RADA16 hydrogel use during adult tonsillectomy
Official title: Use of Novel Self-assembling RADA-16 Peptide Matrix to Decrease Postoperative Epistaxis for Tonsillectomy Surgeries
Run by Rutgers, The State University of New Jersey · NCT07060495 · Data updated 2026-11-12
This trial will test whether applying RADA16 hydrogel during adult tonsillectomy reduces postoperative pain, bleeding, and the need for extra opioid medication.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 134 (estimated) |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Locations | 2 sites (Livingston, New Jersey and 1 other locations) |
| Status | Recruiting |
| Started | September 12, 2025 |
| Main results expected | December 1, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | July 23, 2026 |
| Trial ID | NCT07060495 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age ≥18) scheduled for tonsillectomy who can consent and are not undergoing additional procedures like adenoidectomy, who are not on chronic opioids or anticoagulants, and who have no bleeding disorder are ideal candidates.
✕Probably not a fit
Patients under 18, pregnant women, prisoners, those unable to consent, patients having concurrent adenoidectomy or uvulopalatopharyngoplasty, those with bleeding disorders or on anticoagulants, and chronic opioid users are unlikely to be eligible or may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, controlled Phase 3 trial enrolling adults undergoing tonsillectomy to compare standard postoperative care with and without intraoperative application of RADA16 hydrogel. Participants will be randomized to receive RADA16 plus the usual analgesic regimen (acetaminophen and NSAIDs with oxycodone as needed) or the usual regimen alone. Outcomes include postoperative pain, bleeding events, hospital readmission, and use of rescue opioids, collected via an emailed symptom survey every two days for 15 days and from clinical records. The trial is led by Rutgers and enrolls patients at Cooperman Barnabas Medical Center in Livingston and University Hospital in Newark, New Jersey.
Why it matters
Potential benefit: If successful, RADA16 could lower bleeding and pain after tonsillectomy and reduce patients' need for opioid rescue medication.
How similar studies have gone: Hemostatic peptide hydrogels like RADA16 have shown promise controlling bleeding in other ENT and gastrointestinal procedures, but randomized data specifically for adult tonsillectomy are limited.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
-
Cooperman Barnabas Medical Center
Livingston, New Jersey, United States Recruiting -
University Hospital
Newark, New Jersey, United States Not yet recruiting
Study contacts
- Principal investigator: Wayne D Hsueh, MD — Rutgers University
- Study coordinator: Wayne D Hsueh, MD
- Email: wayne.hsueh@rutgers.edu
- Phone: 973-972-4588
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.