Head-Only Draping in Pediatric Tonsillectomy

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Infections; Tonsillectomy
• Intervention / Treatment: Other: Head-Only Surgical Draping; Other: Full-Body Surgical Draping

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Neelima Tummala, MD; Phone Number: 646-501-7890; Email: neelima.tummala@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Head-Only Draping; Pediatric tonsillectomy will be performed with head-only draping.	Other: Head-Only Surgical Draping; Use of head drape instead of full-body drape.
Active Comparator: Full-Body Draping; Pediatric tonsillectomy will be performed with traditional full-body draping.	Other: Full-Body Surgical Draping; Standard full-body drape.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
30-day postoperative infection rate	Day 30 Post Operation

Secondary Outcome Measures

Outcome Measure	Time Frame
Total weight of waste	Day 0 (Day of Operation)
Disposal costs	Day 0 (Day of Operation)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Neelima Tummala, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Estimated): February 2, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 9, 2026
• First Submitted That Met QC Criteria: January 9, 2026
• First Posted (Estimated): January 16, 2026

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: 25-01372

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No