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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Head-Only Draping | Experimental | Pediatric tonsillectomy will be performed with head-only draping. |
|
| Full-Body Draping | Active Comparator | Pediatric tonsillectomy will be performed with traditional full-body draping. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Full-Body Surgical Draping | Other | Standard full-body drape. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day postoperative infection rate | Day 30 Post Operation |
| Measure | Description | Time Frame |
|---|---|---|
| Total weight of waste | Day 0 (Day of Operation) | |
| Disposal costs | Day 0 (Day of Operation) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Neelima Tummala, MD | Contact | 646-501-7890 | neelima.tummala@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Neelima Tummala, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
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.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
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.
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| ID | Term |
|---|---|
| D007239 | Infections |
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| Head-Only Surgical Draping |
| Other |
Use of head drape instead of full-body drape. |
|