Continuous Topical Triple-tube Instillation and Suction for for Open Abdomen in the Septic Patients With Complicated Intra-abdominal Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Delayed primary fascial closure
研究概览
简要总结
The closed systems, such as conventional negative pressure wound therapy (NPWT), were usually avoided in infected or critical colonized wounds. To our observation, the additional continuous irrigation tube attached beside the suction tube in the NPWT system could provide the effective drainage by reducing the occlusion of suction tube, enable effective debridement by diluting infected/necrotized tissues and decrease the incidence of fistula by providing relatively moist ambient. At our institutions, the modified system combined with a "triple-tube" device to allow a continuous instillation became more active and efficient. The study is to investigate if a continuous triple-tube instillation and suction could improve the outcomes of acute severely infected open abdomen.
详细描述
This study was performed on the patients with a severely complicated infected open abdomen treated with topical triple-tube irrigation and suction, compared with a control group of the patients treated with standard NPWT without topical irrigation. The clinical outcomes were recorded. Profiles of cytokines/proteinase in wound fluid were quantified weekly.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 years patients with complicated intra-abdominal infections who needed open abdomen (OA) and vacuum-assisted wound closure and mesh-mediated fascial traction (VAWCM)
- •Eligible patients were properly consented before enrollment. If the patient was incapable, the patient's legal representative was asked to provide consent on the patient's behalf.
- •Patients with grade 1b (contaminated OA without adherence between bowel and abdominal wall), 2b (contaminated OA developing adherence) open abdomen, as classified by Bjorck.
排除标准
- •< 18 years,
- •pre-existing large ventral hernia
- •Frozen OA with adherent bowel (OA of grade 4),
- •Clean wound (OA of grade 1a or 2a)
- •chronic wound infection
- •critical wound ischemia
- •severe systemic infection
- •end-stage renal disease
- •severe liver disease
- •uncontrolled diabetes mellitus
- •any issue with an obviously high risk of delayed wound healing
研究组 & 干预措施
triple-tube group
The patients were treated with continuous topical triple-tube irrigation and suction
干预措施: Continuous topical triple-tube irrigation and suction (Device)
SOC group
The patients were treated with standard of care (SOC) without topical irrigation
干预措施: SOC (Device)
结局指标
主要结局
Delayed primary fascial closure
时间窗: Up to 8 weeks
Delayed primary fascial closure, Time to infection clearance and abdomen closure, ICU and hospital length of stay
次要结局
- Levels of cytokines/proteinase in wound fluid(Up to 8 weeks)
研究者
Qingsong Tao
Attending Surgeon
Southeast University, China