Influence of Thyroid Hormones on the Woundhealing Process

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Hannover Medical School.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT00929318
First received: June 26, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted

June 26, 2009
June 26, 2009
June 2009
December 2009   (final data collection date for primary outcome measure)
Evidence for different cytokine levels in euthyroid vs hypothyroid condition confirmed by bood serum samples [ Time Frame: 21 days after surgery ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Differences in duration and clinical characteristics of the wound healing process verified by a modified ASEPSIS score. [ Time Frame: 21 days after surgery ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Influence of Thyroid Hormones on the Woundhealing Process
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Masking: Open Label
Primary Purpose: Basic Science
  • Thyroid Neoplasms
  • Thyroid Carcinoma
Procedure: blood sampling
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
26
April 2010
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Stephan S Kaaden, Dr 0049-511-532 6131 Kaaden.Stephan@mh-hannover.de
Contact: Georg FW Scheumann, Prof 0049-511-532 2032 scheumann.georg@mh-hannover.de
Germany
 
NCT00929318
MHH-THY-WH-09
No
Prof. Dr Georg FW Scheumann, Medizinische Hochschule Hannover
Hannover Medical School
Genzyme, a Sanofi Company
Not Provided
Hannover Medical School
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP