Influence of Thyroid Hormones on the Woundhealing Process

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Thyroid Neoplasms, Thyroid Carcinoma

Intervention / Treatment
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* Procedure: blood sampling
* Procedure: blood sampling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: benign<br>patients after surgery because of a benign disease | Procedure: blood sampling<br> <br> Procedure: blood sampling<br> <br> |
| Active Comparator: DTC<br>Patients after thyroidectomy because of papillary carcinoma of the thyroid gland | Procedure: blood sampling<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence for different cytokine levels in euthyroid vs hypothyroid condition confirmed by bood serum samples |  | 21 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in duration and clinical characteristics of the wound healing process verified by a modified ASEPSIS score. |  | 21 days after surgery |