Prevention of Seroma Following Inguinal Lymph Node Dissection With Prophylactic Incisional Negative Pressure Wound Therapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Number of participants with seroma
研究概览
简要总结
Inguinal lymph node dissection (ILND) is indicated following metastatic malignant melanoma, and is associated with a high-complication rate, of which many begin with the formation of seroma and ends in complicated wound healing, reoperation, multiple outpatient visits and re-hospitalization. Prevention of seroma may therefore lead to a reduction of many of the preceding complications and improve patient quality-of-life. The aim of this study is to evaluate the efficacy and oncological safety of prophylactic negative pressure wound therapy following ILND in melanoma patients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All malignant melanoma patients who are candidates for ILND and 18 years of age or older
排除标准
- •Patients suspected of having tumor residuals after ILND, previous groin irradiation or patients suffering from dementia or any psychiatric disorder making them incapable of informed consent or adherence to follow up, along with patients who are unable to communicate in Danish or English will not be included in the study.
研究组 & 干预措施
Negative pressure wound therapy
干预措施: Negative pressure wound therapy (Device)
Control
Micropore tape
干预措施: Micropore tape (Other)
结局指标
主要结局
Number of participants with seroma
时间窗: 3 months
One or more inguinal seroma(s) which require aspiration
次要结局
- Number of participants with wound rupture(3 months)
- Questionnaire EQ-5D-5L(Baseline, 3 months and 2 years)
- Number of participants with lymphedema(2 years)
- Number of participants with regional recurrence(2 years)
- Number of seromas for each participant(3 months)
- Number of participants with surgical wound infection(3 months)
- Number of participants with wound necrosis(3 months)
- Hospitalization readmission time(3 months)
- Questionnaire LYMQOL(2 years)
- Volume of seromas for each participant(3 months)
- Number of participants with hematoma(3 months)
- Hospitalization time(3 months)
- Number of participants with reoperations(3 months)
研究者
Mads Gustaf Jørgensen
MD
Odense University Hospital