RecruitingPhase 2NCT07188779

Impact of RADA16 Use on Outcomes Following Tonsillectomy in Children

Sponsor

Rutgers, The State University of New Jersey

Enrollment

134 participants

Start Date

May 1, 2026

Study Type

INTERVENTIONAL

Conditions

Postoperative Pain

Summary

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.

Eligibility

Min Age: 3 YearsMax Age: 17 Years

Inclusion Criteria9

Children aged 3-17 years undergoing tonsillectomy +/- adenoidectomy CPT codes
(Tonsillectomy and adenoidectomy; younger than age 12)
(… age 12 or over)
(Tonsillectomy; primary or secondary; younger than age 12)
(… age 12 or over)
(Adenoidectomy, primary; younger than age 12)
(… age 12 or over)
(Adenoidectomy; secondary; younger than age 12)
(… age 12 or over)

Exclusion Criteria1

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

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Interventions

DEVICERADA16 hydrogel

Application of 2.5% RADA16 hydrogel to the tonsillar fossae following tonsillectomy using a sterile syringe tip applicator. The gel will be spread into a thin layer within the tonsillar fossae. The gel will be left to sit for 60 seconds. A suction device will then be used to remove any excess RADA16 hydrogel, leaving a thin layer of RADA16 over the tonsillar fossae.