Head-Only Draping in Pediatric Tonsillectomy

NCT ID: NCT07347301

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-02

Study Completion Date

2026-12-01

Brief Summary

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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).

Detailed Description

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Conditions

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Tonsillectomy Infections

Study Design

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Allocation Method

NA

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Head-Only Draping

Pediatric tonsillectomy will be performed with head-only draping.

Group Type EXPERIMENTAL

Head-Only Surgical Draping

Intervention Type OTHER

Use of head drape instead of full-body drape.

Full-Body Draping

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

Group Type ACTIVE_COMPARATOR

Full-Body Surgical Draping

Intervention Type OTHER

Standard full-body drape.

Interventions

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Full-Body Surgical Draping

Standard full-body drape.

Intervention Type OTHER

Head-Only Surgical Draping

Use of head drape instead of full-body drape.

Intervention Type OTHER

Eligibility Criteria

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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.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neelima Tummala, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status

Countries

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United States

Central Contacts

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Neelima Tummala, MD

Role: CONTACT

646-501-7890

Other Identifiers

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25-01372

Identifier Type: -

Identifier Source: org_study_id

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