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
  Purpose

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 Intervention
Thyroid Neoplasms
Thyroid Carcinoma
Procedure: blood sampling

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 26
Study Start Date: June 2009
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: June 26, 2009
Last Updated: June 26, 2009
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on August 21, 2014