Impact of RADA16 Use on Outcomes Following Tonsillectomy in Children
Recruiting
Phase 2
Interventional Study
Postoperative Pain
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 3 – 17
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 134 (estimated)
- Sponsor
- Rutgers, The State University of New Jersey · Other
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About This Trial
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 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 sur…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
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 (Adenoid…
Contacts