Thyroid Dysfunction in Head and Neck Surgery Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00592514
First received: December 27, 2007
Last updated: August 31, 2011
Last verified: August 2011

December 27, 2007
August 31, 2011
July 2005
July 2008   (final data collection date for primary outcome measure)
Thyroid dysfunction in head and neck surgery patients [ Time Frame: Baseline serum and 24-hour urine iodine levels will be measured preoperatively. Serum iodine levels will be drawn at 10 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours and 1 week after exposure. ] [ Designated as safety issue: No ]
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.
Not Provided
Complete list of historical versions of study NCT00592514 on ClinicalTrials.gov Archive Site
Thyroid dysfunction in head and neck surgery patients [ Time Frame: Thyroid function will be assessed by measuring serum levels of free thyroxine, free triiodothyronine, and thyroid stimulating hormone also at 10 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours and 1 week after exposure. ] [ Designated as safety issue: No ]
Specific Aim II: Measurement of iodine induced changes in thyroid function.
Not Provided
Not Provided
Not Provided
 
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

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Serum

Non-Probability Sample

Primary Care Clinic

Thyroid Dysfunction
Not Provided
Not Provided
1. Betadine Solution [product label]. The Purdue Frederick Company. Stamford, CT. 2. Cannon, C. R. Hypothyroidism in head and neck cancer patients: experimental and clinical observations. Laryngoscope. 104(11 Pt 2 Suppl 66):1-21, 1994 Nov. 3. Ferguson, M., Geddes, D., Wray, D. The effect of a povidone-iodine mouthwash upon thyroid function and plaque accumulation. British Dental Journal. 144, 14, 1978. 4. Fradkin, J. E. and Wolff, J. Iodide-Induced Thyrotoxicosis. Medicine, 62, 1-20, 1983. 5. Guyétant, S., et al. Hyperthyroidism induced by amiodarone and hyperthyroidism induced by iodine. Histologic, immunohistochemical and ultrastructural aspects. Annales de Pathologie. 15(6):431-7, 1995.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
July 2008
July 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients undergoing any head and neck surgery requiring entry into the upper aerodigestive tract and thus necessitating the oral administration of the antimicrobial agent povidone-iodine 10%.

Exclusion Criteria:

  • Patients with history of hypothyroidism currently taking thyroid hormone medications (i.e. Synthroid, Levothyroxine, Thyroxine) and women who are pregnant.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00592514
45976
No
University of Arkansas
University of Arkansas
Not Provided
Principal Investigator: James Suen, MD University of Arkansas
University of Arkansas
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP