Status:
NOT_YET_RECRUITING
Impact of RADA16 Use on Outcomes Following Tonsillectomy in Children
Lead Sponsor:
Rutgers, The State University of New Jersey
Conditions:
Postoperative Pain
Eligibility:
All Genders
3-17 years
Phase:
PHASE2
Brief Summary
The purpose of the research is to determine if RADA16 (also known as PuraStat®, PuraGel®, or PuraSinus®) improves patient outcomes following pediatric tonsillectomy procedures. Researchers will compar...
Detailed Description
This is a prospective study evaluating the impact of intraoperative RADA16 application on the postoperative course following pediatric tonsillectomy as it relates to pain, bleeding, readmission, and u...
Eligibility Criteria
Inclusion
- Children aged 3-17 years undergoing tonsillectomy +/- adenoidectomy CPT codes
- 42820 (Tonsillectomy and adenoidectomy; younger than age 12)
- 42821 (… age 12 or over)
- 42825 (Tonsillectomy; primary or secondary; younger than age 12)
- 42826 (… age 12 or over)
- 42830 (Adenoidectomy, primary; younger than age 12)
- 42831 (… age 12 or over)
- 42835 (Adenoidectomy; secondary; younger than age 12)
- 42836 (… age 12 or over)
Exclusion
- Children with bleeding disorders or other hematologic malignancy or taking anticoagulant medications Developmental delay affecting pain reporting Children with known allergies to RADA16 components Children with prior tonsillectomy or tonsillotomy Children undergoing tonsillectomy with concern for cancer, Children taking opioids chronically prior to surgery, Anyone pregnant women, incarcerated individuals, children unable to speak English or Spanish
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT07188779
Start Date
December 1 2025
End Date
May 1 2027
Last Update
September 23 2025
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