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临床试验/NCT03557489
NCT03557489Unknown不适用

Effectiveness of Sacral Foam Pad in Preventing Pressure Injury in Surgical Patients With Supine Position

Taipei Medical University Shuang Ho Hospital0 个研究点目标入组 210 人开始时间: 2018年6月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
210
主要终点
Sacral pressure injury

研究概览

简要总结

In surgical patients, prevention of pressure injury is a challenge because of the high risk for multiple comorbid conditions, hemodynamic instability, and long duration of immobility.

The objectives of our study is to compare the difference in incidence rates of sacral pressure injury in surgical patients with supine position more than 3 hours between those treated with usual preventive care and a sacral foam pad versus a control group receiving usual care.

详细描述

The incidence of pressure injury in surgical patients about 12% to 45%, though these patients were treated with "gel pad" as routine. Based on the nutritional status of patients, long-term surgery, surgical posture, and anesthesia-induced hypotension, pressure injury still occurred. Sacral foam pad (Mepilex(®) Border Sacrum) is an unique 5-layer design, was designed to protect sacral pressure injury. In this study, we enrolled surgical patients who need to supine over ≧ 3 hours to evalute the effectiveness of sacral foam pad in preventing sacral pressure injury. The patients will randomized to control and intervention groups, both groups recruited 105 patients. In control group, patients use gel pad during surgery; whereas patients use gel pad in addition to sacrum foam pad (Mepilex(®) Border Sacrum) in intervention group. After surgery, the occurrence and severity of sacral pressure injury was evaluated. The results of this study can provide evidence to improve the awareness of operating room medical staff on surgical pressure injury, and find out the risk factors in avoiding of pressure injury, and offer an effective strategy to enhance the quality of surgery throughout the perioperative care.

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
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • 1.20-99 years old surgical patients who need to supine position over ≧ 3 hours 2.Patients have no any skin lesion.

排除标准

  • under 20 years
  • Patients have any skin lesion.

研究组 & 干预措施

Experimental group

Experimental

Patients use gel pad(in usual) in addition to(Mepilex Border Sacrum)foam pad during surgery.

干预措施: Mepilex Border Sacrum (Device)

Control group

No Intervention

patients use gel pad(in usual) during surgery.

结局指标

主要结局

Sacral pressure injury

时间窗: After 1 hour surgery

After surgery check patient's sacral skin condition

次要结局

未报告次要终点

研究者

发起方
Taipei Medical University Shuang Ho Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

MAH CHUN

Deputy Director of Nursing Department

Taipei Medical University Shuang Ho Hospital

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