Wound Complications in Head and Neck Surgery

Head and Neck Cancer Clinical Trial

Official title:

Wound Complications in Head and Neck Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03134976
• Other study ID #: HUM00124347
• Status: Completed
• Start date: May 1, 2017
• Est. completion date: May 1, 2020

Study information

• Verified date: May 2020
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: May 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fistula
• Head and Neck Cancer
• Head and Neck Neoplasms
• Hypothyroidism
• Hypothyroidism; Surgery
• Laryngeal Cancer
• Laryngeal Fistula
• Laryngeal Neoplasms
• Wound Heal
• Wounds and Injuries

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients treated with Levothyroxine who develop pharyngocutaneous fistula after salvage laryngectomy	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.	30 days post-operatively