AzTrials
AzTrials

Surgical Site InfectionNCT05434182

Intradermal Suture Versus Stapling for Groin Skin Closure in Vascular Surgery (VASC-INF Trial)

A study testing Intradermal Suture and Metallic Staples in people with Surgical Site Infection, run by Hospital Universitari de Bellvitge at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Surgical Site Infection
What is being tested?
Intradermal Suture and Metallic Staples
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
225 participants
Where
1 siteSpain
Study dates
4 Mar 2022to 14 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

Other trials in Spain

About this study

Official title: 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

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.

Being tested
Intradermal Suture, Metallic Staples
Keywords
Femoral approach, Intradermal suture, Metallic staples, Surgical Site Infection, Groin
Medical subject headings
Surgical Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intradermal SutureProcedure or surgery

    Skin closure with an intradermal suture using Monosyn® (Braun®) 4/0 absorbable monofilament.

  • Metallic StaplesProcedure or surgery

    Skin closure with metallic stapling using Visistat® (Weck®) 35W skin stapler.

Study groups in NCT05434182
Study groupRoleWhat they receive
Intradermal Suture GroupExperimentalVascular 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.
Receives: Procedure: Intradermal Suture
Metallic StaplesActive comparatorVascular 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.
Receives: Procedure: Metallic Staples

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 28 (±2) days after surgery

Secondary outcomes (13)

  1. 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.

    Measured: 28 (±2) days after surgery

  2. Number (percentage) of patients who develop sepsis up to 28 (±2) days after surgery

    Measured: 28 (±2) days after surgery

  3. Number (percentage) of patients with SSI who develop sepsis up to 28 (±2) days after surgery.

    Measured: 28 (±2) days after surgery

  4. Time of prophylactic antibiotic administration

    Measured: 28 (±2) days after surgery

  5. Types of microorganisms isolated from skin microbiological culture, subcutaneous tissue sample culture, and SSI secretion culture up to 28 (±2) days after surgery.

    Measured: 28 (±2) days after surgery

  6. Types of antibiotic therapy used in patients with SSI

    Measured: 84 (±7) days after surgery

  7. Plasma albumin concentration

    Measured: Baseline visit to 28 (±2) days after surgery

  8. Body Mass Index

    Measured: Baseline visit to 28 (±2) days after surgery

  9. 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.

    Measured: On the day of performing the surgical procedure

  10. 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.

    Measured: On the day of performing the surgical procedure

  11. Type of hemostatic material used during surgery

    This information will be collected on the day of performing the surgery, once it is over.

    Measured: On the day of performing the surgical procedure

  12. 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.

    Measured: From the day of hospital admission to the day of performing the surgical procedure

  13. 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

    Measured: 84 (±7) days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2022
  2. Study start4 Mar 2022
  3. Primary completion14 Mar 2025
  4. Study completion14 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
225 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05434182
Sponsor's protocol ID
VASC-INF-2021-01
Status last verified
Mar 2025
First submitted
16 Jun 2022
Last updated
4 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Perencevich EN, Sands KE, Cosgrove SE, Guadagnoli E, Meara E, Platt R. Health and economic impact of surgical site infections diagnosed after hospital discharge. Emerg Infect Dis. 2003 Feb;9(2):196-203. doi: 10.3201/eid0902.020232.

    PubMed 12603990

  • Chakfe N, Diener H, Lejay A, Assadian O, Berard X, Caillon J, Fourneau I, Glaudemans AWJM, Koncar I, Lindholt J, Melissano G, Saleem BR, Senneville E, Slart RHJA, Szeberin Z, Venermo M, Vermassen F, Wyss TR, Esvs Guidelines Committee, de Borst GJ, Bastos Goncalves F, Kakkos SK, Kolh P, Tulamo R, Vega de Ceniga M, Document Reviewers, von Allmen RS, van den Berg JC, Debus ES, Koelemay MJW, Linares-Palomino JP, Moneta GL, Ricco JB, Wanhainen A. Editor's Choice - European Society for Vascular Surgery (ESVS) 2020 Clinical Practice Guidelines on the Management of Vascular Graft and Endograft Infections. Eur J Vasc Endovasc Surg. 2020 Mar;59(3):339-384. doi: 10.1016/j.ejvs.2019.10.016. Epub 2020 Feb 5. No abstract available.

    PubMed 32035742

  • Groin wound Infection after Vascular Exposure (GIVE) Study Group. Groin wound infection after vascular exposure (GIVE) multicentre cohort study. Int Wound J. 2021 Apr;18(2):164-175. doi: 10.1111/iwj.13508. Epub 2020 Nov 25.

