RADA16 for Postoperative Pain
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?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo tonsillectomy procedure with or without RADA16 application
Follow-up
Participants are monitored for pain, bleeding, and recovery post tonsillectomy
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?
2
Treatment groups
Active Control
Patients randomized to the control arm will not undergo application of RADA16 hydrogel following hemostasis with suction monopolar electrocautery.
Patients randomized to the treatment arm will undergo 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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rutgers, The State University of New Jersey
Lead Sponsor
Citations
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 Tonsillectomy
This 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 Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.