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Influence of Thyroid Hormones on the Woundhealing Process
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by Hannover Medical School.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Hannover Medical School
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
| Tracking Information | |||
|---|---|---|---|
| First Received Date ICMJE | June 26, 2009 | ||
| Last Updated Date | June 26, 2009 | ||
| Start Date ICMJE | June 2009 | ||
| Estimated Primary Completion Date | December 2009 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
Evidence for different cytokine levels in euthyroid vs hypothyroid condition confirmed by bood serum samples [ Time Frame: 21 days after surgery ] | ||
| Original Primary Outcome Measures ICMJE | Same as current | ||
| Change History | No Changes Posted | ||
| Current Secondary Outcome Measures ICMJE |
Differences in duration and clinical characteristics of the wound healing process verified by a modified ASEPSIS score. [ Time Frame: 21 days after surgery ] | ||
| Original Secondary Outcome Measures ICMJE | Same as current | ||
| Current Other Outcome Measures ICMJE | Not Provided | ||
| Original Other Outcome Measures ICMJE | Not Provided | ||
| Descriptive Information | |||
| Brief Title ICMJE | Influence of Thyroid Hormones on the Woundhealing Process | ||
| Official Title ICMJE | 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. | ||
| Detailed Description | Not Provided | ||
| Study Type ICMJE | Interventional | ||
| Study Phase | Not Provided | ||
| Study Design ICMJE | Allocation: Randomized Masking: Open Label Primary Purpose: Basic Science |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: blood sampling | ||
| Study Arms |
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| Publications * | Not Provided | ||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Unknown status | ||
| Estimated Enrollment ICMJE | 26 | ||
| Estimated Completion Date | April 2010 | ||
| Estimated Primary Completion Date | December 2009 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Senior) | ||
| Accepts Healthy Volunteers | No | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | Germany | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT00929318 | ||
| Other Study ID Numbers ICMJE | MHH-THY-WH-09 | ||
| Has Data Monitoring Committee | No | ||
| U.S. FDA-regulated Product | Not Provided | ||
| Plan to Share Data | Not Provided | ||
| IPD Description | Not Provided | ||
| Responsible Party | Prof. Dr Georg FW Scheumann, Medizinische Hochschule Hannover | ||
| Study Sponsor ICMJE | Hannover Medical School | ||
| Collaborators ICMJE | Genzyme, a Sanofi Company | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | Hannover Medical School | ||
| Verification Date | June 2009 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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