    PubMed 33236858

  • Kirkland KB, Briggs JP, Trivette SL, Wilkinson WE, Sexton DJ. The impact of surgical-site infections in the 1990s: attributable mortality, excess length of hospitalization, and extra costs. Infect Control Hosp Epidemiol. 1999 Nov;20(11):725-30. doi: 10.1086/501572.

    PubMed 10580621

  • Gwilym BL, Dovell G, Dattani N, Ambler GK, Shalhoub J, Forsythe RO, Benson RA, Nandhra S, Preece R, Onida S, Hitchman L, Coughlin P, Saratzis A, Bosanquet DC. Editor's Choice - Systematic Review and Meta-Analysis of Wound Adjuncts for the Prevention of Groin Wound Surgical Site Infection in Arterial Surgery. Eur J Vasc Endovasc Surg. 2021 Apr;61(4):636-646. doi: 10.1016/j.ejvs.2020.11.053. Epub 2021 Jan 7.

    PubMed 33423912

  • Nikulainen V, Helmio P, Hurme S, Hakovirta H. Intra-Dermal Absorbable Suture in the Groin Incision Associated with Less Groin Surgical Site Infections than Trans-Dermal Sutures in Vascular Surgical Patients. Surg Infect (Larchmt). 2019 Jan;20(1):45-48. doi: 10.1089/sur.2018.202. Epub 2018 Oct 6.

    PubMed 30300081

  • Parizh D, Ascher E, Raza Rizvi SA, Hingorani A, Amaturo M, Johnson E. Quality improvement initiative: Preventative Surgical Site Infection Protocol in Vascular Surgery. Vascular. 2018 Feb;26(1):47-53. doi: 10.1177/1708538117719155. Epub 2017 Jul 14.

    PubMed 28708024

  • Engin C, Posacioglu H, Ayik F, Apaydin AZ. Management of vascular infection in the groin. Tex Heart Inst J. 2005;32(4):529-34.

    PubMed 16429897

  • Yashar JJ, Weyman AK, Burnard RJ, Yashar J. Survival and limb salvage in patients with infected arterial prostheses. Am J Surg. 1978 Apr;135(4):499-504. doi: 10.1016/0002-9610(78)90027-2.

    PubMed 637195

  • Pleger SP, Nink N, Elzien M, Kunold A, Koshty A, Boning A. Reduction of groin wound complications in vascular surgery patients using closed incision negative pressure therapy (ciNPT): a prospective, randomised, single-institution study. Int Wound J. 2018 Feb;15(1):75-83. doi: 10.1111/iwj.12836. Epub 2017 Oct 25.

    PubMed 29068153

  • Antonios VS, Noel AA, Steckelberg JM, Wilson WR, Mandrekar JN, Harmsen WS, Baddour LM. Prosthetic vascular graft infection: a risk factor analysis using a case-control study. J Infect. 2006 Jul;53(1):49-55. doi: 10.1016/j.jinf.2005.10.004. Epub 2005 Nov 28.

    PubMed 16310254

  • Oderich GS, Panneton JM. Aortic graft infection. What have we learned during the last decades? Acta Chir Belg. 2002 Feb;102(1):7-13. doi: 10.1080/00015458.2002.11679254. No abstract available.

    PubMed 11925745

  • Siracuse JJ, Nandivada P, Giles KA, Hamdan AD, Wyers MC, Chaikof EL, Pomposelli FB, Schermerhorn ML. Prosthetic graft infections involving the femoral artery. J Vasc Surg. 2013 Mar;57(3):700-5. doi: 10.1016/j.jvs.2012.09.049. Epub 2013 Jan 9.

    PubMed 23312940

  • Wiseman JT, Fernandes-Taylor S, Barnes ML, Saunders RS, Saha S, Havlena J, Rathouz PJ, Kent KC. Predictors of surgical site infection after hospital discharge in patients undergoing major vascular surgery. J Vasc Surg. 2015 Oct;62(4):1023-1031.e5. doi: 10.1016/j.jvs.2015.04.453. Epub 2015 Jul 3.

    PubMed 26143662

  • Leekha S, Lahr BD, Thompson RL, Sampathkumar P, Duncan AA, Orenstein R. Preoperative risk prediction of surgical site infection requiring hospitalization or reoperation in patients undergoing vascular surgery. J Vasc Surg. 2016 Jul;64(1):177-84. doi: 10.1016/j.jvs.2016.01.029. Epub 2016 Feb 27.

    PubMed 26926939

Questions about this trial

What is this clinical trial studying?

A study testing Intradermal Suture and Metallic Staples in people with Surgical Site Infection, run by Hospital Universitari de Bellvitge at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number (percentage) of patients who present a femoral approach SSI* -(superficial and/or deep) up to 28 (±2) after surgery. (time frame: 28 (±2) days after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05434182, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in