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

Surgical Site Infection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05434182
• Other study ID #: VASC-INF-2021-01
• Status: Recruiting
• Phase: N/A
• Start date: March 4, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2022
• Source: Hospital Universitari de Bellvitge
• Contact: Albert González-Sagredo, M.D.
• Phone: +34932607221
• Email: albertgonzalezsagredo[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 224
• Est. completion date: December 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infections
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Procedure:
• Intradermal Suture
Skin closure with an intradermal suture using Monosyn® (Braun®) 4/0 absorbable monofilament.
• Metallic Staples
Skin closure with metallic stapling using Visistat® (Weck®) 35W skin stapler.

Locations

Country	Name	City	State
Spain	Hospital Universitari de Bellvitge	L'Hospitalet De Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge

Country where clinical trial is conducted

Spain, 

References & Publications (17)

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. Epub 2005 Nov 28. — View Citation

Chakfé 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 Gonçalves 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. Erratum in: Eur J Vasc Endovasc Surg. 2020 Dec;60(6):958. — View Citation

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

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. — View Citation

Gurusamy KS, Toon CD, Allen VB, Davidson BR. Continuous versus interrupted skin sutures for non-obstetric surgery. Cochrane Database Syst Rev. 2014 Feb 14;(2):CD010365. doi: 10.1002/14651858.CD010365.pub2. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Nikulainen V, Helmiö 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. — View Citation

Oderich GS, Panneton JM. Aortic graft infection. What have we learned during the last decades? Acta Chir Belg. 2002 Feb;102(1):7-13. Review. — View Citation

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. — View Citation

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. — View Citation

Pleger SP, Nink N, Elzien M, Kunold A, Koshty A, Böning 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. — View Citation

Pounds LL, Montes-Walters M, Mayhall CG, Falk PS, Sanderson E, Hunter GC, Killewich LA. A changing pattern of infection after major vascular reconstructions. Vasc Endovascular Surg. 2005 Nov-Dec;39(6):511-7. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	28 (±2) days after surgery
Secondary	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.	28 (±2) days after surgery
Secondary	Number (percentage) of patients who develop sepsis up to 28 (±2) days after surgery		28 (±2) days after surgery
Secondary	Number (percentage) of patients with SSI who develop sepsis up to 28 (±2) days after surgery.		28 (±2) days after surgery
Secondary	Time of prophylactic antibiotic administration		28 (±2) days after surgery
Secondary	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
Secondary	Types of antibiotic therapy used in patients with SSI		84 (±7) days after surgery
Secondary	Plasma albumin concentration		Baseline visit to 28 (±2) days after surgery
Secondary	Body Mass Index		Baseline visit to 28 (±2) days after surgery
Secondary	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.	On the day of performing the surgical procedure
Secondary	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.	On the day of performing the surgical procedure
Secondary	Type of hemostatic material used during surgery	This information will be collected on the day of performing the surgery, once it is over.	On the day of performing the surgical procedure
Secondary	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.	From the day of hospital admission to the day of performing the surgical procedure
Secondary	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	84 (±7) days after surgery