Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
NCT Number: NCT05434182
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
*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
Skin closure with an intradermal suture using Monosyn® (Braun®) 4/0 absorbable monofilament.
Skin closure with metallic stapling using Visistat® (Weck®) 35W skin stapler.
Time frame: 28 (±2) days after surgery
According to the National Healthcare Safety Network (NHSN) Classification
Time frame: 28 (±2) days after surgery
Complications include but are not limited to seroma, hematoma, lymphorrhagia.
Time frame: 28 (±2) days after surgery
Time frame: 28 (±2) days after surgery
Time frame: 28 (±2) days after surgery
Time frame: 28 (±2) days after surgery
Time frame: 84 (±7) days after surgery
Time frame: Baseline visit to 28 (±2) days after surgery
Time frame: Baseline visit to 28 (±2) days after surgery
Time frame: 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.
Time frame: 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.
Time frame: On the day of performing the surgical procedure
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
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: 84 (±7) days after surgery
According to the NHSN classification
Hospital Universitari de Bellvitge
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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