A Randomized Controlled Parallel-group Trial to Investigate the Effectiveness of Two Silicone Dressings for Sacral and Heel Pressure Ulcer Prevention Compared to no Dressings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 475
- 试验地点
- 1
- 主要终点
- Number of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion)
研究概览
简要总结
The aim of this randomized controlled trial is to test the efficacy of preventive dressings for pressure ulcer prevention.
详细描述
Patients of intensive acute care and residents of institutional long-term care facilities are at high risk for developing pressure ulcers (PUs). PU standard prevention includes repositioning, early mobilization and the use of special support surfaces. The use of prophylactic dressings might reduce friction and shear forces and/or modify the microclimate of the skin and might therefore protect the skin and underlying tissues from pressure/deformation injury. The primary objective of this study is to determine if preventive silicone dressings (Mepilex® border) applied to the heels and to the sacrum in addition to PU standard prevention reduces PU incidence category II, III, IV, and deep tissue injury compared to PU standard alone in at risk hospital patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 否
入选标准
- •Major trauma patients and/or critically ill patients (e.g. with cardiac arrest) admitted to the emergency department and being transferred and/or admitted directly to a surgical or internal ICU
- •Being at "high" or "very high" PU risk according to the Charité PU prevention standard:
- •Category 3 (= partly care dependent/limited mobility in bed), 4A (= care depended, limited mobility in bed), 4B (= totally immobile) according to the Jones classification modified by Charité
- •Expected minimum length of stay at least three days
- •Informed consent (or by legal representative)
排除标准
- 未提供
研究组 & 干预措施
Mepilex® Border
If a patient is assigned to the intervention group the dressings Mepilex® Border Sacrum and Mepilex® Border Heel will be applied onto the respective intact skin areas in addition to standard pressure ulcer prevention
干预措施: Mepilex® Border Sacrum and Mepilex® Border Heel (Device)
Control
Standard pressure ulcer prevention according to hospital standard
结局指标
主要结局
Number of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion)
时间窗: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days
The primary outcome was the cumulative incidence of Pressure ulcer category II, III, IV, unstageable and DTI at heels or sacrum. Pressure ulcers were categorized according to the NPUAP/EPUAP 2014 classification System. The occurrence of a new pressure ulcer of any category was assessed and documented daily during the study period. The Categories are defined as follows: Category I (nonblanchable erythema); Category II (Partial thickness Skin loss); Category III (Full Thickness Skin loss); Category IV (Full Thickness tissue loss); Unstageable (Depth unknown); Deep tissue injury (suspected Deep tissue injury, Depth unknown)
次要结局
- Number of Preventive Sacrum Dressings Used for Pressure Ulcer Prevention(Duration of hospital stay, an average of 12.6 (SD +/-12.7) days)
- Time to Pressure Ulcer Development of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum(Duration of hospital stay, an average of 12.6 (SD +/-12.7) days)
- Event Free Survival Time of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Days, Kaplan Meier Analysis)(Duration of hospital stay, an average of 12.6 (SD +/-12.7) days)
- Density Rate of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion Per 1000 Bed Days, Rate)(Duration of hospital stay, an average of 12.6 (SD +/-12.7) days)
- Number of Pressure Ulcer Category I (Non-blanchable Erythema) II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion)(Duration of hospital stay, an average of 12.6 (SD +/-12.7) days)
- Numbers of Support Surface Used for Pressure Ulcer Prevention (Total)(Duration of hospital stay, an average of 12.6 (SD +/-12.7) days)
- Number of Preventive Heel Dressings Used for Pressure Ulcer Prevention(Duration of hospital stay, an average of 12.6 (SD +/-12.7) days)
- Number of Pressure Ulcers Category I (Non-blanchable Erythema) II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion Per 1000 Bed Days, Rate)(Duration of hospital stay, an average of 12.6 (SD +/-12.7) days)
- Time to Pressure Ulcer Development of Pressure Ulcers Category I, II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum(Duration of hospital stay, an average of 12.6 (SD +/-12.7) days)
- Event Free Survival Time of Pressure Ulcers Category I, II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Days, Kaplan Meier Analysis)(Duration of hospital stay, an average of 12.6 (SD +/-12.7) days)
- Follow up Period of Included ICU Patients (Days)(Duration of hospital stay, an average of 12.6 (SD +/-12.7) days)
研究者
PD Dr. Jan Kottner
PD Dr. rer cur
Charite University, Berlin, Germany