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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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19 February 2015 |
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Main ID: |
NCT01542346 |
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Date of registration:
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25/02/2012 |
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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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Subcutaneous Adaption and Cosmetic Outcome Following Caesarean Delivery
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Scientific title:
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Date of first enrolment:
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March 2012 |
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Target sample size:
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116 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01542346 |
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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, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Austria
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Contacts
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Name:
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Heinrich Husslein, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Klinikum Klagenfurt am Woerthersee and Medical University Vienna |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- women undergoing cesarean section for any indication
- literate in german language
Exclusion Criteria:
- history of keloids
- previous transversal suprapubic scars
- known patient hypersensitivity to any of the suture materials used in the protocol
- a medical disorder that could affect wound healing (eg, diabetes mellitus, chronic
corticosteroid use)
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Caesarean Delivery
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Intervention(s)
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Procedure: subcutaneous adaption
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Primary Outcome(s)
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Objective and subjective cosmetic appearance
[Time Frame: after 6 months]
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Secondary Outcome(s)
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Haematoma
[Time Frame: within 5 days after surgery]
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Surgical site infection and wound breakdown
[Time Frame: within 30 days after surgery]
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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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