Influence of Thyroid Hormones on the Woundhealing Process

Tracking Information
First Submitted Date ICMJE	June 26, 2009
First Posted Date ICMJE	June 29, 2009
Last Update Posted Date	June 29, 2009
Study Start Date ICMJE	June 2009
Estimated Primary Completion Date	December 2009 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: June 26, 2009)	Evidence for different cytokine levels in euthyroid vs hypothyroid condition confirmed by bood serum samples [ Time Frame: 21 days after surgery ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ICMJE; (submitted: June 26, 2009)	Differences in duration and clinical characteristics of the wound healing process verified by a modified ASEPSIS score. [ Time Frame: 21 days after surgery ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Influence of Thyroid Hormones on the Woundhealing Process
Official Title ICMJE	Clinical Investigations on Cytokin-Gradients in Hypo/Euthyroid Patients. Evaluation of Expression of Different Pro-and Anti-Inflammatory Cyto-/Chemokines in Skin Wounds After Surgery of Benign Goitres (Struma Multinodosa) or Malignant Diseases of Thyroid Gland (Papillary Thyroid Carcinoma) in Correlation to the Status of Wound Healing of the Neck Wound
Brief Summary	Main goal of this clinical investigation is to investigate different cytokines in wound fluids of euthyroid vs. hypothyroid patients. As a primary endpoint we want to evaluate if different cytokine levels in euthyroid vs. hypothyroid patients exist and to what extent these cytokines differ. Our targeted cytokines are: IL6, IL10, TNFa and MCP-1. From the literature these 4 factors seem to be the most reasonable to measure and to focus on. Additionally we focus on these 4 factors for financial reasons, technically there wouldn't be a problem to measure more, which is correlated with higher costs. Besides, more than 6 factors would mean larger amounts of sample fluids needed, which would cause technical problems. These factors don`t have to change in the same direction. Secondarily, we believe that differences in cytokine profiles of hypothyroidism vs. euthyroidism will correlate to differences in duration and clinical characteristics of the wound healing process.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Masking: None (Open Label); Primary Purpose: Basic Science
Condition ICMJE	Thyroid Neoplasms; Thyroid Carcinoma
Intervention ICMJE	Procedure: blood sampling
Study Arms	Active Comparator: benign patients after surgery because of a benign disease Interventions: Procedure: blood sampling Procedure: blood sampling; Active Comparator: DTC Patients after thyroidectomy because of papillary carcinoma of the thyroid gland Intervention: Procedure: blood sampling
Publications *	Not Provided
* 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	Unknown status
Estimated Enrollment ICMJE; (submitted: June 26, 2009)	26
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	April 2010
Estimated Primary Completion Date	December 2009 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Near total or total thyroidectomy because of struma multinodsa (nodular goiter) with or without substitution of thyroid hormone after operation; Total thyroidectomy because of papillary carcinoma of thyroid gland (T1/T2 carcinoma, N1, M0) with planned radio-ablative therapy (RAT) without or with rhTSH Exclusion Criteria: Pat< 18 years; Immune disease of thyroid gland (Graves disease); Severe immunodeficiency; Immunosuppressive medication because of solid Organ transplantation; Hepatitis A/B/C or HIV; All exclusion criteria for any surgical procedure
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Germany
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00929318
Other Study ID Numbers ICMJE	MHH-THY-WH-09
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Prof. Dr Georg FW Scheumann, Medizinische Hochschule Hannover
Study Sponsor ICMJE	Hannover Medical School
Collaborators ICMJE	Genzyme, a Sanofi Company
Investigators ICMJE	Not Provided
PRS Account	Hannover Medical School
Verification Date	June 2009
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP