Preoperative CHG Cloth (2)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02291601 |
Recruitment Status :
Completed
First Posted : November 14, 2014
Last Update Posted : December 8, 2015
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Sponsor:
Medline Industries
Information provided by (Responsible Party):
Medline Industries
Tracking Information | ||||
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First Submitted Date ICMJE | November 11, 2014 | |||
First Posted Date ICMJE | November 14, 2014 | |||
Last Update Posted Date | December 8, 2015 | |||
Study Start Date ICMJE | October 2014 | |||
Actual Primary Completion Date | September 2015 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Count the number of bacteria on skin [ Time Frame: 10 minutes to 8 hours ] Bacteria on the skin will be evaluated at time 0, 10 minutes, 6 hours and 8 hours after treatment.
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
Assess the side effects on the skin [ Time Frame: 10 min to 8 hours ] Treated skin will be assessed for any irritation.
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Preoperative CHG Cloth (2) | |||
Official Title ICMJE | Assessment of the Antimicrobial Efficacy of 2% CHG Cloth Preoperative Skin Preparation | |||
Brief Summary | Demonstrate the reduction of bacteria on the skin. | |||
Detailed Description | Examine the antimicrobial cloth effects on bacteria of the abdomen and groin area. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Prevention |
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Condition ICMJE | Surgical Skin Preparation | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
879 | |||
Original Estimated Enrollment ICMJE |
375 | |||
Actual Study Completion Date ICMJE | September 2015 | |||
Actual Primary Completion Date | September 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 16 Years and older (Child, Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02291601 | |||
Other Study ID Numbers ICMJE | R13-052 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Medline Industries | |||
Study Sponsor ICMJE | Medline Industries | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Medline Industries | |||
Verification Date | December 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |