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NOT YET RECRUITING
NCT07188779
PHASE2

Impact of RADA16 Use on Outcomes Following Tonsillectomy in Children

Sponsor: Rutgers, The State University of New Jersey

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

3 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

134

Start Date

2026-04-01

Completion Date

2027-12-01

Last Updated

2026-04-01

Healthy Volunteers

No

Interventions

DEVICE

RADA16 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.