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Early Feeding After Oral Cavity Reconstruction

This study is looking at whether allowing patients to drink liquids by mouth on the first day after oral cavity reconstructive surgery (a surgery to rebuild parts of the mouth) is safe. Traditionally, doctors have waited several days to allow eating after this surgery due to concerns about leaks. This study will compare the rate of orocutaneous fistula (a type of leak where saliva escapes through the skin) in patients who receive early feeding to rates seen in patients who had delayed feeding in past studies. We are enrolling 89 patients who are at least 18 years old and speak English, Spanish, or Chinese (Mandarin). The study will track your care, wound healing, and quality of life for 30 days after surgery.

Study design
This is a single-arm study, meaning all participants will receive the early feeding intervention. It aims to enroll 89 participants.
What's involved
You will be permitted to drink liquids by mouth on the first day after surgery. Outcomes related to your care, wound healing, and quality of life will be followed for 30 days after surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 30 days after surgery to measure outcomes like wound healing and quality of life.

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NCT04787939

Early Feeding After Oral Cavity Reconstruction

UNKNOWN
NAAges 18+InterventionalSupportive care
Icahn School of Medicine at Mount Sinai
~89 participants
Updated 2024-04-12 on ClinicalTrials.gov
What's tested:Early Feeding

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Orocutaneous Fistula
Measured over 30 days

Conditions

Head and Neck Cancer
Free Tissue Transfer

Explore related trials

Malignant Head and Neck NeoplasmMalignant Oral Neoplasm

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Mohemmed Khan, MD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

Who to contact

Rocco Ferrandino, MD
[email protected]
(212) 844-8775
Email the study team

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Eligibility criteria

Inclusion

Patients receiving free tissue transfer regardless of the indication for oral cavity reconstruction will be included.
Age ≥ 18 years.
English, Spanish, and Chinese (Mandarin) speaking patients
Ability to understand and the willingness to sign a written informed consent.

Exclusion

Patients having undergone prior major oral cavity surgery or radiation to the oral cavity (also known as surgical salvage patients).
Patients with a known history of dysphagia or with current enteral feeding needs
Patients with a history of traumatic brain injury, stroke, or dementia
Patients unable to understand the research protocol and/or provide informed consent. The consent will be translated into English, Spanish, and Chinese (Mandarin). Given patient demographics at Mount Sinai Hospital, this will include the overwhelming majority of patients.
Patients under the age of 18
Patients whose participation in this trial would require exclusion from participation in another clinical research trial related to the patient's malignant diagnosis.
Vulnerable populations (adults unable to consent, individuals who are not yet adults, wards of the state, pregnant women, prisoners, pregnant women)

What this trial measures

  • Incidence of Orocutaneous Fistula30 days

    Orocutaneous Salivary Fistula Formation - An orocutaneous fistula or salivary leak is a wound complication that results when saliva or other liquids leak from the mouth through the skin of the face or neck. The subject's oral cavity and neck will be monitored in the standard fashion for development of orocutaneous fistula. The oral cavity will be monitored daily for signs of wound breakdown. The neck will be examined for redness, tenderness to palpation, or increased swelling. Additionally, systemic signs of fistula formation will be monitored such as leukocytosis and fever.