Wound Complications in Head and Neck Surgery
Completed
Conditions studied: Hypothyroidism; Surgery, Head and Neck Cancer, Wound Heal, Laryngeal Cancer, Laryngeal Fistula
In brief
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.
Key facts
- Study ID
- NCT03134976
- Run by
- University of Michigan
- People needed
- 51
- Starts
- 2017-05-01
- Expected to finish
- 2020-05-01
- Last updated by the study team
- 2020-06-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- In both groups: subjects must be 18 years or older with biopsy confirmed cancer of the head and neck.
You may not qualify if…
- Children and vulnerable populations are not eligible for participation. Patients undergoing functional (non cancer related) surgery, patients who have undergone more than 1 course of radiation to the head and neck, patients with a history of thyroid cancer, patients presenting initially with a malignant fistula, patients with previous intolerance or allergy to levothyroxine, and patients without a cancer diagnosis are not eligible. Patients may enroll if they are currently hypothyroid, but will be excluded from the study if thyroid function is not normalized by the time of surgery.
Where it is running
- University of Michigan — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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