Impact of RADA16 Use on Outcomes Following Tonsillectomy in Children

NCT07188779 | Recruiting Phase 2 FDA Device

• 1 other identifier: Pro2025001802
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 2

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

Keywords

tonsillectomy; adenoidectomy; hemostasis; postop complications

Outcome Measures

Primary Outcomes (1)

• Postoperative pain

  Pain assessed via the Wong Baker Faces scale. The primary outcome measure will be assessed via online survey on post-operative day one then subsequently every other day until post-operative day fifteen, with a final survey on day 30.

  From enrollment to post-operative day 30.

Secondary Outcomes (5)

• Number of Participants with post-tonsillectomy hemorrhage who receive topical agents

  From enrollment to post-operative day 30

• Number of Participants with post-tonsillectomy hemorrhage who require a return to the operating room

  From enrollment to post-operative day 30

• Number of participants who require hospital readmission for post tonsillectomy hemorrhage management

  From enrollment to post-operative day thirty

• Number of participants who require a rescue analgesic for management following tonsillectomy procedure

  From enrollment to post-operative day 30

• Days participants take to resume their regular diet post operation

  From enrollment to post-operative day 30

Study Arms (2)

RADA16

ACTIVE COMPARATOR

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.

Device: RADA16 hydrogel

Control arm

NO INTERVENTION

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

Interventions

RADA16 hydrogel DEVICE

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.

Also known as: puragel

RADA16

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 3-17 years undergoing tonsillectomy +/- adenoidectomy CPT codes
• (Tonsillectomy and adenoidectomy; younger than age 12)
• (… age 12 or over)
• (Tonsillectomy; primary or secondary; younger than age 12)
• (… age 12 or over)
• (Adenoidectomy, primary; younger than age 12)
• (… age 12 or over)
• (Adenoidectomy; secondary; younger than age 12)
• (… age 12 or over)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (2)

Cooperman Barnabas Medical Center

Livingston, New Jersey, 07039, United States

NOT YET RECRUITING

University Hospital

Newark, New Jersey, 07103, United States

RECRUITING

Related Publications (3)

• Mitchell RB, Archer SM, Ishman SL, Rosenfeld RM, Coles S, Finestone SA, Friedman NR, Giordano T, Hildrew DM, Kim TW, Lloyd RM, Parikh SR, Shulman ST, Walner DL, Walsh SA, Nnacheta LC. Clinical Practice Guideline: Tonsillectomy in Children (Update). Otolaryngol Head Neck Surg. 2019 Feb;160(1_suppl):S1-S42. doi: 10.1177/0194599818801757.

  PMID: 30798778 BACKGROUND

• Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.

  PMID: 23392233 BACKGROUND

• Pynnonen M, Brinkmeier JV, Thorne MC, Chong LY, Burton MJ. Coblation versus other surgical techniques for tonsillectomy. Cochrane Database Syst Rev. 2017 Aug 22;8(8):CD004619. doi: 10.1002/14651858.CD004619.pub3.

  PMID: 28828761 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Wayne D Hsueh, MD

CONTACT

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

Gabriel Frimpong, MPH, PA

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOC PROF-CLIN

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 23, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)