Negative Pressure Wound Therapy to Soft Tissues Surrounding Percutaneous Devices

 描述(由申请人提供)： 肢体截肢后，悬挂式外假体连接到残肢是目前的护理标准，但并不适用于每一位患者。例如，对于残肢较短、软组织持续恶化和/或受到旺盛的异位骨化阻碍的患者，悬吊技术失败。正是为了这些患者，全球正在开发经皮骨集成对接系统(Pod)，这样他们就可以将体外假体直接连接到残肢的骨骼上。在欧洲，三个主要组织正在与人类志愿者截肢者合作，研究豆荚技术。然而，这些欧洲豆荚目前没有被FDA批准在美国使用，部分原因是它们缺乏证据表明假体周围组织和豆荚装置之间存在无感染的生物密封。在美国，我们的团队自2006年以来一直致力于新型吊舱设备的设计、开发和评估。我们已经证明，包含多孔涂层钛真皮下屏障的假体内支架装置，通过在承重动物身上保持生物附着的上皮密封至少12个月，具有抑制感染的能力。然而，在植入后的头12周内，豆荚装置周围的假体周围组织表现出慢性伤口愈合反应，并沿着经皮界面迁移，可能是为了使装置在皮肤外，这一过程被称为绒毛生长。这是令人担忧的，因为向下生长打破了生物上附着的上皮密封，在假体周围组织和豆荚装置之间形成了一个缝隙，这是微生物入侵的直接通道--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吊舱装置之间建立、维持并在必要时重新建立非迁移性生物密封。在临床上，慢性伤口通常使用一种称为真空辅助闭合(VAC)疗法的技术，也称为负压伤口疗法(NPWT；&GT；&GT；)。我们将首先确定NPWT是否能抑制Pod装置周围假体周围组织的生长抑制。其次，我们将确定是否需要&lt；&lt；NPWT；&gt；在一段时间内保持生物密封。第三，在假体周围组织和吊舱装置之间存在间隙的情况下，我们将确定NPWT能否重建假体周围组织和吊舱装置之间的生物密封。这项研究的结果将促进经皮骨集成假体的安全临床引入，改善退伍军人和更广泛的平民严重肢体损伤患者的生活质量。

 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.