Wound Complications in Head and Neck Surgery
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Cancer, Cancer, Cancer, Cancer, Hospital, Hospital, Endocrine |
| Therapuetic Areas: | Endocrinology, Oncology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/10/2018 |
| Start Date: | May 1, 2017 |
| End Date: | May 2019 |
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.
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.
Inclusion Criteria:
- In both groups: subjects must be 18 years or older with biopsy confirmed cancer of the
head and neck.
Exclusion Criteria:
- 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.
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