Negative Pressure Dressings Versus Non-negative Pressure Dressing for Wound Care Following Soft Tissue Sarcoma Excision
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Surgical Site Infection (proportion)
研究概览
简要总结
This randomised controlled trial aims to evaluate the difference in surgical site infection following excision of soft tissue sarcomas. The intervention is a negative wound pressure therapy dressing for 120 hours, the control is standard absorbent dressings
详细描述
Hypothesis
The application of a negative pressure wound therapy (NPWT) dressing will reduce rates of wound breakdown in patients with resection of soft tissue sarcomas which are primarily closed.
Patients will be randomised into either NPWT or standard absorbent dressings with primary outcome measure of surgical site infection according to the Health Protection Agency guidance. Secondary outcomes are; time to wound dryness, delayed discharge from hospital, adverse events, cost estimation
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
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults undergoing primary soft tissue sarcoma excision which is primarily closed.
排除标准
- •Unable to consent
- •Post radiation sarcomas or sarcoma in presence of active infection
- •Multiple metastatic disease
- •Presence of Endoprosthesis
研究组 & 干预措施
Negative Pressure Wound Therapy
120 hours of negative pressure wound therapy (ActiVAC, KCI) applied to a primarily closed ('acute') wound.
干预措施: Negative Pressure Wound Therapy (ActivVAC, KCI) (Device)
Standard dressings
Absorbant dressings applied in a standard fashion, i.e. only changed as necessary
干预措施: Standard dressings (Device)
结局指标
主要结局
Surgical Site Infection (proportion)
时间窗: 30 days
As diagnosed by independent observer according to the Healthcare Protection Agency (UK) guidelines
次要结局
- Delay to discharge form hospital (nominal scale)(30 days)
- Adverse events (count)(30 days)
- Cost analysis (comparative nominal scale in £)(30 days)
- Time to wound dryness (nominal scale)(30 days)