Prophylactic Single-Use Negative Pressure Wound Therapy Devices for Closed Incision Major Amputations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 728
- 试验地点
- 10
- 主要终点
- Presence of wound complications following amputation between NPWT and standard dressings
研究概览
简要总结
Post-operative wound issues in abdominal surgery have a significant impact on patient outcomes. This study is taking place to investigate if Negative Pressure Wound Therapy (NPWT) dressings reduces Surgical Site Infections, post surgical complications and improves scar appearance compared to standard dressings.
详细描述
Many factors influence the risk of wound complications. Notably, the presence of unreconstructed proximal occlusive arterial disease is a major influence on stump healing. Patient factors such as smoking, diabetes, obesity, malnutrition and chronic kidney disease are non-modifiable, particularly in the short-term setting. However, surgical factors may be altered in an effort to reduce the risk of wound complications.
One option amenable to alteration is what dressing is applied to the closed incision upon procedure completion. The type of dressing may influence factors such as bacterial access to the wound, the development of collections of blood or fluid in the wound or fluid oozing from the wound. Collectively, these wound factors increase the risk of wound infection. Therefore, dressings which reduce these factors have the potential to reduce wound breakdown, thereby reducing the burden for patients and healthcare systems.
The investigators propose to conduct a multicentre randomised controlled trial comparing prophylactic single-use negative pressure wound therapy with standard dressings in patients with a closed incision following major lower extremity amputation in terms of SSI incidence, wound healing complications and scar appearance, patient quality of life and financial impact on the patient and healthcare system.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years or older;
- •Patients undergoing major lower extremity amputation, including below-knee amputation, through-knee amputation and above-knee amputation, for any indication;
- •Patients with primary closure of the surgical incision using either interrupted or continuous sutures
排除标准
- •Patients <18 years;
- •Women who are pregnant and/or breast-feeding;
- •Patients with amputations performed without primary skin closure, including guillotine amputations, amputations deliberately left open for drainage purposes and amputations with soft tissues defects at the stump;
- •Patients with amputations where skin glue is the only means of skin closure
- •Patients with a clinically absent femoral pulse
研究组 & 干预措施
Negative Pressure Wound Therapy.
Application of a negative wound pressure therapy dressing to the wound post major lower extremity amputation
干预措施: Negative Pressure Wound Therapy (Device)
Standard Wound dressing
Application of sterile standard gauze dressing to the wound post major lower extremity amputation
干预措施: Standard Wound Dressing (Device)
结局指标
主要结局
Presence of wound complications following amputation between NPWT and standard dressings
时间窗: 1 month following surgery
Infection(deep or superficial), wound dehiscence, partial (fascia intact), complete (fascia breached), seroma, haematoma or stump necrosis.
次要结局
- Number of days to discharge(6 months following surgery)
- Rate of re-admission(1 Month following surgery)
- Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)(6 months following surgery)
- Wound-QoL (Questionnaire on quality of life with chronic wounds)(6 months following surgery)
- Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)(6 Months following surgery)
- Rate of Re-operation(1 Month following surgery)