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
试验速览
- 阶段
- 不适用
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Evidence for different cytokine levels in euthyroid vs hypothyroid condition confirmed by bood serum samples
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Evidence for different cytokine levels in euthyroid vs hypothyroid condition confirmed by bood serum samples
时间窗: 21 days after surgery
次要结局
- Differences in duration and clinical characteristics of the wound healing process verified by a modified ASEPSIS score.(21 days after surgery)
