RADA16 for Adult Tonsillectomy

NCT07060495 | Recruiting Phase 3 FDA Device

• 2 other identifiers: Pro2024001000FP00039655
• 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 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 and track their symptoms.

Conditions

Postoperative Pain

Keywords

tonsillectomy; hemostasis; postop complications

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain

  Pain assessed via the pain visual analog scale (VAS). 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.

  From enrollment to post-operative day fifteen

Secondary Outcomes (5)

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

  From enrollment to post-operative day fifteen

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

  From enrollment to post-operative day fifteen

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

  From enrollment to post-operative day fifteen

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

  From enrollment to post-operative day fifteen

• Days participants take to resume their regular diet post operation

  From enrollment to post-operative day fifteen

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: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults undergoing tonsillectomy (CPT codes)

You may not qualify if:

• Patients undergoing adenoidectomy or uvulopalatopharyngoplasty in addition to tonsillectomy
• Patients who have had prior tonsillectomy or tonsillotomy
• Patient undergoing tonsillectomy with concern for malignancy
• Patients who are on opioids chronically prior to surgery
• Patients with an additional indication for pain management (i.e. unrelated to tonsillectomy)
• Patients who have been diagnosed with a bleeding disorder or hematologic malignancy
• Patients who are on anticoagulants
• The following at-risk populations:
• Anyone under age 18
• Pregnant women
• Prisoners
• Adults unable to consent (anyone lacking capacity)

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (2)

Cooperman Barnabas Medical Center

Livingston, New Jersey, 07039, United States

RECRUITING

University Hospital

Newark, New Jersey, 07103, United States

NOT YET RECRUITING

Related Publications (3)

• 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

• 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

• 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

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Wayne D Hsueh, MD

  Rutgers University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wayne D Hsueh, MD

CONTACT

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

Emily Kwon, BA

CONTACT

esk104@njms.rutgers.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: June 17, 2025
• First Posted: July 11, 2025
• Study Start: September 12, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)