Cosmetic Outcomes After Skin Closure of Pfannenstiel Incision With Tissue Adhesive (2-octylcyanoacrylate) or Staples in Repeated Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Observer Scar Assessment Scale (OSAS) score
研究概览
简要总结
Recent clinical trials were developed to test the outcomes of skin closure with tissue adhesive, staples and monofilament synthetic suture after cesarean section with Pfannenstiel incision: both clinical outcomes such as blood loss, surgical site infection, length of postpartum hospitalization, or wound disruption, as well as Patient and Observer Scar Assessment Scale (POSAS) scores 8 weeks after surgery, were comparable between these different skin closure methods.
Despite the available studies are often based on robust methodologies and appropriate assessment scales, most of them were aimed to evaluate cosmetic outcomes in primary cesarean section, whereas data analyses published so far do not allow to draw a firm conclusion about repeated cesarean sections. Based on these elements, the aim of this study is to evaluate cosmetic outcomes after skin closure of Pfannenstiel incision with tissue adhesive or staples in a selected population undergoing repeated cesarean section.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Previous cesarean section with Pfannenstiel incision (regardless of the indication, emergency/urgency, weeks of pregnancy and years passed from the previous cesarean section)
- •Maternal age 18-45 years
- •Singleton pregnancy at 37-41 weeks of gestation (based on first-trimester ultrasound) with a viable fetus
排除标准
- •History of keloids
- •Previous transversal suprapubic scars
- •Clinical signs of infection and/or tattoos in the area to be studied
- •Known patient hypersensitivity to any of the suture materials used in the protocol
- •BMI below 20 or above 30
- •Any medical disorder that could affect wound healing, including severe malnutrition, conditions requiring chronic corticosteroid use or immune suppressant, uncontrolled diabetes mellitus (defined as Hemoglobin A1c > 6%, unbalanced daily glucose measurements, and fasting glucose >95 mg/dL).
结局指标
主要结局
Observer Scar Assessment Scale (OSAS) score
时间窗: 6 months after repeated cesarean section
The Observer Scar Assessment Scale (OSAS) rates 5 variables: vascularity, pigmentation, thickness, relief, and pliability. Each variable uses a 10-point scoring system, with 1 representing normal skin. Ratings of individual variables may be summed to obtain a total score ranging from 5-50, with 5 representing normal skin.
次要结局
- Patient Scar Assessment Scale (PSAS) score(6 months after repeated cesarean section)
研究者
Antonio Simone Laganà
Principal Investigator
Università degli Studi dell'Insubria