Clinical trial · Interventional
Early Feeding After Oral Cavity Reconstruction
Early Feeding After Free Flap Reconstruction of Oral Cavity Defects: A Single Arm Non-inferiority Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Free Tissue Transfer | — | UNRESOLVED | — |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Early Feeding | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Early Feeding Arm
- description
- Early Feeding Group
- interventionNames
- Behavioral: Early Feeding
Primary outcomes (1)
- measure
- Incidence of Orocutaneous Fistula
- timeFrame
- 30 days
- description
- 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.
Secondary outcomes (9)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * 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 Criteria * 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)
References
Publications (0)
Data not yet available