Head and Neck Cancer Clinical Trial
Official title:
Early Feeding After Free Flap Reconstruction of Oral Cavity Defects: A Single Arm Non-inferiority Trial
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.
Status | Recruiting |
Enrollment | 89 |
Est. completion date | December 2025 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Mount Sinai Health System | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Icahn School of Medicine at Mount Sinai |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Incidence of Surgical Site Infection | Surgical site infection is defined clinically as fever, erythema, swelling or purulent drainage from the surgical site requiring topical or systemic treatment. | 30 days | |
Secondary | Incidence of Wound Dehiscence | Wound dehiscence is defined as the breakdown at the surgical site with or without intervention. | 30 days | |
Secondary | Rate of PO tolerance | The proportion of patients that are cleared for a diet by the speech language pathology team. | 30 days | |
Secondary | Incidence of Aspiration pneumonia | Aspiration pneumonia is defined clinically based on vital signs, respiratory secretions, and chest x-ray findings indicating pneumonia requiring antibiotic treatment. | 30 days | |
Secondary | Length of hospital stay | Length of hospital stay is defined as the days from admission to discharge. | 30 days | |
Secondary | Jaw range of motion | Bedside swallow evaluation outcomes include jaw Jaw Range of Motion opening which will be measured in millimeters using the Therabite measuring tool and fingers, ranges from 0, indicating <1, to 5, indicating 3 or greater. | 30 days | |
Secondary | Tongue range of motion | Bedside swallow evaluation outcomes include tongue range of motion. Tongue Range of Motion Scale will be measured in millimeters, with a range of 100-0, 100 indicating full tongue range of motion and 0 indication no tongue movement. | 30 days | |
Secondary | MD Anderson Dysphagia Index (MDADI) | MD Anderson Dysphagia Index (MDADI) is a survey designed to assess a subject's perception of his or her swallowing ability. Patient responds to questionnaire that best reflects their current experience, ranges from Strongly Agree to Strongly Disagree. The scores range from a minimum of 0 to a max of 100, with higher scores indicating higher functioning. | 30 Days | |
Secondary | Performance Status Scale for Head and Neck Cancer (PSS-HN) | Performance Status Scale for Head and Neck Cancer (PSS-HN) is a survey aimed at evaluating performance and function with regard to eating, speaking, and eating in public. Subscales provide a range of 100 - No restrictions and full understandability to 0 - Full restrictions and no understandability. Subscales are scored individually with higher scores indicating better performance. | 30 Days |
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