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Incisional negative pressure wound therapy for the prevention of surgical site infection after open lower limb revascularization - Rationale and design of a multi-center randomized controlled trial.

ABSTRACT: Introduction:Lower limb revascularization with inguinal incisions is a common vascular surgical procedure. Due to risk of injury to lymphatic vessels and a diverse bacterial flora in the groin, surgical site infections (SSI) represent a common and sometimes life-threatening complication. While transverse incisions in endovascular aneurysm repair has a low SSI rate, vertical incisions in thrombendarterectomy (TEA) has a higher risk and bypass the highest risk. This randomized controlled trial (RCT) will investigate the protective role of negative pressure wound therapy (NPWT) on closed inguinal incisions in elective vascular surgery undergoing TEA and bypass procedures, respectively, to prevent SSI. Methods:This RCT registered at ClinicalTrials.gov (Identifier: NCT01913132) compares the effects of a NPWT dressing (PICO™, Smith & Nephew, UK) to standard wound dressing on postoperative SSI. The multi-center study includes two distinct vascular procedures with different SSI risk profiles: TEA and lower limb bypass. Three hundred and fifty-eight groin incisions are anticipated to be included in the TEA group and 133 inguinal incisions in the bypass group. Bilateral inguinal incisions will be randomized to NPWT in one groin and control dressing in the contralateral groin, and this dependency was accounted for in sample size calculation and will be addressed in data analysis. Discussion:This RCT attempts to evaluate the potential benefit of NPWT on closed inguinal incisions after two distinct vascular procedures at high risk of SSI. Outcome of this trial could have implications on postoperative wound care in both vascular and non-vascular surgical patients.

SUBMITTER: Rezk F

PROVIDER: S-EPMC6831708 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Incisional negative pressure wound therapy for the prevention of surgical site infection after open lower limb revascularization - Rationale and design of a multi-center randomized controlled trial.

Rezk Francis F Åstrand Håkan H Acosta Stefan S

Contemporary clinical trials communications 20191014

<h4>Introduction</h4>Lower limb revascularization with inguinal incisions is a common vascular surgical procedure. Due to risk of injury to lymphatic vessels and a diverse bacterial flora in the groin, surgical site infections (SSI) represent a common and sometimes life-threatening complication. While transverse incisions in endovascular aneurysm repair has a low SSI rate, vertical incisions in thrombendarterectomy (TEA) has a higher risk and bypass the highest risk. This randomized controlled t ...[more]

PMID: 31701043

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Project description:ImportanceFollowing surgery to treat major trauma-related fractures, deep wound infection rates are high. It is not known if negative pressure wound therapy can reduce infection rates in this setting.ObjectiveTo assess outcomes in patients who have incisions resulting from surgery for lower limb fractures related to major trauma and were treated with either incisional negative pressure wound therapy or standard wound dressing.Design, setting, and participantsA randomized clinical trial conducted at 24 trauma hospitals representing the UK Major Trauma Network that included 1548 patients aged 16 years or older who underwent surgery for a lower limb fracture caused by major trauma from July 7, 2016, through April 17, 2018, with follow-up to December 11, 2018.InterventionsIncisional negative pressure wound therapy (n = 785), which involved a specialized dressing used to create negative pressure over the wound, vs standard wound dressing not involving negative pressure (n = 763).Main outcomes and measuresThe primary outcome measure was deep surgical site infection at 30 days diagnosed according to the criteria from the US Centers for Disease Control and Prevention. A preplanned secondary analysis of the primary outcome was performed at 90 days. The secondary outcomes were patient-reported disability (Disability Rating Index), health-related quality of life (EuroQol 5-level EQ-5D), surgical scar assessment (Patient and Observer Scar Assessment Scale), and chronic pain (Douleur Neuropathique Questionnaire) at 3 and 6 months, as well as other local wound healing complications at 30 days.ResultsAmong 1548 participants who were randomized (mean [SD] age, 49.8 [20.3] years; 561 [36%] were aged ≤40 years; 583 [38%] women; and 881 [57%] had multiple injuries), 1519 (98%) had data available for the primary outcome. At 30 days, deep surgical site infection occurred in 5.84% (45 of 770 patients) of the incisional negative pressure wound therapy group and in 6.68% (50 of 749 patients) of the standard wound dressing group (odds ratio, 0.87 [95% CI, 0.57 to 1.33]; absolute risk difference, -0.77% [95% CI, -3.19% to 1.66%]; P = .52). There was no significant difference in the deep surgical site infection rate at 90 days (11.4% [72 of 629 patients] in the incisional negative pressure wound therapy group vs 13.2% [78 of 590 patients] in the standard wound dressing group; odds ratio, 0.84 [95% CI, 0.59 to 1.19]; absolute risk difference, -1.76% [95% CI, -5.41% to 1.90%]; P = .32). For the 5 prespecified secondary outcomes reported, there were no significant differences at any time point.Conclusions and relevanceAmong patients who underwent surgery for major trauma-related lower limb fractures, use of incisional negative pressure wound therapy, compared with standard wound dressing, resulted in no significant difference in the rate of deep surgical site infection. The findings do not support the use of incisional negative pressure wound therapy in this setting, although the event rate at 30 days was lower than expected.Trial registrationisrctn.org Identifier: ISRCTN12702354.

