Endovenous ablation for venous leg ulcers.

BACKGROUND: Venous leg ulcers (VLUs) are a serious manifestation of chronic venous disease affecting up to 3% of the adult population. This typically recalcitrant and recurring condition significantly impairs quality of life, and its treatment places a heavy financial burden upon healthcare systems. The longstanding mainstay treatment for VLUs is compression therapy. Surgical removal of incompetent veins reduces the risk of ulcer recurrence. However, open surgery is an unpopular option amongst people with VLU, and many people are unsuitable for it. The efficacy of the newer, minimally-invasive endovenous techniques has been established in uncomplicated superficial venous disease, and these techniques can also be used in the management of VLU. When used with compression, endovenous ablation aims to further reduce pressure in the veins of the leg, which may impact ulcer healing. OBJECTIVES: To determine the effects of superficial endovenous ablation on the healing and recurrence of venous leg ulcers and the quality of life of people with venous ulcer disease. SEARCH METHODS: In April 2022 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scrutinised reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions on the language of publication, but there was a restriction on publication year from 1998 to April 2022 as superficial endovenous ablation is a comparatively new technology. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing endovenous ablative techniques with compression versus compression therapy alone for the treatment of VLU were eligible for inclusion. Studies needed to have assessed at least one of the following primary review outcomes related to objective measures of ulcer healing such as: proportion of ulcers healed at a given time point; time to complete healing; change in ulcer size; proportion of ulcers recurring over a given time period or at a specific point; or ulcer-free days. Secondary outcomes of interest were patient-reported quality of life, economic data and adverse events. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed studies for eligibility, extracted data, carried out risk of bias assessment using the Cochrane RoB 1 tool, and assessed GRADE certainty of evidence. MAIN RESULTS: The previous version of this review found no RCTs meeting the inclusion criteria. In this update, we identified two eligible RCTs and included them in a meta-analysis. There was a total of 506 participants with an active VLU, with mean durations of 3.1 months ± 1.1 months in the EVRA trial and 60.5 months ± 96.4 months in the VUERT trial. Both trials randomised participants to endovenous treatment and compression or compression alone, however the compression alone group in the EVRA trial received deferred endovenous treatment (after ulcer healing or from six months). There is high-certainty evidence that combined endovenous ablation and compression compared with compression therapy alone, or compression with deferred endovenous treatment, improves time to complete ulcer healing (pooled hazard ratio (HR) 1.41, 95% CI 1.36 to 1.47; I2 = 0%; 2 studies, 466 participants). There is moderate-certainty evidence that the proportion of ulcers healed at 90 days is probably higher with combined endovenous ablation and compression compared with compression therapy alone or compression with deferred endovenous treatment (risk ratio (RR) 1.14, 95% CI 1.00 to 1.30; I2 = 0%; 2 studies, 466 participants). There is low-certainty evidence showing an unclear effect on ulcer recurrence at one year in people with healed ulcers with combined endovenous treatment and compression when compared with compression alone or compression with deferred endovenous treatment (RR 0.29, 95% CI 0.03 to 2.48; I2 = 78%; 2 studies, 460 participants). There is also low-certainty evidence that the median number of ulcer-free days at one year may not differ (306 (interquartile range (IQR) 240 to 328) days versus 278 (IQR 175 to 324) days) following combined endovenous treatment and compression when compared with compression and deferred endovenous treatment; (1 study, 450 participants). There is low-certainty evidence of an unclear effect in rates of thromboembolism between groups (RR 2.02, 95% CI 0.51 to 7.97; I2 = 78%, 2 studies, 506 participants). The addition of endovenous ablation to compression is probably cost-effective at one year (99% probability at GBP 20,000/QALY; 1 study; moderate-certainty evidence). AUTHORS' CONCLUSIONS: Endovenous ablation of superficial venous incompetence in combination with compression improves leg ulcer healing when compared with compression alone. This conclusion is based on high-certainty evidence. There is moderate-certainty evidence to suggest that it is probably cost-effective at one year and low certainty evidence of unclear effects on recurrence and complications. Further research is needed to explore the additional benefit of endovenous ablation in ulcers of greater than six months duration and the optimal modality of endovenous ablation.

