Evaluation of Vacuum-Assisted Closure Veraflo Therapy With Cleanse Choice Dressing on Wound Healing in Patients With Pressure Sores: A Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Total Length of Stay
研究概览
简要总结
The primary objective of this study is to assess the effectiveness of the Negative Pressure Wound Therapy system with instillation therapy (NPWTi) on closure of chronic pressure sores. This intervention will be compared to wet-to-dry dressings, which is standard of care. In this post-market, on-label study, we hope to show that the NPWTi system more effectively closes pressure sores following debridement than traditional care.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischial and sacral wounds at stage 3 and
- •Any pressure sore that has the potential for a good seal.
排除标准
- •Any pressure sore that does not have potential for a good seal.
- •Patients with fecal incontinence (due to potential for pressure sore to be near the anus).
- •Patients who by the opinion of the Principal Investigator are not candidates for surgical closure (age, BMI, comorbidities, etc.).
- •Patients who are pregnant. This is standard of care for surgery anyway, and there is uncertainty of how both the surgery and intervention would affect the fetus. We therefore stress any form of birth control, abstinence, and method to prevent pregnancy for those enrolled in the study.
研究组 & 干预措施
Control (Wet-to-dry dressings)
Subjects randomized to the control group with receive standard of care (wet-to-dry dressings) for treatment of their pressure sore.
干预措施: Standard of Care (Wet-to-dry dressings) (Other)
Treatment (NPWT with Instillation)
Subjects who are randomized into the treatment arm (NPWT with Instillation) will receive the V.A.C. VeraFlo™ Cleanse Choice Dressing Systems for treatment of their pressure sore.
干预措施: V.A.C.Ulta™ Negative Pressure Wound Therapy System (Device)
结局指标
主要结局
Total Length of Stay
时间窗: up to 3 months
Record the number of days spent in the hospital from initial debridement (first visit with plastic surgeon) to discharge from hospital following surgery
次要结局
- Cost Analysis(Through study completion, approximately 5 months)
- Number of debridements(Through study completion, approximately 5 months)
- Successful closure of pressure sores(2 weeks and 6 weeks post-closure surgery)
研究者
Robert Galiano
Associate Professor of Surgery
Northwestern University