Key messages
• Antibiotics seem to reduce surgical site infections in people undergoing surgery to fix the lower limb arteries (peripheral arterial reconstruction of the lower limb).
• Closed incision negative pressure therapy (a special wound care technique) may reduce the graft infection rate and the surgical site infection rate, but we need more standardised studies.
• Other interventions assessed appear to make little or no difference in reducing the incidence of graft and surgical site infections.
What is peripheral arterial disease?
Peripheral artery disease (PAD) is a condition where the arteries that supply blood to the limbs become narrowed or blocked, usually due to a build up of plaque, which reduces blood flow. This can lead to symptoms like pain or cramping in the legs when walking. Severe PAD may require surgery (arterial reconstruction) to repair the arteries. However, infections at the surgical site are a major concern, causing serious illness and death. These infections have a large impact on health care worldwide. It is important to check if the steps we can take to prevent these infections work. This review looked at ways to prevent surgical site infections after leg artery surgery.
What did we want to find out?
We wanted to find out how medicines and other treatments – antibiotics, cleaning methods, surgical techniques, and wound care – affect the risk of surgical site infections and graft infections in people who have surgery to repair their lower limb arteries, which are important blood vessels.
What did we do?
We looked at all types of randomised studies that tested different treatments to prevent infections after surgery on the arteries of the lower limb. This only included studies where people were randomly assigned to different treatments. We also looked at whether different treatments had an impact on other important outcomes, such as overall mortality, the rate of failed arterial reconstructions, the need for additional surgery, the rate of amputations, pain resulting from anti-infective treatments, and any harms/side effects caused by these treatments. We assessed how well the studies were conducted, collected and combined the data for analysis whenever we could, and also examined the quality of the evidence.
What did we find?
We included a total of 40 studies involving 7970 participants in this review. We looked at 16 comparisons for nine outcomes.
Antibiotics before surgery: The evidence suggests that antibiotics may reduce surgical site infections compared to no antibiotics. There was no difference between the groups in the other outcomes that we could assess.
Different types of systemic antibiotic preventative: We found no clear difference between specific types of antibiotics or between long-term and short-term use. There was no difference between the groups in the other outcomes that we could assess.
Short- compared to long-duration preventative antibiotics: We found no difference between short- and long-duration antibiotics for preventing graft infections or surgical site infections. There was no difference between the groups in the other outcomes that we could assess.
Closed incision negative pressure therapy (a special wound care technique) versus standard wound closure: The evidence suggests that this technique may reduce surgical site infections, but more research is needed. There was no difference between the groups in the other outcomes that we could assess.
Other methods: We found little or no difference between the other methods we assessed, such as different wound dressings, surgical techniques, or special sutures. The results may be unreliable due to the few events studied.
In summary, the results showed that antibiotics may be effective in preventing surgical site infections. Closed incision negative pressure therapy may reduce the graft infection rate and the surgical site infection rate, but we need more standardised studies. However, for other methods, there was not enough evidence to show significant differences in preventing infections.
What are the limitations of this evidence?
The available studies had mixed populations and used various criteria to diagnose infections. In addition, the length of follow-up after surgery varied a lot. We also noticed that some studies had methodological problems that could lead to biased results, and for most outcomes we had low confidence in the evidence. We listed these challenges when we looked at the results and considered them before drawing conclusions.
How up-to-date is this evidence?
The evidence is up-to-date to August 2024.
Read the full abstract
Peripheral arterial disease (PAD) results from the narrowing of arteries. Arterial reconstruction surgery is the treatment of choice for severe cases. Graft infections and 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, to prevent infection in patients undergoing any open or hybrid lower limb peripheral arterial reconstruction.
Search strategy
The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, LILACS, and CINAHL databases, as well as the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov up to 26 August 2024.
Selection criteria
We included all randomised controlled trials (RCTs) with a parallel (e.g. cluster or individual) design and quasi-RCTs that assessed any intervention to reduce or prevent infection following peripheral arterial reconstruction of the lower limb. There were no limitations on age and gender.
Data collection and analysis
We used standard Cochrane methodological procedures. Two review authors independently extracted the data and assessed the risk of bias in the included studies. We assessed the certainty of evidence using the GRADE approach.
Main results
We included 35 RCTs and five quasi-RCTs with a total of 7970 participants. We analysed 16 comparisons for nine outcomes. The four main comparisons were prophylactic antibiotics versus placebo or no treatment; short- (≤ 24 hours) versus long-duration prophylactic antibiotics (> 24 hours); different types of systemic antibiotic prophylaxis (one versus another); and closed incision negative pressure therapy versus standard wound closure.
