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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: |
NCT02560155 |
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Date of registration:
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16/09/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Preoperative Decolonization and Surgical Site Infections - a Prospective Randomized Trial
DECO-SSI |
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Scientific title:
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Preoperative Decolonization and Surgical Site Infections - a Prospective Randomized Trial (DECO-SSI Trial) |
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Date of first enrolment:
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November 2015 |
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Target sample size:
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1300 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02560155 |
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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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N/A
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Jan Brügger, Dr. med. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Lindenhofgruppe AG |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- patient older than 16 years
- patient undergoing elective orthopedic procedure at the Sonnenhof hospital
- decolozination protocol can be performed timely
- signed informed consent
Exclusion Criteria:
- no orthopedic surgery planned
- allergy to mupirocin or chlorhexidine
- presence of a nasal foreign body
- no informed consent
- pregnancy
- decolozination protocol can't be followed timely
- patients undergoing treatment/surgery for a documented infection
Age minimum:
16 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Surgical Site Infection
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Orthopedic Disorders
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Intervention(s)
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Drug: Chlorhexidine sol 4%
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Drug: Mupirocin 2% nasal ointement
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Primary Outcome(s)
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Overall number of participants with surgical site infections 3 months postoperatively
[Time Frame: 3 months]
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Secondary Outcome(s)
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Number of participants with surgical site infections at 1 and 3 months postoperatively
[Time Frame: 1 and 3 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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