Influence of Thyroid Hormones on the Woundhealing Process

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Brief Title

Influence of Thyroid Hormones on the Woundhealing Process

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

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.
    



Study Type

Interventional


Primary Outcome

Evidence for different cytokine levels in euthyroid vs hypothyroid condition confirmed by bood serum samples

Secondary Outcome

 Differences in duration and clinical characteristics of the wound healing process verified by a modified ASEPSIS score.

Condition

Thyroid Neoplasms

Intervention

blood sampling

Study Arms / Comparison Groups

 benign
Description:  patients after surgery because of a benign disease

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

26

Start Date

June 2009

Completion Date

April 2010

Primary Completion Date

December 2009

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 0049-511-532 6131, [email protected]

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT00929318

Organization ID

MHH-THY-WH-09



Study Sponsor

Hannover Medical School

Collaborators

 Genzyme, a Sanofi Company

Study Sponsor

, , 


Verification Date

June 2009