A Prospective, Single-Blind, Multicenter, Randomized Controlled Study to Evaluate the Clinical Equivalence of two Triclosan-Coated Polyglactin 910 Sutures, Trusynth Plus Neo and Vicryl Plus in Caesarean Section Wound Closure
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 试验地点
- 4
研究概览
简要总结
Surgical site infections (SSIs) are a common and serious healthcare-associated infection that increase morbidity, hospital stay, costs, and patient dissatisfaction, and they remain a significant concern following caesarean section (CS), the most frequently performed abdominal surgery worldwide. SSI rates after CS range from 2–10%, with superficial, deep, and organ/space infections contributing to delayed recovery, readmission, reoperation, and long-term morbidity. While SSIs are multifactorial in origin, surgical sutures play a key role because they are foreign materials placed directly in the wound and can act as a nidus for bacterial colonization, particularly at suture knots. Appropriate suture selection depends on biological compatibility, mechanical performance, wound tension, tissue characteristics, and handling properties, all of which influence wound healing and infection risk. To reduce bacterial colonization, antibacterial-coated sutures have been developed, most notably triclosan-coated sutures. Triclosan is a broad-spectrum antibacterial agent effective against common SSI pathogens, with proven in vitro, in vivo, and clinical evidence showing reduced bacterial adhesion and lower SSI rates. Based on this evidence, both the World Health Organization and the National Institute for Health and Care Excellence recommend the use of triclosan-coated sutures to reduce the risk of SSIs. Vicryl Plus Triclosan-Coated Polyglactin 910 sutures have been widely utilized in caesarean section wound closure. To further expand available treatment options, it is important to demonstrate that other triclosan coated polyglactin 910 sutures, such as Trusynth Plus Neo, can deliver equivalent outcomes. Thus, this study is designed to compare the clinical equivalence of Trusynth Plus Neo (triclosan coated polyglactin 910 suture) with Vicryl Plus (triclosan coated polyglactin 910 suture) in caesarean section wound closure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)(—)
- 性别
- Female
入选标准
- •Pregnant women aged 18 to 40 years scheduled to undergo caesarean section delivery using a Pfannenstiel incision
- •Pregnant women who have given written informed consent.
排除标准
- •Pregnant women with haemoglobin levels less than 7g/dL
- •Pregnant women with active systemic infection or sepsis, or receiving therapeutic antibiotics other than standard perioperative prophylaxis
- •Pregnant women with known HIV infection
- •Pregnant women with a known allergy or hypersensitivity to triclosan and/or polyglactin 910 sutures
- •Pregnant women requiring additional major surgical procedures at the time of caesarean section
- •Pregnant women receiving chronic systemic corticosteroids, immunosuppressive therapy, or other medications known to impair wound healing
- •Pregnant women with known bleeding or coagulation disorders
- •Pregnant women diagnosed with placenta accreta spectrum (PAS) disorders
- •Pregnant women with intrauterine foetal demise (stillbirth)
- •Pregnant women who, in the opinion of the investigator, are unlikely to comply with the study procedures or complete scheduled follow-up visits
- •Any condition which, in the opinion of the investigator, may compromise trial participant’s safety or affect study integrity.
研究者
Dr Ashok Moharana
Healthium Medtech Ltd