The primary outcomes were graft infection rate and SSI rate. The secondary outcomes were all-cause mortality, arterial reconstruction failure rate, re-intervention rate, amputation rate, pain resulting from the interventions to prevent infection, health-related quality of life, and adverse events resulting from the interventions to prevent infection. Not all outcomes were assessed across the different comparisons.
Prophylactic antibiotics versus placebo (eight studies)
Low-certainty evidence from eight included studies suggests that antibiotic prophylaxis may reduce the graft infection rate (risk ratio (RR) 0.19, 95% confidence interval (CI) 0.06 to 0.63; 6 studies, 979 participants; low-certainty evidence; number needed to treat (NNT) 5) and SSI rate (RR 0.20, 95% CI 0.11 to 0.34; 8 studies, 1188 participants; low-certainty evidence, NNT 9). There was no difference between the groups in the other outcomes that we could assess.
Short-duration (≤ 24 hours) versus long-duration prophylactic antibiotics (> 24 hours) (three studies)
Very low-certainty evidence from three included studies suggests that there is little or no significant difference in the graft infection rate (RR 1.40, 95% CI 0.09 to 20.65; 2 studies, 139 participants; very low-certainty evidence) or the SSI rate (RR 0.75, 95% CI 0.40 to 1.40; 3 studies, 247 participants; very low-certainty evidence) between short- and long-duration antibiotic prophylaxis.
Different types of systemic antibiotic prophylaxis (one versus another) (seven studies)
We divided seven studies comparing one antibiotic to another into four subgroups that compared different classes of antibiotics amongst themselves for short and long-term time points. We found little or no difference between the groups analysed. For graft infection rate, only the second- or third-generation cephalosporins versus first-generation cephalosporins comparison had quantitative data (RR 1.71, 95% CI 0.35 to 8.45; 4 studies, 1512 participants; very low-certainty evidence). For SSI rate, we could assess the following comparisons: second- or third-generation cephalosporins versus first-generation cephalosporins (RR 0.71, 95% CI 0.26 to 1.97; 4 studies, 956 participants; very low-certainty evidence); ciprofloxacin versus cefuroxime (RR 1.02, 95% CI 0.61 to 1.70; 1 study, 580 participants; very low-certainty evidence); cefazolin plus daptomycin versus cefazolin plus vancomycin (RR 1.44, 95% CI 0.58 to 3.54; 1 study, 178 participants; low-certainty evidence); teicoplanin versus cephradine (RR 0.68, 95% CI 0.17 to 2.72; 1 study, 134 participants; very low-certainty evidence); cloxacillin plus gentamicin versus cefotaxime (only in the long term) (RR 1.19, 95% CI 0.33 to 4.23; 1 study, 36 participants; very low-certainty evidence). For amputation rate, there was little or no difference between the second- or third-generation cephalosporin versus first-generation cephalosporin antibiotic classes (RR 3.14, 95% CI 0.33 to 30.13; 2 studies, 1269 participants; very low-certainty evidence).
Closed incision negative pressure therapy versus standard wound drainage (nine studies)
For graft infection rate, data from five studies showed little or no difference between the groups (RR 0.55, 95% CI 0.19 to 1.59; 5 studies, 802 participants; very low-certainty evidence). Data from nine studies may show a reduction in SSI rate (RR 0.49, 95% CI 0.27 to 0.86; 5 studies, 772 groin access; very low-certainty evidence) in the short and long term. For all-cause mortality (RR 1.78, 95% CI 0.22 to 14.32; 2 studies, 363 participants; very low-certainty evidence), re-intervention rate (RR 0.46, 95% CI 0.20 to 1.04; 3 studies, 436 participants; very low-certainty evidence), amputation (RR 0.34, 95% CI 0.01 to 8.38; 1 study, 234 participants; low-certainty evidence), and pain outcome (MD -0.10, 95% CI -0.25 to 0.05; 1 study, 242 participants; low-certainty evidence) there was little or no difference between the groups.
Authors' conclusions
Prophylactic antibiotics may reduce SSIs in peripheral arterial reconstruction of the lower limb with low-certainty evidence. We found no superiority among specific antibiotics or differences in extended use (over 24 hours) compared with shorter use (up to 24 hours), with low-certainty evidence. Closed incision negative pressure therapy may lower the SSI risk, but this is based on very low-certainty evidence. For other interventions, very low- to moderate-certainty evidence showed little or no significant differences across various outcomes. We advise caution when interpreting these conclusions due to the limited number of events in all groups and comparisons.
