Wound Complications in Head and Neck Surgery

Completed

• Conditions: Hypothyroidism; Surgery; Head and Neck Cancer; Wound Heal; Laryngeal Cancer; Laryngeal Fistula
• Interventions: Drug: Levothyroxine

• Registration Number: NCT03134976
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-20
• Study First Submitted QC: 2017-04-26
• Study Start: 2017-05-01
• Study First Posted: 2017-05-01
• Primary Completion: 2020-04-01
• Status Verified: 2020-05
• Study Completion: 2020-05-01
• Last Update Submitted: 2020-05-29
• Last Update Posted: 2020-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Salvage Larynx	Levothyroxine	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.

Primary Outcome Measures

Name	Time	Method
Number of patients treated with Levothyroxine who develop pharyngocutaneous fistula after salvage laryngectomy	30 days post-operatively	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.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States