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NCT07060495PHASE3Recruiting

RADA16 for Adult Tonsillectomy

Rutgers, The State University of New Jersey

Start Date

9/12/2025

Completion Date

12/1/2026

Summary

The purpose of the research is to determine if RADA16 (also known as PuraStat®, PuraGel®, or PuraSinus®) improves patient outcomes following 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 and track their symptoms.

Detailed Description

This is a prospective study evaluating the impact of intraoperative RADA16 application on the postoperative course following tonsillectomy as it relates to pain, bleeding, readmission, and use of a rescue analgesic (ex., oxycodone). We propose a randomized controlled trial whereby patients undergoing tonsillectomy would either receive a standard analgesic regimen (postoperative acetaminophen and NSAIDs plus oxycodone as a supplemental analgesic) versus intraoperative RADA16 application plus a standard analgesic regimen.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion criteria: Adults undergoing tonsillectomy (CPT codes) Exclusion criteria: Patients undergoing adenoidectomy or uvulopalatopharyngoplasty in addition to tonsillectomy Patients who have had prior tonsillectomy or tonsillotomy Patient undergoing tonsillectomy with concern for malignancy Patients who are on opioids chronically prior to surgery Patients with an additional indication for pain management (i.e. unrelated to tonsillectomy) Patients who have been diagnosed with a bleeding disorder or hematologic malignancy Patients who are on anticoagulants The following at-risk populations: Anyone under age 18 Pregnant women Prisoners Adults unable to consent (anyone lacking capacity)

Interventions

DEVICE

RADA16 hydrogel

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Conditions

Postoperative Pain

Locations

Cooperman Barnabas Medical Center

Livingston, New Jersey 07039

United States

University Hospital

Newark, New Jersey 07103

United States