Head-Only Draping in Pediatric Tonsillectomy

NYU Langone Health

Status: Not yet enrolling

Conditions: Infections; Tonsillectomy

Treatments: Other: Head-Only Surgical Draping; Other: Full-Body Surgical Draping

Study type: Interventional

Funder types: Other

Identifiers

NCT07347301

25-01372

Details and patient eligibility

About

This single-center, interventional study will compare 30-day postoperative infection rates in pediatric tonsillectomy performed with either head-only draping or traditional full-body draping. Secondary analyses will evaluate differences in waste production, material and disposal costs, and provider attitudes between the two draping techniques. This study will randomize participants 1:1 to either the head-only draping cohort (intervention) or the full-body draping cohort (control).

Enrollment: 200 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Pediatric patients <18 years at time of surgery.
2. Scheduled for tonsillectomy, with or without adenoidectomy, without any other procedures requiring full-body draping.
3. Ability to complete 30-day outcome assessment (i.e., remain in follow-up or reachable via phone/electronic health record).
4. Parent/guardian able to provide parental permission and consent for both them and their children.

Exclusion criteria

1. Significant deviation from planned surgical technique during case.
2. Pre-existing systemic infection prior to surgery.
3. Known immunodeficiency or current systemic immunosuppressive therapy.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Head-Only Draping

Experimental group

Description:

Pediatric tonsillectomy will be performed with head-only draping.

Treatment:

Other: Head-Only Surgical Draping

Full-Body Draping

Active Comparator group

Description:

Pediatric tonsillectomy will be performed with traditional full-body draping.

Treatment:

Other: Full-Body Surgical Draping