Surgical Site Infection
Conditions
Keywords
Femoral approach, Intradermal suture, Metallic staples, Surgical Site Infection, Groin
Brief summary
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.
Interventions
PROCEDUREIntradermal Suture
Skin closure with an intradermal suture using Monosyn® (Braun®) 4/0 absorbable monofilament.
PROCEDUREMetallic Staples
Skin closure with metallic stapling using Visistat® (Weck®) 35W skin stapler.
Sponsors
Hospital Universitari de Bellvitge
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number (percentage) of patients who present a femoral approach SSI* -(superficial and/or deep) up to 28 (±2) after surgery. | 28 (±2) days after surgery | According to the National Healthcare Safety Network (NHSN) Classification |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number (percentage) of patients who develop sepsis 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 | — |
| 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 | — |
| Types of antibiotic therapy used in patients with SSI | 84 (±7) days after surgery | — |
| Plasma albumin concentration | Baseline visit to 28 (±2) days after surgery | — |
| Number (percentage) of patients with other surgical wound complications up to 28 (±2) days after surgery. | 28 (±2) days after surgery | Complications include but are not limited to seroma, hematoma, lymphorrhagia. |
| Surgical incision length | On the day of performing the surgical procedure | Length (in centimeters \[cm\]) of the cutaneous incision performed to gain access to the surgical site. This information will be collected on the day of performing the surgery, once it is over. |
| Total surgery duration | On the day of performing the surgical procedure | Duration (in minutes) of the surgical procedure. This information will be collected on the day of performing the surgery, once it is over. |
| Type of hemostatic material used during surgery | On the day of performing the surgical procedure | This information will be collected on the day of performing the surgery, once it is over. |
| Number of days between hospital admission and the surgical intervention | From the day of hospital admission to the day of performing the surgical procedure | The number of days gone by from hospital admission until the day the surgery is performed. This information will be collected on the day of performing the surgery, once it is over. |
| 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 | According to the NHSN classification |
| Body Mass Index | Baseline visit to 28 (±2) days after surgery | — |
Countries
Spain
Outcome results
None listed