RADA16 for Adult Tonsillectomy

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified March 2026 by Rutgers, The State University of New Jersey
Sponsor
Rutgers, The State University of New Jersey
Information Provided by (Responsible Party)
Wayne Daniel Hsueh, MD
Clinicaltrials.gov Identifier
NCT07060495
Other Study ID Numbers:
Pro2024001000
First Submitted
June 16, 2025
First Posted
July 10, 2025
Last Update Posted
April 20, 2026
Last Verified
March 2026

ClinicalTrials.gov processed this data on April 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

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.

Condition or DiseaseIntervention/Treatment
Postoperative Pain
Device: RADA16 hydrogel

Study Design

Study TypeInterventional
Actual Enrollment134 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingSingle
Primary PurposeTreatment
Official TitleUse of Novel Self-assembling RADA-16 Peptide Matrix to Decrease Postoperative Epistaxis for Tonsillectomy Surgeries
Study Start DateSeptember 11, 2025
Actual Primary Completion Date5mos 4w from now
Actual Study Completion Date5mos 4w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
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.
Device: 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.
Control arm
Patients randomized to the control arm will not undergo application of RADA16 hydrogel following hemostasis with suction monopolar electrocautery.

Outcome Measures

Primary Outcome Measures
  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.
Secondary Outcome Measures
  1. Number of Participants with post-tonsillectomy hemorrhage who receive topical agents
    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
    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
    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
    Number of participants who use a rescue analgesic following their tonsillectomy procedure
  5. Days participants take to resume their regular diet post operation
    Recording how many days it takes for participants to return to their regular diet post operation

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Inclusion criteria: Adults undergoing tonsillectomy (CPT codes)
Exclusion Criteria
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)

Contacts and Locations

Sponsors and CollaboratorsRutgers, The State University of New Jersey
Locations
Cooperman Barnabas Medical Center | Livingston New Jersey, United States, 07039University Hospital | Newark New Jersey, United States, 07103
Investigators
Principal Investigator: Wayne D Hsueh, MD, Rutgers University