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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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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN65289389 |
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Date of registration:
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09/12/2002 |
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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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Cracked nipples colonized with Staphylococcus aureus: a randomised treatment trial
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Scientific title:
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Date of first enrolment:
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01/11/2001 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN65289389 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Treatment)
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Phase:
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Countries of recruitment
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Australia
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Contacts
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Name:
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Judith
Lumley |
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Address:
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Director
Centre for the Study of Mothers' and Children's Health
La Trobe University
251 Faraday Street
VIC 3053
Carlton
Australia |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Breastfeeding women with at least one damaged nipple
2. English-speaking
3. Live in Melbourne
4. Not allergic to penicillin
Exclusion criteria: Not provided at time of registration.
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Mastitis (prevention of) in lactating women
Pregnancy and Childbirth
Mastitis
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Intervention(s)
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Women with nipple swab positive for Staphylococcus aureus are randomised to receive a seven-day course of:
1. Flucloxacillin 500 mg qid, or
2. Identical placebo capsules
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Primary Outcome(s)
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Incidence of mastitis in each group in the week following recruitment.
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Secondary Outcome(s)
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Nipple healing, nipple pain.
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Secondary ID(s)
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Research Ethics Number (La Trobe University): 00/124
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Source(s) of Monetary Support
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Medical Research Foundation for Women and Babies, Melbourne (Australia), Australian National Health and Medical Research Council Public Health scholarship (Australia), Postgraduate grant, Faculty of Health Sciences, La Trobe University (Australia), Antibiotics provided by CSL Ltd
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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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