Extracorporeal shockwave therapy for the treatment of lower limb intermittent claudication: Study protocol for a randomised controlled trial (the SHOCKWAVE 1 trial)

© 2017 The Author(s). Background: Peripheral arterial disease (PAD) has a population prevalence of 4.6% with intermittent claudication (IC) presenting as one of the earliest and most common symptoms. PAD has detrimental effects on patients' walking ability in terms of maximum walking distance (MWD) and pain-free walking distance (PFWD). Research has suggested extracorporeal shockwave therapy (ESWT) may induce angiogenesis in treated tissue; therefore, our objective is to assess the tolerability and efficacy of ESWT as a novel treatment of intermittent claudication. Methods/design: Patients with unilateral claudication will be randomised to receive either ESWT (PiezoWave 2 shockwave system) or sham treatment to the calf muscle bulk three times per week for 3 weeks. All patients are blinded to treatment group, and all assessments will be performed by a masked assessor. Treatment tolerability using a visual analogue scale, ankle-brachial pressure index, MWD, PFWD and safety will all be formally assessed as outcome measures at baseline and at 4, 8 and 12 weeks follow-up. Discussion: This trial will be the first of its kind in terms of methodology in relation to ESWT for intermittent claudication. A double-masked randomised controlled trial will provide useful information about the potential for the use of ESWT as a non-invasive treatment option and the need for further robust research. Trial registration: ClinicalTrials.gov, NCT02652078. Registered on 17 October 2014

Long term outcomes of ‘Christmas Tree’ banding for haemodialysis access induced distal ischemia: A 13-year experience

Background: The reduction in distal arterial flow following arteriovenous fistula (AVF) creation can cause a perfusion deficit known as haemodialysis access induced distal ischemia (HAIDI). Various techniques have been advocated to treat this difficult problem with varying success. We present the long-term outcomes following a novel banding technique. Methods: 46 patients in this cohort from 2008 to 2021 underwent a novel banding procedure using a Dacron™ patch shaped with one slit-end and saw-tooth edges (resulting in a ‘Christmas-tree’ pattern) to provide a ratchet mechanism to progressively constrict the fistula outflow. Real-time finger perfusion pressure monitoring allowed an accurate reduction in AVF flow whilst increasing distal arterial perfusion pressure. Baseline characteristic were recorded and Kaplan-Meier survival curves were obtained to calculate the post-intervention primary, assisted primary and secondary patency. Results: 29 patients presented with rest pain and 11 presented with tissue loss due to distal ischemia. The post-intervention primary access patency was 100%, 98%, 78% and 61% at 30, 60 and 180 days and 1 year respectively. Complete resolution of symptoms was achieved in 74% (n = 34) of patients and a partial response needing no further intervention was achieved in 11% (n = 5) of patients. A Youden index calculation suggested that digital pressures of 41 mm Hg or lower in an open AVF were highly sensitive for symptomatic hand ischemia whereas pressures greater than 65 mm Hg ruled out distal ischemia. Conclusion: ‘Christmas-tree’ banding with on table finger systolic pressures is not only an efficacious and durable method for treating HAIDI but also preserves fistula patency

Dialkylcarbamoyl Chloride Dressings in the Prevention of Surgical Site Infections after Nonimplant Vascular Surgery

© 2017 Elsevier Inc. Background Dressings coated with dialkylcarbamoyl chloride (DACC) are highly hydrophobic and irreversibly bind multiple types of bacteria, trapping them in the dressing and reducing the number of organisms at the wound surface. We aimed to assess the impact of DACC-coated postoperative dressings on the incidence of surgical site infection (SSI) in nonimplant vascular surgery patients. Methods Two hundred patients undergoing nonimplant vascular surgery were prospectively recruited at a single vascular center. The initial 100 patients had their operative wounds dressed with conventional dressings followed by 100 patients who received DACC-coated postoperative dressings. Wounds were reviewed at day 5 and day 30 to determine the presence of SSI using the ASEPSIS scoring system. The variation in outcomes between groups was assessed using chi-squared test and logistic regression analysis to assess the effects of other variables, which may affect healing. Results Between August 1, 2015 and February 29, 2016, a total of 120 men and 80 women were recruited. The mean age was 63 (range 27–97) years, 92% were current or ex-smokers and 45.5% were diabetic. Rate of SSI at 5 days was significantly lower in the DACC group compared with standard dressings (1% vs. 10%, P < 0.05). There was no difference in the rates of SSI at 30 days. Logistic regression suggested that the type of dressing used was the most prominent predictor variable for the presence of early SSI (P = 0.028, odds ratio = 0.09, 95% confidence interval: 0.01–0.77). Conclusions DACC-coated dressings were associated with a significant reduction in SSI rates in the early postoperative period

