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

NCT07148895 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2026-01-16

No results posted yet for this study

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

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-09
Primary Completion
2028-12-31
Completion
2029-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07148895 on ClinicalTrials.gov