Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated Fascial Traction (VAWCPOM) in Patients With Open Abdomen - a Prospective Multi-center Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Incisional hernia at 1 year
研究概览
简要总结
Open abdomen therapy is used in trauma and non-trauma patients where the abdomen is not possible to close, or the intraabdominal conditions is not suitable for closure. In 2007, a new technique that made use of negative pressure wound therapy and mesh-mediated fascial traction for closure of the open abdomen was described from the Department of Surgery in Malmö, Sweden. With this new technique, fascial closure rates were high but long-term incisional hernia formation was seen in approximately half of the patients alive after five years. To overcome the high incisional hernia incidence, a new technique utilizing a permanent on-lay mesh for traction and reinforcement of the incision at fascial closure was developed.
Hypothesis Lower incisional hernia rates in comparison with literature reported results of other techniques for open abdomen treatment, with similar complication rates.
Aims To evaluate early and late clinical outcome of the novel vacuum-assisted wound closure and permanent on-lay mesh-mediated fascial traction technique.
Design A prospective six-center cohort study in Sweden and Denmark. Study inclusion during a two-year period or longer to include at least 100 patients. Statistical analysis will be done by intention-to-treat and as sub-group per-protocol analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •All patients ≥18 years old treated with an open abdomen with a midline incision, regardless of indication.
排除标准
- •Patient declining participation
- •Existing incisional hernia or primary ventral hernia ≥3 cm
- •Existing mesh in the abdominal wall, located in the midline and irrespective of mesh size
- •Existing ostomy/parastomal hernia located in a position that prevents the VAWCPOM technique to be utilized
- •Closure of the abdomen at first dressing change, e. g. without mesh traction
结局指标
主要结局
Incisional hernia at 1 year
时间窗: 1 year, year 1
Incidence of incisional hernia after open abdomen closure with the technique
次要结局
- Fascial closure rate(During hospital stay)
- Incisional hernia(Through study completion, 3 years)
- EQ5D(Through study completion, 3 years)
- HERO(Through study completion, 3 years)
- Complications(Up to 12 weeks)
研究者
Ulf Petersson
Principal investigator
Skane University Hospital