Malliti Miriam, Page Philippe, Gury Charles, Chomette Eric, Nataf François, Roux François-Xavier
Department of Pharmacy, Sainte-Anne Hospital, Paris, France.
Neurosurgery. 2004 Mar;54(3):599-603; discussion 603-4. doi: 10.1227/01.neu.0000108640.45371.1a.
The need to repair dural defects has prompted the use of dura mater substitutes. Many synthetic materials have been used for dural closure. Neuro-Patch (B. Braun Médical S.A., Boulogne, France) is a nonabsorbable microporous fleece composed of polyester urethane that has been approved for human use by the European Union since 1995. To the best of our knowledge, no clinical series with Neuro-Patch have been published thus far, particularly with regard to septic complications. The aim of our study was to compare the safety of Neuro-Patch with that of pericranium graft with regard to postoperative wound infections.
This is a retrospective study of 1 year's experience including all patients who underwent dural plasty with a Neuro-Patch (n = 61) or pericranium graft (n = 63). The follow-up period was at least 12 months after surgery. Before wound infection rates in the two groups were compared, factors suspected of being risks for neurosurgical site infection were evaluated.
Patient characteristics (mean age, neurological diagnosis), surgical procedures, prophylactic antibiotics, and risk factors for surgical infections (including duration of surgery, emergency, contaminated operations, and external cerebrospinal fluid drainage) were similar in the Neuro-Patch and pericranium groups. Deep wound infection rates in the Neuro-Patch and pericranium groups were 15 and 5%, respectively (P = 0.06), and cerebrospinal fluid leaks were significantly more frequent in the Neuro-Patch group (13 versus 1.6%, P < 0.05).
The results of our investigations show that Neuro-Patch raised the risk of wound infection, as do foreign materials implanted in the body. Synthetic dural grafts should be reserved for when autologous grafts are not sufficient or possible. An extensive prospective multicenter randomized trial is needed to confirm our results.
修复硬脑膜缺损的需求促使了硬脑膜替代物的使用。许多合成材料已被用于硬脑膜闭合。Neuro-Patch(法国布洛涅市贝朗医疗公司)是一种由聚酯聚氨酯制成的不可吸收微孔绒毛,自1995年起已获欧盟批准用于人类。据我们所知,迄今为止尚未发表有关Neuro-Patch的临床系列报道,尤其是关于感染性并发症的报道。我们研究的目的是比较Neuro-Patch与颅骨膜移植在术后伤口感染方面的安全性。
这是一项回顾性研究,纳入了1年经验中所有接受Neuro-Patch(n = 61)或颅骨膜移植(n = 63)进行硬脑膜成形术的患者。随访期为术后至少12个月。在比较两组伤口感染率之前,评估了怀疑为神经外科手术部位感染风险的因素。
Neuro-Patch组和颅骨膜组的患者特征(平均年龄、神经诊断)、手术操作、预防性抗生素以及手术感染的风险因素(包括手术时间、急诊手术、污染手术和外部脑脊液引流)相似。Neuro-Patch组和颅骨膜组的深部伤口感染率分别为15%和5%(P = 0.06),Neuro-Patch组脑脊液漏的发生率明显更高(13%对1.6%,P < 0.05)。
我们的调查结果表明,Neuro-Patch增加了伤口感染的风险,植入体内的异物也会如此。合成硬脑膜移植物应仅在自体移植物不足或无法使用时使用。需要进行广泛的前瞻性多中心随机试验来证实我们的结果。