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Meta-Analysis
. 2025 Apr 22;4(4):CD015192.
doi: 10.1002/14651858.CD015192.pub2.

Prevention of infection in aortic or aortoiliac peripheral arterial reconstruction

Mateus Ab Cristino  1 , Luis Cu Nakano  1   2 , Vladimir Vasconcelos  1   2 , Rebeca M Correia  1 , Ronald Lg Flumignan  1   2
Affiliations
Meta-Analysis

Prevention of infection in aortic or aortoiliac peripheral arterial reconstruction

Mateus Ab Cristino et al. Cochrane Database Syst Rev. .

Abstract

Background: Peripheral arterial disease (PAD) results from the narrowing of arteries. Aortic aneurysms - abnormal dilatations in artery walls - are a related concern. For severe cases, arterial reconstruction surgery is the treatment option. Surgical site infections (SSIs) are a feared and common complication of vascular surgery. These infections have a significant global healthcare impact. Evaluating the effectiveness of preventive measures is essential.

Objectives: To assess the effects of pharmacological and non-pharmacological interventions, including antimicrobial therapy, antisepsis, and wound management, for the prevention of infection in people undergoing any open or hybrid aortic or aortoiliac peripheral arterial reconstruction.

Search methods: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases, and the World Health Organization International Clinical Trials Registry Platform, LILACS, and ClinicalTrials.gov up to 11 November 2024.

Selection criteria: We included all randomised controlled trials (RCTs) with a parallel (e.g. cluster or individual) or split-body design, and quasi-RCTs, which assessed any intervention to reduce or prevent infection following aortic or aortoiliac procedures for the treatment of aneurysm or PAD. There were no limitations regarding age and sex.

Data collection and analysis: We used standard Cochrane methodological procedures. Two review authors independently extracted the data and assessed the risk of bias of the trials. A third review author resolved disagreements when necessary. We assessed the evidence certainty for key outcomes using GRADE.

Main results: We included 21 RCTs with 4952 participants. Fifteen studies were assessed as having a high risk of bias in at least one domain, and 19 studies had an unclear risk of bias in at least one domain. We analysed 10 different comparisons for eight different outcomes. The comparisons were antibiotic versus placebo or no treatment; short-duration antibiotics (≤ 24 hours) versus long-duration antibiotics (> 24 hours); different types of systemic antibiotics (one versus another); antibiotic-bonded implant versus standard implant; Dacron graft versus stretch polytetrafluoroethylene graft; prophylactic closed suction drainage versus undrained wound; individualised goal-directed therapy (IGDT) versus fluid therapy based on losses, standard haemodynamic parameters and arterial blood gas values (standard care); comprehensive geriatric assessment versus standard preoperative care; percutaneous versus open-access technique; and negative pressure wound therapy (NPWT) versus standard dressing. The primary outcomes were graft infection rate and SSI rate. The secondary outcomes included all-cause mortality, arterial reconstruction failure rate, re-intervention rate, amputation rate, pain resulting from the intervention, and adverse events resulting from the interventions to prevent infection. We did not assess all the outcomes across the different comparisons. The main findings are presented below. Antibiotic versus placebo or no treatment (five studies) Very low-certainty evidence from five included studies suggests that antibiotic prophylaxis reduces SSI (risk ratio (RR) 0.33, 95% confidence interval (CI) 0.15 to 0.71; 5 studies, 583 participants; number needed to treat for an additional beneficial outcome (NNT) 9). With very low- to low-certainty evidence, there was little or no difference between the groups in the other assessed outcomes (graft infection rate, all-cause mortality, re-intervention rate, and amputation rate). We did not quantitatively assess other outcomes in this comparison. Short duration antibiotics (≤ 24 hours) versus long duration antibiotics (> 24 hours) (three studies) Very low-certainty evidence from three included studies suggests that there is little or no difference in graft infection rate (RR 2.74, 95% CI 0.11 to 65.59; 1 study, 88 participants) or SSI rate (RR 3.65, 95% CI 0.59 to 7.71; 1 study, 88 participants) between short- and long-duration antibiotic prophylaxis. We did not quantitatively assess other outcomes in this comparison. Different types of systemic antibiotics (one versus another) (seven studies) We grouped seven studies comparing one antibiotic to another into three subgroups that compared different classes of antibiotics amongst themselves. We found little or no difference between the groups analysed. Graft infection rate: beta-lactams versus cephalosporins (RR 0.36, 95% CI 0.02 to 8.71; 1 study, 88 participants; very low-certainty evidence); glycopeptides versus cephalosporins (RR 5.00, 95% CI 0.24 to 103.05; 1 study, 238 participants; low-certainty evidence); one cephalosporin versus another (RR not estimable, CI not estimable; 1 study; 69 participants; very low-certainty evidence); SSI rate: beta-lactams and cephalosporins (RR 0.27, 95% CI 0.03 to 2.53; 2 studies, 229 participants; very low-certainty evidence); glycopeptides versus cephalosporins (RR 2.17, 95% CI 0.65 to 7.23; 2 studies, 312 participants; very low-certainty evidence); and one cephalosporin versus another (RR 1.26, 95% CI 0.21 to 7.45; 3 studies, 625 participants; very low-certainty evidence). We could extract all-cause mortality data for the glycopeptide versus cephalosporin comparison; there was little or no difference between groups (RR 1.33, 95% CI 0.30 to 5.83; 1 study, 238 participants; low-certainty evidence). We did not quantitatively assess other outcomes in this comparison.

Authors' conclusions: Very low-certainty evidence suggests that the use of prophylactic antibiotics may prevent SSIs in aortic or aortoiliac peripheral arterial reconstruction. We found no superiority amongst specific antibiotics or differences in extended antibiotic use (over 24 hours) compared with shorter use (up to 24 hours), with low-certainty evidence. For other interventions, very low- to moderate-certainty evidence showed little or no difference across various outcomes. We advise interpreting these conclusions with caution due to the limited number of events in all groups and comparisons.

Trial registration: ClinicalTrials.gov NCT02581904 NCT02084017 NCT02836990 NCT02395159 NCT00428623 NCT01790529 NCT02992951 NCT03308253 NCT03512470 NCT03746132 NCT04238923 NCT05434182.

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Conflict of interest statement

MABC: none known

LCUN: none known

VV: none known

RMC: none known

RLGF: none known

Update of

References

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Pleger 2018 {published data only}
    1. NCT02395159. Reduction of groin wound infections after vascular surgery by using an incision management system (IMS) [Reduction of groin wound infections after vascular surgery in patients with risk factors by the use a negative pressure wound incision management system (KCI Prevena)]. clinicaltrials.gov/show/NCT02395159 (first received 20 March 2015).
    1. 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. International Wound Journal 2018;15(1):75-83. [DOI: 10.1111/iwj.12836] - DOI - PMC - PubMed
Recker 1987 {published data only}
    1. Recker F, Geroulanos S, Turina M. [Perioperative antibiotic prophylaxis in heart and vascular surgery. A prospective randomized comparative study with cefazolin and ceftriaxone] [Perioperative antibiotika-prophylaxe in der herz- und gefäß-chirurgie: prospektive randomisierte vergleichsstudie mit cefazolin und ceftriaxon]. Deutsche Medizinische Wochenschrift 1987;112(4):135-8. [DOI: 10.1055/s-2008-1068018] - DOI - PubMed
Risberg 1995 {published data only}
    1. Risberg B, Drott C, Dalman P, Holm J, Ivarsson L, Jivegard L, et al. Oral ciprofloxacin versus intravenous cefuroxime as prophylaxis against postoperative infection in vascular surgery: a randomised double-blind, prospective multicentre study. European Journal of Vascular & Endovascular Surgery 1995;10(3):346-51. [DOI: 10.1016/s1078-5884(05)80055-3] - DOI - PubMed
Rotman 1991 {published data only}
    1. Rotman N, Flamant Y, Hay JM, Fagniez PL. [Antibiotic prophylaxis in abdominal surgery. Prospective randomized study organized by the French Surgical Research Association]. Presse Medicale 1991;20(34):1659-63. [PMID: ] - PubMed
Sabat 2016 {published data only}
