Clinical Trials Directory

Trials / Completed

CompletedNCT00592514

Thyroid Dysfunction in Head and Neck Surgery Patients

Thyroid Dysfunction in Head and Neck Surgery Patients Treated With Intraoperative Oral Administration With Povidone-iodine 10% Solution

Status
Completed
Phase
Study type
Observational
Enrollment
14 (actual)
Sponsor
University of Arkansas · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Specific Aim I: Determine absorption of iodine after oropharyngeal application of povidone-iodine 10% solution when used in head and neck surgery involving the upper aero-digestive tract. Specific Aim II: Measurement of iodine induced changes in thyroid function.

Detailed description

Serial blood draws will be obtained from approximately 10 men and women age 18 and over who have been exposed to intraoperative oropharyngeal application with povidone-iodine 10%. Baseline serum and 24-hour urine iodine levels will be measured preoperatively. Serum iodine levels will be drawn at 1 hour, 2 hours, 4 hours, 6 hours, 24 hours, 1 week, and 1 month after exposure. A postoperative 24-hour urine iodine level will also be obtained. With the above measurements, the amount of iodine absorption as well as the time period of peak absorption and duration of elevated iodine levels will be elucidated. Thyroid hormone metabolism is highly dependent on serum levels of iodine. Thyroid function will be assessed by measuring serum levels of free thyroxine, free triiodothyronine, and thyroid stimulating hormone also at 1 hour, 2 hours, 4 hours, 6 hours, 24 hours, 1 week, and 1 month after exposure. Measuring thyroid function is important since hypothyroidism has been known to have a major impact on postoperative wound healing.

Conditions

Timeline

Start date
2005-07-01
Primary completion
2008-07-01
Completion
2008-07-01
First posted
2008-01-14
Last updated
2011-09-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00592514. Inclusion in this directory is not an endorsement.