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Generated: December 10, 2018

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CLINICAL TRIALS PROFILE FOR CHLORAPREP ONE-STEP

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Clinical Trials for Chloraprep One-step

Trial ID Title Status Sponsor Phase Summary
NCT00290290 Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections Completed Medical College of Wisconsin Phase 3 Most cases of infection of clean-contaminated wounds (wounds without gross spillage of organisms from the gastrointestinal tract) are thought to originate from the skin. Therefore, it is conceivable that application of an optimal antiseptic agent can reduce the rate of surgical wound infections. This trial is to compare the impact of disinfecting the skin with Chloraprep (2%chlorhexidine and 70% isopropyl alcohol) vs. Betadine on the rates of infection of clean-contaminated surgical wounds. The study will also assess the occurrence of adverse effects on the skin from either antiseptic agent and the cost-savings associated with the use of Chloraprep vs Betadine.
NCT00290290 Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections Completed Michael Debakey Veterans Affairs Medical Center Phase 3 Most cases of infection of clean-contaminated wounds (wounds without gross spillage of organisms from the gastrointestinal tract) are thought to originate from the skin. Therefore, it is conceivable that application of an optimal antiseptic agent can reduce the rate of surgical wound infections. This trial is to compare the impact of disinfecting the skin with Chloraprep (2%chlorhexidine and 70% isopropyl alcohol) vs. Betadine on the rates of infection of clean-contaminated surgical wounds. The study will also assess the occurrence of adverse effects on the skin from either antiseptic agent and the cost-savings associated with the use of Chloraprep vs Betadine.
NCT00290290 Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections Completed VA Office of Research and Development Phase 3 Most cases of infection of clean-contaminated wounds (wounds without gross spillage of organisms from the gastrointestinal tract) are thought to originate from the skin. Therefore, it is conceivable that application of an optimal antiseptic agent can reduce the rate of surgical wound infections. This trial is to compare the impact of disinfecting the skin with Chloraprep (2%chlorhexidine and 70% isopropyl alcohol) vs. Betadine on the rates of infection of clean-contaminated surgical wounds. The study will also assess the occurrence of adverse effects on the skin from either antiseptic agent and the cost-savings associated with the use of Chloraprep vs Betadine.
NCT00290290 Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections Completed Baylor College of Medicine Phase 3 Most cases of infection of clean-contaminated wounds (wounds without gross spillage of organisms from the gastrointestinal tract) are thought to originate from the skin. Therefore, it is conceivable that application of an optimal antiseptic agent can reduce the rate of surgical wound infections. This trial is to compare the impact of disinfecting the skin with Chloraprep (2%chlorhexidine and 70% isopropyl alcohol) vs. Betadine on the rates of infection of clean-contaminated surgical wounds. The study will also assess the occurrence of adverse effects on the skin from either antiseptic agent and the cost-savings associated with the use of Chloraprep vs Betadine.
NCT00739583 Visibility of Site Marking for Surgical Time Out With Two Different Skin Preparation Solutions Completed Johns Hopkins University Phase 4 Skin preparation solutions are used to clean the skin of the patient before surgery to decrease the rate of infection. This is particularly important for hip replacement to reduce the risk of prosthetic joint infection. The use of a mark on the skin for site identification has become the standard of care to decrease wrong site surgery. The Joint Commission has mandated site identification as part of the surgical "time-out". This procedure is also mandated by hospital policy. Preliminary work on cadaveric skin shows that the type of skin preparation can erase the mark used for surgical site identification. Erasure of the mark presents the surgeon with difficulty in performing the site identification. Any error or lack of visualization of the site marking could lead to catastrophic wrong site surgery. The investigators hypothesis is that chlorhexidine based skin preparation solutions erase site marking in comparison to iodine based skin preparation solutions. The investigators intend to prospectively study twenty patients undergoing total hip arthroplasty. Patients will be randomized to either a chlorhexidine based or an iodine based skin preparation solution. These solutions are both the current gold standard of clinical care. No differences have been shown in infection rates for total hip arthroplasty between these solutions. The site marking will be performed by the same surgeon in a standardized manner. The site marking will include the surgeon's three initials as per usual routine. Underneath the initials three random initials will be placed with a horizontal line drawn underneath. The preparation of the skin will be performed according to the manufacturer's specifications. Digital photographs will be taken of the skin marking after skin preparation. Photographs of the three random initials will be de-identified and placed in a "Powerpoint" presentation form. Ten orthopaedic surgeons will then read the site markings to identify the random initials and to tell whether the mark looks appropriate to perform a surgical timeout. The horizontal line will be digitally analyzed using Adobe Photoshop to quantitatively measure blackness of the mark.
NCT00799812 Test for Preoperative Skin Preparations Completed CareFusion Phase 1/Phase 2 Compare 2 application techniques of ChloraPrep Swabstick--3 swabsticks at once versus 3 swabsticks used one-at-a-time. Hibiclens applied according to the manufacturer's directions. Sterile swabsticks (wetted with sterile water) applied using the same method as the ChloraPrep Swabstick.
NCT00896402 Chlorhexidine Versus Betadine in Preventing Colonization of Femoral Nerve Catheters After Total Joint Arthroplasty (TJA) Withdrawn Northwell Health N/A Continuous femoral nerve block (CFNB) techniques continue to be increasingly used in the management of postoperative pain after total knee arthroplasty. Although the risk of full blown infection with CFNB has been poorly defined, the rate of catheter colonization after antisepsis with povidone-iodine has been demonstrated to be high (Cuivillion et al. showed the rate of colonization to be 57% after 48 hours). Recently, several anecdotal case reports have demonstrated severe infectious complications including psoas abscess and necrotizing fasciitis associated with continuous nerve block techniques. As the use of CFNB techniques increase in popularity, infectious complications will undoubtedly become more common. The American Society of Regional Anesthesia and Pain Medicine recommends the routine use of antiseptic solutions with an alcohol base for skin disinfection before peripheral regional techniques due to their penetration of the stratum corneum and their rapid and prolonged effect. Chlorhexidine(chloraprep) has been proven to be better than povidone iodine solution for skin preparation before epidural catheter and intravascular device insertion (Kinirons et al., Ostrander et al., Mimoz et al.,). The goal of this prospective trial therefore is to determine if an alcoholic solution of 0.5% chlorhexidine is more effective than an aqueous solution of 10% povidone-iodine in reducing catheter colonization and reducing skin flora associated with short term ( 48 hours) postoperative continuous femoral nerve catheter placement. The investigators will also compare the ability of chloraprep and betadine disinfection at the time of catheter placement to prevent bacterial contamination of the continuous femoral catheter.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Chloraprep One-step

