关键词：临床研究;可行性研究;无能力;伊拉克;角质化;医学研究;军事人员;神经;患者;周围神经系统;随机变量;再生(生理学);手术;创伤;创伤和损伤
摘 要：Common injuries sustained by war fighters in Iraq and Afghanistan result from blast and shrapnel wounds which cause extensive damage to skin, bones, and nerves. The management of damaged peripheral nerves is challenging for patients and surgeons. Peripheral nerve transection injuries may fail to regenerate even when managed surgically. These injuries are associated with long term disability and impaired function. Nerve guidance conduits have been developed for use in surgery to bridge the gap between transected nerve ends and to support nerve regeneration. A team of scientist and clinicians at Wake Forest School of Medicine has developed a keratin biomaterial hydrogel that can be used as luminal filler in nerve guidance conduits to facilitate nerve regeneration. Studies in mice, rabbits, and nonhuman primates have established the feasibility of this keratin hydrogel to promote nerve regeneration. A Phase I prospective, randomized trial is designed to compare nerve regeneration in patients sustaining peripheral nerve injuries treated either with keratin hydrogel and a nerve conduit or with a nerve conduit alone. The clinical trial will be initiated as soon as the FDA provides an IND for the keratin biomaterial hydrogel.