The Edinburgh Claudication Questionnaire has poor diagnostic accuracy in people with intermittent claudication.

BACKGROUND: The screening and diagnosis of intermittent claudication is a challenging process and often relies on the expertise of specialist vascular clinicians. We sought to investigate the diagnostic performance of the Edinburgh Claudication Questionnaire (ECQ) as a screening tool for referrals of suspected intermittent claudication from primary to secondary care. METHOD: Prospectively, 100 referrals from primary care with a stated diagnosis or query regarding intermittent claudication were recruited. All participants who completed the ECQ, underwent an anklebrachial pressure index (ABPI) assessment and treadmill exercise testing. Outcomes of the ECQ were compared to clinical diagnoses of intermittent claudication. RESULTS: The ECQ had a sensitivity of 46.8% (95% CI: 27-65%), specificity of 63.2% (95% CI: 43-82%) and accuracy of 53.0% (95% CI: 43-63%). The diagnostic performance was not changed by combining the ECQ with a positive ABPI or post-exercise ABPI outcome for PAD. CONCLUSION: The ECQ had a poor diagnostic performance in this cohort. Considering the results found here and in other recent studies, the utility of the ECQ as a screening tool and epidemiological survey tool must be questioned. Novel, low-resource diagnostic tools are needed in this population.

Extracorporeal shockwave therapy for diabetic foot ulcers: a feasibility study.

OBJECTIVE: The purpose of this study was to assess the feasibility of delivering extracorporeal shockwave therapy (ESWT) to patients with diabetic foot ulcers (DFUs). It also aimed to explore any potential clinical effect of ESWT on wound healing and investigate whether ESWT offers any patient-reported benefits. METHOD: In this single-centre, mixed methods feasibility study, patients with a DFU who met the eligibility criteria underwent ESWT three times over a seven-day period. Primary outcome was feasibility of delivering the intervention. Secondary outcomes included wound size, number of DFUs healed at 12 weeks and quality of life (QoL). Semi-structured interviews explored participants' experience of undergoing ESWT. RESULTS: Of 106 patients screened, 24 (22.6%) were recruited. Following recruitment, two patients were withdrawn from the study with 22 patients included in the final analysis. The mean attendance at clinic was 90.9% and 65.1% for follow-up. The mean score for acceptability and tolerability was 9.86±0.48 (95% confidence interval (CI): 9.62-10.01) and 9.15±2.57 (95% CI: 7.87-10.42), respectively. There were no serious adverse events or side-effects. Of the DFUs, 45.5% healed during follow-up and QoL scores improved until eight weeks. Key themes identified from the qualitative interviews were: desire for fast healing; improved QoL; flexibility of new treatments; and accessibility of transport. CONCLUSION: This study has shown that it is possible to recruit and retain patents into a single-arm study of ESWT for DFUs. This study supports development of a large randomised control trial to determine the clinical and cost-effectiveness of ESWT for DFU healing.

A rare case of intestinal malrotation in pregnancy resulting in hemicolectomy postnatally.

INTRODUCTION: Small and large bowel obstruction secondary to volvulus on the background of intestinal malrotation is a very rare occurrence, especially in pregnancy. This can be associated with significant feto-maternal morbidity and mortality. CASE REPORT: We report a case of a pregnant lady who developed symptoms of subacute intestinal obstruction during the 2nd trimester of pregnancy and was subsequently dia-gnosed with intestinal malrotation on imaging. Though she had symptoms of abdominal pain and constipation persisting for 9 long weeks during pregnancy, there was no evidence of definite intestinal obstruction or volvulus on her abdominal magnetic resonance imaging. She underwent a caesarean section at 34 weeks of pregnancy due to worsening abdominal pain. Postnatally, she was dia-gnosed with midgut volvulus on a computer tomography scan, leading to obstruction of both small and large bowels and needed an emergency laparotomy and right hemicolectomy. CONCLUSION: The case highlights the importance of timely dia-gnosis and prompt management of intestinal obstruction in pregnancy with a multidisciplinary team approach.

