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Recruiting Phase 3 NCT07060495

RADA16 for Adult Tonsillectomy

Phase 3 – large-scale trial before approval
Conditions: Postoperative Pain

Sponsor: Rutgers, The State University of New Jersey

trial.available_in: БГ
Overview
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.
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.
Who can participate
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
RADA16 hydrogel
DEVICE
Locations 2
United States (2)
Cooperman Barnabas Medical Center
Livingston , New Jersey
University Hospital
Newark , New Jersey
NOT_YET_RECRUITING
Gabriel Frimpong, MPH, PA
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
12.09.2025
Completion date
01.12.2026
Registry ID
NCT07060495
Source
clinicaltrials.gov
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