A pilot feasibility randomised clinical trial comparing dialkylcarbamoylchloride-coated dressings versus standard care for the primary prevention of surgical site infection

A surgical site infection (SSI) may occur in up to 30% of procedures and results in significant morbidity and mortality. We aimed to assess the feasibility of conducting a randomised controlled trial (RCT) examining the use of dialkylcarbamoylchloride (DACC)-impregnated dressings, which bind bacteria at the wound bed, in the prevention of SSI in primarily closed incisional wounds. This pilot RCT recruited patients undergoing clean or clean-contaminated vascular surgery. Participants were randomised intraoperatively on a 1:1 basis to either a DACC-coated dressing or a control dressing. Outcomes were divided into feasibility and clinical outcomes. The primary clinical outcome was SSI at 30 days (assessed using Centers for Disease Control criteria and Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of the deep tissues, Isolation of bacteria and duration of inpatient Stay scoring methods). This study recruited 144 patients in 12 months at a median rate of 10 per month. Eligibility was 73% and recruitment 60%. At 30 days, there was a 36.9% relative risk reduction in the DACC-coated arm (16.22% versus 25.71%, odds ratio 0.559, P = 0.161). The number needed to treat was 11 patients. A large-scale RCT is both achievable and desirable given the relative risk reduction shown in this study. Further work is needed to improve the study protocol and involve more centres in a full-scale RCT

Mortality and pulmonary complications in patients undergoing surgery with perioperative SARS-CoV-2 infection: an international cohort study

Background: The impact of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on postoperative recovery needs to be understood to inform clinical decision making during and after the COVID-19 pandemic. This study reports 30-day mortality and pulmonary complication rates in patients with perioperative SARS-CoV-2 infection. Methods: This international, multicentre, cohort study at 235 hospitals in 24 countries included all patients undergoing surgery who had SARS-CoV-2 infection confirmed within 7 days before or 30 days after surgery. The primary outcome measure was 30-day postoperative mortality and was assessed in all enrolled patients. The main secondary outcome measure was pulmonary complications, defined as pneumonia, acute respiratory distress syndrome, or unexpected postoperative ventilation. Findings: This analysis includes 1128 patients who had surgery between Jan 1 and March 31, 2020, of whom 835 (74·0%) had emergency surgery and 280 (24·8%) had elective surgery. SARS-CoV-2 infection was confirmed preoperatively in 294 (26·1%) patients. 30-day mortality was 23·8% (268 of 1128). Pulmonary complications occurred in 577 (51·2%) of 1128 patients; 30-day mortality in these patients was 38·0% (219 of 577), accounting for 81·7% (219 of 268) of all deaths. In adjusted analyses, 30-day mortality was associated with male sex (odds ratio 1·75 [95% CI 1·28–2·40], p\textless0·0001), age 70 years or older versus younger than 70 years (2·30 [1·65–3·22], p\textless0·0001), American Society of Anesthesiologists grades 3–5 versus grades 1–2 (2·35 [1·57–3·53], p\textless0·0001), malignant versus benign or obstetric diagnosis (1·55 [1·01–2·39], p=0·046), emergency versus elective surgery (1·67 [1·06–2·63], p=0·026), and major versus minor surgery (1·52 [1·01–2·31], p=0·047). Interpretation: Postoperative pulmonary complications occur in half of patients with perioperative SARS-CoV-2 infection and are associated with high mortality. Thresholds for surgery during the COVID-19 pandemic should be higher than during normal practice, particularly in men aged 70 years and older. Consideration should be given for postponing non-urgent procedures and promoting non-operative treatment to delay or avoid the need for surgery. Funding: National Institute for Health Research (NIHR), Association of Coloproctology of Great Britain and Ireland, Bowel and Cancer Research, Bowel Disease Research Foundation, Association of Upper Gastrointestinal Surgeons, British Association of Surgical Oncology, British Gynaecological Cancer Society, European Society of Coloproctology, NIHR Academy, Sarcoma UK, Vascular Society for Great Britain and Ireland, and Yorkshire Cancer Research

Chlorhexidine versus povidone–iodine skin antisepsis before upper limb surgery (CIPHUR) : an international multicentre prospective cohort study

