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Impact of RADA16 Use on Outcomes Following Tonsillectomy in Children
Who can join
Ages 3 to 17 · All sexes
Full eligibility criteria
Inclusion Criteria: Children aged 3-17 years undergoing tonsillectomy +/- adenoidectomy CPT codes * 42820 (Tonsillectomy and adenoidectomy; younger than age 12) * 42821 (… age 12 or over) * 42825 (Tonsillectomy; primary or secondary; younger than age 12) * 42826 (… age 12 or over) * 42830 (Adenoidectomy, primary; younger than age 12) * 42831 (… age 12 or over) * 42835 (Adenoidectomy; secondary; younger than age 12) * 42836 (… age 12 or over) Exclusion Criteria: * Children with bleeding disorders or other hematologic malignancy or taking anticoagulant medications Developmental delay affecting pain reporting Children with known allergies to RADA16 components Children with prior tonsillectomy or tonsillotomy Children undergoing tonsillectomy with concern for cancer, Children taking opioids chronically prior to surgery, Anyone pregnant women, incarcerated individuals, children unable to speak English or Spanish
About the study
The purpose of the research is to determine if RADA16 (also known as PuraStat®, PuraGel®, or PuraSinus®) improves patient outcomes following pediatric tonsillectomy procedures. Researchers will compare application of device RADA16 to application of no device to see if RADA16 works to treat post tonsillectomy hemorrhage.Participants will:
Undergo tonsillectomy procedure. Receive and fill out a survey sent via email every 2 days following their procedure for 15 days, plus an additional survey on day 30, and track their symptoms.
What is being tested
- RADA16 hydrogel (device)
Sponsor: Rutgers, The State University of New Jersey · Participants: 134 · Started: Jul 9, 2026
Contact the study team
- Wayne D Hsueh, MD · Phone: 973-972-4588
- Gabriel Frimpong, MPH, PA · Phone: 973-972-2309
Official record on ClinicalTrials.gov — NCT07188779
Locations in the U.S.
| New Jersey | Cooperman Barnabas Medical Center, Livingston (Not yet recruiting) University Hospital, Newark |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.