Early Feeding After Oral Cavity Reconstruction

NCT04787939 | Recruiting DMC

• 1 other identifier: HSM 20-01801
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective single-arm non-inferiority trial evaluating surgical outcomes in subjects who are fed in the first days after oral cavity reconstructive surgery. The purpose of the study is to specifically compare the rates of orocutaneous fistula in subjects who are allowed to eat immediately after surgery to those rates published in the literature (individuals for whom oral feeding is delayed for several days after surgery). Eighty nine subjects who will undergo oral cavity reconstructive surgery will be enrolled between Mount Sinai Hospital and Mount Sinai West. Study participation will last for 30 days after surgery during which time patients will be examined for any signs or symptoms of surgical site infection or wound breakdown, have several clinical evaluations of swallow function, and be asked to report on several patient reported outcome measures.

Conditions

Head and Neck Cancer; Free Tissue Transfer

Keywords

Oral Cavity Cancer; Oral Cavity Reconstruction; Early Postoperative Feeding; Orocutaneous Fistula; Salivary Leak

Outcome Measures

Primary Outcomes (1)

• Incidence of Orocutaneous Fistula

  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.

  30 days

Secondary Outcomes (9)

• Incidence of Surgical Site Infection

  30 days

• Incidence of Wound Dehiscence

  30 days

• Rate of PO tolerance

  30 days

• Incidence of Aspiration pneumonia

  30 days

• Length of hospital stay

  30 days

Study Arms (1)

Early Feeding Arm

EXPERIMENTAL

Early Feeding Group

Behavioral: Early Feeding

Interventions

Early Feeding BEHAVIORAL

Subjects will be permitted to drink liquids by mouth on the first day after surgery. Outcomes related to their care, wound healing, and quality of life will be followed for 30 days after surgery.

Early Feeding Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Vulnerable populations (adults unable to consent, individuals who are not yet adults, wards of the state, pregnant women, prisoners, pregnant women)

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Health System

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Mouth Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Mohemmed Khan, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rocco Ferrandino, MD

CONTACT

(212) 844-8775; Rocco.ferrandino@mountsinai.org

Catharine Kappauf, MD

CONTACT

catharine.kappauf@mountsinai.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Medicine

Model Details: The study is a single arm non-inferiority study evaluating wound healing outcomes (orocutaneous fistula, salivary leak, wound dehiscence) in subjects undergoing free tissue transfer for oral cavity reconstruction who are permitted to drink liquids by mouth on postoperative day 1. Outcomes are tracked and assessed over a 30 day period postoperatively.

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 9, 2021
• Study Start: March 10, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)