    1. NCT02954835. Negative pressure therapy for groin wounds [Negative pressure therapy for closed groin wounds in patients undergoing vascular surgery]. clinicaltrials.gov/show/NCT02954835 (first received 3 November 2016).
    1. Sabat J, Tyagi S, Srouji A, Pechman D, Gupta AM, Lucido D, et al. Prophylactic negative-pressure therapy for femoral incision in vascular surgery: preliminary results of a prospective, randomized trial. Journal of Vascular Surgery 2016;1:94S-95S. [DOI: ]
Salzmann 1983 {published data only}
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Schwartz 2014 {published data only}
    1. Schwartz J, Goss S, Facchin F, Manizate F, Gendics C, Braitman E, et al. A prospective two-armed trial assessing the efficacy and performance of a silver dressing used postoperatively on high-risk, clean surgical wounds. Ostomy Wound Management 2014;60(4):30-40. [PMID: ] - PubMed
Stone 2010 {published data only}
    1. Stone P, Campbell J, AbuRahma A, Safley L, Emmett M, Asmita M. Vascular surgical antibiotic prophylaxis study (VSAPS). Vascular & Endovascular Surgery 2010;44(7):521-8. [DOI: 10.1177/1538574410373837] - DOI - PubMed
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Totty 2019 {published data only}
    1. Totty JP, Harwood AE, Cai PL, Hitchman LH, Smith GE, Chetter IC. Assessing the effectiveness of dialkylcarbamoylchloride (DACC)-coated post-operative dressings versus standard care in the prevention of surgical site infection in clean or clean-contaminated vascular surgery (the DRESSINg trial): study protocol for a pilot feasibility randomised controlled trial. Pilot & Feasibility Studies 2019;5(1):11. [DOI: 10.1186/s40814-019-0400-2] - DOI - PMC - PubMed
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    1. NCT00873704. Supplemental oxygen in vascular surgery. clinicaltrials.gov/show/NCT00873704 (first received 2 April 2009).
    1. Turtiainen J, Saimanen EI, Partio TJ, Makinen KT, Reinikainen MT, Virkkunen JJ, et al. Supplemental postoperative oxygen in the prevention of surgical wound infection after lower limb vascular surgery: a randomized controlled trial. World Journal of Surgery 2011;35(6):1387-95. [DOI: 10.1007/s00268-011-1090-y] - DOI - PubMed
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Vogt 2007 {published data only}
    1. NCT00428623. Aquacel compared to traditional post-surgical wound dressing in vascular surgery patients. clinicaltrials.gov/show/NCT00428623 (first received 30 January 2007).
    1. Vogt KC, Uhlyarik M, Schroeder TV. Moist wound healing compared with standard care of treatment of primary closed vascular surgical wounds: a prospective randomized controlled study. Wound Repair and Regeneration 2007;15(5):624-7. [DOI: 10.1111/j.1524-475X.2007.00294.x] - DOI - PubMed
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Whitley 2024 {published data only}
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References to ongoing studies

