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Influence of Thyroid Hormones on the Woundhealing Process

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ClinicalTrials.gov Identifier: NCT00929318
Recruitment Status : Unknown
Verified June 2009 by Hannover Medical School.
Recruitment status was:  Recruiting
First Posted : June 29, 2009
Last Update Posted : June 29, 2009
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by:
Hannover Medical School

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.

Condition or disease Intervention/treatment Phase
Thyroid Neoplasms Thyroid Carcinoma Procedure: blood sampling Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Study Start Date : June 2009
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: benign
patients after surgery because of a benign disease
Procedure: blood sampling Procedure: blood sampling
Active Comparator: DTC
Patients after thyroidectomy because of papillary carcinoma of the thyroid gland
Procedure: blood sampling



Primary Outcome Measures :
  1. Evidence for different cytokine levels in euthyroid vs hypothyroid condition confirmed by bood serum samples [ Time Frame: 21 days after surgery ]

Secondary Outcome Measures :
  1. Differences in duration and clinical characteristics of the wound healing process verified by a modified ASEPSIS score. [ Time Frame: 21 days after surgery ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00929318


Contacts
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

Locations
Germany
Medizinische Hoochschule Hannover, Allgemein-, Viszeral-und Transplantationscirurgie OE 6220 Recruiting
Hannover, Germany, 30625
Contact: Stephan Kaaden, Dr         
Sub-Investigator: Stephan Kaaden, Dr         
Sponsors and Collaborators
Hannover Medical School
Genzyme, a Sanofi Company

Responsible Party: Prof. Dr Georg FW Scheumann, Medizinische Hochschule Hannover
ClinicalTrials.gov Identifier: NCT00929318     History of Changes
Other Study ID Numbers: MHH-THY-WH-09
First Posted: June 29, 2009    Key Record Dates
Last Update Posted: June 29, 2009
Last Verified: June 2009

Additional relevant MeSH terms:
Carcinoma
Thyroid Diseases
Thyroid Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms