Maas C S, Eriksson T, McCalmont T, Mabry D, Cooke D, Schindler R
Department of Otolaryngology, University of California, San Francisco 94143-0342, USA.
Plast Reconstr Surg. 1998 Apr;101(5):1307-14. doi: 10.1097/00006534-199804050-00023.
Soft-tissue augmentation using the synthetic nonfluid biomaterial expanded polytetrafluoroethylene (ePTFE) has been supported by number of recent reports citing the favorable characteristics of biocompatibility, soft and natural feel, ease of use, and permanent augmentation. Concern has been expressed about this application for ePTFE material because of the proximity of the implants to the skin surface and potential problems with infection and extrusion. We evaluated the behavior of a series of specific ePTFE implant designs using a long-term subcutaneous augmentation model. By using a porcine model, 466 implants of ePTFE in the form of strips, rolls, or tubes were placed using a percutaneous insertion device subcutaneously over the dorsum and face. The animals were divided into three study groups by length of implantation (3 weeks, control; 6 months, intermediate term; and 12 months, long-term) and en-bloc tissue specimens, including skin, implants, and underlying soft tissue, were harvested for gross and histologic examination. Implants were removed at the earliest sign of infection, exposure, or extrusion and the difficulty of removal was ascertained and recorded. These data reveal that ePTFE material elicits acceptable levels of tissue activity with low extrusion rates over the short and long term supporting its use for soft-tissue augmentation. The data show a clear difference, however, in the host response and behavior of the implants for this application based on shape or design. A statistically significant difference in the low, but measurable, extrusion rates was observed amongst these implant designs. ePTFE tubes showed greater stability and predictable augmentation over other implant designs for soft-tissue augmentation and seem to represent a substantial improvement for this application.
使用合成非流体生物材料膨体聚四氟乙烯（ePTFE）进行软组织填充，已得到近期多项报告的支持，这些报告列举了其生物相容性良好、触感柔软自然、使用方便以及可永久性填充等优点。由于植入物靠近皮肤表面，且存在感染和挤出的潜在问题，人们对ePTFE材料的这种应用表示担忧。我们使用长期皮下填充模型评估了一系列特定ePTFE植入物设计的表现。通过使用猪模型，采用经皮插入装置将466个呈条带、卷状或管状的ePTFE植入物皮下放置于背部和面部。根据植入时间长短将动物分为三个研究组（3周，对照组；6个月，中期；12个月，长期），并采集包括皮肤、植入物和下方软组织的整块组织标本进行大体和组织学检查。一旦出现感染、暴露或挤出的最早迹象，就将植入物取出，并确定和记录取出的难度。这些数据表明，ePTFE材料在短期和长期内引发的组织活性水平可接受，挤出率低，支持其用于软组织填充。然而，数据显示，基于形状或设计，宿主对该应用中植入物的反应和行为存在明显差异。在这些植入物设计中，观察到挤出率虽低但可测量，且存在统计学上的显著差异。与其他用于软组织填充的植入物设计相比，ePTFE管表现出更高的稳定性和可预测的填充效果，似乎代表了该应用的实质性改进。
