RADA16 Hydrogel for Post-Tonsillectomy Complications
(RADA16 for Ped Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a gel called RADA16 hydrogel to determine if it aids recovery in children after tonsil removal. Tonsil removal can sometimes cause bleeding, and the study aims to find out if RADA16 can reduce this issue. Children undergoing tonsil removal who have experienced this problem before might be suitable for the trial. Participants will apply the gel during their procedure and report their experiences through regular online surveys for a month. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.
What prior data suggests that the RADA16 hydrogel is safe for post-tonsillectomy use?
Research has shown that RADA16 hydrogel is generally safe for people. In earlier studies, patients who used RADA16 during surgeries did not report any specific issues caused by the gel. For example, one study found that fewer patients treated with RADA16 had to return to the hospital because of bleeding. Specifically, only 4.8% of patients who received RADA16 needed to come back for bleeding, compared to 14.6% in the group that did not use it. These findings suggest that the hydrogel is not only safe but also helps reduce problems like bleeding after surgery. Overall, RADA16 appears to be well-tolerated.12345
Why do researchers think this study treatment might be promising?
Unlike the standard care options for post-tonsillectomy complications, such as pain relief through medications like ibuprofen or acetaminophen and the use of cold compresses, RADA16 hydrogel offers a unique approach. This treatment involves applying a 2.5% hydrogel directly to the tonsillar area, forming a protective layer. Researchers are excited because this gel acts as a barrier, potentially reducing bleeding and promoting faster healing. This method could lead to a more comfortable recovery compared to conventional care, which primarily addresses symptoms rather than directly enhancing the healing process.
What evidence suggests that the RADA16 hydrogel is effective for post-tonsillectomy complications?
Research has shown that RADA16 hydrogel can help reduce complications after tonsil removal. In this trial, participants in the treatment arm will receive RADA16 hydrogel. Previous studies have demonstrated that it significantly lowers the chance of returning to the hospital for post-surgery bleeding—only 4.8% compared to 14.6% for those who did not use it. Another review found that RADA16 reduced the risk of bleeding after surgery from 16.7% to 6.3%. These findings suggest that RADA16 effectively aids recovery by reducing bleeding after tonsil removal. Participants in the control arm will not receive the RADA16 hydrogel.12346
Are You a Good Fit for This Trial?
This trial is for children aged 3 to 17 years who are having their tonsils removed, with or without adenoid removal. Participants must be scheduled for a tonsillectomy procedure.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
Postoperative Monitoring
Participants receive and fill out a survey every 2 days for 15 days, plus an additional survey on day 30, to track symptoms and outcomes
Follow-up
Participants are monitored for safety and effectiveness after treatment, including pain, bleeding, and readmission
What Are the Treatments Tested in This Trial?
Interventions
- RADA16 hydrogel
Trial Overview
The study compares the use of RADA16 hydrogel (a gel applied during surgery) versus no gel in children after tonsil removal, to see if it helps reduce bleeding and improve recovery. Participants will track symptoms through surveys after surgery.
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
Application of the Self-Assembling Peptide Hydrogel RADA16 ...
Readmission rates for postoperative bleeding were 3-fold higher in Controls (14.6%; n = 24/164 subjects) than in the RADA16-treated group (4.8%; ...
NCT07060495 | RADA16 for Adult Tonsillectomy
The purpose of the research is to determine if RADA16 (also known as PuraStat®, PuraGel®, or PuraSinus®) improves patient outcomes following tonsillectomy ...
3.
researchgate.net
researchgate.net/figure/Readmission-and-re-operation-rates-after-tonsillectomy-with-and-without-RADA16-hemostatic_fig1_384123801Readmission and re-operation rates after tonsillectomy ...
Readmission and re-operation rates after tonsillectomy with and without RADA16 hemostatic hydrogel application to the tonsil wound beds.
RADA16 for Postoperative Pain
These findings suggest that RADA16 may improve recovery after tonsillectomy by reducing pain and bleeding. Show more. Who Is on the Research Team ...
A Systematic Review of RADA16 Self-Assembling Peptide ...
Results: Eight studies involving 1761 patients were included. In oropharyngeal surgery, RADA16 significantly reduced postoperative haemorrhage (6.3% vs. 16.7%, ...
RADA16 for Post-Tonsillectomy Recovery in Children
This clinical study explores how using a substance called RADA16 during surgery might affect children who have their tonsils removed. Tonsillectomy, or the ...
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