NCT07218679进行中（未招募）不适用
Clinical Trial on the Use of Stratafix Symmetric vs. Resorbable Monofilament for Closure of Large Median Laparotomy in Oncological Patients
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2025年5月21日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Incisional hernia
研究概览
简要总结
The aim of this study is to evaluate the safety and efficacy of using Stratafix (a type of symmetric, barbed, and coated suture) for abdominal wall closure in oncologic patients undergoing elective midline laparotomy, compared to the use of a monofilament suture following the Small Stitch technique.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients over 18 years of age who will undergo midline laparotomy for oncologic resection of a retroperitoneal tumor or cytoreductive surgery for carcinomatosis of any origin.
排除标准
- •Diagnosed incisional hernia.
- •When the planned midline laparotomy is expected to be less than 20 cm.
- •Patients with a BMI > 45 kg/m².
- •Patients with abdominal aortic aneurysm.
- •Patients with coagulopathy: previously diagnosed with von Willebrand disease, hemophilia, or idiopathic thrombocytopenic purpura.
- •Patients with collagen disorders: previously diagnosed with Marfan syndrome, Ehlers-Danlos syndrome, homocystinuria, or scleroderma.
研究组 & 干预措施
Stratafix
Experimental
Midline laparotomy closure with Stratafix suture.
干预措施: Stratafix Suture (Device)
PDS plus
Active Comparator
Midline laparotomy closure with PDS plus suture
干预措施: PDS plus suture (Device)
结局指标
主要结局
Incisional hernia
时间窗: 12 months
Incisional hernia rate after midline laparotomy closure.
次要结局
- Wound infection(12 months.)
- Wound seroma(12 months)
- Hematoma(12 months)
- Evisceration(1 month)
研究者
研究点 (1)
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