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Steri-Strip Application Versus Standard Wound Closure for Cesarean Section Incisions (STRIP-CS)

2026年6月29日 更新者:Matthew X Perera, DO、Riverside University Health System Medical Center

A Randomized Prospective Trial Comparing Steri-Strip Application Versus Standard Wound Closure for Cesarean Section Incisions

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.

研究概览

研究类型

介入性

注册 (估计的)

610

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • California
      • Moreno Valley、California、美国、92555
        • 招聘中
        • Riverside University Health System Medical Center
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Standard Closure + Steri-Strips
Participants undergo standard cesarean skin closure followed by application of Steri-Strip™ skin closure strips according to a standardized study protocol.
Application of Steri-Strip adhesive skin closure strips following standard cesarean section wound closure according to a standardized protocol.
Standard skin closure performed following cesarean delivery according to institutional practice.
有源比较器:Standard Closure Alone
Participants undergo standard cesarean skin closure without application of Steri-Strip™ skin closure strips.
Standard skin closure performed following cesarean delivery according to institutional practice.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Incidence of Cesarean Section Wound Complications
大体时间:Within 30 days postpartum
Composite incidence of postoperative wound complications including surgical site infection, wound seroma, and wound separation/dehiscence following cesarean delivery.
Within 30 days postpartum

次要结果测量

结果测量
措施说明
大体时间
Length of Hospital Stay
大体时间:From cesarean delivery until hospital discharge (up to 7 days)
Duration of hospitalization measured from cesarean delivery until discharge.
From cesarean delivery until hospital discharge (up to 7 days)
Readmission Related to Wound Complications
大体时间:Within 30 days postpartum
Hospital readmission attributable to wound infection, seroma, or wound separation/dehiscence following cesarean delivery.
Within 30 days postpartum
Cost of Wound Management
大体时间:From cesarean delivery through 30 days postpartum
Comparison of direct healthcare costs associated with wound closure materials and management of postoperative wound complications between study groups.
From cesarean delivery through 30 days postpartum

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月1日

初级完成 (估计的)

2027年6月1日

研究完成 (估计的)

2027年12月1日

研究注册日期

首次提交

2026年6月24日

首先提交符合 QC 标准的

2026年6月29日

首次发布 (实际的)

2026年7月7日

研究记录更新

最后更新发布 (实际的)

2026年7月7日

上次提交的符合 QC 标准的更新

2026年6月29日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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