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临床试验/NCT00590551
NCT00590551终止不适用

Slings and Repositioning Devices: Their Effects on Skin Pressure

Christiana Care Health Services2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2007年12月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
240
试验地点
2
主要终点
There will be no difference in skin integrity with or without the use of slings.

研究概览

简要总结

There are many reasons that cause skin to breakdown. This study will only compare

  • pressure
  • pH
  • temperature

with the use of slings and without the use of slings (fabricated device used to safely handle patient transfers and repositioning).

There will be no difference in skin pressure, pH, or temperature with or without the use of slings.

详细描述

Preventing the development of pressure wounds in patients and preventing staff injuries and a safe work environment has been an ongoing effort at Christiana Care Health System (CCHS). Skin damage on hospitalized patients can be devastating. Not only does it increase patient's hospital stay, but it also causes pain and affects patients quality of life and subsequently costs. One practice in prevention and treatment of wounds is the use of pressure reducing, relieving or pressure redistribution surfaces (mattresses) and repositioning devices (electric lifts). Manufacturers of mattresses emphasize the need to limit layers between surface (mattress) and the patient.

Safe work environments focus on programs that help to ensure the prevention of work related injuries. Injury prevention programs have focused on equipment to eliminate manual lifting in an effort to decrease staff injuries from patient transfers and repositioning. Part of this practice is to leave the sling under the patient in order to reduce the amount of times staff are manually repositioning or turning the patient. With an increasing patient population that is either obese or extremely obese (bariatric patients) positioning and lifting equipment need to manage large weight limits. In response, manufacturers have constructed slings with increased fabric strength to handle heavier patients. There is concern that the newer sling fabrics may interfere with the low airloss and pressure redistribution purpose of mattresses. Information from this study may help in making slings with materials that can support higher weights while not causing any added skin problems.

A convenience sample of 240 adult patients meeting the study criteria will be recruited from the inpatient units at Wilmington Hospitaland Christiana Hospital for this comparison study. After obtaining informed consent, subjects will be randomized by a member of the study team to one of six groups, yielding 40 subjects per group. Groups will be assigned as follows

  • Supine and with sling
  • 30 degrees HOB (Head of bed)elevation without leg elevation and with sling
  • 30 degrees HOB elevation with 10 degrees leg elevation and with sling
  • Supine and without sling
  • 30 degrees HOB elevation without leg elevation and without sling
  • 30 degrees HOB elevation with 10 degrees leg elevation and without sling

Study Methodology

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • need assistance with mobility, using any patient handling equipment
  • are ≥ 18 years of age
  • are English speaking or guardian is English speaking
  • are medically stable

排除标准

  • have positional hypotension
  • are on aspiration precautions
  • are paralyzed
  • have neuromuscular disease
  • have below the knee amputation(s)
  • weigh greater than 500 lbs

结局指标

主要结局

There will be no difference in skin integrity with or without the use of slings.

时间窗: At 1 and 20 minutes pressure, pH and temperature will be measured.

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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