Use of an Oxidized Regenerated Cellulose After Thyroid Surgery: A Prospective, Randomized Study (ORC)

This study has been completed.

Sponsor:

Information provided by:

Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT01171079

First received: July 26, 2010

Last updated: July 27, 2010

Last verified: July 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	July 26, 2010
Last Updated Date	July 27, 2010
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01171079 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Use of an Oxidized Regenerated Cellulose After Thyroid Surgery: A Prospective, Randomized Study
Official Title ^ICMJE	Use of an Oxidized Regenerated Cellulose After Thyroid Surgery: A Prospective, Randomized Study
Brief Summary	The purpose of this study is to evaluate the effects and safety of oxidized, regenerated cellulose as an absorbable adhesion barrier after thyroidectomy.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Not Provided
Condition ^ICMJE	Thyroidectomy
Intervention ^ICMJE	Device: application of oxidized regenerated cellulose
Study Arm (s)	Experimental: Interceed Intervention: Device: application of oxidized regenerated cellulose
Publications *	Yigit O, Uslu Coskun B, Coskun H, Yilmaz B, Alkan S, Cinar U, Dadas B. Efficacy of anti-adhesive barriers in secondary thyroidectomy: an experimental study. Laryngoscope. 2004 Sep;114(9):1668-73. Yilmaz O, Genc A, Taneli F, Demireli P, Deliaga H, Taneli C. Assessment of the efficacy of absorbable adhesion barriers on dissection in esophagus operations. Int J Pediatr Otorhinolaryngol. 2007 Mar;71(3):409-14. Epub 2006 Dec 11.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: operable thyroid neoplasm Exclusion Criteria: a history of previous neck surgeries or uncontrolled medical diseases such as hyperthyroidism, diabetes, and hypertension administration of non-steroidal anti-inflammatory drugs (NSAIDs) or anti-platelet agents within 1 week before surgery
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	Not Provided
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01171079
Other Study ID Numbers ^ICMJE	ORC-100
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Seoul National University Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Seoul National University Hospital
Verification Date	July 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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