Single blind, randomized study comparing clinical equivalence of Trulon® and Ethilon® polyamide sutures, for closure of the skin following laparotomy incisions
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- 1. To compare the rate of wound infection with Trulon (Healthium) and Ethilon (J & J) polyamide sutures
研究概览
简要总结
The abdominal wallsurrounds the abdominal cavity, where many important organs are located.Laparotomy is a surgical incision in the abdominal wall which is used to gainaccess to the organs of the abdominal cavity. The abdominal wall has multiplelayers of tissues, with the skin as the outermost layer. The surgeon will closethese layers after completion of the procedure and abdominal skin closure isthe final step of surgical intervention. The two primary methods of skinclosure are with suture or staples. Sutures are more preferred to close the skinbecause of their several benefits. Monofilament polyamide (nylon) sutures arecommonly used for closing the skin due to its low infectivity, satisfactorywound tissue strength, even when used in infected wounds. In this study, weplan to assess differences in the rate of post-operative complications afterskin closure, between two commonly used brands of non-absorbable polyamide(nylon) sutures, Trulon® and Ethilon®.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women aged 18 to 50 years, undergoing laparotomy-based obstetric/ gynecological procedures
- •Women with CDC surgical wound classification class I/II
- •Women with good systemic/ mental health as per opinion of investigator
- •Subjects who have given written informed consent.
排除标准
- •Women with BMI >30 Kg/m2
- •Women with hemoglobin levels <7g/dL
- •Women with a history of any laparotomy procedure or laparoscopic surgery
- •Women having urogenital tract infection within 2 weeks before the procedure
- •Women needing prophylactic mesh augmentation after laparotomy
- •Women undergoing elective/emergency laparoscopic abdominal surgeries
- •Women having active infection at or around the skin incision site
- •Women with history of allergy to nylon or similar products
- •Women already participating in another trial
- •Women unlikely to comply with the surgical procedure or complete the scheduled follow up visit, in the opinion of investigator
- •Other indication-based exclusion, in opinion of investigator.
结局指标
主要结局
1. To compare the rate of wound infection with Trulon (Healthium) and Ethilon (J & J) polyamide sutures
时间窗: Day 3, Day 7-14, Week 6 and Week 12
次要结局
- 1. To evaluate tissue reaction, wound dehiscence, skin disruptions, suture sinus, seroma, and hematoma(2. To assess overall intraoperative handling between two sutures)