RADA16 for Adult Tonsillectomy

Rutgers The State University of New Jersey

Status and phase: Enrolling; Phase 3

Conditions: Postoperative Pain

Treatments: Device: RADA16 hydrogel

Study type: Interventional

Funder types: Other

Identifiers

NCT07060495

Pro2024001000

FP00039655 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 134 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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134 participants in 2 patient groups

RADA16

Active Comparator group

Description:

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.

Treatment:

Device: RADA16 hydrogel

Control arm

No Intervention group

Description:

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