A 12-week, Single Site, Randomized Controlled Trial to Compare the Efficacy of Quantum NPWT With and Without Simultaneous Irrigation Versus Standard of Care on Reduction of the Volume of Stage III/IV Pressure Ulcers.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Comparison of reduction in wound volume between Quantum with Irrigation v Standard of Care
研究概览
简要总结
Negative-pressure wound therapy (NPWT) is an important adjunct for management of wounds, and promotes granulation tissue and angiogenesis. Despite these known means for facilitation of wound management, further research is needed to examine whether this modality is superior to other currently used options, thus defining clear indications for and benefits of NPWT. This would also help establish the role of combination therapy, using NPWT with simultaneous irrigation or other forms of dressings. This study aims to compare treatment efficacy of NPWT, NPWT plus proprietary simultaneous irrigation, and traditional hospital standard of care for treatment of grade III & IV pressure ulcers. Primary endpoint of this study is comparison of reduction of wound volume between the three treatment arms; and secondary endpoints include bacterial load, rate of wound healing, preparation for grafting, and pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female between the ages of 18 and 70
- •Any patient with a stage III/IV pressure ulcer of the size large enough to indicate use of Negative Pressure Treatment.
排除标准
- •Clinical evidence of active, gross infection.
- •Patient or patient's guardian refuses consent.
结局指标
主要结局
Comparison of reduction in wound volume between Quantum with Irrigation v Standard of Care
时间窗: 12-weeks
Comparison of reduction in wound volume between Quantum with Irrigation versus standard of care over 12 weeks treatment period.
次要结局
- Comparison of reduction in wound volume between Quantum with Irrigation v Quantum without irrigation(12 weeks)