Supplemental Fluid & Collagen Deposition

描述（由申请人提供）：背景：压疮在疗养院很普遍。他们愈合缓慢，引起疼痛，损害生活质量，治疗费用昂贵。脱水是一个问题，在一些养老院居民和灌注不足的问题，在其他人。从理论上讲，为水分不足的居民提供补充液体应该增加身体各个液体隔室中的液体，增加皮下氧气，压疮血流和压疮愈合，包括胶原蛋白的产生。这一主张尚未在患有压疮的疗养院居民中进行过研究。目的：这项随机临床试验（RCT）的目的是确定对患有II至IV期压疮的疗养院居民补充液体是否会增强胶原蛋白沉积，受试者作为其自身对照。具体而言，本研究将确定II期至IV期压疮患者每日口服补充液体5天是否会增强胶原蛋白沉积、增加全身水分、增加皮下组织氧、增加压疮氧合，以及是否安全。方法：以护理院压疮患者为研究对象.在知情同意后，将测量胶原蛋白沉积、压疮氧、液体摄入量和各种液体隔室中的身体水分的基线测量值。将使用膨胀聚四氟乙烯（ePTFE）管测量胶原蛋白沉积。生物电阻抗将用于测量体内水分。在治疗阶段，受试者将被随机分配至两种补充液体方案之一。将给予补充液体5天，并再次测量各隔室中的胶原蛋白沉积、皮下组织氧、压疮氧和身体水分。将监测受试者的液体超负荷。将使用RMANOVA和logistic回归技术分析数据。重要性：这项研究的结果有可能显著改变疗养院居民的液体管理方式，并为压疮愈合的主要干预研究奠定基础。

DESCRIPTION (provided by applicant): Background: Pressure ulcers are prevalent in nursing homes. They heal slowly, cause pain, impair quality of life, and are expensive to treat. Dehydration is a problem in some nursing home residents and under-perfusion a problem in others. Theoretically, providing supplemental fluid to under-hydrated residents should increase fluid in the various fluid compartments of the body, increase subcutaneous oxygen, pressure ulcer blood flow and pressure ulcer healing, including collagen production. This proposition has not been examined in nursing home residents with pressure ulcers. Aims: The purpose of this randomized clinical trial (RCT) in which subjects serve as their own control is to determine whether administration of supplemental fluid to nursing home residents with Stage II to IV pressure ulcers enhances collagen deposition. Specifically, this study will determine whether oral administration of supplemental fluid given daily for 5 days to persons with Stage II to IV pressure ulcers enhances collagen deposition, increases total body water, augments subcutaneous tissue oxygen, increases pressure ulcer oxygenation, and is safe. Methods: The sample will be nursing home residents with pressure ulcers. After consent, baseline measures of collagen deposition, pressure ulcer oxygen, fluid intake, and body water in the various fluid compartments will be measured. Expanded polytetrafluorothlene (ePTFE) tubes will be used to measure collagen deposition. Bioelectrical impedance will be used to measure body water. In the treatment phase, subjects will be randomized to one of the two supplemental fluid regimes. Supplemental fluid will be administered for 5 days and collagen deposition, subcutaneous tissue oxygen, pressure ulcer oxygen, and body water in the various compartments again measured. Subjects will be monitored for fluid overload. Data will be analyzed with RMANOVA and logistic regression techniques. Significance: Findings from the study have the potential to significantly change how fluid is managed in nursing home residents and to lay the foundation for a major intervention study on pressure ulcer healing.