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Набира участници Фаза 3 NCT07060495

RADA16 for Adult Tonsillectomy

Фаза 3 – широко изпитване преди одобрение
Заболявания: Postoperative Pain

Спонсор: Rutgers, The State University of New Jersey

Налично на: БГ
Обобщение
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.
Описание
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.
Кой може да участва
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)
Интервенции
RADA16 hydrogel
DEVICE
Места на провеждане 2
САЩ (2)
Cooperman Barnabas Medical Center
Livingston , New Jersey
University Hospital
Newark , New Jersey
NOT_YET_RECRUITING
Gabriel Frimpong, MPH, PA
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
12.09.2025
Крайна дата
01.12.2026
Регистрационен номер
NCT07060495
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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