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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02526667 |
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Date of registration:
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16/08/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Preoperative Chlorhexidine Gluconate (CHG) Cloth on Healthy Volunteers
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Scientific title:
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Assessment of the Antimicrobial Efficacy of 2% CHG Cloth Preoperative Skin Preparation |
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Date of first enrolment:
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August 2015 |
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Target sample size:
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340 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02526667 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Romania
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Contacts
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Name:
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R Olsavcszky, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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S.C. BIO HIGH TECH S.R.L. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Males or Females
- 18 years of age or older
- Signed informed consent
- Good Health
- Six inches of abdomen and groin areas without tattoos, or skin disorders
Exclusion Criteria:
- Dermatological Conditions
- Sensitivity to latex
- Sensitivity to CHG
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Surgery
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Intervention(s)
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Drug: DynaHex-2
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Other: Vehicle
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Drug: Chlorhexidine gluconate
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Primary Outcome(s)
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Responder Rates (%) of Sites Identified for Bacterial Reduction on the Abdomen and Groin
[Time Frame: 10 minutes, 6 hours, 8 hours]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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