NCT07148895

Assessing Post-operative Outcomes After Children's Sistrunk Procedure With or Without a Drain

A Prospective, Randomized, Multi-Center Trial Assessing Post-Operative Outcomes Following Pediatric Sistrunk Procedures With or Without Drain Placement

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 178 (estimated)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thyroglossal Duct Cysts

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	No post-surgical drain	Patients will be recovered in SOC manner from Sistrunk surgery without drain placement

Timeline

• Start date: 2026-01-09
• Primary completion: 2028-12-31
• Completion: 2029-12-31
• First posted: 2025-08-29
• Last updated: 2026-01-16

Locations

5 sites across 1 country: United States