Novel Wound Powder RGN107 to Reduce Wound Odor, Pain and Exudate at End-of-Life

描述：姑息治疗可以为有伤口的生命末期的个人提供安慰和支持。这些人经常面临严重影响生活质量的痛苦症状。关于可行的舒适措施的伤口护理研究很少，无法解决疼痛、气味和伤口引流（渗出液）等身体症状，这些症状通常伴随着生命结束时出现的伤口。我们建议研究一种伤口舒适性干预措施，包括低成本的伤口粉末，RGN 107，可以使用喷瓶喷洒在伤口上。经过几次应用，粉末形成一个“地壳”密封边界的伤口，保护它从敷料，可以坚持脆弱的伤口床，并防止操作擦拭，这两个都可能导致疼痛。我们的目标是加强常规伤口护理，增加临终者及其护理人员的舒适度和生活质量。以前没有研究确定使用专门开发的伤口粉末来检查接受临终关怀的个人对伤口舒适协议的依从性的可行性。我们的初步数据表明，RGN 107是无毒的，有效的，可显著缓解腿部静脉溃疡的疼痛和渗出液。我们建议将这些发现扩展到具有高度挑战性的临终关怀患者人群，如压疮。大约50%的发展伤口的个体尝试了各种方法来控制症状，但继续遭受不受控制的伤口疼痛，气味和渗出物。我们研究的目的是检查增强伤口护理方法的可行性，并检查依从性监测、症状控制有效性信号的测量以及使用RGN 107后对生活质量的影响。该R21将采用比较组设计，以确定临终关怀组织的两种模式的可行性，即家庭护理和住院临终关怀，目标是50名预期寿命超过1个月但不到6个月的人。我们将为每个模型定制培训，以识别护理人员的可变性。在住院 培训将分三班进行，为期数天。在家庭中，计划伤口护理的注册护士，沿着相关机构和家庭护理人员将在家庭环境中接受几次培训。将使用伤口程序的DVD来加强学习。我们的团队将通过忠诚过程来监测依从性，例如定期访问以评估护理人员的表现，评估伤口本身以及审查文件。数据收集来源包括项目记录、患者/提供者日志、在三个时间点、基线以及第2周和第4周进行的调查和访谈。我们假设我们的干预将提高舒适护理和生活质量，在生命的最后，为病人和照顾者。

DESCRIPTION: Palliative care can provide comfort and support for individuals at the end of life who have a wound. Such people frequently face distressing symptoms that profoundly affect quality of life. Wound care research on feasible comfort measures is minimal to address physical symptoms such as pain, odor, and wound drainage (exudate) that often accompany wounds that develop at the end of life. We propose to study a wound comfort intervention comprised of a low-cost wound powder, RGN107 that can be sprinkled on wounds using a squirt bottle. After several applications, the powder forms a "crust" seal border over the wound, protecting it from dressings that can stick to the fragile wound bed and preventing manipulation from wiping, both of which can cause pain. The goal is to augment usual wound care, adding to the comfort and quality of life of dying individuals as well as their caregivers. No previous studies have determined the feasibility of using a specially developed wound powder to examine adherence to a wound comfort protocol for individuals receiving hospice care. Our pilot data indicate that RGN107 is nontoxic, and efficacious, providing substantial relief from pain and exudate from venous leg ulcers. We propose to extend these findings to a highly challenging population of hospice enrollees with wounds such as pressure ulcers. Approximately 50% of the individuals who develop wounds have tried various methods to manage symptoms, but continue to suffer from uncontrolled wound pain, odor, and exudate. The purpose of our study is to examine the feasibility of an enhanced wound care approach and examine monitoring of adherence, measures of signals of efficacy in the control of symptoms, and impact on quality of life after use of RGN107. This R21 will employ a comparative group design to determine feasibility in two models of a hospice organization, home based care and inpatient hospice that will target 50 individuals with life expectancies more than 1 month, but less than 6 months. We will tailor the training for each model recognizing the variability of caregivers. In the inpatient setting, training will be delivered over the three shifts and over several days. In the home, the registered nurses that plan wound care, along with associated agency and family caregivers will be instructed in the home setting over several training sessions. A DVD of wound procedures will be used to reinforce learning. Our team will monitor adherence by fidelity processes such as making regular visits to assess caregiver performance, evaluating the wound itself, and reviewing documentation. Data collection sources include project records, patient/provider logs, surveys and interviews conducted at three time points, baseline, and then weeks 2 and 4. We hypothesize our intervention will enhance comfort care and quality of life at the end of life for both the patient and the caregiver.