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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: |
NCT01756534 |
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Date of registration:
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19/12/2012 |
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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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Oxidized Cellulose Hemostatic Agent in Thyroid Surgery: a Prospective Randomized Controlled Study
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Scientific title:
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The Effectiveness of an Oxidized Cellulose Patch Hemostatic Agent in Thyroid Surgery: a Prospective Randomized Controlled Study |
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Date of first enrolment:
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January 2011 |
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Target sample size:
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100 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01756534 |
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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, Masking: Double Blind (Subject, Investigator), 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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Israel
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Contacts
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Name:
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ZIV GIL, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Tel-Aviv Sourasky Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All patients who required a thyroidectomy
Exclusion Criteria:
- Unwilling or unable to consent
- Age < 18 years
- known allergy to oxidized cellulose
- Inability to discontinue use of anticoagulants 10 days before surgery
- Coagulopathy that could not be corrected
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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Thyroid Nodule
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Goiter
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Thyroid Diseases
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Intervention(s)
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Device: SURGICEL
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Primary Outcome(s)
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The primary endpoint of the study was the postoperative volume of wound drainage
[Time Frame: 1 WEEK]
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Secondary Outcome(s)
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duration of drain use
[Time Frame: 1 WEEK]
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The secondary endpoints were events of bleeding requiring wound exploration under anesthesia
[Time Frame: 48 HOURS]
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Secondary ID(s)
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TASMC-ZG-AA-0633-CTIL
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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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