IDEAL in Meshes for Prolapse, Urinary Incontinence, and Hernia Repair
IDEAL in Meshes for Prolapse, Urinary Incontinence, and Hernia Repair
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DOI：
10.1177/1553350612472987
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发表时间：
2013-10-01
影响因子：
1.5
通讯作者：
Otto, Thomas
中科院分区：
文献类型：
--
作者：
Gerullis, Holger;Klosterhalfen, Bernd;Otto, Thomas
目的.补片手术是最常用的外科手术之一。尽管补片应用手术在全球范围内传播，但目前尚无对补片植入后不良事件发生率和可能预防的系统分析。材料和方法。根据IDEAL的建议，已经生成了外科补片生物相容性的体外试验系统（创新）。已经开发了用于生物相容性优化的涂层策略（开发）。在动物模型中对天然和改性异体材料进行了2年的试验（探索和评估以及长期研究）。结果在3个补片中，植入绵羊体内，并在4个不同的时间点植入（a，3个月; B，6个月; c，12个月; d，24个月）24个月内，炎症组织厚度（TVT a，35 μ m; B，32 μ m; c，33 μ m; d，28 μ m; UltraPro，a，25 μ m; B，24 μ m; c，21 μ m; d，22 μ m; PVDF a，20 μ m; B，21 μ m; c，14 μ m; d，15 μ m），结缔组织（TVT a，37 μ m; B，36 μ m; c，43 μ m; d，41 μ m; UltraPro a，33 μ m; B，32 μ m; c，40 μ m; d，38 μ m; PVDF a，25 μ m; B，22 μ m; c，22 μ m; d，24 μ m）和巨噬细胞浸润（TVT a，36%; B，33%; c，23%; d，20%; UltraPro a，34%; B，28%; c，25%; d，22%; PVDF a，24%; B，18%; c，18%; d，16%）显示了相似的排名特征，在每个时间点后，再灌注。这些补片在绵羊模型中的体内性能可通过先前开发的体外试验系统预测。植入前用自体血浆涂覆补片似乎对补片生物相容性有积极影响。结论我们将IDEAL标准应用于外科补片的新创新。结果允许生成当前可用网格的排名，具有优化未来网格的潜力。
Purpose. Mesh surgeries are counted among the most frequently applied surgical procedures. Despite global spread of mesh applying surgeries, there is no current systematic analysis of incidence and possible prevention of adverse events after mesh implantation. Materials and Methods. Based on the recommendations of IDEAL an in vitro test system for biocompatibility of surgical meshes has been generated (Innovation). Coating strategies for biocompatibility optimization have been developed (Development). The native and modified alloplastic materials have been tested in an animal model over 2 years (Exploration and Assessment and Long-term study). Results. In 3 meshes, implanted in sheep and explanted at 4 different time points (a, 3 months; b, 6 months; c, 12 months; and d, 24 months) over 24 months, thickness of inflammatory tissue (TVT a, 35 mu m; b, 32 mu m; c, 33 mu m; d, 28 mu m; UltraPro, a, 25 mu m; b, 24 mu m; c, 21 mu m; d, 22 mu m; PVDF a, 20 mu m; b, 21 mu m; c, 14 mu m; d, 15 mu m), connective tissue (TVT a, 37 mu m; b, 36 mu m; c, 43 mu m; d, 41 mu m; UltraPro a, 33 mu m; b, 32 mu m; c, 40 mu m; d, 38 mu m; PVDF a, 25 mu m; b, 22 mu m; c, 22 mu m; d, 24 mu m), and macrophage infiltration (TVT a, 36%; b, 33%; c, 23%; d, 20%; UltraPro a, 34%; b, 28%; c, 25%; d, 22%; PVDF a, 24%; b, 18%; c, 18%; d, 16%) revealed comparable ranking characteristics at every time point after explantation. The in vivo performance of these meshes in a sheep model was predictable with a previously developed in vitro test system. Coating of meshes with autologous plasma prior to implantation seems to have a positive effect on the meshes biocompatibility. Conclusion. We have applied IDEAL criteria on a new innovation for surgical meshes. The results permit the generation of a ranking of currently available meshes with potential to optimize future meshes.