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NCT Number: NCT07060495

RADA16 for Adult Tonsillectomy

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cooperman Barnabas Medical Center, Livingston, New Jersey, United States

Loading trial locations.

About this study

This is a prospective study evaluating the impact of intraoperative RADA16 application on the postoperative course following 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adults undergoing tonsillectomy (CPT codes)

Exclusion criteria

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)

Treatment and study plan

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.

Other names: puragel

Primary outcomes

  1. Postoperative Pain

    Time frame: From enrollment to post-operative day fifteen

    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.

Secondary outcomes

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

    Time frame: From enrollment to post-operative day fifteen

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

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

    Time frame: From enrollment to post-operative day fifteen

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

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

    Time frame: From enrollment to post-operative day fifteen

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

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

    Time frame: From enrollment to post-operative day fifteen

    Number of participants who use a rescue analgesic following their tonsillectomy procedure

  5. Days participants take to resume their regular diet post operation

    Time frame: From enrollment to post-operative day fifteen

    Recording how many days it takes for participants to return to their regular diet post operation

Study contacts

Contact information is provided by the study sponsor or research team.

Emily Kwon, BA

CONTACT

[email protected]

Wayne D Hsueh, MD

CONTACT

[email protected]

973-972-4588

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Official study title

Use of Novel Self-assembling RADA-16 Peptide Matrix to Decrease Postoperative Epistaxis for Tonsillectomy Surgeries

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 11, 2025
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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