Extracorporeal Shockwave Therapy for Diabetic Foot Ulcers: A Systematic Review and Meta-Analysis.

BACKGROUND: Diabetes mellitus is one of the most common chronic diseases worldwide. Diabetic foot ulcers (DFUs) occur in over 10% of diabetic patients and are associated with high morbidity. Clinical trials have shown benefit from extracorporeal shockwave therapy (ESWT) in a DFU healing. This systematic review aims to assess the currently available evidence examining the efficacy of ESWT on healing of DFU. METHODS: Electronic databases including PubMed, Ovid MEDLINE, Web of Science, Embase, CINAHL Plus, Cochrane Central Registry of Controlled Trials, and Clinical Trials Registry were searched up to November 2017 for terms related to ESWT in DFU. Articles were identified, and data were extracted by 2 independent reviewers onto Review Manager 5.3 software. RESULTS: This review included 5 trials of 255 patients published between 2009 and 2016. Three studies compared ESWT to standard wound care, and 2 studies compared ESWT to hyperbaric oxygen therapy (HBOT). All studies contained unclear to high risk of bias assessed by the Cochrane Risk of Bias Tool. ESWT was superior to standard wound care at complete wound healing (odds ratio [OR] 2.66 95% confidence interval [CI] 1.03, 6.87, I2 0%) and time to healing (64.5 ± 8.06 days versus 81.17 ± 4.35 days). DFU healing improved more with ESWT than HBOT (OR 2.45 95% CI 1.07, 5.61 I2 28%). There was variable evidence of effect on the blood flow perfusion rate. Infection rate and amputation rate were not reported. CONCLUSIONS: This systematic review concludes that ESWT has the potential to improve healing in DFUs, although there is, as yet, insufficient evidence to justify its use in routine clinical practice. The meta-analysis has a high risk of bias and is unlikely to reflect true effect size because of problematic risk of bias in included studies. This review highlights the variable quality of methodology of trials and dosing of shockwave therapy and the need for robust adequately powered research into this promising therapy.

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.

Extracorporeal Shockwave for Intermittent Claudication and Quality of Life: A Randomized Clinical Trial.

Importance: Intermittent lower limb claudication limits function and quality of life. Supervised exercise programs are not readily available, and a noninvasive alternative is needed. Objective: To assess extracorporeal corporeal shockwave therapy in improving quality of life in patients with claudication. Design, Setting, and Participants: In this double-blind, placebo-controlled randomized clinical trial, patients in the outpatient setting at a single tertiary center for vascular surgery were randomized in a 1:1 ratio to extracorporeal shockwave therapy or placebo therapy with no shockwaves delivered. Recruitment was between June 2015 and January 2020, with 12-week follow-up ending in March 2020. A convenience sample of patients with claudication and conservative treatment requirements who refused or were unable to participate in supervised exercise were eligible. Patients receiving anticoagulation therapy or with an active cancer were excluded. Of 522 patients screened, 389 were eligible, 138 were enrolled, and 110 completed follow-up and were included in the primary analysis. Statistical analysis was completed by May 2021. Intervention: In the intervention group, patients received 100 impulses of 0.1mJ/mm/cm2 in an area of the gastrocnemius muscle 3 times weekly for 3 weeks. The steps for treatment were replicated for the control group without delivering the treatment. Main Outcomes and Measures: The primary outcome was the Physical Functioning domain of the 36-item Short-Form Quality of Life Questionnaire at 12-week follow-up. Secondary outcomes included walking distances, ankle brachial pressure index, and other quality-of-life measures. Results: Of 138 patients recruited and randomized, 92 (67%) were male, and the mean (SD) age of the study population was 67 (9.6) years. The intervention group had a significantly higher physical function score at 12 weeks (estimated median difference 3.8; 95% CI, 0.0-7.7; P = .03). However, this significance did not remain when adjusting for covariates. At 12 weeks, the intervention group had significantly longer pain-free and maximum walking distances (pain-free estimated median difference, 34.1, 95% CI, 11.4-56.8; P = .004; maximum estimated median difference, 51.4; 95% CI, 10.7-86.5; P = .01). Conclusions and Relevance: To our knowledge, this is the first double-blind, placebo-controlled, randomized clinical trial to consider extracorporeal shockwave therapy for the management of intermittent claudication. It demonstrated efficacy for walking distances, may have a positive effect on quality of life, and may provide a safe, noninvasive alternative therapy for patients with intermittent claudication. Trial Registration: ClinicalTrials.gov Identifier: NCT02652078.

