A new class of biodegradable synthetic biomaterial for seroma prevention

描述（由申请人提供）：血清瘤是一种常见的术后并发症，尤其在消融和重建手术后普遍存在。如果不及时干预，术后血清肿可导致严重的患者并发症，包括感染、组织坏死、永久性囊性腔、肢体活动能力降低和永久性毁容。由于血肿形成的高发生率和由此导致的患者发病率的增加，导致在血肿形成后广泛使用引流术治疗。在过去的几十年里，一些临床和实验性的预防性治疗策略也得到了发展和实施；然而，迄今为止，没有任何预防策略显示出临床相关的疗效，血清肿率仍然处于不可接受的高水平。因此，显然需要一种临床有效的预防性血清肿治疗方法。目前STTR资助的研究工作将为一种新型生物材料的商业化奠定基础

DESCRIPTION (provided by applicant): Seromas are a common post-operative complication particularly prevalent following ablative and reconstructive surgeries. Without timely intervention post-operative seromas can lead to significant patient morbidity including infection, tissue necrosis, permanent cystic cavities, reduced limb mobility and permanent disfigurement. The high incidence of seroma formation and the resulting increase in patient morbidity has led to the widespread use of drainage to treat seroma after formation. The last several decades have also seen the development and implementation of several clinical and experimental preventative treatment strategies; however, to date no preventative strategy has shown clinically relevant efficacy and seroma rates remain at unacceptably high levels. Consequently, there is a clear need for a clinically effective, preventative seroma treatment. The current STTR funded research effort will lay the foundation for the commercialization of a new class of biomaterial for the prevention of seroma, thereby enhancing patient health through improved patient outcomes and reduced patient morbidity. Preliminary studies have shown that a novel coblock polymer in hydrogel form, consisting of a methoxy polyethylene glycol (MPEG) block and a block of the polycarbonate form of dihidroxyacetone (pDHA), has shown efficacy in preventing seroma formation. Through the completion of research and development tasks during Phase I/II efforts, a compelling data set will be compiled on the biocompatibility, the efficacy and the mode of action of MPEG-pDHA in seroma prevention. This data set will support the entry of MPEG-pDHA into the FDA's regulatory process. A significant preliminary data set demonstrating the clinical utility of MPEG-pDHA hydrogels in seroma prevention has been developed. Key features of this biomaterial are: in vitro and in vivo biodegradation (within 24h in vitro and 3 das in vivo) into biocompatible products, and successful elimination of seroma in an accepted animal model of radical mastectomy. Phase I efforts will focus on determining the range of efficacy of MPEG-pDHA in vivo and on evaluating its biocompatibility using FDA accepted in vitro and in vivo biocompatibility testing standards. The key tasks are listed below: Task 1 - Synthesize and characterize the MPEG-pDHA polymers to be used during the Phase I study. Task 2 - Determine the range of efficacy in vivo using a model involving the harvesting of the rat latissimus dorsi muscle. Task 3 - Use FDA accepted ISO 10993 standards to quantify biocompatibility through in vitro cytotoxicity, genotoxicity, systemic toxicity, and hemocompatibility studies and local toxic effects after implantation through in vivo animal studies. PUBLIC HEALTH RELEVANCE: Seroma formation is a common post-operative complication that diminishes patient health and for which there are no accepted preventative treatments. The current STTR funded research effort aims to advance the development of a new biodegradable material for the prevention of seroma and thereby improve patient health through improved surgical outcomes.