TonsillectomyNCT07347301
Head-Only Draping in Pediatric Tonsillectomy
A study testing Full-Body Surgical Draping and Head-Only Surgical Draping in people with Tonsillectomy and Infections, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Tonsillectomy, Infections
- What is being tested?
- Full-Body Surgical Draping and Head-Only Surgical Draping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Significant deviation from planned surgical technique during case.
- Pre-existing systemic infection prior to surgery.
- Known immunodeficiency or current systemic immunosuppressive therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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).
- Conditions
- Tonsillectomy, Infections
- Being tested
- Full-Body Surgical Draping, Head-Only Surgical Draping
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full-Body Surgical DrapingOther
Standard full-body drape.
Head-Only Surgical DrapingOther
Use of head drape instead of full-body drape.
| Study group | Role | What they receive |
|---|---|---|
| Head-Only Draping | Experimental | Pediatric tonsillectomy will be performed with head-only draping. Receives: Other: Head-Only Surgical Draping |
| Full-Body Draping | Active comparator | Pediatric tonsillectomy will be performed with traditional full-body draping. Receives: Other: Full-Body Surgical Draping |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day postoperative infection rate
Measured: Day 30 Post Operation
Secondary outcomes (2)
Total weight of waste
Measured: Day 0 (Day of Operation)
Disposal costs
Measured: Day 0 (Day of Operation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start2 Feb 2026 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TonsillectomyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neelima Tummala, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347301
- Sponsor's protocol ID
- 25-01372
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 30-Day Postoperative Infection Rate in Pediatric Tonsillectomy: Head-Drape vs. Full-Body Surgical Draping
- ClinicalTrials.gov ID
- NCT07347301
- Acronym / sponsor ID
- 25-01372
- Conditions
- Tonsillectomy, Infections
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 2 Feb 2026 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Head-Only Draping | Experimental | Other: Head-Only Surgical DrapingPediatric tonsillectomy will be performed with head-only draping. |
| Full-Body Draping | Active comparator | Other: Full-Body Surgical DrapingPediatric tonsillectomy will be performed with traditional full-body draping. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Significant deviation from planned surgical technique during case.
- Pre-existing systemic infection prior to surgery.
- Known immunodeficiency or current systemic immunosuppressive therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full-Body Surgical DrapingStandard full-body drape. | Other | Full-Body Draping |
| Head-Only Surgical DrapingUse of head drape instead of full-body drape. | Other | Head-Only Draping |
Primary outcome
30-day postoperative infection rate
Time frame: Day 30 Post Operation
2 secondary outcomes
Total weight of waste
Time frame: Day 0 (Day of Operation)
Disposal costs
Time frame: Day 0 (Day of Operation)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neelima Tummala, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full-Body Surgical Draping and Head-Only Surgical Draping in people with Tonsillectomy and Infections, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neelima Tummala, MD (646-501-7890, neelima.tummala@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day postoperative infection rate (time frame: Day 30 Post Operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.