Controlling the controls: what is negative pressure wound therapy compared to in clinical trials?

AIM: Surgical site infections (SSIs) are common following colorectal operations. Clinical trials suggest that closed incision negative pressure wound therapy (ciNPWT) may reduce SSIs compared to a 'standard of care' group. However, wound management in the standard of care group may vary. The aim of this review was to assess the control arms in trials of ciNPWT for potential confounding variables that could influence the rates of SSI and therefore the trial outcomes. METHODS: A mapping review of the PubMed database was undertaken in the English language for randomized controlled trials that assessed, in closed surgical wounds, the use of ciNPWT compared to standard of care with SSI as an outcome. Data regarding wound care to assess potential confounding factors that may influence SSI rates were compared between the ciNPWT and standard of care groups. Included were the method of wound closure, control dressing type, frequency of dressing changes and postoperative wound care (washing). RESULTS: Twenty-seven trials were included in the mapping review. There was heterogeneity in ciNPWT duration. There was little control in the comparator standard of care groups with a variety of wound closure techniques and different control dressings used. Overall standard of care dressings were changed more frequently than the ciNPWT dressing and there was no control over wound care or washing. No standard for 'standard of care' was apparent. CONCLUSION: In randomized trials assessing the intervention of ciNPWT compared to standard of care there was considerable heterogeneity in the comparator groups and no standard of care was apparent. Heterogeneity in dressing protocols for standard of care groups could introduce potential confounders impacting SSI rates. There is a need to standardize care in ciNPWT trials to assess potential meaningful differences in SSI prevention.

Feasibility of the Complete Endovascular Reconstruction of the Trifurcation (CERT) Technique for Revascularisation in Chronic Limb Threatening Ischemia.

BackgroundRevascularisation of patients with chronic limb threatening ischaemia due to arterial lesions in the below the knee segment can be challenging. This study describes a novel technique that allows a complete endovascular reconstruction of the trifurcation (CERT) utilising stents in the below the knee segment when conventional techniques are exhausted, or have failed to deliver an acceptable result, leading to remaining outflow compromise. Methods: Eight patients with Rutherford 5 chronic limb threatening ischaemia underwent CERT between January 1st, 2018 and January 1st, 2020. All patients underwent ultrasound at 6 weeks post operatively and then at variable intervals until the completion of the follow up period in March 2020. Results: Technical success of the CERT technique was achieved in all patients. Six patients had anterior tibial artery/Tibioperoneal trunk reconstructions, whilst 2 patients were stented directly into posterior tibial and peroneal artery. Five patients (63%) achieved wound healing. All-cause mortality was 25% (2 patients) with 1 patient achieving wound healing prior to death. Two stents were occluded during the follow up period. The first was asymptomatic and had achieved wound healing. The second was symptomatic with stent occlusion and a delayed presentation with Rutherford 3 acute limb ischaemia. Conclusions: Complete endovascular reconstruction of the trifurcation is a feasible option to achieve revascularisation in patients with tissue loss and below the knee arterial lesions allowing a continuous reconstruction of the trifurcation segment keeping the anatomical configuration intact. Clinical outcomes appear acceptable however larger series are needed.

Ultrasound patterns of venous disease in patients with venous leg ulcers and morbid obesity.

BACKGROUND/AIMS: Obesity affects over two-thirds of the Australian population and is associated with increased risk of venous leg ulceration (VLU). Management is challenging to both patients and staff. Surgical treatment of superficial venous incompetence in patients with VLU reduces ulcer healing time and recurrence, but this has not yet been investigated in patients with obesity. We aimed to determine in patients with VLU and morbid obesity if their ultrasound pattern of superficial venous incompetence was like those patients without morbid obesity. METHODS: Consecutive patients attending the outpatient leg ulcer clinic from January to December 2019 were eligible for inclusion if they had an active or healed VLU. Age, gender, BMI, and ulcer sidedness were collected from the electronic medical record and assessed against findings of venous duplex ultrasound. Primary outcome was the proportion of patients with morbid obesity with superficial venous incompetence. Secondary outcomes included the proportion of patients with morbid obesity who were investigated with a duplex ultrasound, and any presence of deep venous incompetence. RESULTS: Of 231 patients that attended 156 were eligible for inclusion. 103 patients had full data and were used for the primary outcome analysis. There were 29 patients (28.2%) with morbid obesity. They were younger than those without morbid obesity (69.0 vs 73.0 years, p .026) with no difference in gender, active or healed ulcer classification (CEAP C5/6), or ulcer sidedness. We found no difference in the proportion of patients with morbid obesity with superficial venous incompetence on ultrasound (72.4% vs 79.7%, p.423). Patients with morbid obesity were equally as likely to undergo ultrasound investigation (73.2% vs 75.8%, p.748). CONCLUSIONS: In patients with VLU there appeared no difference in the proportion of patients with morbid obesity with superficial venous incompetence. Directed studies are needed to determine the effectiveness of intervention in this patient population.

Frail patients having vascular surgery during the early COVID-19 pandemic experienced high rates of adverse perioperative events and amputation.

BACKGROUND: Frailty predicts adverse perioperative outcomes and increased mortality in patients having vascular surgery. Frailty assessment is a potential tool to inform resource allocation, and shared decision-making about vascular surgery in the resource constrained COVID-19 pandemic environment. This cohort study describes the prevalence of frailty in patients having vascular surgery and the association between frailty, mortality and perioperative outcomes. METHODS: The COVID-19 Vascular Service in Australia (COVER-AU) prospective cohort study evaluates 30-day and six-month outcomes for consecutive patients having vascular surgery in 11 Australian vascular units, March-July 2020. The primary outcome was mortality, with secondary outcomes procedure-related outcomes and hospital utilization. Frailty was assessed using the nine-point visual Clinical Frailty Score, scores of 5 or more considered frail. RESULTS: Of the 917 patients enrolled, 203 were frail (22.1%). The 30 day and 6 month mortality was 2.0% (n = 20) and 5.9% (n = 35) respectively with no significant difference between frail and non-frail patients (OR 1.68, 95%CI 0.79-3.54). However, frail patients stayed longer in hospital, had more perioperative complications, and were more likely to be readmitted or have a reoperation when compared to non-frail patients. At 6 months, frail patients had twice the odds of major amputation compared to non-frail patients, after adjustment (OR 2.01; 95% CI 1.17-3.78), driven by a high rate of amputation during the period of reduced surgical activity. CONCLUSION: Our findings highlight that older, frail patients, experience potentially preventable adverse outcomes and there is a need for targeted interventions to optimize care, especially in times of healthcare stress.