Supplemental Fluid & Collagen Deposition

描述(申请人提供)：背景：压疮在疗养院很普遍。它们愈合缓慢，引起疼痛，损害生活质量，而且治疗费用昂贵。一些养老院居民脱水是一个问题，而另一些人则是灌流不足的问题。从理论上讲，向水分不足的居民提供补充液体应该会增加身体各个液体间隔中的液体，增加皮下氧气，压力溃疡的血流量和压力溃疡的愈合，包括胶原的产生。这一主张还没有在患有压疮的疗养院居民中得到检验。目的：这项以受试者为自身对照的随机临床试验(RCT)的目的是确定对患有II至IV期压疮的疗养院居民补充补液是否促进胶原沉积。具体地说，这项研究将确定，对于II至IV期压疮患者，连续5天每天口服补充液是否会增加胶原沉积，增加全身水分，增加皮下组织氧气，增加压疮氧气，并且是安全的。方法：以有压疮的疗养院居民为研究对象。在同意后，将测量各液体舱内胶原沉积、压疮氧气、液体摄入量和体水的基线测量。将使用膨胀的聚四氟乙烯(EPTFE)管来测量胶原沉积。生物电阻抗将被用来测量人体水分。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。补充液体将持续5天，并再次测量各隔室的胶原沉积、皮下组织氧、压疮氧和体水。受试者将接受体液超载监测。数据将使用RMANOVA和Logistic回归技术进行分析。意义：这项研究的发现有可能显著改变疗养院居民的液体管理方式，并为一项关于压疮愈合的重大干预研究奠定基础。

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.