ACTRN12622000360718 {published data only}ACTRN12622000360718
    1. ACTRN12622000360718. Nutrition supplementation before and after revascularisation procedure for people with peripheral arterial disease compared to usual care. trialsearch.who.int/Trial2.aspx?TrialID=ACTRN12622000360718 (first received 1 March 2022).
CTRI/2024/03/064885 {published data only}
    1. CTRI/2024/03/064885. What's better? Suture or staple for skin closure of groin wound in lower extremity revascularisation surgeries [Comparison of suture vs staple for skin closure of groin wound in lower extremity revascularisation: a randomised controlled trial]. ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=ODYxNzc=&Enc=&us... (first received 28 March 2024).
EUCTR2013‐004743‐23‐GB {published data only}EUCTR2013‐004743‐23‐GB
    1. EUCTR2013-004743-23-GB. Comparison of skin preparations to prevent surgical site infections in clean or clean-contaminated, non-implant vascular surgery [A randomised controlled trial to assess the clinical and cost-effectiveness of pre-operative skin cleansing with chlorhexidine and povidone-iodine in preventing surgical site infection and establish the impact of aqueous versus alcoholic solutions, in patients undergoing clean or clean-contaminated, non-implant vascular surgery. Chlorhexidine Against Povidone-Iodine Trial (CAPIT)]. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2013-004743-23-GB (first received 22 November 2013).
EUCTR2016‐001584‐36‐SE {published data only}EUCTR2016‐001584‐36‐SE
    1. EUCTR2016-001584-36-SE. Is high oxygen concentration a risk factor for postoperative complications? A prospective, randomized single-blinded study in elderly patients undergoing vascular surgery. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2016-001584-36-SE (first received 14 April 2016).
NCT02992951 {published data only}
    1. NCT02992951. DACC in the reduction of surgical site infection [A pilot feasibility randomised controlled trial to assess the clinical and cost-effectiveness of dialkylcarbamoylchloride (DACC) coated post-operative dressings versus standard care in the prevention of surgical site infection in clean or clean-contaminated, vascular and cardiothoracic surgery]. clinicaltrials.gov/show/NCT02992951 (first received 14 December 2016).
    1. Totty JP, Harwood AE, Cai PL, Hitchman LH, Smith GE, Chetter IC. Assessing the effectiveness of dialkylcarbamoylchloride (DACC)-coated post-operative dressings versus standard care in the prevention of surgical site infection in clean or clean-contaminated, vascular surgery (the DRESSINg trial): study protocol for a pilot feasibility randomised controlled trial. Pilot and Feasibility Studies 2019;5(1):11. [DOI: 10.1186/s40814-019-0400-2] - DOI - PMC - PubMed
NCT03308253 {published data only}
    1. NCT03308253. Study for antibiotic impregnated calcium sulfate beads as prophylaxis for surgical site infection [Pilot study for antibiotic impregnated calcium sulfate beads as prophylaxis for surgical site infection in vascular surgery patients]. clinicaltrials.gov/ct2/show/NCT03308253 (first received 12 October 2017).
NCT03512470 {published data only}
    1. NCT03512470. Clinical study on the prevention of surgical wound complications for aneurysmal thoracic-abdominal aortic pathology using the "PREVENA" system [A clinical study, spontaneous, randomized and controlled, on the prevention of surgical wound complications for aneurysmal thoracoabdominal aortic disease by using the "PREVENA ™" negative topical pressure system (TVAC STUDY)]. clinicaltrials.gov/show/NCT03512470 (first received 30 April 2018).
NCT03746132 {published data only}
    1. NCT03746132. Oxygen for vascular incisional healing [A prospective, randomized, crossover study of transdermal, continuous oxygen therapy for surgical site wound healing in high-risk subjects undergoing lower extremity revascularization]. clinicaltrials.gov/show/NCT03746132 (first received 19 November 2018).
NCT04238923 {published data only}
    1. NCT04238923. Topical gentamicin and vancomycin for vascular surgical site infection prophylaxis [Topical gentamicin and vancomycin for surgical site infection prophylaxis in patients undergoing high-risk vascular surgery]. clinicaltrials.gov/show/NCT04238923 (first received 23 January 2020).
NCT05434182 {published data only}
    1. González-Sagredo A, Gil M, D'Oria M, Spanos K, Salinas Á, Matus S, et al. Groin surgical site infection incidence in vascular surgery with intradermal suture versus metallic stapling skin closure: a study protocol for a pragmatic open-label parallel-group randomised clinical trial (VASC-INF trial). Medicine (Baltimore) 2022;101(50):e31800. [DOI: 10.1097/MD.0000000000031800] - DOI - PMC - PubMed
    1. NCT05434182. Intradermal suture versus stapling for groin skin closure in vascular surgery (VASC-INF Trial) [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]. clinicaltrials.gov/ct2/show/NCT05434182 (first received 27 June 2022). - PMC - PubMed

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