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：姑息治疗可以为生命末期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令人痛苦的症状。伤口护理对可行的舒适措施的研究很少，以解决身体症状，如疼痛、气味和伤口渗出(渗出物)，这些症状通常伴随着伤口在生命末期发展。我们建议研究一种伤口舒适干预措施，它由一种低成本的伤口粉末RGN107组成，可以使用喷水瓶将其洒在伤口上。几次使用后，这种粉末会在伤口上形成一层“硬壳”封口，防止敷料粘在脆弱的伤口床上，并防止操作擦拭，这两种情况都会导致疼痛。其目标是加强通常的伤口护理，增加临终个体及其照顾者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遵守伤口舒适方案的可行性。我们的试验数据表明，RGN107无毒有效，可显著缓解腿部静脉性溃疡的疼痛和渗出物。我们建议将这些发现扩展到极具挑战性的临终关怀登记人员中，这些人有伤口，如压疮。大约50%的创面患者尝试了各种方法来控制症状，但仍有无法控制的伤口疼痛、气味和渗出物。我们研究的目的是研究加强伤口护理方法的可行性，并检查依从性的监测，控制症状的有效性信号的测量，以及使用RGN107后对生活质量的影响。R21将采用比较小组设计来确定两种临终关怀组织模式的可行性，这两种模式是基于家庭的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。我们将为每一种模式量身定做培训，认识到照顾者的多样性。在住院病人中 在这种情况下，培训将分三班进行，分几天进行。在家庭中，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几个培训课程中接受家庭环境方面的指导。将使用创伤程序的DVD来加强学习。我们的团队将监测忠诚程序的遵守情况，例如定期访问以评估照顾者的表现，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、在三个时间点进行的调查和访谈、基线，然后是第二周和第四周。我们假设我们的干预将提高患者和照顾者在生命结束时的舒适护理和生活质量。