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Recruiting Phase 3 NCT07060495

NCT07060495 RADA16 for Adult Tonsillectomy

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Clinical Trial Summary
NCT ID NCT07060495
Status Recruiting
Phase Phase 3
Sponsor Rutgers, The State University of New Jersey
Condition Postoperative Pain
Study Type INTERVENTIONAL
Enrollment 134 participants
Start Date 2025-09-12
Primary Completion 2026-12-01

Trial Parameters

Condition Postoperative Pain
Sponsor Rutgers, The State University of New Jersey
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 134
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-09-12
Completion 2026-12-01
Interventions
RADA16 hydrogel

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Brief 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.

Eligibility Criteria

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)

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