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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00929318

Enrollment

Registered

2009-06-29

Start date

2009-06-30

Completion date

2010-04-30

Last updated

2009-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Carcinoma, Thyroid Neoplasms

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.

Interventions

PROCEDUREblood sampling

Study design

Allocation

RANDOMIZED

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Evidence for different cytokine levels in euthyroid vs hypothyroid condition confirmed by bood serum samples	21 days after surgery

Secondary

Measure	Time frame
Differences in duration and clinical characteristics of the wound healing process verified by a modified ASEPSIS score.	21 days after surgery

Countries

Germany

Contacts

Primary ContactStephan S Kaaden, Dr

Kaaden.Stephan@mh-hannover.de0049-511-532 6131

Backup ContactGeorg FW Scheumann, Prof

scheumann.georg@mh-hannover.de0049-511-532 2032

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026