Subcuticular Continuous Suture Versus Skin Staples to Reduce Surgical Site Infections in Colorectal Surgery Patients
Prospective and Comparative Pilot Study Between Subcuticular Continuous Suture Versus Skin Staples to Reduce Surgical Site Infections in Colorectal Surgery Patients.
研究概览
详细说明
In colorectal surgery, there has been a growing interest in the study of Surgical Site Infections (SSI), with an outstanding variability of reported incidence, ranging from 3% up to 30% depending on the series. Although general risk factors for infection have been identified, there is still a need to identify specific risk factors for colorectal surgery patients, to try to reduce these numbers. The technique and materials used for wound closure have been considered as interesting variables for study.
Main question of our study: is subcuticular (reabsorbable, continuous) suture better than skin staples for reducing wound SSIs in colorectal surgery? The study is sponsored by the Surgical Infection Society Europe, and was awarded the SIS-E Fellowship for young investigators (2013)
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Madrid、西班牙、28040
- 招聘中
- Hospital Fundacion Jimenez Diaz
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接触：
- Ignacio Valverde, PhD
- 邮箱：ivalverden@fjd.es
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副研究员：
- Hector Guadalajara, PhD
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副研究员：
- Mariano Garcia Arranz, PhD
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副研究员：
- Ignacio Valverde, PhD
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副研究员：
- Damian Garcia Olmo, PhD
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副研究员：
- Carlos Pastor
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Madrid、西班牙、28046
- 招聘中
- Hospital Universitario La Paz
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接触：
- Ines Rubio-Perez, MD
- 邮箱：dr.inesrubio@gmail.com
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副研究员：
- Miguel Leon Arellano, Resident
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副研究员：
- Isabel Prieto Nieto, PhD
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副研究员：
- Mario Álvarez Gallego, MD
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副研究员：
- Jose Luis Marijuan, PhD
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副研究员：
- Ramon Cantero, PhD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Adults (age >18), both genders.
- Elective colorectal surgery interventions
- Open surgery incisions and laparoscopic extraction incisions
- Incisions >5cm, any location
- Intervention performed by a specialist colorectal surgeon
- Patient suitable for surgery in preoperative assessment
- Informed consent
Exclusion Criteria:
- Emergency colorectal surgery
- Scheduled multiple surgical procedures
- Unsuitable preoperative assessment
- Other infections present/being treated.
- Incorrect application of standard surgical infection prevention measures (antibiotic prophylaxis, antibiotic treatment prior to surgery, intraoperative heat/O2/glycemic control,etc.)
- Inability to understand the study/sign informed consent
学习计划
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 |
|---|---|
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实验性的：Subcuticular suture
Subcuticular suture (absorbable) for skin closure
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其他名称：
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有源比较器：Skin staples
Standard skin staples for wound closure
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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 |
|---|---|---|
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incidence of surgical site infection
大体时间：30 days, as by CDC definition
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The primary endpoint is the incidence of wound infection, measured from the moment of surgery up to 30 days postoperatively.
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30 days, as by CDC definition
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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prolongation of hospitalization
大体时间：30 days
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Length of hospital stay, and if it is prolonged as a consequence of infection
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30 days
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合作者和调查者
调查人员
- 首席研究员：Ines Rubio-Perez, MD、Hospital Universitario La Paz
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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