Groin Surgical Site Infection Incidence in Vascular Surgery With Intradermal Suture Versus Metallic Stapling Skin Closure: A Pragmatic Open-Label Parallel-Group Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 225
- 试验地点
- 2
- 主要终点
- Number (percentage) of patients who present a femoral approach SSI* -(superficial and/or deep) up to 28 (±2) after surgery.
研究概览
简要总结
Surgical site infection (SSI) is one of the most frequent and fearsome complications in vascular surgery due to its high morbidity and mortality. In addition, SSI is one of the factors related to the development of prosthetic infection. Consequently, it represents a significant increase in hospital stay and healthcare costs.
A 2021 meta-analysis on groin SSI prevention strategies in arterial surgeries reported that using intradermal sutures could be associated with a lower SSI rate. The published results from a single-center retrospective study comparing SSI rates before and after implementing an SSI prevention protocol also suggest better outcomes with intradermal suturing.
This study aims to assess the SSI incidences of both skin closure techniques in vascular surgery patients undergoing femoral artery approach through a perpendicular groin skin incision.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with chronic lower limb ischemia or aortic, iliac, or femoral aneurysm
- •With a scheduled surgery for one of the following indications:
- •Femoropopliteal Bypass
- •Femorodistal Bypass
- •Aortobifemoral Bypass
- •Axillofemoral or Axillobifemoral Bypass
- •Femorofemoral Bypass
- •Femoral Endarterectomy
- •Femoral approach for exclusion of an aortic aneurysm
- •Surgical procedure with an incision perpendicular to the inguinal fold
- •Patients who undergo both unilateral and bilateral surgical approaches *
- •*Note: We will consider one patient as one intervention (i.e., bilateral approaches will be quantified as one single inguinal surgical approach). In the case of bilateral procedures, the same closure technique will be used for both sides.
- •Patients who sign the written informed consent
排除标准
- •Background of a previous surgical intervention in the groin area.
- •Femoral approach carried out in a surgical emergency setting
- •Femoral approach performed due to a femoral pseudoaneurysm
- •A surgical procedure performed with a transverse/oblique incision to the groin
- •A patient who withdraws consent for participating in the trial
结局指标
主要结局
Number (percentage) of patients who present a femoral approach SSI* -(superficial and/or deep) up to 28 (±2) after surgery.
时间窗: 28 (±2) days after surgery
According to the National Healthcare Safety Network (NHSN) Classification
次要结局
- Number (percentage) of patients who develop sepsis up to 28 (±2) days after surgery(28 (±2) days after surgery)
- Types of antibiotic therapy used in patients with SSI(84 (±7) days after surgery)
- Number (percentage) of patients with other surgical wound complications up to 28 (±2) days after surgery.(28 (±2) days after surgery)
- Number (percentage) of patients with SSI who develop sepsis up to 28 (±2) days after surgery.(28 (±2) days after surgery)
- Plasma albumin concentration(Baseline visit to 28 (±2) days after surgery)
- Number (percentage) of patients who present a femoral approach SSI (superficial and/or deep) up to 84 (±7) days after surgery(84 (±7) days after surgery)
- Time of prophylactic antibiotic administration(28 (±2) days after surgery)
- Types of microorganisms isolated from skin microbiological culture, subcutaneous tissue sample culture, and SSI secretion culture up to 28 (±2) days after surgery.(28 (±2) days after surgery)
- Total surgery duration(On the day of performing the surgical procedure)
- Type of hemostatic material used during surgery(On the day of performing the surgical procedure)
- Body Mass Index(Baseline visit to 28 (±2) days after surgery)
- Surgical incision length(On the day of performing the surgical procedure)
- Number of days between hospital admission and the surgical intervention(From the day of hospital admission to the day of performing the surgical procedure)
研究者
Albert Gonzalez-Sagredo
Surgeon at the Vascular Surgery and Angiology Department
Hospital Universitari de Bellvitge