Project description:BackgroundThere is a paucity of data examining the impact of advancing chronic kidney disease stages on outcomes following revascularization for acute limb ischemia. The present study examined the association of chronic kidney disease with in-hospital mortality, amputation, and resource utilization following revascularization for acute limb ischemia using a nationally representative cohort.MethodsThe 2016-2018 National Inpatient Sample was queried to identify all adult hospitalizations with lower extremity acute limb ischemia requiring surgical and/or endovascular interventions. Patients were grouped according to the presence of chronic kidney disease and its severity: no chronic kidney disease, chronic kidney disease 1-3 (chronic kidney disease stages 1 through 3), chronic kidney disease 4-5 (chronic kidney disease stages 4 through 5), and end-stage renal disease. Multivariable logistic and linear models were used to evaluate association of chronic kidney disease stage with outcomes of interest.ResultsOf an estimated 82,610 patients meeting study criteria, 14.8% had chronic kidney disease (chronic kidney disease 1-3: 63.4%, chronic kidney disease 4-5: 12.1%, end-stage renal disease: 24.5%). Compared to those with chronic kidney disease, chronic kidney disease patients were on average older, were more frequently female, and had a higher median Elixhauser Comorbidity Index. Increasing severity of chronic kidney disease was associated with a stepwise increase in unadjusted mortality rates (4.7% in no chronic kidney disease to 12.6% in end-stage renal disease, P < .001). Following risk adjustment, only end-stage renal disease was associated with increased odds of mortality (adjusted odds ratio 3.10, 95% confidence interval 2.28-4.22) and limb amputation (adjusted odds ratio 1.99, 95% confidence interval 1.59-2.48) compared to patients with no chronic kidney disease. Similarly, advancing chronic kidney disease stage conferred increased odds of prolonged length of stay and greater hospitalization costs.ConclusionAdvanced renal dysfunction demonstrated inferior perioperative outcomes and greater health care expenditures in the study population. These findings imply that quality improvement efforts in acute limb ischemia revascularization should target patients with chronic kidney disease 4-5 and end-stage renal disease.

Project description:IntroductionPatients with chronic kidney disease (CKD) have a high prevalence of peripheral artery disease. How best to manage lower extremity peripheral artery disease remains unclear in this patient population. We therefore sought to compare the outcomes after endovascular versus surgical lower extremity revascularization among patients with CKD.MethodsWe used data from Optum's de-identifed Clinformatics® Data Mart Database, a nationwide database of commercially insured persons in the United States to study patients with CKD who underwent lower extremity endovascular or surgical revascularization. We used inverse probability of treatment weighting to balance covariates. We employed proportional hazard regression to study the primary outcome of major adverse limb events (MALE), defined as a repeat revascularization or amputation. We also studied each of these events separately and death from any cause.ResultsIn our cohort, 60,057 patients underwent endovascular revascularization and 9,338 patients underwent surgical revascularization. Endovascular revascularization compared with surgical revascularization was associated with a higher adjusted hazard of MALE (hazard ratio (HR) 1.52; 95% confidence interval (CI) 1.46-1.59). Endovascular revascularization was also associated with a higher adjusted hazard of repeat revascularization (HR 1.65; 95% CI 1.57-1.72) but a lower adjusted risk of amputation (HR 0.71; CI 0.73-0.89). Patients undergoing endovascular revascularization also had a lower adjusted hazard for death from any cause (0.85; CI 0.82-0.88).ConclusionsIn this analysis of patients with CKD undergoing lower extremity revascularization, an endovascular approach was associated with a higher rate of repeated revascularization but a lower risk of subsequent amputation and death compared with surgical revascularization. Multiple factors must be considered when counseling patients with CKD, who have a high burden of comorbid conditions. Clinical trials should include more patients with kidney disease, who are often otherwise excluded from participation, to better understand the most effective treatment strategies for this vulnerable patient population.

