Effect of Oasis® Wound Matrix on Stage III and IV Trunk Pressure Wounds Treated With Negative Pressure Wound Therapy (NPWT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Closure Rate of Non-healing Wounds
研究概览
简要总结
This study evaluates the therapeutic effect of Oasis® Matrix along with Negative Pressure Wound Therapy (NPWT) on pressure wounds. Either Oasis or standard foam will be applied to the wound prior to activating the NPWT.
详细描述
In this study, patients being treated with Negative Pressure Wound Therapy (NPWT) will be randomized to receive either:
- Oasis® matrix, applied to the wound, along with standard of care including NPWT OR
- Standard foam, applied to the wound prior to activation of NPWT, which is standard care.
Wounds will be examined weekly for up to 12 weeks. At weeks 4, 8, and 12, the NPWT evacuation canister will be collected for specimen analysis.
The aim of this study is to determine the therapeutic effect of using Oasis® Wound Matrix with NPWT. Outcomes include: a) closure rate of non-healing wounds, and b) levels of growth factors and interleukins in fluid evacuated from the wound.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-89 who exhibit stage III or IV trunk pressure wounds with no signs of infection.
- •HbA1C < 8 (if patient is diabetic)
- •Adequate nutrition including albumin above 2.0 and prealbumin above 15.
排除标准
- •Wounds that cannot have a NPWT device properly applied due to location (too close to anus), diarrhea, periwound skin issues.
- •Patients with Infected wounds.
研究组 & 干预措施
Routine NPWT Standard of Care
Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, standard of care dressing will be placed.
干预措施: Routine NPWT Standard of Care (Device)
NPWT Standard of Care plus Oasis wound product
Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, Oasis wound product will be applied in addition to standard of care dressing.
干预措施: NPWT Standard of Care plus Oasis wound product (Device)
结局指标
主要结局
Closure Rate of Non-healing Wounds
时间窗: 12 weeks
Wound dimensions will be measured weekly and monitored for changes
次要结局
- Growth Factors(12 weeks)