A Randomized Prospective Trial Comparing Steri-Strip Application Versus Standard Wound Closure for Cesarean Section Incisions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 610
- 试验地点
- 1
- 主要终点
- Incidence of Cesarean Section Wound Complications
研究概览
简要总结
This study is evaluating whether Steri-Strips® provide additional benefits when used after cesarean section (C-section) surgery. Steri-Strips are adhesive strips that are commonly placed over a surgical incision to provide support while the wound heals. At our hospital, Steri-Strips are routinely used after C-sections in addition to standard wound closure techniques, although they are not considered part of the standard recommended closure method.
Researchers want to determine whether adding Steri-Strips actually reduces wound complications such as infection, fluid collection under the skin, or reopening of the incision. Previous studies have shown mixed results, with some suggesting little difference in wound healing outcomes while others reported differences in scar appearance. Steri-Strips may also increase costs, add time to the surgery, and occasionally cause skin irritation or allergic reactions.
Participants in this study will be randomly assigned to one of two groups. One group will receive standard cesarean wound closure with Steri-Strips, while the other group will receive standard wound closure without Steri-Strips. Researchers will compare wound healing, complications, patient outcomes, and costs between the two groups.
The goal of this study is to determine whether Steri-Strips improve recovery after cesarean delivery and whether their routine use is beneficial and cost-effective. The findings may help guide future recommendations for cesarean wound care and improve outcomes for patients undergoing C-section delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Neither participants nor treating clinicians will be blinded to treatment allocation because Steri-Strip application is readily visible following surgery.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients age 18 years or older
- •Pregnant patients undergoing cesarean delivery at Riverside University Health System Medical Center (RUHS)
- •Able and willing to provide informed consent
排除标准
- •Known allergy or hypersensitivity to Steri-Strip™ materials or adhesives
- •Inability or unwillingness to provide informed consent
- •Anticipated inability to complete the 30-day postpartum follow-up evaluation
结局指标
主要结局
Incidence of Cesarean Section Wound Complications
时间窗: Within 30 days postpartum
Composite incidence of postoperative wound complications including surgical site infection, wound seroma, and wound separation/dehiscence following cesarean delivery.
次要结局
- Length of Hospital Stay(From cesarean delivery until hospital discharge (up to 7 days))
- Readmission Related to Wound Complications(Within 30 days postpartum)
- Cost of Wound Management(From cesarean delivery through 30 days postpartum)
研究者
Matthew X Perera, DO
Research Coordinator
Riverside University Health System Medical Center
