Dural repair with acellular biomembrane:multicenter clinical trials

Objective To evaluate the safety and efficacy of novel artificial dural acellular biomembrane(Zhenghai biomembrane) in dural repair.Methods A multicenter,randomized control trial was carried out with 155 patients undergone dural repair from Dec.2007 to Dec.2008.The patients were randomly divided into experimental group and control group and received dural repair with novel artificial dural acellular biomembrane and autologous fascia,respectively.There were 74 patients(34 males and 40 females;aged 46.6±14.6 years;reparation area 14.28±13.29cm2) in experimental group and 81 patients(36 males and 45 females;aged 44.8±12.7 years;reparation area 13.44±7.74cm2) in control group.Vital signs,laboratory indexes,cerebral CT/MRI scanning,incision healing and occurrence of complications were observed at 10 days and 1,3,6 months after operation,respectively,and the safety and efficacy of the novel artificial dural acellular biomembrane were evaluated.Results No cerebrospinal fluid leakage,intracranial infection or epileps