RecruitingPhase 3NCT07060495

RADA16 for Adult Tonsillectomy

Use of Novel Self-assembling RADA-16 Peptide Matrix to Decrease Postoperative Epistaxis for Tonsillectomy Surgeries

Sponsor

Rutgers, The State University of New Jersey

Enrollment

134 participants

Start Date

Sep 12, 2025

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 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

Min Age: 18 Years

Inclusion Criteria1

Adults undergoing tonsillectomy (CPT codes)

Exclusion Criteria12

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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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.