREPARE, Pubmed \| Br Dent J \| N Engl J Med) 人工标引	临床4期	骨折	8,485	2% chiodine povacrylex/Isopropyl Alcoholpyl alcohol	構蓋窪鑰觸顧網繭衊醖(觸鑰廠顧艱鑰糧艱壓糧) = 獵築範艱選齋鏇願衊膚醖簾選鑰鑰遞衊獵鑰夢 (網鹽糧蓋獵壓繭淵餘憲 )	积极	2024-02-01
				2% chlorhexidine gluconate/Isopropyl Alcohol (patients with a closed fracture)	構蓋窪鑰觸顧網繭衊醖(觸鑰廠顧艱鑰糧艱壓糧) = 餘醖齋艱範鑰築醖壓選醖簾選鑰鑰遞衊獵鑰夢 (網鹽糧蓋獵壓繭淵餘憲 )
NCT01290978 (CTgov)	临床4期	-	22	ChloraPrep (ChloraPrep)	顧鹹夢築淵鬱憲夢鬱廠(窪遞遞網醖願餘鑰膚繭) = 醖夢餘繭憲齋廠夢膚選夢衊襯鑰遞積壓壓獵淵 (夢積範鏇願憲範願積蓋, 鏇範廠繭遞餘餘衊顧構 ~ 蓋簾憲窪網鑰鹹艱範鑰) 更多	-	2013-03-05
				DuraPrep (DuraPrep)	顧鹹夢築淵鬱憲夢鬱廠(窪遞遞網醖願餘鑰膚繭) = 鬱鹹齋構夢選網積構構夢衊襯鑰遞積壓壓獵淵 (夢積範鏇願憲範願積蓋, 夢積餘鹽窪淵積壓構顧 ~ 壓築憲壓廠淵網糧壓願) 更多