Cosgrove G Rees, Delashaw Johnny B, Grotenhuis J Andre, Tew John M, Van Loveren Harry, Spetzler Robert F, Payner Troy, Rosseau Gail, Shaffrey Mark E, Hopkins L Nelson, Byrne Richard, Norbash Alex
Massachusetts General Hospital, Boston, Massachusetts, USA.
J Neurosurg. 2007 Jan;106(1):52-8. doi: 10.3171/jns.2007.106.1.52.
The authors prospectively evaluated the safety and efficacy of a novel polyethylene glycol (PEG) hydrogel sealant in patients undergoing elective cranial surgery with documented cerebrospinal fluid (CSF) leakage after sutured dural repair.
The PEG hydrogel sealant was used at 11 different study sites in 111 patients with documented intraoperative CSF leakage after neurosurgical dural repair for a variety of conditions. Intraoperative CSF leakage was either spontaneous or induced by a Valsalva maneuver. Patients were monitored for 3 months postoperatively with physical examinations, clinical laboratory analyses, and diagnostic imaging. The PEG hydrogel sealant was 100% effective in stopping CSF leakage in all patients. There were no sealant-related adverse events and all clinical outcomes were consistent with expectations for seriously ill patients undergoing prolonged neurosurgical procedures.
The PEG hydrogel sealant provides a safe and effective watertight closure when used as an adjunct to sutured dural repair during cranial surgery.
作者前瞻性评估了一种新型聚乙二醇（PEG）水凝胶密封剂在择期开颅手术且硬膜修复后有脑脊液（CSF）漏记录患者中的安全性和有效性。
PEG水凝胶密封剂在11个不同研究地点用于111例因各种情况行神经外科硬膜修复术后有术中CSF漏记录的患者。术中CSF漏为自发性或由瓦尔萨尔瓦动作诱发。术后对患者进行3个月的监测，包括体格检查、临床实验室分析和诊断成像。PEG水凝胶密封剂在所有患者中阻止CSF漏的有效率为100%。没有与密封剂相关的不良事件，所有临床结果与接受长时间神经外科手术的重症患者的预期一致。
PEG水凝胶密封剂在开颅手术中作为缝合硬膜修复的辅助手段使用时，可提供安全有效的水密性封闭。
