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

Conditions

• Thyroglossal Duct Cysts

Eligibility Criteria

Sex

ALL

Age

3 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Post-surgical drain — PROCEDURE
  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 — PROCEDURE
  Patients will be recovered in SOC manner from Sistrunk surgery without drain placement

Study Details

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.

Key Dates

Start date

Jan 9, 2026

Status verified

Jan 2026

Primary completion

Dec 31, 2028

Completion

Dec 31, 2029

Study Design

Enrollment

178 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Drain
  During surgery, at the completion of the Sistrunk procedure, participants will have a suction drain placed. The drain will be removed later based on standard criteria prior to discharge from the hospital.
• Active Comparator: No Drain
  At the completion of the Sistrunk procedure, participants will not have a suction drain placed.

Primary Outcome Measure

Occurrence of Hematoma [ Time Frame: 30 days post-procedure ]

Locations (5)

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