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NCT03134976 · ClinicalTrials.gov registry record
Wound Complications in Head and Neck Surgery
A clinical trial, sponsored by University of Michigan.
- Completed
- Registry status
- 51
- Enrollment target
NCT03134976: Completed study, sponsored by University of Michigan.
NCT03134976 is a clinical trial that has completed, run by University of Michigan. The registered enrollment target is 51 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03134976 has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- 51 participants
- Enrollment target
Study Summary
This is a prospective observational study evaluating wound complications following head and neck surgery. Patients undergoing major head and neck surgery will be included in the study. Patients meeting eligibility criteria will be identified by members of the University of Michigan Head and Neck Oncology Division of the Department of Otolaryngology. The primary aim of this study is to identify risk factors for poor wound healing as well as biologic markers associated with wound related complications in head and neck surgery. Most specifically, this study evaluates the effects of thyroid hormone on wound healing. This study will also evaluate pre-operative labs and comorbidities as well as reconstructive factors, post-operative labs, and other variables associated with wound healing. All interventions regarding wound healing fall under current standards of care and standard practice. Data regarding post-operative wound complications will be collected in a prospective fashion on the variables under study using study-specific datasheets. Data sheet will be entered into a secure database for analysis.
Primary Outcome
Blood will be drawn and analyzed for thyroid stimulating hormone (TSH), free T3, and free T4 levels at specified intervals. Subjects will be monitored for pharyngocutaneous fistula formation.
Interventions
- DRUG Levothyroxine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2017-05-01 |
| Est. Completion | 2020-05-01 |
What the finished NCT03134976 record still lists
NCT03134976 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 51 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Levothyroxine is the first listed.
NCT03134976 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03134976 about?
NCT03134976 is a clinical study titled "Wound Complications in Head and Neck Surgery". This is a prospective observational study evaluating wound complications following head and neck surgery. Patients undergoing major head and neck surgery will be included in the study. Patients meeting eligibility criteria will be identified by members of the University of Michigan Head and Neck Onc...
What is the current status of trial NCT03134976?
This trial is currently completed. The enrollment target is 51 participants. The study started on 2017-05-01. Estimated completion is 2020-05-01.
What interventions are being tested in trial NCT03134976?
The interventions under investigation include: Levothyroxine (DRUG).
Who is sponsoring clinical trial NCT03134976?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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