Negative Pressure Wound Therapy to Soft Tissues Surrounding Percutaneous Devices

经皮装置周围软组织的负压伤口治疗

• 批准号: 9248815
• 负责人: Kent N. Bachus
• 金额: --
• 依托单位: VA SALT LAKE CITY HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-05-01 至 2019-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9248815
• 关键词: Amputees; Animal Model; Animals; Biochemical; Biological; Cavia; Clinical; Complex; Cues; Deterioration; Development; Devices; Docking; Epithelial; Etiology; Europe; European; Evaluation; Exhibits; FDA approved; Fostering; Goals; Growth; Healthcare Systems; Heterotopic Ossification; Histologic; Human Volunteers; Implant; Infection; Lead; Maintenance; Military Personnel; Modeling; Operative Surgical Procedures; Patients; Population; Postoperative Period; Process; Prosthesis; Pseudomonas aeruginosa; Quality of life; Recovery of Function; Residual state; Site; Staphylococcus aureus; Suspensions; System; Systemic infection; Techniques; Technology; Testing; Time; Tissues; Titanium; United States; Vacuum; Weight-Bearing state; Work; Wound Healing; bone; chronic wound; clinical application; clinically relevant; cooking; design; experience; healing; implantation; improved; limb amputation; limb injury; microbial; pressure; prevent; public health relevance; residual limb; response; seal; soft tissue; standard of care; subcutaneous; working group; wound

 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.

 描述（由申请人提供）： 截肢后，将外假体悬挂在残肢上是目前的标准治疗方法，但并不适合所有患者，例如，对于残肢较短、软组织持续恶化的患者来说，悬挂技术就失效了。和/或受到旺盛的异位骨化的阻碍，世界范围内正在为这些患者开发经皮骨整合对接系统（PODS），以便他们可以将外假体直接附着到骨骼上。在欧洲，三个主要团体正在与人类志愿者截肢者合作研究 PODS 技术。然而，这些欧洲 PODS 目前尚未获得 FDA 批准在美国使用，部分原因是它们缺乏无感染的证据。假体周围组织和 PODS 装置之间的生物密封，我们的团队自 2006 年以来一直致力于新型 PODS 装置的设计、开发和评估。 PODS 装置采用多孔涂层钛皮下屏障，能够通过在负重动物体内维持生物附着的上皮密封至少 12 个月来抑制感染，但是，在植入后的前 12 周内，假体周围会发生感染。 PODS 装置周围的组织<<表现出慢性伤口愈合反应并且>>沿着经皮界面迁移，可能是为了使装置在皮外生长，这一过程称为向下生长。令人担忧的是，因为<<向下生长会破坏生物附着的上皮密封，在假体周围组织和 PODS 装置之间产生间隙>>，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 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。临床上，慢性伤口通常使用称为真空辅助闭合（VAC）疗法的技术来闭合，<<也称为负压伤口疗法（NPWT）>>我们将首先确定<<NPWT是否可以抑制向下生长>>。其次，我们将确定是否需要《NPWT》来长期维持生物密封。第三，在假体周围存在间隙的情况下。 >>，我们将确定 NPWT 是否可以重新建立假体周围组织和 PODS 装置之间的生物密封。这项研究的结果将有助于安全地临床引入经皮骨整合假体，提高生活质量。适用于退伍军人管理局、军队和更广泛的肢体严重受伤的平民患者。