Health TrialsbyHealthPanel

Head-Only Draping in Pediatric Tonsillectomy

ConditionsTonsillectomyInfections
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorNYU Langone Health

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Significant deviation from planned surgical technique during case.

Pre-existing systemic infection prior to surgery.

Known immunodeficiency or current systemic immunosuppressive therapy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Full-Body Surgical Draping

    Other intervention

    Standard full-body drape.

  • Head-Only Surgical Draping

    Other intervention

    Use of head drape instead of full-body drape.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Head-Only DrapingExperimental treatment 1 intervention
Group B: Full-Body DrapingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

30-day postoperative infection rate

Time frame
Day 30 Post Operation

Secondary outcomes

1

Total weight of waste

Time frame
Day 0 (Day of Operation)
2

Disposal costs

Time frame
Day 0 (Day of Operation)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NYU Langone Health

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: