Multicenter parallel randomized trial evaluating incisional negative pressure wound therapy for the prevention of surgical site infection after lower extremity bypass.

OBJECTIVE: Incisional negative pressure wound therapy (iNPWT) applied over all incisions after lower extremity bypass in the prevention of surgical site infections (SSIs) is unclear. The primary and secondary aims of this study were to investigate if prophylactic iNPWT after the elective lower extremity bypass prevents SSI and other surgical wound complications. METHODS: This was a multicenter, parallel, randomized controlled trial. Patients undergoing elective lower extremity bypass in 3 hospitals were randomized to either iNPWT or standard dressings. SSIs or other wound complications were assessed within the first 90 days by wound care professionals blinded to the randomized result. The validated Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissues, Isolation of bacteria, and Stay (ASEPSIS) score was used to objectively assess the wounds. ASEPSIS score ≥21 is defined as an SSI. Unilateral and bilateral groups were analyzed with the Fisher exact test and the McNemar test, respectively. RESULTS: In the unilateral group (n = 100), the incidence of SSI in the iNPWT group was 34.9% (15/43), compared with 40.3% (23/57) in the control group, according to the ASEPSIS score (P = .678). In the bilateral group (n = 7), the SSI rate was 14.3% (1/7) in the iNPWT group compared with 14.3% (1/7) in the control group (P = 1.00). In the unilateral group, there was a higher wound dehiscence rate in the control group (43.9%) compared with the iNPWT group (23.3%) (P = .0366). No serious iNPWT-related adverse events were recorded. CONCLUSIONS: There was no reduction of SSI rates in leg incisions with iNPWT compared with standard dressings in patients undergoing elective lower extremity bypass, whereas iNPWT reduced the incidence of wound dehiscence.

Prospective Comparison of Wound Complication Rates after Elective Open Peripheral Vascular Surgery - Endovascular Versus Open Vascular Surgeons.

BACKGROUND: Skill and experience of surgeons are likely to influence the incidence of surgical wound complications (SWC) after open lower limb revascularization. Differences in SWC between surgeons with predominantly endovascular or open vascular surgical profiles could be expected. The aim of this study was to compare SWC rates after elective open vascular surgery between primarily endovascular and primarily open vascular surgeons. METHODS: Prospective data from patients undergoing elective surgery for peripheral artery disease (PAD) was collected between 2013 and 2019. Senior surgeons were assigned to the open-surgeon or the endo-surgeon group based on the percentage of their open surgical case load during the 6 year study period. SWC was measured by their clinical impact scale (grade 1-outpatient treatment to grade 6-death). Surgical site infection was defined by Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissues, Isolation of bacteria, and Stay (ASEPSIS) criteria. Propensity score adjusted analysis (PSAA) was used to account for differences in baseline and perioperative characteristics and expressed as odds ratios (ORs) with 95% confidence intervals (CIs). RESULTS: The proportion of chronic limb-threatening ischemia (P = 0.001), ipsilateral foot wound (P = 0.012) and femoro-popliteal bypass procedures (P < 0.001) were higher in the open-surgeon group. A lower incidence of SWC according to ASEPSIS criteria (25.6% vs. 38.6%, respectively, P = 0.042) and SWC grade ≥1 (33.7% vs. 51.0%, respectively, P = 0.010) was found in the endo-surgeon group (n = 86) compared to the open-surgeon group (n = 153). These differences disappeared after PSAA (OR 0.63, 95% CI 0.27-1.44, and OR 0.60, 95% CI 0.27-1.33, respectively). CONCLUSIONS: Patients operated by endo-surgeons had less advanced PAD and lower incidence of SWC compared to those treated by open-surgeons. No difference in SWC remained after PSAA.

Negative Pressure Wound Therapy for the Prevention of Surgical Site Infections Using Fascia Closure After EVAR-A Randomized Trial.

BACKGROUND: Surgical site infections (SSI) in the groin after vascular surgery are common. The aim of the study was to evaluate the effect of negative pressure wound therapy (NPWT) on SSI incidence when applied on closed inguinal incisions after endovascular aneurysm repair (EVAR). METHODS: A multicenter randomized controlled trial (RCT). Between November 2013 and December 2020, 377 incisions (336 bilateral and 41 unilateral) from elective EVAR procedures with the primary intent of fascia closure were randomized and included, receiving either NPWT or a standard dressing. In bilateral incisions, each incision randomly received the opposite dressing of the other side, thereby becoming each other's control. The primary endpoint was SSI incidence at 90 days postoperatively, analyzed on an intention-to-treat basis. Uni and bilaterally operated incisions were analyzed separately, and their respective p-values combined using Fisher's method for combining P-values. Study protocol (NCT01913132). RESULTS: The SSI incidence at 90 days postoperatively in bilateral incisions was 1.8% (n = 3/168) in the NPWT and 4.8% (n = 8/168) in the standard dressing group, and in unilateral incisions 13.3% (n = 2/15) and 11.5% (n = 3/26), respectively (combined p = 0.49). In all SSIs, bacteria were isolated from incisional wound cultures. No additional SSIs were diagnosed between 90 days and 1 year follow-up. CONCLUSIONS: No evidence of difference in SSI incidence was seen in these low-risk inguinal incisions when comparing NPWT with standard dressings after EVAR with the primary intent of fascia closure. CLINICAL TRIALS: NCT01913132.

Performance of Computed Tomography Angiography Before Revascularization Is Associated With Higher Amputation-Free Survival in Rutherford IIb Acute Lower Limb Ischaemia.

Background: Acute lower limb ischemia with a motor deficit (Rutherford IIb) needs urgent revascularization to avoid major amputation and mortality. It is unclear whether immediate revascularization without performing CT angiography (CTA) prior to revascularization in Rutherford IIb acute lower limb ischemia (ALI) is associated with better outcomes. Methods: Retrospective observational study of Rutherford IIb ALI patients treated between 2006 and 2018. A propensity score adjusted analysis was performed to compare outcomes after the performance of CTA examination or not. Results: Among 681 patients, 260 had Rutherford IIb ALI. CTA prior to revascularization was performed in 131 (50.4%) and increased (p < 0.001) throughout the study period. Open vascular and endovascular surgery was first performed in 147 (56.5%) and 113 (43.5%) patients, respectively. The proportion of endovascular treatment increased while the open vascular surgery decreased during the study period (p = 0.031). In the propensity score adjusted analysis, the performance of CTA was associated with decreased risk of combined major amputation /mortality (odds ratio 0.52, 95% confidence interval 0.27-0.99; p = 0.046) at 1 year. Conclusion: Performance of CTA was associated with a higher amputation-free survival in revascularized patients with Rutherford IIb ALI. CTA seem to provide guidance in selecting the most appropriate candidates for revascularization and choice of technique.

Cost-effectiveness analysis of negative pressure wound therapy dressings after open inguinal vascular surgery - The randomised INVIPS-Trial.

AIM: While the scientific evidence in favour of negative pressure wound therapy (NPWT) dressings on sutured incisions in the prevention of surgical site infections (SSIs) has increased, the cost-effectiveness after vascular surgery has not been evaluated. The aim of this study was to evaluate the cost-effectiveness of NPWT compared to standard dressings for the prevention of SSIs after open inguinal vascular surgery. MATERIALS AND METHODS: Patient data were retrieved from the randomised INVIPS-trial's open arm, which included patients randomised to either NPWT or standard dressings. The patients were surveyed for SSIs for 90 days postoperatively. The patients' individual cost data were included and analysed from a healthcare perspective. The patients' quality of life was measured using the Vascuqol-6 questionnaire pre- and 30 days postoperatively. Cost-effectiveness of NPWT was determined by decreased or equal total costs and a significant reduction in SSI incidence. RESULTS: The mean vascular procedure-related costs at 90 days were €16,621 for patients treated with NPWT (n = 59) and €16,285 for patients treated with standard dressings (n = 60), p = 0.85. The SSI incidence in patients treated with NPWT was 11.9% (n = 7/59) compared to 30.0% (n = 18/60) with standard dressings, p = 0.015. This corresponds to an increased mean cost of €1,853 per SSI avoided. The cost-effectiveness plane of incremental vascular procedure-related costs and difference in Vascuqol-6 score showed that 42% of estimates were in the quadrant where NPWT was dominant. CONCLUSION: NPWT is considered cost-effective over standard dressings in patients undergoing open inguinal vascular surgery due to reduced SSI incidence at no higher costs.

Inguinal Vascular Surgical Wound Protection by Incisional Negative Pressure Wound Therapy: A Randomized Controlled Trial-INVIPS Trial.

OBJECTIVE: A randomized controlled trial (RCT) was undertaken to determine the effect of negative pressure wound therapy (NPWT) on closed incisions after inguinal vascular surgery regarding surgical site infections (SSIs) and other wound complications. BACKGROUND: SSIs are a major concern in open vascular procedures involving the inguinal region. Prophylactic NPWT on closed incisions has shown promising results, but the quality of evidence can be debated. This study aims to objectively evaluate whether NPWT on sutured inguinal incisions after elective vascular surgery can decrease the incidence of surgical site complications. METHODS: One hundred thirty-nine patients undergoing elective open vascular surgery with inguinal incisions received either NPWT or a standard dressing. Patients with bilateral incisions randomly received a dressing on one incision and the opposite dressing on the other. The primary endpoints were SSI or other wound complications at 3 months, assessed by wound care experts blinded to the treatment arm and using objective wound assessment criteria (ASEPSIS-score). Statistical analysis was performed on an intention-to-treat basis and obtained P values from analyses in the uni- and bilateral groups were combined to an overall P value using Fisher's method for combining P values. RESULTS: The incidence of SSI was reduced in the NPWT group compared with the control group [11.9% vs 29.5% in the unilateral group (n = 120), 5.3% vs 26.3% in the bilateral group (n = 19), respectively; combined P = 0.02]. No differences regarding other surgical site complications were observed between the groups. CONCLUSION: NPWT on closed inguinal vascular surgical incisions in elective patients reduces the incidence of SSI.

Proposed Classification of Incision Complications: Analysis of a Prospective Study on Elective Open Lower-Limb Revascularization.

Background: Incision complications (IC) have a significant impact on procedure-related morbidity after lower-limb revascularization. One of the most studied IC is surgical site infection (SSI). Reporting these complications in a uniform way is crucial to evaluate treatment approaches. The aim of this study was to propose a comprehensive classification of IC and apply it to compare SSI with other IC in a trial on elective open lower-limb revascularization procedures. Methods: Two hundred twenty-three eligible patients undergoing elective unilateral inguinal and infra-inguinal arterial vascular surgery were extracted from a randomized controlled trial on incisional negative-pressure wound therapy (NPWT) on inguinal vascular surgical incisions. The IC were classified by grades of severity (grade 0-6) that focused on IC-related consequences such as out-patient treatment (grade 1), prolonged in-patient treatment (grade 2), re-admission (grade 3), and re-operation (grade ≥4). An SSI was defined by the ASEPSIS score criteria. Results: An SSI was diagnosed in 63 patients (28.3%). Thirty-five of 160 patients (21.8%) not suffering from SSI underwent IC treatment. Treatment for IC was recorded for 25/144 patients (17.4%) with satisfactory site healing as judged by the ASEPSIS score. The median incision-related in-hospital stay in those with SSI (n = 79) and disturbed healing (n = 16) according to the ASEPSIS score was 13 days in both groups (p = 0.53). Five patients had peri-vascular SSI (IC grade 4 n = 4; grade 5 n = 1). The proposed classification of IC and the ASEPSIS score correlated highly (r = 0.77; p < 0.001). Inter-rater reliability for IC grading was substantial for three investigators with different levels of experience (k = 0.81, 0.71, and 0.70). Conclusions: The proposed incision classification suggests a comparable clinical significance of vascular IC in terms of IC-related in-patient stay, whether there was a surgical site infection or not. This classification system requires external validation.

Evaluation of inguinal vascular surgical scars treated with closed incisional negative pressure wound therapy using three-dimensional digital imaging-A randomized controlled trial on bilateral incisions.

PURPOSE OF THE INVESTIGATION: Scar formation is an important, permanent surrogate marker for wound healing. The main aim of this randomized trial was to evaluate the effects of incisional negative pressure wound therapy (iNPWT) on scar formation in uncomplicated wound healing with 3-dimensional (3D) digital imaging. BASIC PROCEDURES: Patients undergoing bilateral inguinal incisions after vascular surgery were randomized to receive iNPWT and standard dressing on separate sides. The incisional scars were documented at a median time of 808 days (range 394-1194) after surgery with 3D photography, which were objectively evaluated by two plastic surgeons using the Stony Brook scar evaluation scale (SBSES) and a 10-point graded numeric ranking scale (NRS10). Subjective evaluation was performed with the patient observer scar assessment scale (POSAS). Patients with surgical site infection or other wound complications were excluded to minimize bias. The p-values were calculated using McNemar's and Wilcoxon signed-rank test for paired nominal and paired continuous data, respectively. MAIN FINDINGS: Among 33 patients, 32 patients had undergone endovascular aortic repair (EVAR) and 31 patients had transverse inguinal incisions. Objective and subjective scar evaluation showed no difference between iNPWT and standard dressing. In objective scorings, 18.8 and 21.9% received the highest possible SBSES total score in the iNPWT and standard dressing groups, while 43.8 and 37.5% received the highest possible NRS10 score, respectively. The inter-rater reliability between the two assessors for SBSES total score and NRS10 showed an intra-class correlation (ICC) of 0.78 and 0.68 for NPWT and 0.70 and 0.77 for traditional dressing, respectively. PRINCIPAL CONCLUSION: The present randomized trial showed that iNPWT and standard dressings on closed transverse inguinal incisions after EVAR resulted in equal subtle scar formation. Objective scar evaluation with 3D images showed good inter-rater agreement.