- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01171079
Use of an Oxidized Regenerated Cellulose After Thyroid Surgery: A Prospective, Randomized Study (ORC)
July 27, 2010 updated by: Seoul National University Hospital
The purpose of this study is to evaluate the effects and safety of oxidized, regenerated cellulose as an absorbable adhesion barrier after thyroidectomy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of, 110-744
- Seoul National University College of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Interceed
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.1097/00005537-200409000-00031.
- 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. doi: 10.1016/j.ijporl.2006.11.010. Epub 2006 Dec 11.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 7, 2022
Primary Completion
December 7, 2022
Study Completion
December 7, 2022
Study Registration Dates
First Submitted
July 26, 2010
First Submitted That Met QC Criteria
July 27, 2010
First Posted (Estimate)
July 28, 2010
Study Record Updates
Last Update Posted (Estimate)
July 28, 2010
Last Update Submitted That Met QC Criteria
July 27, 2010
Last Verified
July 1, 2010
More Information
Terms related to this study
Other Study ID Numbers
- ORC-100
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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NYU Langone HealthCompleted
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Clinical Trials on application of oxidized regenerated cellulose
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Grifols Biologicals, LLCInstituto Grifols, S.A.CompletedSoft Tissue Surgical BleedingUnited States, Hungary, Serbia
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Ethicon, Inc.CompletedHemorrhage | Soft Tissue Bleeding | Hepatic Parenchyma BleedingUnited Kingdom, Belgium
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Ethicon, Inc.OMRIX BiopharmaceuticalsCompletedBlood Loss, SurgicalUnited States
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Ethicon, Inc.CompletedHemorrhage | Soft Tissue BleedingBelgium, Canada, United Kingdom
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National Taiwan University HospitalRecruitingGoiter | Thyroid Cancer | ThyroidectomyTaiwan
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October 6 UniversityCompleted