The Effect of Triclosan-coated Sutures for Reducing Risk of Surgical Site Infection After Episiotomy: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- number of patients with wound complications (infection, hematoma, disruption)
研究概览
简要总结
Surgical repair of perineal lesions after delivery can be associated with infection of the surgery site. The aim of this study was to compare the surgical site infection with triclosan-coated suture (Vicryl Plus) versus coated suture (Vicryl) in the episiotomy after delivery.
详细描述
Women undergoing planned were randomized to either episiotomy suture with VICRYL PLUS or VICRYL. The primary outcome measures were number of sutures used and the development of hematoma, seroma, surgical site infection (SSI) or wound disruption one week after episiotomy. Secondary outcome measures were the cost of the treatment with or without infection, and scar evaluation (wound complication).
Data were analyzed according to the intention to treat principle.
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
- Single (Participant)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women who had had an episiotomy at the delivery
- •vaginal delivery
- •no further perineal or vaginal lesions present
排除标准
- •collagen disease
- •known immunodeficiency
- •Clinical signs of infection at the time of episiotomy
- •History of keloids and a medical disorder that could affect wound healing
- •Hypersensitivity to any of the suture materials used in the protocol
- •Diabetes mellitus
- •Disorders requiring chronic corticosteroid use or immunosuppression
- •Instrumental extraction
结局指标
主要结局
number of patients with wound complications (infection, hematoma, disruption)
时间窗: one week
number of sutures used
时间窗: two hours
次要结局
- cost of the treatment with and without infection(two weeks)
- number of patients with adverse outcomes(two weeks)
研究者
Amira Ayachi
University Assistant in Obstetrics and gynecology
University Tunis El Manar