Project description:BackgroundSurgical site infections (SSIs) are common, costly, and associated with increased morbidity and potential mortality after lower limb revascularization surgery (ie, arterial bypass, endarterectomy, and patch angioplasty). Identifying evidence-informed risk factors for SSI in patients undergoing these surgeries is therefore important.ObjectiveThe aim of this study is to conduct a systematic review and meta-analysis of prognostic studies to identify, synthesize, and determine the certainty in the cumulative evidence associated with reported risk factors for early and delayed SSI after lower limb revascularization surgery in adults with peripheral artery disease.MethodsWe will search MEDLINE, Embase, the seven databases in Evidence-Based Medicine Reviews, review articles identified during the search, and included article bibliographies. We will include studies of adults (aged ≥18 years) with peripheral artery disease that report odds ratios, risk ratios, or hazard ratios adjusted for the presence of other risk factors or confounding variables and relating the potential risk factor of interest to the development of SSI after lower limb revascularization surgery. We will exclude studies that did not adjust for confounding, exclusively examined certain high-risk patient cohorts, or included >20% of patients who underwent surgery for indications other than peripheral artery disease. The primary outcomes will be early (in-hospital or ≤30 days) SSI and Szilagyi grade I (cellulitis involving the wound), grade II (infection involving subcutaneous tissue), and grade III (infection involving the vascular graft) SSI. Two investigators will independently extract data and evaluate the study risk of bias using the Quality in Prognosis Studies tool. Adjusted risk factor estimates with similar definitions will be pooled using DerSimonian and Laird random-effects models. Heterogeneity will be explored using stratified meta-analyses and meta-regression. Finally, we will use the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach to determine certainty in the estimates of association between reported risk factors and the development of SSI.ResultsThe protocol was registered in PROSPERO (International Prospective Register of Systematic Reviews). We will execute the peer-reviewed search strategy on June 30, 2021, and then complete the review of titles and abstracts and full-text articles by July 30, 2021, and September 15, 2021, respectively. We will complete the full-text study data extraction and risk of bias assessment by November 15, 2021. We anticipate that we will be able to submit the manuscript for peer review by January 30, 2022.ConclusionsThis study will identify, synthesize, and determine the certainty in the cumulative evidence associated with risk factors for early and delayed SSI after lower limb revascularization surgery in patients with peripheral artery disease. The results will be used to inform practice, clinical practice statements and guidelines, and subsequent research.Trial registrationPROSPERO International Prospective Register of Systematic Reviews CRD42021242557; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=242557.International registered report identifier (irrid)PRR1-10.2196/28759.

Project description:To determine whether diabetes mellitus has an independent impact on major limb outcomes at 1 year after endovascular treatment of lower extremity peripheral artery disease (PAD).The study involved 1906 consecutive patients (mean age 66 years; 1469 men) enrolled in the observational Excellence in Peripheral Artery Disease (XLPAD) registry ( ClinicalTrials.gov identifier NCT01904851) between January 2005 and October 2015 after undergoing index endovascular procedures in 2426 limbs for arterial occlusive disease. Patient outcomes included 12-month target limb amputation (above ankle) and target limb revascularization as well as all-cause death. Kaplan-Meier analysis and adjusted Cox proportional hazard models were used for time-to-event analysis of outcomes for the entire study sample as well as for the critical limb ischemia (CLI) and claudication subgroups. Results of the Cox regression models are reported as the hazard ratio (HR) and 95% confidence interval (CI).Diabetics undergoing endovascular procedures had higher rates of comorbid conditions (p<0.001), CLI (p<0.001), heavily calcified lesions (p=0.002), multivessel disease (p=0.030), and fewer infrapopliteal runoff vessels (p<0.001). Regression analysis after adjusting for confounders revealed significantly higher target limb major amputation in diabetics compared with nondiabetics (HR 5.02, 95% CI 1.44 to 17.56, p=0.011). However, repeat revascularization rates were similar. When considering CLI and claudication subgroups, diabetes was associated with a nonsignificant increased risk of 12-month major amputation only for patients presenting with CLI (HR 3.48, 95% CI 0.97 to 12.51, p=0.056). Diabetes was also associated with an increased risk of 12-month all-cause mortality in the overall study sample (HR 4.64, 95% CI 2.01 to 10.70, p<0.001) and in the CLI subgroup (HR 14.15, 95% CI 3.16 to 63.32, p<0.001) but not in the claudication subgroup (HR 1.42, 95% CI 0.45 to 4.54, p=0.552).Diabetes increases the risk of major amputation and all-cause death at 12 months following endovascular revascularization in patients with symptomatic PAD. These risks are especially heightened in patients presenting with CLI.

Dataset Information

Incisional negative pressure wound therapy for the prevention of surgical site infection after open lower limb revascularization - Rationale and design of a multi-center randomized controlled trial.

Publications

Incisional negative pressure wound therapy for the prevention of surgical site infection after open lower limb revascularization - Rationale and design of a multi-center randomized controlled trial.

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