Intracuticular Sutures Versus Glue (Dermabond) for Skin Closure After Cesarean Delivery
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Patient and Observer Scar Assessment Scale (POSAS)
研究概览
简要总结
To investigate the effect of intracutaneous suture closure versus Glue (dermabond) closure at cesarean section (CS) on long-term cosmetic and maternal outcome.
详细描述
Women undergoing planned CS were randomized to either intracutaneous suture closure or glue closure using a 1:1 allocation algorithm. Participants and outcome assessors were blinded to group allocation. Scar evaluation was performed after two months.
Primary outcome measures were Patient and Observer Scar Assessment Scale (POSAS) summary scores 2 months after surgery. Secondary outcome measures were, duration of surgery, and development of hematoma, seroma, surgical site infection (SSI) or wound disruption.
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
- Double (Participant, 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
- 是
入选标准
- •Pregnant women between 18 and 45 years
- •Elective cesarian section
排除标准
- •Clinical signs of infection at the time of CS
- •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
研究组 & 干预措施
MODIFIED VICRYL PLUS
The intra-cuticular layer will closed with with VICRYL PLUS suture
干预措施: MODIFIED VICRYL PLUS (Device)
DERMABOND GLUE
The intra-cuticular layer will closed with with DERMABOND GLUE
干预措施: DERMABOND GLUE (Device)
结局指标
主要结局
Patient and Observer Scar Assessment Scale (POSAS)
时间窗: 2 month
Subjective scar rating will be performed using the patient component of the POSAS. The POSAS Scale consists of 2 numerical numeric scales: The Patient Scar Assessment Scale and the Observer Scar Assessment Scale
次要结局
- post operative complication(1 month)