Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2026-01-02 @ 12:10 AM
Study NCT ID:
NCT07060495
Status:
RECRUITING
Last Update Posted:
2025-11-13
First Post:
2025-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RADA16 for Adult Tonsillectomy
Sponsor:
Rutgers, The State University of New Jersey
Organization:
Study Overview
Official Title:
Use of Novel Self-assembling RADA-16 Peptide Matrix to Decrease Postoperative Epistaxis for Tonsillectomy Surgeries
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the research is to determine if RADA16 (also known as PuraStat®, PuraGel®, or PuraSinus®) improves patient outcomes following tonsillectomy procedures.
Researchers will compare application of device RADA16 to application of no device to see if RADA16 works to treat post tonsillectomy hemorrhage.
Participants will:
* Undergo tonsillectomy procedure.
* Receive and fill out a survey sent via email every 2 days following their procedure for 15 days and track their symptoms.
Researchers will compare application of device RADA16 to application of no device to see if RADA16 works to treat post tonsillectomy hemorrhage.
Participants will:
* Undergo tonsillectomy procedure.
* Receive and fill out a survey sent via email every 2 days following their procedure for 15 days and track their symptoms.
Detailed Description:
This is a prospective study evaluating the impact of intraoperative RADA16 application on the postoperative course following tonsillectomy as it relates to pain, bleeding, readmission, and use of a rescue analgesic (ex., oxycodone). We propose a randomized controlled trial whereby patients undergoing tonsillectomy would either receive a standard analgesic regimen (postoperative acetaminophen and NSAIDs plus oxycodone as a supplemental analgesic) versus intraoperative RADA16 application plus a standard analgesic regimen.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| FP00039655 | OTHER_GRANT | 3-D Matrix | View |