DuraSeal Sealant Post Market Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 237
- 试验地点
- 2
- 主要终点
- Percentage of Subjects With Surgical Wound Complications, Central Nervous System Events, and Neurosurgical Complications Related to Unplanned Intervention or Return to the Operating Room.
研究概览
简要总结
DuraSeal Dural Sealant has been approved as a dural sealant by the FDA for use in cranial and spinal procedures. This study was completed to further evaluate the safety of the DuraSeal Sealant in a post-approval setting as compared to control (defined as methods typically employed by surgeons to seal the dura).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is between 18 and 75 years of age
- •Patient is scheduled for an elective cranial procedure that entails a dural incision
- •Evidence of intraoperative non-watertight closure
排除标准
- 未提供
研究组 & 干预措施
1
DuraSeal Dural Sealant System - FDA Approved Device:
The DuraSeal™ Dural Sealant System is a polyethylene glycol (PEG) hydrogel that has been FDA approved as a dural sealant to achieve watertight dural closure in cranial and spinal surgery after primary repair with suturing is complete. It was developed as a means of providing a dural seal by covering small holes around the suture with an absorbable hydrogel.
干预措施: DuraSeal Dural Sealant System (Device)
2
Standard of Care (control):
Standard procedure to obtain intraoperative watertight dural closure. These methods could have included additional sutures, adhesive glue, absorbable gelatin sponge, dural substitute, soft tissue patch, or another method typically used by the investigator.
干预措施: Standard of Care (Other)
结局指标
主要结局
Percentage of Subjects With Surgical Wound Complications, Central Nervous System Events, and Neurosurgical Complications Related to Unplanned Intervention or Return to the Operating Room.
时间窗: 30 days
Surgical Wound Complications; * Superficial incisional surgical site infection (SSI) * Deep incisional SSI * Organ/Space SSI * Late incisional infection: superficial incisional infection that occurs more than 31 but less than 38 days after surgery * Poor wound healing Central Nervous System Events; * Cerebrospinal Fluid (CSF) leak * Hydrocephalus * Bacterial meningitis * Aseptic meningitis In addition, any complication related to the neurosurgical procedure that required unplanned intervention (i.e., minimally invasive procedures) or return to the operating room was counted.
次要结局
- Percentage of Subjects With Post-operative Surgical Site Infections(30 days)
- Percentage of Subjects With a Cerebrospinal Fluid (CSF) Leak(30 days)