Introduction Surgical site infection (SSI) is the most common and costly complication of surgery. International guidelines recommend topical alcoholic chlorhexidine (CHX) before surgery. However, upper limb surgeons continue to use other antiseptics, citing a lack of applicable evidence, and concerns related to open wounds and tourniquets. This study aimed to evaluate the safety and effectiveness of different topical antiseptics before upper limb surgery. Methods This international multicentre prospective cohort study recruited consecutive adults and children who underwent surgery distal to the shoulder joint. The intervention was use of CHX or povidone–iodine (PVI) antiseptics in either aqueous or alcoholic form. The primary outcome was SSI within 90 days. Mixed-effects time-to-event models were used to estimate the risk (hazard ratio (HR)) of SSI for patients undergoing elective and emergency upper limb surgery. Results A total of 2454 patients were included. The overall risk of SSI was 3.5 per cent. For elective upper limb surgery (1018 patients), alcoholic CHX appeared to be the most effective antiseptic, reducing the risk of SSI by 70 per cent (adjusted HR 0.30, 95 per cent c.i. 0.11 to 0.84), when compared with aqueous PVI. Concerning emergency upper limb surgery (1436 patients), aqueous PVI appeared to be the least effective antiseptic for preventing SSI; however, there was uncertainty in the estimates. No adverse events were reported. Conclusion The findings align with the global evidence base and international guidance, suggesting that alcoholic CHX should be used for skin antisepsis before clean (elective upper limb) surgery. For emergency (contaminated or dirty) upper limb surgery, the findings of this study were unclear and contradict the available evidence, concluding that further research is necessary

Cardiovascular and musculoskeletal response to supervised exercise in patients with intermittent claudication

ObjectiveIntermittent claudication occurs in 20 % of the population over 70 and treatment includes a supervised exercise programme (SEP). Whilst there is evidence demonstrating walking improvements following a SEP there is conflicting data on the physiological changes behind this; therefore this study aimed to explore and identify the potential cardiovascular and musculoskeletal changes with exercise

Global incidence of incomplete surgical excision in adult patients with non-melanoma skin cancer: Study protocol for a systematic review and meta-analysis of observational studies

Background: Non-melanoma skin cancer, which includes basal cell carcinoma and cutaneous squamous cell carcinoma, is the commonest malignancy worldwide. The mainstay of treatment is surgical excision. Despite this being an exceptionally common procedure, it is not known what the accepted standard is for incomplete excision. Multiple single-centre, regional and national studies have previously reported their incidence of incomplete excision in isolation. Furthermore, is it not known what effect potential risk factors such as the operating group, location of lesions, type of reconstruction, histological components or use of loupe magnification have on the incidence of incomplete excisions. The objective of this study will be to systematically evaluate observational data that present incidence of incomplete surgical excision amongst adult patients with non-melanoma skin cancer worldwide. Methods: We designed and registered a study protocol for a systematic review and meta-analysis of descriptive epidemiology data. A comprehensive literature search will be conducted (from January 2000 onwards) in MEDLINE, EMBASE, Scopus, CINAHL, EMCare and Cochrane Library. Grey literature will be identified through searching Open Grey, dissertation databases (e.g. Open Access Theses and Dissertations) and clinical trial registers (e.g. WHO ICTRP). Observational studies (cohort, cross-sectional, case series and clinical audits) reporting the incidence of incomplete surgical excision and conducted in adult patients with non-melanoma skin cancer will be included. The primary outcome will be the incidence of incomplete surgical excision (defined as residual tumour at either the peripheral or deep margin). Secondary outcomes will be risk factors that may affect incomplete excision (e.g. operating group, location of lesions, types of reconstruction, histological components). Data will not be extracted if the study uses other surgical techniques such as Mohs micrographic surgery, intra-operative frozen section, incision, shave or punch biopsies. Two investigators will independently screen all citations, full-text articles and abstract data. Potential conflicts will be resolved through discussion. No limitations will be imposed on publication status or language of publication. The study methodological quality (or bias) will be appraised using an appropriate tool. If feasible, we will conduct a random effect meta-analysis of observational data. Incidence estimates will be stratified according to cancer type (e.g. basal cell carcinoma vs squamous cell carcinoma) and operating group (e.g. dermatology, plastic surgery and general practice). Additional analyses will be conducted to explore the potential sources of heterogeneity (e.g. methodological quality, sample size). Discussion: This systematic review will summarise the best available evidence and definitively establish the incidence of incomplete surgical excision in non-melanoma skin cancer. It will determine if there is variation observed amongst different operating groups and provide some evidence for potential other factors causing this difference. This knowledge will provide a standard for future audits and will contribute to improving the treatment of non-melanoma skin cancer treatment. Systematic Review Registration: PROSPERO CRD4201915793