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Early Feeding After Oral Cavity Reconstruction

NCT04787939 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2024-04-12

No results posted yet for this study

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

Interventions

BEHAVIORAL

Early Feeding

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.

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-10
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04787939 on ClinicalTrials.gov