The enrolment of patients and the randomization process were conducted by nurses at the outpatient clinic, neither connected to the study investigators nor the operating surgeons. ![]() Randomization and wound dressing allocation Informed consent was retrieved before the surgical procedure was conducted. If there is a significant bleeding, the introducer with its dilator is reinserted over the safety wire to stop the bleeding and another horizontal mattress suture is placed close to the access siteĮligible patients were given written information about the study per ordinary mail and oral information at the outpatient clinic before written informed consent was retrieved from participating patients. If hemostasis is achieved and there is a palpable femoral pulse distal to the tied knot, the safety wire is removed. b The introducer is gently withdrawn along with tightening of the suture knot, while the guidewire acts as a safety wire. a A non-absorbable horizontal (lying) mattress suture (2–0 or larger) is placed in the fascia longitudinal to the artery (red) with the guidewire and introducer sheath and dilator in left in place (green). The fascia (curved translucent sheet) is exposed using blunt dissection. A 4–6 cm long transversal skin incision is made over the access site. Schematic drawings illustrating the fascia closure suturing technique. Occasionally, the artery was exposed further for patch angioplasty where a patch of autologous, xenogenous or synthetic material was sutured over the arterial wall deficit. As a bale-out procedure, if hemostasis was not achieved by fascia closure, cut-down with exposure of the common femoral artery for direct arterial suturing (abbreviated cut-down) was performed. The primary technique for arterial access closure was bilateral fascia closure (Fig. The surgical incisions in EVAR procedures were performed at the end of the endovascular treatment to achieve local hemostasis at the arterial access site. The preoperative skin-preparation, constituted of preoperative shower, hair removal with electric clipper if necessary, and antiseptic skin preparation using chlorhexidine gluconate. The preoperative antibiotic prophylaxes used was the combination of 800 mg sulfamethoxazole and 160 mg trimethoprim orally, cloxacillin 2 g intravenously or clindamycin 600 mg intravenously in case of penicillin allergy. Īll types of elective EVAR procedures including fenestrated EVAR and thoracic EVAR were included. Postoperative exclusion criteria were no inguinal incision (vascular hemostasis with percutaneous closure device or non-inguinal arterial access) incorrect allocation of interventional or control wound dressings withdrawn consent re-operation with an inguinal incision for acute bleeding, peripheral ischemia, or stent graft-reintervention or non-incisional related mortality within 90 days postoperatively. Preoperative exclusion criteria were inability to understand the study instructions and purpose, age < 18 years old, inability to give informed consent or ongoing inguinal infection. ![]() The aim of the present RCT was to evaluate if NPWT dressings on inguinal incisions after EVAR procedures decrease the risk of developing an SSI.Īll patients undergoing elective EVAR procedures between November 2013 and December 2020 at two vascular centers in Sweden, Skåne university hospital in Malmö and Örebro university hospital, were considered for study participation. To date, no study has evaluated NPWT dressings on incisions after EVAR procedures only. The risk of developing an SSI differs greatly between different inguinal vascular surgical procedures, with incidences varying between approximately 2–5% in inguinal incisions after endovascular aneurysm repair (EVAR) and 20–30% after open revascularization procedures. However, the included studies evaluated SSI incidence after mainly open inguinal revascularization procedures. The evidence on its efficacy has increased in recent years, with five meta-analyses of randomized controlled trials (RCTs) showing significant reductions in SSI incidence when using NPWT compared to standard dressings. Use of negative pressure wound therapy (NPWT), dressings with an active suction, on sutured incisions has for the last decade been proposed as a possible prevention of SSIs. Decreasing SSI incidence is therefore highly prioritized. It has also been reported that approximately 55% of all SSIs are preventable with the implementation of the current evidence-based strategies. Surgical site infections (SSI) are a major concern after inguinal vascular surgery, increasing inpatient stay and patient morbidity.
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