Supplemental Fluid & Collagen Deposition

描述（由申请人提供）：背景：压疮在养老院很普遍。它们愈合缓慢，引起疼痛，影响生活质量，治疗费用昂贵。脱水是一些养老院居民的问题，而灌注不足则是另一些人的问题。理论上，给缺水的病人补充液体应该能增加身体各个液体区室的液体，增加皮下氧气，促进压疮血流量和压疮愈合，包括胶原蛋白的产生。这一主张尚未在患有压疮的养老院居民中进行过检验。目的：本随机临床试验（RCT）的目的是确定对II期至IV期压疮养老院居民补充液体是否能促进胶原沉积。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天是否能增强胶原沉积，增加全身水分，增加皮下组织氧，增加压疮氧合，并且是否安全。方法：以患有压疮的养老院居民为调查对象。征得同意后，将测量胶原蛋白沉积、压疮氧、液体摄入量和各个液体室中的身体水分的基线测量。膨胀聚四氟乙烯（ePTFE）管将用于测量胶原沉积。生物电阻抗将用于测量人体水分。在治疗阶段，受试者将被随机分配到两种补充液体方案中的一种。给予补充液体5天，并再次测量胶原沉积、皮下组织氧、压疮氧和各隔室体内水分。将监测受试者是否体液过量。数据将用方差分析和逻辑回归技术进行分析。意义：该研究的发现有可能显著改变养老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.