NCT07347301

Brief Summary

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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress31%
Feb 2026Dec 2026

First Submitted

Initial submission to the registry

January 9, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

February 2, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

7 months

First QC Date

January 9, 2026

Last Update Submit

January 9, 2026

Conditions

TonsillectomyInfections

Outcome Measures

Primary Outcomes (1)

  • 30-day postoperative infection rate

    Day 30 Post Operation

Secondary Outcomes (2)

  • Total weight of waste

    Day 0 (Day of Operation)

  • Disposal costs

    Day 0 (Day of Operation)

Study Arms (2)

Head-Only Draping

EXPERIMENTAL

Pediatric tonsillectomy will be performed with head-only draping.

Other: Head-Only Surgical Draping

Full-Body Draping

ACTIVE COMPARATOR

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

Other: Full-Body Surgical Draping

Interventions

Full-Body Surgical DrapingOTHER

Standard full-body drape.

Full-Body Draping
Head-Only Surgical DrapingOTHER

Use of head drape instead of full-body drape.

Head-Only Draping

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Infections

Study Officials

  • Neelima Tummala, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Neelima Tummala, MD

CONTACT

646-501-7890neelima.tummala@nyulangone.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2026

First Posted

January 16, 2026

Study Start

February 2, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: neelima.tummala@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access Criteria
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to neelima.tummala@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.

Locations

US(1)