A Randomised Controlled Trial Comparing PICO™ Single Use Negative Pressure Wound Therapy System (Smith & Nephew Healthcare Limited, UK) to Conventional Wound Care Following Inguinal Lymphadenectomy for Metastatic Cutaneous Malignancy
试验速览
- 阶段
- 不适用
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Time to wound healing
研究概览
简要总结
This study investigates the use of a negative pressure wound therapy device (PICO™, Smith & Nephew Healthcare, UK) on clean, closed surgical wounds, in patients who are undergoing inguinal lymphadenectomy for metastatic carcinoma of cutaneous origin.
详细描述
Patients may develop inguinal lymph node metastases from a variety of cutaneous neoplasms. A number of factors conspire to cause a high rate of wound breakdown and other complications in this patient group. Reported rates of wound healing complications vary in the literature, but tend to affect > 40% of patients.
A new negative pressure wound therapy device is recommended for use in clean, closed surgical wounds (PICO™ system, Smith & Nephew Healthcare, UK). Patients will be randomised to receive either PICO™ system for up to seven days, or conventional dressings, and then assessed for wound healing and other outcome measures.
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
- •Histologically- or cytologically-proven inguinal lymph node metastases from neoplasm of cutaneous origin
排除标准
- •inability to give informed consent for participation
结局指标
主要结局
Time to wound healing
时间窗: From date of surgery until epithelial integrity is restored at the surgical site. Assessed at least weekly until wound is healed, up to 20 weeks after surgery
Determination of wound healing
次要结局
- Wound infection As defined by Comprehensive Complication Index (CCI)(From date of surgery until wound is healed (epithelial integrity restored at surgical site), up to 20 weeks after surgery.)
- Need for further surgical interventions to achieve wound healing(From date of surgery until wound is healed, up to 20 weeks after surgery.)
- Scar appearance (POSAS)(From date of surgery up to one year post-operatively.)
- Patient reported outcomes (qualitative interview)(From date of surgery to six months post-operatively.)
- Lymphoedema (Limb volume measurements)(From date of surgery up to one year post-operatively.)
研究者
Sandra McAllister
Academic Clinical Lecturer
South Eastern Health and Social Care Trust