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

新型伤口粉 RGN107 可减少临终时的伤口气味、疼痛和渗出物

• 批准号: 8640207
• 负责人: Teresa J Kelechi
• 金额: $ 18.66万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-04-01 至 2016-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8640207
• 关键词: Address; Adherence; Admission activity; Adverse effects; Affect; Anecdotes; Beds; Burn injury; Caregivers; Caring; Data; Data Collection; Decubitus ulcer; Distress; Documentation; Drainage procedure; Enrollment; Exudate; Face; Family; Family Caregiver; Feasibility Studies; Frequencies; Goals; Healed; Home environment; Hospice Care; Human Resources; Individual; Inpatients; Intervention; Interview; Learning; Leg Ulcer; Licensing; Life Expectancy; Measurement; Measures; Methods; Modeling; Monitor; Movement; Odors; Outcome; Pain; Pain management; Painless; Palliative Care; Patients; Performance; Perfusion; Physiological; Population; Powder dose form; Prevalence; Procedures; Process; Protocols documentation; Provider; Quality of life; Records; Registered nurse; Research; Services; Signal Transduction; Source; Sterile coverings; Surveys; Symptoms; Time; Tissues; Training; Ulcer; Venous; Visit; absorption; base; clinical efficacy; clinical practice; comparative; cost; design; eligible participant; end of life; healing; hospice environment; immune function; improved; lens; novel; organizational structure; pressure; prevent; primary outcome; public health relevance; satisfaction; seal; secondary outcome; skin irritation; symptom management; theories; treatment as usual; usability; wound

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.

描述：姑息治疗可以为临终时有伤口的人提供安慰和支持。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能解决临终时伤口经常出现的疼痛、气味和伤口引流（渗出物）等身体症状。我们建议研究一种伤口舒适干预措施，该干预措施由低成本伤口粉末 RGN107 组成，可以使用喷瓶将其喷洒在伤口上。多次使用后，粉末会在伤口上形成一层“硬壳”密封边界，保护伤口免受敷料粘在脆弱的伤口床上的影响，并防止擦拭，这两种情况都会引起疼痛。其目标是加强日常伤口护理，提高临终者及其护理人员的舒适度和生活质量。之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方案的遵守情况的可行性。我们的试验数据表明，RGN107 无毒且有效，可显着缓解腿部静脉溃疡的疼痛和渗出物。我们建议将这些发现扩展到具有压疮等伤口的临终关怀参与者中极具挑战性的人群。大约 50% 的伤口患者尝试过各种方法来控制症状，但仍然遭受不受控制的伤口疼痛、气味和渗出液的困扰。我们研究的目的是检查强化伤口护理方法的可行性，并检查依从性监测、控制症状的功效信号测量以及使用 RGN107 后对生活质量的影响。 R21 将采用比较组设计来确定临终关怀组织、家庭护理和住院临终关怀两种模式的可行性，该模式将针对 50 名预期寿命超过 1 个月但不到 6 个月的个体。我们将为每个模型量身定制培训，以认识到护理人员的可变性。在住院部 培训将分三班制、持续几天进行。在家里，计划伤口护理的注册护士以及相关机构和家庭护理人员将在家里接受多次培训课程的指导。将使用伤口手术 DVD 来强化学习。我们的团队将通过保真流程来监控遵守情况，例如定期拜访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措施将增强患者和护理人员临终时的舒适护理和生活质量。