Cesarean Randomized Control Trial Of Sutures vs. Staples (CROSS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 746
- 试验地点
- 3
- 主要终点
- Number of Participants With Wound Complications
研究概览
简要总结
To determine whether the rate of wound complications differs based on method of closure of skin incision (staples vs. suture) after cesarean delivery.
详细描述
Despite this large number of cesareans performed annually, there is a paucity of data to suggest which technique is superior for closure of the skin incision with regards to wound complications, including wound separation and infection. As the morbidity associated with a cesarean delivery is usually related to wound complications, especially infection, we feel that it is important to examine this outcome by comparing the current skin closure techniques: staples versus suture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women undergoing cesarean delivery for pregnancy greater than 23 weeks gestation.
排除标准
- •Poorly controlled diabetes (defined as ≥ 50% of fasting or 2 hour postprandial glucose levels > 95 and 120 respectively within the week prior to delivery),
- •Vertical skin incisions
- •Chronic steroid use
- •Active lupus flare
- •Current treatment for cancer or a history of radiation to the abdomen/pelvis
- •Current treatment with immunosuppressant medications secondary to history of transplantation
- •Emergency cesarean(precluding informed consent prior to surgery)
- •Lack of access to a phone
- •Allergy to suture or staple material
结局指标
主要结局
Number of Participants With Wound Complications
时间窗: Within 6 weeks of postpartum
The primary outcome is to evaluate the rate of wound complications for patients undergoing cesarean whose skin incision is closed with staples versus with suture. Wound complications included infection, hematoma, seroma, and separation and readmission for wound complication.
次要结局
- Patient Scar Assessment Scale Scores for Evaluation of Cosmesis(Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.)
- Patient Satisfaction With Closure Method and Scar Appearance(Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.)
- Pain Perception(Immediately postpartum to time of discharge, which is typically 3-4 days post-cesarean)
- Additional Provider Visits(Within 6 weeks postpartum)
- Number of Participants With Primary Versus Repeat Cesarean(At randomization.)
- Intraoperative Trial Details - Duration of Operation and Skin Closure(Time of Cesarean)
- Number of Participants That Received Anticoagulation Within 24 Hours(Within 24 hours postpartum.)
- Intraoperative Trial Details - Closure of Subcutaneous Tissue(Time of Cesarean)
- Length of Hospital Stay(Immediate postpartum.)
- Number of Participants Diagnosed With Endomyometritis(Immediate postpartum.)
- Change in Hemoglobin Pre-operatively to Post-operatively(Up to 72 hours before and 24 hours after cesarean.)
- Observer Evaluation of Cosmesis of the Cesarean Incision Based on Closure Method: Staples vs Sutures.(Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.)