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Not yet recruiting NCT07347301

Head-Only Draping in Pediatric Tonsillectomy

No phase Interventional Tonsillectomy Infections

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Full-Body Surgical Draping, Head-Only Surgical Draping.
Who it may be relevant to
Registry conditions: Tonsillectomy, Infections. Basic parameters: up to 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

30-Day Postoperative Infection Rate in Pediatric Tonsillectomy: Head-Drape vs. Full-Body Surgical Draping

Overview

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).

Interventions

  • Other Full-Body Surgical Draping
    Standard full-body drape.
  • Other Head-Only Surgical Draping
    Use of head drape instead of full-body drape.

Primary outcome measures

  • 30-day postoperative infection rate [Time frame: Day 30 Post Operation]
Secondary outcome measures (2)
  • Total weight of waste [Time frame: Day 0 (Day of Operation)]
  • Disposal costs [Time frame: Day 0 (Day of Operation)]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT07347301 · 25-01372

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