Evaluation of incision related complication in emergent abdominal fascial closure with barbed vs non-barbed suture type in hollow viscous perforation: randomized clinical trial in north Indian population
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Rate of abdominal wall dehiscence/or burst abdomen in the patients undergoing emergent abdominal fascial closure in hollow viscous perforation.
研究概览
简要总结
| Midline laparotomy incisions provide rapid access to the abdomen where keyhole surgery may be inadequate specially in emergency cases . Abdominal wall dehiscence incidence ranges between 2 and 5.5% after elective laparotomy and 8.5–45% after emergency laparotomy and typically occurs between the 6th and 12th postoperative day(1,5,6) |
Prophylactic use of antibiotics, mechanical bowel preparation, hair removal at the surgical site, skin disinfection, hand decontamination, and the use of sterile gloves and gowns are some of the recent advancements in the prevention of surgical site infections (SSIs). (7) Suture used for abdominal wall closure is another factor that may have an impact on SSI. The most current method for closing the abdominal fascia involves using absorbable monofilament sutures coated with triclosan. That being said, evisceration rates are elevated following unclean surgery and can up to 15% (8)In order to prevent segmental ischaemia, tissue necrosis, and secondary infection, it’s also critical to provide a uniform distribution of tension throughout the suture, as seen with barbed sutures (9)
In a study done by Ruiz-Tovar et al found that TCB suture reduces the incidence of SSI and acute evisceration compared with standard fascial closure with triclosan-coated polydioxanone (PDS) looped suture and noncoated PDS looped suture in emergency nontraumatic laparotomy(10).The limitation of above study is suboptimal estimation of the SSI rate in the control group for the sample size calculation, might have led to a certain underpower of the study. The above study also did not include trauma laparotomy.
There are no other randomized clinical trial study to support or refute the findings noted by Ruiz-Tovar et al .As far as we are aware, no research has examined the impact of closing abdominal fascia with barbed sutures following unclean surgery in Indian subcontinent. In this study, we are concentrating on a specific patient population: peritonitis due to hollow viscous perforation, who are more likely to experience wound degradation and surgical site infections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Adult patients undergoing emergency laparotomy for hollow viscous perforation with primary fascial closure.
排除标准
- •1.Age less than 18 years 2.Immunocompromised patient 3.Unstable patient undergoing damage control surgery 4.Patient having midline scar /incisional hernia.
结局指标
主要结局
Rate of abdominal wall dehiscence/or burst abdomen in the patients undergoing emergent abdominal fascial closure in hollow viscous perforation.
时间窗: 30 days
次要结局
- superficial SSI in 30 days fallow up period length of hospital stay(6 month follow up)
研究者
Dr. Amit Kumar Gupta
AIIMS Raebareli
