Intracuticular Suture Alone Compared to Intracuticular Suture and Skin Adhesive Material for Skin Closure After Cesarean Delivery : a Prospective Randomized Control Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Skin wound complecations
研究概览
简要总结
The goal of this randomized control trial is to compare two skin closure techniques after cesarean section. Both techniques are currently in wide use but no comparison between the two was reaserched yet. The two techniques are- First technique isintracuticular suture using monofilament suture, Second technique is intracuticular suture and biological adhesive material. Our primary outcome is to explore the rate of skin scar complications to understand whether one technique has a lower complication rate then the other. Our secondary outcomes is to check whether one technique is better then the other in terms of patients' satisfaction, convenience and scar healing and appearance.
Patients at the age of 18 and above, undergoing elective cesarean section at the Hadassa medical center, can participate.
participants will be randomly assigned to one of the groups- the firs or the second technique.
Patients will be asked to fill out a questionnaire on POD 2 and attend a check-up appointment in-person with their surgeon 6-8 weeks post surgery. at the check-up the patient will be asked to fill out another questionnaire and undergo a scar appearance evaluation by the surgeon.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing elective cesarean section at Hadassa medical center
排除标准
- •Patients undergoing emergency cesarean section, patients undergoing cesarean section before 37+0/7 weeks of gestation, patients with a history of previous wound complications after previous Caesarean section
研究组 & 干预措施
Skin closure using intracuticular suture alone
this group will undergo skin closure at the end of the cesarean section using intracuticular suture alone using monofilament suture.
Skin closure using intracuticular suture and biological adhesive material in addition
this group will undergo skin closure at the end of the cesarean section using intracuticular suture using monofilament suture and biological adhesive material in addition.
干预措施: Dermabond (Other)
结局指标
主要结局
Skin wound complecations
时间窗: From the surgery and up to 8 weeks post surgery
Any skin complications including superficial infection, deep infection, seroma, skin open, the need for antibiotics and skin related complaints including rash, itching, discharge.
次要结局
- Recovery and connivance of the patient at POD 2(From the day of the surgery up to 8 weeks post surgery)
- Patients' satisfaction from their recovery and scar healing process 6-8 weeks post surgery(6-8 weeks post surgery)
- Scar appearance after 6-8 weeks(6-8 weeks post surgery)
研究者
Doron Kabiri
maternal-fetal medicine specialist at hadassah university medical center
Hadassah Medical Organization