Wound Complications in Head and Neck Surgery

NCT ID: NCT03134976

Last Updated: 2020-06-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 51 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2020-05-01

Brief 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.

Conditions

Hypothyroidism; Surgery; Head and Neck Cancer; Wound Heal; Laryngeal Cancer; Laryngeal Fistula

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Salvage Larynx

The first group includes subjects with cancer of the voice box (laryngeal squamous cell carcinoma) that has already been treated by either chemotherapy or radiation. This group will be treated using the standard of care, which includes starting thyroid hormone replacement therapy (levothyroxine) after surgery.

Levothyroxine

Intervention Type: DRUG

Immediately post-operatively, all patients undergoing laryngectomy will be started on established weight-based dosing of levothyroxine administered intravenously due to the variable enteral absorption in post-operative patients including those on continuous tube feed regimens. Standard enteral dose is 1.6 mcg/kg/day. Eighty percent of this dose (1.3 mcg/kg/day) will be given IV to account for the increased bioavailability of IV levothyroxine compared to enteral levothyroxine. The maximum dose will be 200 mcg/day. Patients previously on levothyroxine at doses lower than the above dose will changed to the aforementioned standard dose. Patients on higher doses of levothyroxine pre-operatively will be maintained on on their current dosing.

Non-Salvage Larynx

The second group of subjects will consist of patients who have head and neck cancer of sites other than the voice box (larynx) without prior exposure to radiation or chemotherapy who are undergoing flap reconstruction surgery. This group will not be treated with levothyroxine so long as the subject has normal thyroid function. If a subject is hypothyroid, then thyroid hormone replacement will be given as a part of routine clinical care.

No interventions assigned to this group

Interventions

Levothyroxine

Immediately post-operatively, all patients undergoing laryngectomy will be started on established weight-based dosing of levothyroxine administered intravenously due to the variable enteral absorption in post-operative patients including those on continuous tube feed regimens. Standard enteral dose is 1.6 mcg/kg/day. Eighty percent of this dose (1.3 mcg/kg/day) will be given IV to account for the increased bioavailability of IV levothyroxine compared to enteral levothyroxine. The maximum dose will be 200 mcg/day. Patients previously on levothyroxine at doses lower than the above dose will changed to the aforementioned standard dose. Patients on higher doses of levothyroxine pre-operatively will be maintained on on their current dosing.

Intervention Type: DRUG

Other Intervention Names

Synthroid; Tirosint; Levoxyl; Levothroid; Unithroid; Novothyrox

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Matthew E. Spector

Assistant Professor of Otolaryngology- Head and Neck Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00124347

Identifier Type: -

Identifier Source: org_study_id