RADA16 hydrogel use during adult tonsillectomy
Use of Novel Self-assembling RADA-16 Peptide Matrix to Decrease Postoperative Epistaxis for Tonsillectomy Surgeries
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 |
| Enrollment | 134 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Locations | 2 sites (Livingston, New Jersey and 1 other locations) |
| Trial ID | NCT07060495 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Livingston, New Jersey and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.