Influence of Thyroid Hormones on the Woundhealing Process

Thyroid Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00929318
• Other study ID #: MHH-THY-WH-09
• Status: Recruiting
• Phase: N/A
• First received: June 26, 2009
• Last updated: June 26, 2009
• Start date: June 2009
• Est. completion date: April 2010

Study information

• Verified date: June 2009
• Source: Hannover Medical School
• Contact: Stephan S Kaaden, Dr
• Phone: 0049-511-532 6131
• Email: Kaaden.Stephan[@]mh-hannover.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: April 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Thyroid Carcinoma
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Procedure:
• blood sampling

• blood sampling

Locations

Country	Name	City	State
Germany	Medizinische Hoochschule Hannover, Allgemein-, Viszeral-und Transplantationscirurgie OE 6220	Hannover

Sponsors (2)

Lead Sponsor	Collaborator
Hannover Medical School	Genzyme, a Sanofi Company

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence for different cytokine levels in euthyroid vs hypothyroid condition confirmed by bood serum samples		21 days after surgery	Yes
Secondary	Differences in duration and clinical characteristics of the wound healing process verified by a modified ASEPSIS score.		21 days after surgery	Yes