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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rutgers, The State University of New Jersey
Lead Sponsor