A randomised clinical trial of ultrasound guided cannulation of difficult fistulae for dialysis access.

BACKGROUND: Arteriovenous fistulae (AVF) are preferred for dialysis access but require accurate cannulation for effective dialysis. Evidence supports improvements in cannulation and complication rates using ultrasound guidance (USG) in cannulating other sites. This mixed methods, randomised controlled trial aimed to assess effects of USG during AVF cannulation. METHODS: Participants with difficult to cannulate AVF had each cannulation event randomised to USG or standard technique (no USG). The primary outcome was the incidence and number of additional needle passes. Secondary outcomes included: the incidence and number of additional skin punctures; time to achieve two needle cannulation; pain associated with cannulation; local complications. Qualitative outcomes were assessed using patient and staff questionnaires. RESULTS: Thirty-two participants had 346 cannulation events randomised (170 to USG and 176 to standard cannulation). USG resulted in a significant reduction in additional needle passes (72 vs 99 p = 0.007) and additional skin punctures (10 vs 25 p = 0.016.) but prolonged time to cannulation (p > 0.001). There was no difference in pain score (p = 0.705) or complications between groups. Questionnaires demonstrated that USG cannulation is acceptable to patients and staff. CONCLUSION: USG cannulation of AVF is more accurate and no more painful than non-image guided cannulation, but prolonged time to cannulation. Some of the excess time involved may be due to the trial being performed early in cannulating staff's learning curve with the USG technique. Further work to elucidate which patients gain most benefit from USG cannulation and the effect of USG on cannulation complications and AVF patency is warranted.

Assessing the effectiveness of dialkylcarbamoylchloride (DACC)-coated post-operative dressings versus standard care in the prevention of surgical site infection in clean or clean-contaminated, vascular surgery (the DRESSINg trial): study protocol for a pilot feasibility randomised controlled trial.

BACKGROUND: Surgical site infection in vascular surgery has a reported incidence of up to 19%. A novel method of reducing this rate of infection is dressings coated with dialkylcarbamoylchloride (DACC), a hydrophobic wound contact layer that binds bacteria and removes them from the wound bed. Early research has suggested that DACC-coated wound dressings are effective in reducing surgical site infection when applied to wounds healing by primary intention post-operatively, therefore this trial aims to assess the feasibility of producing high-quality evidence assessing this theory. METHODS: Patients undergoing clean or clean-contaminated vascular surgery will be randomised to have their surgical wounds dressed with a DACC-coated dressing or a non-coated occlusive absorbent post-operative dressing. All other aspects of their peri-operative care will be standardised or carried out in line with hospital policy. Wound assessments will be carried out between day 5-7, day 30 (± 3 days) and 6 months post-operatively (± 7 days) by a blinded assessor using the ASEPSIS scoring tool. Quality of life data using EQ-5D and SF-36, resource use and mortality data will also be collected. This feasibility trial will dictate the conduct of a full-scale trial through the collection of data on recruitment and retention rates, and fitness-for-purpose of the follow-up arrangements. DISCUSSION: Surgical site infections are now the second most common hospital acquired infections with a significant cost implication. The aim of the DRESSINg trial is to investigate the effectiveness of a novel preventative measure at reducing wound infections post-surgery and will provide robust evidence to support or deny its use. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT02992951, Registered 12/12/16. REC Reference: 16/LO/2135.