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Early Feeding After Oral Cavity Surgery
N/A
Recruiting
Led By Mohemmed Khan, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
Study Summary
This trial is comparing 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).
Who is the study for?
This trial is for adults over 18 who need reconstructive surgery in the oral cavity and can consent in English, Spanish, or Mandarin. It's not for those with prior major oral surgery, radiation to the mouth, unable to understand the study, or have swallowing issues.Check my eligibility
What is being tested?
The study tests if eating right after oral cavity reconstruction is as safe as waiting several days before eating. Patients' healing and swallowing function are monitored for a month post-surgery at Mount Sinai Hospital locations.See study design
What are the potential side effects?
Since this trial involves early feeding rather than medication, side effects may include discomfort while eating, potential infection risk at surgical sites, or complications related to wound healing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Orocutaneous Fistula
Secondary outcome measures
Incidence of Aspiration pneumonia
Incidence of Surgical Site Infection
Incidence of Wound Dehiscence
+6 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Early Feeding ArmExperimental Treatment1 Intervention
Early Feeding Group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Early Feeding
2006
N/A
~60
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Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
860 Previous Clinical Trials
524,387 Total Patients Enrolled
Mohemmed Khan, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Patients who have received surgery to rebuild their oral cavity using their own tissue can participate.You speak either English, Spanish or Mandarin Chinese.You have a history of brain injury, stroke, or memory loss condition.
Research Study Groups:
This trial has the following groups:- Group 1: Early Feeding Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment in this experiment still ongoing?
"This research project, which had its first post on March 10th 2021 and was last edited April 25th 2022, is not enrolling new participants at this time. Luckily, 481 other studies are currently open for enrollment."
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