Recently the use of biologic materials as dura mater repair patches has been increasing. The purpose of this study is to assess the basis for efficacy and safety of using a novel fish derived acellular dermis (Kerecis...Recently the use of biologic materials as dura mater repair patches has been increasing. The purpose of this study is to assess the basis for efficacy and safety of using a novel fish derived acellular dermis (Kerecis Omega3 DuraTM). In an ovine model a craniotomy under general anaesthesia was performed. A defect was produced in the dural covering of approximately 1 × 2 cm and closed with an onlay technique, with Kerecis Omega3 Dura. The bone defect was covered with the bony flap and the overlying tissues closed in layers. At 2, 5, 8 and 11 weeks the sheep underwent MRI scanning followed by euthanasia, necropsy and histological assessment. MRI images taken at 2, 5, 8 and 11 weeks showed initially moderate inflammatory response, which diminished over time, and at 11 weeks no evidence of inflammation existed. There was evidence of cerebrospinal fluid leakage at no time point. Necropsy revealed some adhesions at 5 and 8 weeks, in particular at 5 weeks, but at 11 weeks there were no adhesions found. From 2 - 11 weeks, there was evidence of initially an inflammatory reaction followed by neodura formation at the defect site through cellular ingrowth and remodeling of the acellular fish skin. Histology showed a histiocytic foreign body reaction initially that subsided over time. As early as 8 weeks there was evidence of neodura formation and by 11 weeks there was a minimal inflammatory response with an intact neodura formed. In this pilot study the Kerecis Omega3 Dura patches performed in a safe and efficacious manner. This new material needs to be fully assessed and compared with other products that are currently on the market in a larger scale animal study.展开更多
目的探讨硬膜双层修补在额颞区大骨瓣减压术后颅骨缺损修补中的临床效果。方法选取2014年2月至2016年2月本院收治的120例额颞区大骨瓣减压术后颅骨缺损患者为研究对象,根据患者于本院行硬膜双层修补时间(以2015年1月1日为节点)不同,将...目的探讨硬膜双层修补在额颞区大骨瓣减压术后颅骨缺损修补中的临床效果。方法选取2014年2月至2016年2月本院收治的120例额颞区大骨瓣减压术后颅骨缺损患者为研究对象,根据患者于本院行硬膜双层修补时间(以2015年1月1日为节点)不同,将其分为观察组(2015年1月1日前,62例)和对照组(2015年1月1日后,58例)。观察组患者行硬膜双层修补术,对照组患者行硬膜单层修补术。记录和比较两组患者的手术时间、术中出血量、引流管拔除时间及住院天数;记录和观察术前1天(T1)、术后7天(T2)、术后14天(T3)两组患者的认知功能、运动功能及日常生活能力。术前1天和术后3个月,采用磁共振灌注加权成像评估患者脑灌注情况,记录并比较两组患者灌注异常指数(perfusion abnormality index,PAI)。结果观察组患者住院天数和引流管拔除时间均显著短于对照组(P<0.05),两组患者手术时间和术中出血量比较均无显著差异(P>0.05)。两组患者简易精神状况检查(mini-mental state examination,MMSE)量表评分随时间延长显著上升(P<0.05),神经功能缺损程度评分随时间延长显著下降(P<0.05)。T2和T3时,观察组患者术后MMSE量表评分均显著高于对照组(P<0.05),神经功能缺损程度评分均显著低于对照组(P<0.05)。观察组患者并发症发生率显著低于对照组(P<0.05)。术后3个月,两组患者PAI较术前1天均显著下降(P<0.05),且观察组患者PAI显著低于对照组(P<0.05)。结论硬膜双层缝合在额颞区大骨瓣减压术后颅骨缺损修补中的效果明显,手术时间较短,术中出血量较少,术后并发症发生率较低。展开更多
文摘Recently the use of biologic materials as dura mater repair patches has been increasing. The purpose of this study is to assess the basis for efficacy and safety of using a novel fish derived acellular dermis (Kerecis Omega3 DuraTM). In an ovine model a craniotomy under general anaesthesia was performed. A defect was produced in the dural covering of approximately 1 × 2 cm and closed with an onlay technique, with Kerecis Omega3 Dura. The bone defect was covered with the bony flap and the overlying tissues closed in layers. At 2, 5, 8 and 11 weeks the sheep underwent MRI scanning followed by euthanasia, necropsy and histological assessment. MRI images taken at 2, 5, 8 and 11 weeks showed initially moderate inflammatory response, which diminished over time, and at 11 weeks no evidence of inflammation existed. There was evidence of cerebrospinal fluid leakage at no time point. Necropsy revealed some adhesions at 5 and 8 weeks, in particular at 5 weeks, but at 11 weeks there were no adhesions found. From 2 - 11 weeks, there was evidence of initially an inflammatory reaction followed by neodura formation at the defect site through cellular ingrowth and remodeling of the acellular fish skin. Histology showed a histiocytic foreign body reaction initially that subsided over time. As early as 8 weeks there was evidence of neodura formation and by 11 weeks there was a minimal inflammatory response with an intact neodura formed. In this pilot study the Kerecis Omega3 Dura patches performed in a safe and efficacious manner. This new material needs to be fully assessed and compared with other products that are currently on the market in a larger scale animal study.
文摘目的探讨硬膜双层修补在额颞区大骨瓣减压术后颅骨缺损修补中的临床效果。方法选取2014年2月至2016年2月本院收治的120例额颞区大骨瓣减压术后颅骨缺损患者为研究对象,根据患者于本院行硬膜双层修补时间(以2015年1月1日为节点)不同,将其分为观察组(2015年1月1日前,62例)和对照组(2015年1月1日后,58例)。观察组患者行硬膜双层修补术,对照组患者行硬膜单层修补术。记录和比较两组患者的手术时间、术中出血量、引流管拔除时间及住院天数;记录和观察术前1天(T1)、术后7天(T2)、术后14天(T3)两组患者的认知功能、运动功能及日常生活能力。术前1天和术后3个月,采用磁共振灌注加权成像评估患者脑灌注情况,记录并比较两组患者灌注异常指数(perfusion abnormality index,PAI)。结果观察组患者住院天数和引流管拔除时间均显著短于对照组(P<0.05),两组患者手术时间和术中出血量比较均无显著差异(P>0.05)。两组患者简易精神状况检查(mini-mental state examination,MMSE)量表评分随时间延长显著上升(P<0.05),神经功能缺损程度评分随时间延长显著下降(P<0.05)。T2和T3时,观察组患者术后MMSE量表评分均显著高于对照组(P<0.05),神经功能缺损程度评分均显著低于对照组(P<0.05)。观察组患者并发症发生率显著低于对照组(P<0.05)。术后3个月,两组患者PAI较术前1天均显著下降(P<0.05),且观察组患者PAI显著低于对照组(P<0.05)。结论硬膜双层缝合在额颞区大骨瓣减压术后颅骨缺损修补中的效果明显,手术时间较短,术中出血量较少,术后并发症发生率较低。
