An interventional study of Intradermal Suture and Metallic Staples in Surgical Site Infection, sponsored by Hospital Universitari de Bellvitge. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-04.
Sponsored by Hospital Universitari de Bellvitge · Not applicable, Interventional, and Prevention
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 225 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Hospital Universitari de Bellvitge is the lead sponsor of 118 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Vascular surgery patients undergoing a femoral approach surgery and randomized to this group will have their skin closed with an intradermal suture using Monosyn® (Braun®) 4/0 absorbable monofilament.
Procedure: Intradermal Suture
Vascular surgery patients undergoing a femoral approach surgery and randomized to this group will have their skin closed with metallic stapling using Visistat® (Weck®) 35W skin stapler.
Procedure: Metallic Staples
Skin closure with an intradermal suture using Monosyn® (Braun®) 4/0 absorbable monofilament.
Skin closure with metallic stapling using Visistat® (Weck®) 35W skin stapler.
Number (percentage) of patients who present a femoral approach SSI* -(superficial and/or deep) up to 28 (±2) after surgery.
According to the National Healthcare Safety Network (NHSN) Classification
Time frame: 28 (±2) days after surgery
Number (percentage) of patients with other surgical wound complications up to 28 (±2) days after surgery.
Complications include but are not limited to seroma, hematoma, lymphorrhagia.
Time frame: 28 (±2) days after surgery
Number (percentage) of patients who develop sepsis up to 28 (±2) days after surgery
Time frame: 28 (±2) days after surgery
Number (percentage) of patients with SSI who develop sepsis up to 28 (±2) days after surgery.
Time frame: 28 (±2) days after surgery
Time of prophylactic antibiotic administration
Time frame: 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.
Time frame: 28 (±2) days after surgery
Types of antibiotic therapy used in patients with SSI
Time frame: 84 (±7) days after surgery
Plasma albumin concentration
Time frame: Baseline visit to 28 (±2) days after surgery
Body Mass Index
Time frame: Baseline visit to 28 (±2) days after surgery
Surgical incision length
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.
Time frame: On the day of performing the surgical procedure
Total surgery duration
Duration (in minutes) of the surgical procedure. This information will be collected on the day of performing the surgery, once it is over.
Time frame: On the day of performing the surgical procedure
Type of hemostatic material used during surgery
This information will be collected on the day of performing the surgery, once it is over.
Time frame: On the day of performing the surgical procedure
Number of days between hospital admission and the surgical intervention
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.
Time frame: From the day of hospital admission to the day of performing the surgical procedure
Number (percentage) of patients who present a femoral approach SSI (superficial and/or deep) up to 84 (±7) days after surgery
According to the NHSN classification
Time frame: 84 (±7) days after surgery
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — The sponsor will oversee the dataset. Granting access to this information will be evaluated on a case-by-case basis and upon reasonable request by the interested party.
Supporting information: Study protocol, Icf
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Hospital Universitari de Bellvitge