Impact of RADA16 Use on Outcomes Following Tonsillectomy in Children

NCT ID: NCT07188779

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2027-05-01

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.

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 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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

RADA16 hydrogel

Intervention Type: 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.

Control arm

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Intervention Type: DEVICE

Other Intervention Names

puragel

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 (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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Wayne Daniel Hsueh, MD

ASSOC PROF-CLIN

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Wayne D Hsueh, MD

Role: CONTACT

wayne.hsueh@rutgers.edu

973-972-4588

Gabriel Frimpong, MPH, PA

Role: CONTACT

gf345@njms.rutgers.edu

973-972-2309

References

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.

Reference Type: BACKGROUND

PMID: 30798778 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23392233 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28828761 (View on PubMed)

Other Identifiers

Pro2025001802

Identifier Type: -

Identifier Source: org_study_id