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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT01155154 |
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Date of registration:
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29/06/2010 |
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Primary sponsor: |
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Public title:
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Antibiotic Prophylaxis for Simple Hand Lacerations
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Scientific title:
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Antibiotic Prophylaxis for Prevention of Infection in Emergency Department Patients With Simple Hand Lacerations |
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Date of first enrolment:
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February 2010 |
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Target sample size:
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300 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01155154 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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shahriar zehtabchi, MD |
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Address:
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Telephone:
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718-245-2973 |
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Email:
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shahriar.zehtabchi@downstate.edu |
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Affiliation:
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Name:
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shahriar zehtabchi, 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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State University of New York - Downstate Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All adult patients (= 18 years of age) presenting to the ED with simple hand
lacerations. Anatomically, lacerations distal to the radial carpal ligament will be
considered "hand" lacerations. "Simple" or "uncomplicated" laceration refers to one
that does not involve any special tissue (bone, tendon, blood vessel, or nerve).
Exclusion Criteria:
- Immunocompromised patients (cancer, chemotherapy, transplant, HIV/AIDs)
- Current or recent (within two weeks) use of any antibiotics
- Allergy to clindamycin or cephalexin
- Bites (e.g. dog, cat, or human)
- Lacerations resulted from crush injury
- Lacerations involving bone, tendon, blood vessel, or nerve
- Lacerations inflicted more than 12 hours prior to ED visit
- Pregnant or breast-feeding women
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Simple Hand Lacerations
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Intervention(s)
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Drug: cephalexin
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Drug: clindamycin
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Drug: placebo
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Primary Outcome(s)
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Wound Infection
[Time Frame: 2 weeks]
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Secondary Outcome(s)
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Risk of side effects from antibiotics
[Time Frame: 2 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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