Condition Name

Condition Name for Chloraprep One-step
Intervention Trials
Surgical Site Infection 8
Surgical Skin Preparation 2
Infection 2
Antimicrobial Effectiveness 2
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Condition MeSH

Condition MeSH for Chloraprep One-step
Intervention Trials
Surgical Wound Infection 9
Infection 4
Communicable Diseases 4
Bacteremia 2
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Clinical Trial Locations for Chloraprep One-step

Trials by Country

Trials by Country for Chloraprep One-step
Location Trials
United States 26
Canada 2
Italy 1
Thailand 1
United Kingdom 1
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Trials by US State

Trials by US State for Chloraprep One-step
Location Trials
Virginia 7
Montana 5
Maryland 2
Massachusetts 2
Pennsylvania 2
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Clinical Trial Progress for Chloraprep One-step

Clinical Trial Phase

Clinical Trial Phase for Chloraprep One-step
Clinical Trial Phase Trials
Phase 4 11
Phase 3 8
Phase 2 4
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Clinical Trial Status

Clinical Trial Status for Chloraprep One-step
Clinical Trial Phase Trials
Completed 15
Recruiting 7
Terminated 2
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Clinical Trial Sponsors for Chloraprep One-step

Sponsor Name

Sponsor Name for Chloraprep One-step
Sponsor Trials
Zurex Pharma, Inc. 7
3M 4
CareFusion 3
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Sponsor Type

Sponsor Type for Chloraprep One-step
Sponsor Trials
Other 18
Industry 17
U.S. Fed 2
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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKesson
Daiichi Sankyo
AstraZeneca
QuintilesIMS
Accenture
McKinsey
Teva
Chubb

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