Negative Pressure Wound Therapy to Soft Tissues Surrounding Percutaneous Devices

 描述（由申请人提供）： 在截肢之后，外假体与残肢的悬挂式附接是目前的护理标准，但并不适合于每个患者。例如，悬吊技术在短残肢患者中失败，这些患者经历软组织的持续恶化，和/或受到过度异位骨化的阻碍。正是针对这些患者，全世界正在开发经皮骨整合对接系统（PODS），以便他们可以将外假体直接连接到残肢的骨骼上。在欧洲，三个主要的研究小组正在与人类志愿截肢者一起研究PODS技术。然而，这些欧洲PODS目前未被FDA批准在美国使用，部分原因是它们缺乏假体周围组织和PODS器械之间无感染生物密封的证据。在美国，我们的团队自2006年以来一直致力于设计，开发和评估一种新型PODS设备。我们已经证明，内置PODS装置，结合多孔涂层钛皮下屏障，有能力抑制感染，保持生物附着的上皮密封在承重动物至少12个月。然而，在植入后的前12周内，PODS装置周围的假体周围组织< exhibit a chronic wound healing response and >沿着经皮界面迁移，可能是试图使装置在皮肤外，这一过程被称为向下生长。这是令人担忧的，因为“绒毛生长破坏了生物附着的上皮密封，在假体周围组织和PODS装置之间产生了间隙”，这是微生物入侵的直接管道-这可能导致局部甚至全身感染。“为了最大限度地恢复截肢患者的功能，我们需要在假体周围组织和PODS装置之间建立、维持并在必要时重新建立非迁移性生物密封。在临床上，慢性伤口通常使用称为真空辅助闭合（VAC）疗法的技术闭合，&lt;&lt;也称为负压伤口疗法（NPWT）&gt;&gt;。我们将首先确定< NPWT can inhibit the down growth >PODS器械周围假体周围组织是否感染.其次，我们将确定< NPWT >随着时间的推移是否需要&lt; &gt;来维持生物密封。第三，在&lt; &gt;中< presence of a gap between the periprosthetic tissues and the PODS device >，我们将确定NPWT是否可以重新建立假体周围组织和PODS器械之间的生物密封。本研究的结果将促进经皮骨整合假体的安全临床引入，改善VA、军队和更广泛的严重肢体损伤平民人群患者的生活质量。

 DESCRIPTION (provided by applicant): Following limb amputation, suspension-type attachment of an exoprosthesis to the residual limb is currently the standard of care, but is not suitable for every patient. For example, suspension technology fails with patients with short residual limbs, whom experience persistent deterioration of soft tissues, and/or hampered by exuberant heterotopic ossification. It is for these patients that Percutaneous Osseointegrated Docking Systems (PODS) are being developed worldwide so they can attach their exoprosthesis directly to the bone of their residual limb. In Europe, thre primary groups are working with human volunteer amputees to investigate PODS technology. However, these European PODS are not currently FDA approved for use in the United States, in part, because they lack evidence of an infection-free biological seal between the periprosthetic tissues and the PODS device. Here in the United States, our team has worked since 2006 on the design, the development, and the evaluation of a new type of PODS device. We have shown that endoprosthetic PODS devices, incorporating porous-coated titanium subdermal barriers, have the ability to inhibit infection by maintaining a biologically attached epithelial seal in load-bearing animals for at least 12- months. However, within the first 12-weeks post-implantation, the periprosthetic tissues surrounding the PODS device << exhibit a chronic wound healing response and >> migrate along the percutaneous interface, possibly in an attempt to make the device extra-cutaneous, a process known as down growth. This is of concern because << down growth breaks the biologically attached epithelial seal, creating a gap >> between the periprosthetic tissues and the PODS device, a direct conduit for microbial invasion - one that can lead to local, or even systemic infection. << To maximize the functional recovery of patients with amputated limbs, we >> need to establish, to maintain, and if necessary, to re-establish a non-migratory biological seal between the periprosthetic tissues and the PODS device. Clinically, chronic wounds are often closed using a technique known as Vacuum Assisted Closure (VAC) therapy, << also known as Negative Pressure Wound Therapy (NPWT) >>. We will first determine if << NPWT can inhibit the down growth >> and subsequent infection of the periprosthetic tissues surrounding PODS devices. Second, we will establish whether << NPWT >> is required to maintain the biological seal over time. Third, in the << presence of a gap between the periprosthetic tissues and the PODS device >>, we will determine whether NPWT can re-establish the biological seal between the periprosthetic tissues and the PODS device. The results from this study will facilitate the safe clinical introduction of percutaneous osseointegrated prostheses, improving the quality of life for patients in the VA, military, and broader civilian populations with severe limb injuries.