Use of Novel Self-assembling RADA-16 Peptide Matrix to Decrease Postoperative Epistaxis for Tonsillectomy Surgeries
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 134
- 试验地点
- 3
- 主要终点
- Postoperative Pain
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults undergoing tonsillectomy (CPT codes)
排除标准
- •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
- •Adults unable to consent (anyone lacking capacity)
研究组 & 干预措施
Control arm
Patients randomized to the control arm will not undergo application of RADA16 hydrogel following hemostasis with suction monopolar electrocautery.
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.
干预措施: RADA16 hydrogel (Device)
结局指标
主要结局
Postoperative Pain
时间窗: 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.
次要结局
- Number of Participants with post-tonsillectomy hemorrhage who receive topical agents(From enrollment to post-operative day fifteen)
- Days participants take to resume their regular diet post operation(From enrollment to post-operative day fifteen)
- Number of Participants with post-tonsillectomy hemorrhage who require a return to the operating room(From enrollment to post-operative day fifteen)
- Number of participants who require hospital readmission for post tonsillectomy hemorrhage management(From enrollment to post-operative day fifteen)
- Number of participants who require a rescue analgesic for management following tonsillectomy procedure(From enrollment to post-operative day fifteen)
研究者
Wayne Daniel Hsueh, MD
ASSOC PROF-CLIN
Rutgers, The State University of New Jersey