134 Participants Needed

RADA16 for Postoperative Pain

Recruiting at 1 trial location
WD
EK
Overseen ByEmily Kwon, BA
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Rutgers, The State University of New Jersey
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a gel called RADA16 can reduce bleeding after tonsil removal. Researchers will compare patients who receive the RADA16 gel with those who do not to assess its impact on recovery. Participants must complete a survey every two days for 15 days post-surgery to track symptoms and recovery. The trial seeks adults scheduled for tonsil removal who have no complicating medical conditions. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on anticoagulants or opioids chronically before surgery.

What prior data suggests that the RADA16 device is safe for postoperative use?

Research has shown that RADA16, a special gel, is safe for use during surgeries. In earlier studies, patients did not report any problems caused by the gel, and surgeons found it easy to use. The gel aids in wound healing and reduces the risk of scar tissue formation after surgery. This indicates that RADA16 is safe and does not cause harm when used in surgeries.12345

Why do researchers think this study treatment might be promising?

Unlike standard treatments for postoperative pain, which often involve oral pain relievers or opioids, RADA16 is a hydrogel applied directly to the surgical site. This unique delivery method allows for targeted pain management right at the source, potentially reducing the need for systemic medications and their associated side effects. Researchers are excited about RADA16 because it could offer a safer, localized option for managing pain after surgery, minimizing discomfort and promoting faster recovery. Moreover, the hydrogel's direct application may be more effective in providing immediate relief compared to oral medications that take time to work through the body.

What evidence suggests that the RADA16 device is effective for postoperative pain following tonsillectomy?

Studies have shown that RADA16, a protein-based gel, can effectively reduce pain when applied to surgical sites. In this trial, some participants will receive RADA16, and patients have reported less pain on the side treated with RADA16 compared to other treatments. Research also indicates that RADA16 helps control bleeding after surgery, performing as well as other common solutions used to stop bleeding. Additionally, using RADA16 has been linked to fewer hospital readmissions and fewer additional surgeries for issues like bleeding and pain. These findings suggest that RADA16 may improve recovery after tonsillectomy by reducing pain and bleeding.13567

Who Is on the Research Team?

WD

Wayne D Hsueh, MD

Principal Investigator

Rutgers University

Are You a Good Fit for This Trial?

This trial is for adults who are scheduled to have their tonsils removed. They must be willing to fill out a survey every two days after the procedure for 15 days to track symptoms.

Inclusion Criteria

I am an adult scheduled for a tonsillectomy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo tonsillectomy procedure with or without RADA16 application

1 day
1 visit (in-person)

Follow-up

Participants are monitored for pain, bleeding, and recovery post tonsillectomy

15 days
Surveys every 2 days (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • RADA16
Trial Overview The study is testing RADA16 hydrogel, also known as PuraStat®, PuraGel®, or PuraSinus®. It aims to see if applying this device during a tonsillectomy can improve outcomes and treat post-surgery bleeding compared with not using any device.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: Control armActive Control1 Intervention
Group II: RADA16Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials
471
Recruited
81,700+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38932659/
Efficacy of a RADA-16 peptide hydrogel versus chitosan ...During the week 1 postoperative debridement, patients reported significantly less pain on the hydrogel-treated side compared to the chitosan- ...
Efficacy of a RADA‐16 peptide hydrogel versus chitosan ...The primary efficacy hypothesis of the study was that the hydrogel would reduce patient-reported pain during the postoperative debridement of ...
Self-assembling RADA16 peptide hydrogel supports ...We report that RADA16 administration to wound sites reduced postoperative bleeding time similar to a hemostatic gelatin-thrombin comparator formulation, but ...
NCT07060495 | RADA16 for Adult TonsillectomyThis is a prospective study evaluating the impact of intraoperative RADA16 application on the postoperative course following tonsillectomy as it relates to pain ...
Application of the Self-Assembling Peptide Hydrogel ...Main effectiveness outcomes were the readmission and reoperation rates for any reason, for recalcitrant PTH, and for pain management. The primary safety outcome ...
Application of the Self-Assembling Peptide Hydrogel ...No device-related adverse events occurred in the RADA16 group. Surgeons were pleased with the easy learning curve and technical feasibility ...
A blinded randomised controlled study (PuraBond® PROOF)PuraBond® use following head and neck mucosal resections is a safe and potentially useful surgical adjunct in reducing postoperative pain. The ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security