Recruiting
Phase 2

RADA16

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT07188779

Conditions

Postoperative Pain

Eligibility Criteria

Sex: All

Age: 3 - 17

Healthy Volunteers: Not accepted

Interventions

RADA16 hydrogel

Study Details

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 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, plus an additional survey on day 30, and track their symptoms.

Conditions

Postoperative Pain

Study ID

NCT07188779

Start date

Jul 9, 2026

Status verified date

Jul, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 17

Healthy Volunteers: Not accepted

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 (Adenoidectomy, primary; younger than age 12)
  • 42831 (… age 12 or over)
  • 42835 (Adenoidectomy; secondary; younger than age 12)
  • 42836 (… age 12 or over)

Exclusion Criteria:

  • 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

Study Design

Enrollment

134 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: RADA16

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.

no intervention: Control arm

Patients randomized to the control arm will not undergo application of RADA16 hydrogel following hemostasis with suction monopolar electrocautery.

Interventions

RADA16 hydrogel

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.

Primary outcome measure

  • Postoperative pain [ Time Frame: From enrollment to post-operative day 30. ]

Central Contacts and Locations

Central contacts

Wayne D Hsueh, MD

973-972-4588wayne.hsueh@rutgers.edu

Gabriel Frimpong, MPH, PA

973-972-2309gf345@njms.rutgers.edu

Locations

University Hospital

Recruiting

Newark, New Jersey, United States, 07103

Contacts

Wayne D Hsueh, MD

9739722548wayne.hsueh@rutgers.edu

Principal Investigator:

Wayne Hsueh, MD

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

  • tonsillectomy
  • adenoidectomy
  • hemostasis
  • postop complications

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2026-07-22.