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RADA16 for Adult Tonsillectomy
RADA16 for Adult Tonsillectomy

NCT07060495

RecruitingPhase 3

Sponsor: Rutgers, The State University of New Jersey

Conditions: Postoperative Pain

Interventions: RADA16 hydrogel

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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)
Locations (2)
  • Livingston, New Jersey, United States
  • Newark, New Jersey, United States