NCT01171079

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2010

Completed
Last Updated

July 28, 2010

Status Verified

July 1, 2010

First QC Date

July 26, 2010

Last Update Submit

July 27, 2010

Conditions

Keywords

postoperative adhesion after thyroidectomy

Study Arms (1)

Interceed

EXPERIMENTAL
Device: application of oxidized regenerated cellulose

Interventions

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • operable thyroid neoplasm

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University College of Medicine

Seoul, 110-744, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 15475802BACKGROUND
  • 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.

    PMID: 17161874BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 26, 2010

First Posted

July 28, 2010

Last Updated

July 28, 2010

Record last verified: 2010-07

Locations