NCT02891070已完成3 期
A Randomised Controlled Study to Evaluate the Efficacy and Safety of Fibrin Sealant, Vapour Heated, Solvent/Detergent Treated FS VH S/D 500 S-apr (Tisseel) Compared to DuraSeal Dural Sealant as an Adjunct to Sutured Dural Repair in Cranial Surgery.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 25
- 主要终点
- Number of Participants With No CSF Leak During and After Surgery
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of FS VH S/D 500 s-apr for use as an adjunct to sutured dural repair in cranial surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patients undergoing craniotomy/craniectomy for pathological processes in the PF or ST region
- •Patients must be willing and able to participate in the study and provide written IC before any protocol specific assessment is performed
- •Patients must be willing to receive peri-operative antibiotic prophylaxis
- •Female patients of childbearing potential must present with a negative serum pregnancy test, and must agree to employ adequate birth control measures [restricted to abstinence, barrier contraceptives, intrauterine contraceptive devices or licensed hormonal products] for the duration of their participation in the study
- •Patients are willing and able to comply with the requirements of the protocol
排除标准
- •Patients with a dural lesion from a recent surgery that still has the potential for CSF leakage
- •Patients who had undergone chemotherapy treatment, excluding hormonal therapy, within 3 weeks prior to the planned procedure, or with chemotherapy scheduled within 7 days following surgery
- •Patients with radiation therapy to the surgical site or standard fractionated radiation therapy scheduled within 7 days following surgery
- •Patients with a previous craniotomy/craniectomy within 6 months prior to the study surgery
- •Use of corticosteroids on a chronic basis (defined as daily use of corticosteroids for ≥8 weeks) for purposes other than decreasing the symptoms of systemic chemotherapy (unless if those steroids were discontinued 4 weeks prior to the planned surgery)
- •Patients with a known hypersensitivity to the components of the IP or control (human fibrinogen, synthetic aprotinin, human albumin, human FXIII, tri sodium citrate, histidine, niacinamide, polysorbate 80, human thrombin, polyethylene glycol [PEG], trilysine amine)
- •Patients with a known hypersensitivity to US Federal Drug & Cosmetic Blue #1 dye
- •Evidence of an infection indicated by any one of the following: clinical examination supporting the diagnosis of infection, fever (temperature >100.7°F or 38.2°C), positive urine culture, positive blood culture, positive chest X ray consistent with pulmonary infection, or infection along the planned surgical path. A white blood cell (WBC) count of <20000 cells/µL is permitted if the patient is being treated with steroids in the absence of all other infection parameters
- •Female patients of childbearing potential with a positive pregnancy test or intent to become pregnant during the clinical study period
- •Female patients who are nursing
- •Patients with exposure to another investigational drug or device clinical trial within 30 days prior to enrolment or anticipated in the 60-day Follow-up period
- •Patients with severely altered renal function as confirmed by local laboratory reference ranges for serum creatinine and/or hepatic function (alanine aminotransferase [ALT], aspartate aminotransferase >3 × upper limit of normal [ULN])
- •Patients who currently have or have had a compromised immune system (such as Acquired Immune Deficiency Syndrome [AIDS]) or autoimmune disease, or were on chronic immunosuppressant agents
- •Patients with uncontrolled diabetes as evidenced by the institution's standard of care (glycated haemoglobin [HbA1c] >7%, blood glucose, etc.)
- •Patients with traumatic injuries to the head
- •Patients with dural injury during craniotomy/craniectomy that cannot be eliminated by widening the craniotomy/craniectomy to recreate the native dural cuff
- •Patients requiring surgical approaches that would not allow sutured dural closure such as trans-sphenoidal or translabyrinthine/-petrosal/-mastoid. Superficial penetration of mastoid air cells is allowed
- •Patients with hydrocephalus, except occlusive hydrocephalus caused by PF pathology or incompletely open cerebrospinal fluid pathways, to be treated during surgical procedure
- •Existing CSF (ventricular, etc.) drains, Cushing/Dandy cannulation, or Burr holes which damage the dura
- •Patients with confined bony structures where nerves are present and neural compression may result due to swelling
研究组 & 干预措施
FS VH S/D 500 s-apr
Experimental
FS VH S/D 500 s-apr (Tisseel), single use treatment, intraoperative
干预措施: FS VH S/D 500 s-apr (Drug)
DuraSeal Dural Sealant
Active Comparator
DuraSeal Dural Sealant, single use treatment, intraoperative
干预措施: DuraSeal Dural Sealant (Device)
结局指标
主要结局
Number of Participants With No CSF Leak During and After Surgery
时间窗: Day 0 (Intra-operative) to Day 30 (+/-3 days) post-operative
Participants who have no intra-operative CSF leak from dural repair after up to two applications during Valsalva maneuver (25 cm H2O for up to 5 - 10 seconds), or post-operative CSF leak within 30 (+3) days post-operatively. The Valsalva maneuver was performed by the anaesthesiologist to increase the intra-thoracic pressure (e.g., by increasing the positive end-expiratory pressure or by giving a large tidal volume and holding the inflating pressure) to approximately 25 cm H2O, constantly for up to 5 - 10 seconds to transiently elevate the intracranial pressure and test for any CSF leaks. The suture line was to be watertight after up to two product/control applications and Valsalva maneuvers.
次要结局
- Number of Participants With no Intra-operative CSF Leaks Following Final Valsalva Maneuver(Day 0 (Intra-operative))
- Number of Participants With CSF Leaks Within 30 (+3) Days Post-operatively(Day 0 (Intra-operative) to Day 30 (+/-3 days) post-operative)
- Time From Dural Closure (Application of IP) Until End of Surgery(Day 0 (Intra-operatively))
- Duration in Surgery (Minutes)(Day 0 (intra-operatively))
- Length of Stay in Hospital (Days).(Day 0 to Day 60 (Study Completion))
研究者
研究点 (25)
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