Antibacterial-coated Sutures at Time of Cesarean
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 1,169
- 试验地点
- 2
- 主要终点
- Composite of endometritis and/or wound infection and/or other post-cesarean infections
研究概览
简要总结
Abdominal closure with antibacterial-coated sutures has been shown to reduce wound infections after a number of surgical procedures, but none of the previous trials included cesarean delivery. Our objective is to determine whether use of antibacterial-coated sutures reduces surgical site infection (SSI) after cesarean delivery.
详细描述
A review of 18 studies demonstrated a significant benefit of antimicrobial coated sutures in reducing SSI (RCTs: OR 0.72; 95% CI 0.59-0.88; observational studies: OR 0.58; 95% CI 0.40-0.83). As there are no clinical trials focusing on cesarean delivery, and because the risk factors and pathogenesis for post-cesarean SSI may not mirror other procedures, further data is needed before generalizing the WHO recommendations to cesarean procedures.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
A confidential computer-generated simple randomization scheme will be prepared and provided on an ongoing basis. A randomization log will be used to track the randomization process. Patients will be masked to the suture material. Both suture types look similar. Patient, surgeons, and staff ascertaining the outcomes will be masked for the suture type.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18-50 years of age.
- •Women ≥ 24 weeks' viable gestation.
- •To undergo cesarean delivery.
排除标准
- •Patient unwilling or unable to provide consent.
- •No prenatal care or a non-resident patient who is unlikely to be followed-up after delivery.
- •Immunosuppressed patients: i.e., taking systemic immunosuppressant or steroids (e.g. transplant patients; not including steroids for lung maturity), HIV with CD4<200, or other.
- •Decision to use other than suture closure (e.g. secondary wound closure, mesh closure).
- •Skin infection.
- •Coagulopathy.
- •High likelihood of additional surgical procedure beyond cesarean (e.g. scheduled hysterectomy, bowel or adnexal surgery).
- •Allergy to Triclosan.
- •Incarcerated individuals.
研究组 & 干预措施
Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures
Use of Monocryl Plus, Vicryl Plus and PDS Plus Suture (Triclosan-coated sutures) will be used exclusively throughout the entire procedure.
干预措施: Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures) (Drug)
Vicryl, monocryl, PDS (not coated with triclosan)
Use of Monocryl, Vicryl and PDS Suture (equivalent uncoated sutures) will be used exclusively throughout the whole procedure.
干预措施: Vicryl, monocryl, PDS (not coated with triclosan) (Other)
结局指标
主要结局
Composite of endometritis and/or wound infection and/or other post-cesarean infections
时间窗: occurring within 30 days of delivery
surgical site infection after cesarean
Participants With Endometritis, Wound Infection, or Other Post-Cesarean Infections
时间窗: Within 30 days following delivery
Number of Participants With Endometritis, Wound Infection, or Other Post-Cesarean Infections post-cesarean infections occurring within 30 days of delivery, including endometritis, wound infection, or other infections. Endometritis: Presence of two or more of the following signs with no other identified etiology: fever (\>38°C or \>100.4°F), abdominal pain, fundal tenderness, or cervical/vaginal purulent discharge. Wound Infection: Presence of superficial or deep incisional surgical site infection (SSI), including cellulitis/erythema, induration around the incision, or purulent discharge from the incision site with or without fever, including necrotizing fasciitis. Wound hematoma, seroma, or wound breakdown alone without signs of infection was not considered infection. Other Infections: Pelvic septic thrombosis diagnosed based on persistent signs of endometritis with or without radiologic confirmation, or abdominal/pelvic abscess confirmed radiologically.
Participants With Surgical Site Infection
时间窗: Within 30 days following delivery
Number of participants who developed a surgical site infection (SSI) following cesarean delivery.
次要结局
- Maternal Deaths(Within 30 days following delivery)
- Participants With Wound Hematoma or Seroma(Within 30 days following delivery)
- Participants With Puerperal Fever(Within 30 days following delivery)