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Assessing Post-operative Outcomes After Children's Sistrunk Procedure With or Without a Drain
Sponsor: University of Rochester
Summary
Purpose of the Study: This study looks at how kids recover after a type of neck surgery called the Sistrunk procedure. Some kids have a small tube (called a drain) placed during surgery, and some do not. The goal is to see if using a drain makes a difference in how well they heal. Who Is in the Study: Children who are having surgery to remove a thyroglossal duct cyst-a common lump in the neck that some kids are born with. Main Questions the Study Wants to Answer: Does using a drain lower the chance of problems at the surgery site? Does using a drain change how often kids need more treatment or have to go back to the hospital? What Will Happen: Kids will have the Sistrunk surgery, with or without a drain. Doctors will watch how they heal and check for any problems, like infections, needing more procedures, or going back to the hospital.
Official title: A Prospective, Randomized, Multi-Center Trial Assessing Post-Operative Outcomes Following Pediatric Sistrunk Procedures With or Without Drain Placement
Key Details
Gender
All
Age Range
3 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
178
Start Date
2026-01-09
Completion Date
2029-12-31
Last Updated
2026-01-16
Healthy Volunteers
No
Conditions
Interventions
Post-surgical drain
During surgery, at the completion of the Sistrunk procedure, participants in the drain cohort will have a suction drain placed, which will be removed based on standard criteria prior to discharge from the hospital. Wound care following drain removal will be standardized, with instructions for patients to allow the area to heal naturally and to follow a regimen of cleaning and applying topical antibiotic ointment for several days.
No post-surgical drain
Patients will be recovered in SOC manner from Sistrunk surgery without drain placement
Locations (5)
Children's Hospital Los Angeles
Los Angeles, California, United States
Connecticut Children's
Hartford, Connecticut, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Boston Children's Hospital
Boston, Massachusetts, United States
University of Rochester Medical Center
Rochester, New York, United States