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

描述：姑息治疗可以提供安慰和支持个人在生命的尽头谁有伤口。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涉及身体症状，如疼痛、气味和伤口排水（渗出物），这些症状通常伴随着生命末期的伤口发展。我们建议研究一种由低成本伤口粉末RGN107组成的伤口舒适干预措施，RGN107可以用喷瓶洒在伤口上。几次涂抹后，这种粉末在伤口上形成一层“外壳”，密封伤口，防止敷料粘在脆弱的伤口床上，防止操作擦拭，这两种操作都会导致疼痛。目标是增强通常的伤口护理，增加临终者及其护理人员的舒适度和生活质量。没有先前的研究已经确定了可行性，使用一个专门开发的伤口粉末检查遵守伤口舒适协议的个人接受临终关怀。我们的试验数据表明，RGN107无毒且有效，可显著缓解腿部静脉溃疡的疼痛和渗出。我们建议将这些发现扩展到具有创伤（如压疮）的临终关怀入选者的极具挑战性的人群。大约50%的伤口患者尝试了各种方法来控制症状，但仍然遭受无法控制的伤口疼痛、气味和渗出。本研究的目的是研究一种增强伤口护理方法的可行性，并研究使用RGN107后依从性监测、症状控制的疗效信号测量以及对生活质量的影响。本R21将采用比较组设计，以确定两种模式的安宁疗护组织的可行性，居家疗护和住院安宁疗护，将针对50名预期寿命超过1个月，但少于6个月的个体。我们将为每个模型量身定制训练，以识别护理人员的可变性。在住院病人中

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.