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.

Start Date05 Apr 2019

Sponsor / Collaborator

Universidad del Salvador

NCT03523962 / CompletedPhase 4IIT

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.

Start Date21 Aug 2018

Sponsor / Collaborator

University of Maryland Baltimore

[+2]

NCT03393819 / CompletedNot Applicable

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.

Start Date29 Oct 2014

Sponsor / Collaborator

University of Lakehead

[+1]

100 Clinical Results associated with Iodine Povacrylex/Isopropyl Alcohol

100 Translational Medicine associated with Iodine Povacrylex/Isopropyl Alcohol

100 Patents (Medical) associated with Iodine Povacrylex/Isopropyl Alcohol

Literatures (Medical) associated with Iodine Povacrylex/Isopropyl Alcohol

01 Jul 2024·American Journal of Veterinary Research

Saline, chlorhexidine, and povidone-iodine alone or in combination with iodine povacrylex are effective antiseptics in chickens (Gallus gallus domesticus)

Article

Author: Robertson, Jessica ; Kanda, Ian ; Di Girolamo, Nicola ; Ramachandran, Akhilesh ; Brandão, João ; Dugat, Danielle ; Doden, Greta

AbstractOBJECTIVETo evaluate the topical antiseptic activity of saline, chlorhexidine (CHX), and povidone-iodine (PI) scrubs on the skin of chickens with or without the addition of DuraPrep (DP).ANIMALS7 healthy adult Orpington hens (Gallus gallus domesticus).METHODSThe right apterium corporale laterale was swabbed for standard aerobic bacterial culture and colony-forming unit (CFU) determination. The apterium was divided into 3 areas and treated with sterile saline, CHX, or PI. Samples were collected by swabbing each area before and after additional treatment with DP. CFU's were counted after 48 hours of incubation. Statistical analysis was performed using a linear mixed model with a continuous outcome.RESULTSCompared to saline, CHX and PI treatment without DP decreased CFU count by 119 (95% CI, 55 to 183; P < .001) and 123 (95% CI, 58 to 187; P < .001), respectively. The application of DP after CHX and PI further decreased CFU counts by 6 (P = .01) and 9 (P = .01), respectively. DP after saline treatment decreased counts by 128 CFU (95% CI, 63 to 192; P < .001). No significant difference was detected between saline, PI, or CHX after DP application (−1.0 CFU; 95% CI, 63.4 to –65.4; P = .98 for both PI and CHX).CLINICAL RELEVANCECHX or PI provided greater reductions in bacterial CFU than saline, and all combinations with DP provided similar results. No notable cutaneous reactions were detected at any point. This data suggests that a scrub protocol including CHX or PI with DP is acceptable in surgical site preparation of chickens.

01 Feb 2024·New England Journal of MedicineQ1 · MEDICINE

Skin Antisepsis before Surgical Fixation of Extremity Fractures

Q1 · MEDICINE

Article

Author: Della Rocca, Gregory J ; Van Demark, Robert E ; Wood, Amber ; Pierrie, Sarah N ; Marchand, Lucas S ; Chang, Gerard ; 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 ; Szatkowski, Jan ; D'Alleyrand, Jean-Claude G ; Gallant, Jodi L ; Shannon, Steven F ; Kempton, Laurence B ; Hymes, Robert A ; Patterson, Joseph T ; Rivera, Jessica C ; Karunakar, Madhav ; Morellato, John ; Potter, G David ; Zura, Robert D ; Bhandari, Mohit ; Gitajn, I Leah ; Wells, Jeffrey L ; Tanner, Stephanie L ; Lin, Carol A ; Thabane, Lehana ; Sprague, Sheila ; Weaver, Michael J ; Demyanovich, Haley K ; von Keudell, Arvind G ; O'Toole, Robert V ; Slobogean, Gerard ; Bergin, Patrick F ; Devereaux, P J ; Romeo, Nicholas M ; Hebden, Joan N ; Gaski, Greg E ; Pogorzelski, David ; Higgins, Thomas F ; Lee, Christopher ; Halvorson, Jason J ; Mossuto, Franca ; Marmor, Meir T ; Gage, Mark J ; Reilly, Rachel M ; Marvel, Debra ; Joshi, Manjari ; Amirhekmat, Arya ; Leonard, Jordan ; 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 ; Beltran, Michael J ; Mullins, C Daniel ; Friedrich, Jeff ; Moon, Charles N ; Johal, Herman ; Heels-Ansdell, Diane ; Fowler, Justin T ; Matityahu, Amir ; Szasz, Olivia P ; Pilson, Holly T ; Babcock, Sharon ; 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.).

01 Nov 2023·Journal of Neurosurgery: Pediatrics

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

Article

Author: 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 ; Mahaney, Kelly ; Spader, Heather ; Venteicher, Emma ; Oimoen, Maggie ; Walling, Simon ; Endres, McKenzie ; Hersh, David ; Brown, Jaquelyn ; Niazi, Toba ; Bock, Jenna ; Botros, James ; Nunn, Nichol ; Romero, Bianca ; Muhonen, Michael ; Bet, Anthony ; Martin, Jonathan ; Tamber, Mandeep S. ; Szego, Sarah ; Omini, Michael ; Castillo, Ashley ; Cero, Heather ; 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 ; Warf, Benjamin ; Lopez, Lina ; Maugans, Todd ; Ahmad, Samuel ; Morgenstern, Peter ; Vance, Emily ; Morton, Gabriella ; Gupta, Nalin ; Williamson, Alice ; Beaudoin, Wendy ; _, _ ; Stoltz, Petronella ; Valladrez, Adrian ; Kann, Leah ; Ingram, Katherine ; Madura, Casey ; Bowman, Robin ; Gaiser, Jeremy ; Ritter, Ann ; Nader, Amy ; Whittemore, Brett ; 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 ; Gernsback, Joanna ; Benitez-Rosas, Hazani ; Wellons, John C. ; Wiersema, Sarah ; Shears, Danielle ; Lowe, Marissa ; Mehta, Vivek ; Halvorson, Kyle ; Parrimon, Yazandra ; Foy, Andrew ; Gonzales, Allison ; Kobets, Andrew ; Burton, Heather ; Elliott, Cameron ; Benitez, Jonathan ; Meltzer, Hal ; Sandoval-Garcia, Carolina ; Raskin, Jeffrey ; Pen, Catalina ; 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.

100 Deals associated with Iodine Povacrylex/Isopropyl Alcohol

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Indication	Country/Location	Organization	Date
Disinfectants	US	3M Health Care, Inc.	29 Sep 2006

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03523962 (PREPARE, Pubmed \| Br Dent J) Manual	Phase 4	Fractures, Bone	8,485	0.7% iodine povacrylex/Isopropyl Alcohol (patients with a closed fracture)	dmtiiseysn(bkqhcojxob) = iklrtkuurb cqvrffnmcp (ehueqpylxw )	Positive	01 Feb 2024
				2% chlorhexidine gluconate/Isopropyl Alcohol (patients with a closed fracture)	dmtiiseysn(bkqhcojxob) = cotlndpigm cqvrffnmcp (ehueqpylxw )
NCT01290978 (CTgov)	Phase 4	-	22	ChloraPrep (ChloraPrep)	gnofctzjzt(ppnwqucamo) = tksjdqgdjj qcpvhlcivq (xobxtpcqbf, htovhyoirj - hfmrvfidaa) View more	-	05 Mar 2013
				DuraPrep (DuraPrep)	gnofctzjzt(ppnwqucamo) = cdwacxjvmu qcpvhlcivq (xobxtpcqbf, xksoqzleib - bbhupetcsu) View more

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