A Randomized control trial to evaluate the role of absorbable antimicrobial sutures in comparison to conventional sutures in the prevention of surgical site infections
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Incidence of Surgical Site Infection within 30 days post surgery
研究概览
简要总结
•Surgical site infections (SSI) are a risk inherent to surgical procedures and a frequent complication, notably after digestive surgery. SSI are associated with severe morbidity and mortality, especially in high-risk patient populations.
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•The cornerstones for reducing the risk of SSI include exquisite surgical technique, timely and appropriate antimicrobial prophylaxis [5], effective and persistent skin antisepsis, and identification of adjunctive strategies for reducing wound contamination [6] and promoting wound healing.
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•Various bacteria may contaminate not only the tissue in a surgical wound but also the actual suture material.
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•If the surgical suture is implicated as the cause of a wound infection, then an antimicrobial coating should nearly eliminate the possibility of the suture material becoming a vector of infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator 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
- •â€¢ Adult patients (≥18 years) undergoing surgery at the participating hospital • Elective abdominal surgeries (Open abdominal surgery is defined as surgically opened peritoneal cavity.
- •â€¢ Ability to provide informed consent.
排除标准
- •Bowel/Gastric Perforation
- •Any drug, alcohol, or nicotine abuse – People with mental disorders
- •Participants under 18 years 4.Emergency surgery/procedures 5.Not willing to participate in the study) • Pregnant or breastfeeding women • Immunocompromised patients • Patients with known hypersensitivity to any of the components of the suture material • Patients with a pre-existing infection at the surgical site.
结局指标
主要结局
Incidence of Surgical Site Infection within 30 days post surgery
时间窗: Incidence of Surgical Site Infection within 30 days post surgery at 7thDay, 15th day and 30th day
次要结局
- • Evaluate the safety profile:(The trial also aims to assess the safety profile of absorbable antimicrobial sutures compared to standard absorbable sutures. This includes monitoring for any adverse events or complications associated with the use of antimicrobial sutures, such as allergic reactions or tissue irritation.)
研究者
Soumya Tripathi
UPUMS Saifai