Changes in Peristomal Skin Condition and User Experience of a Novel Ostomy Barrier Ring With Assisted Flow: A 6-Week Feasibility Study.

PURPOSE: This purpose of this study was to evaluate a novel barrier ring with an assisted flow mechanism by assessing changes in peristomal moisture-associated skin damage (MASD) and perceptions of comfort, security, handling, and discretion in persons with an ileostomy for 6 months or longer. DESIGN: Single-arm, open-labeled feasibility study. SUBJECTS AND SETTINGS: Twenty participants (aged ≥18 years) with an ileostomy for 6 months or more participated in the study and 12 completed data collection. The primary reason for dropouts concerned compatibility issues with the barrier ring when used with certain convex pouching systems. METHODS: Participants used the barrier ring along with their normal ostomy pouching system for a period of 6 weeks. Changes in skin condition were assessed using the Ostomy Skin Tool (OST). Participants' perception of the barrier rings' comfort, security, handling, and discretion were also recorded on a 10-point scale, where participants would offer a low score if their experience was negative and a higher score if their experience was positive. Participants changed pouches and barrier rings at their own discretion. For participants who completed the study, the average skin condition and median ratings of comfort, security, handling, and discretion at 6 weeks were compared to baseline values. RESULTS: Twelve of the 20 participants (60%) completed the study. For those who completed, the mean score on the OST decreased from 6.2 ± 1.90 (mean ± SD) at baseline to 3.4 ±1.73 at 6 weeks, indicating a mean reduction of 2.8 (95% CI, -1.6 to -3.9; P < .001). The peristomal skin condition of 9 participants improved, whereas 3 experienced no change. All participants who completed the study rated comfort, handling, security, and discretion highly (median score 10 at baseline and at 6 weeks). CONCLUSIONS: Study findings indicate the novel ostomy barrier ring may reduce levels of peristomal MASD in persons living with an ileostomy, though a more extensive trial with a control group is recommended.

Wound drainage for lower limb arterial surgery.

BACKGROUND: Drains are often used in leg wounds after vascular surgery procedures despite uncertainty regarding their benefits. Drains are placed with the aim of reducing the incidence and size of blood or fluid collections. Conversely, drains may predispose patients to infection and may prolong hospitalisation. Surgeons need robust data regarding the effects of drains on complications following lower limb arterial surgery. OBJECTIVES: To determine whether routine placement of wound drains results in fewer complications following lower limb arterial surgery than no drains. SEARCH METHODS: In June 2016 we searched: the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL; the Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE and EBSCO CINAHL. We also searched clinical trial registries for ongoing studies.There were no restrictions with respect to language, date of publication or study setting. SELECTION CRITERIA: We considered randomized controlled trials (RCTs) that evaluated the use of any type of drain in lower limb arterial surgery. DATA COLLECTION AND ANALYSIS: Two authors independently determined study eligibility, extracted data and performed an assessment of bias. An effort was made to contact authors for missing data. The methods and results of each eligible study were summarised and we planned to pool data in meta-analyses when it was considered appropriate, based upon clinical and statistical homogeneity. MAIN RESULTS: We identified three eligible trials involving a total of 222 participants with 333 groin wounds. Suction drainage was compared with no drainage in all studies. Two studies were parallel-group, randomized controlled trials, and one was a split-body, randomized controlled trial. Trial settings were not clearly described. Patients undergoing bypass and endarterectomy procedures were included, but none of the studies provided details on the severity of the underlying arterial disease.We deemed all of the studies to be at a high risk of bias in three or more domains of the 'Risk of bias' assessment and overall the evidence was of very low quality. Two out of three studies had unit of analysis errors (with multiple wounds within patients analysed as independent) and it was not possible to judge the appropriateness of the analysis of the third. Meta-analysis was not appropriate, firstly because of clinical heterogeneity, and secondly because we were not able to adjust for the analysis errors in the individual trials. One trial yielded data on surgical site infections (SSI; the primary outcome of the review): there was no clear difference between drained and non-drained wounds for SSI (risk ratio 1.33; 95% confidence interval 0.30 to 5.94; 50 participants with bilateral groin wounds; very low quality evidence). It was not possible to evaluate any other outcomes from this trial. The results from the other two studies are unreliable because of analysis errors and reporting omissions. AUTHORS' CONCLUSIONS: The data upon which to base practice in this area are limited and prone to biases. Complete uncertainty remains regarding the potential benefits and harms associated with the use of wound drains in lower limb arterial surgery due to the small number of completed studies and weaknesses in their design and conduct. Higher quality evidence is needed to inform clinical decision making. To our knowledge, no trials on this topic are currently active.

Can a Neutrophil-Lymphocyte Ratio Derived from Preoperative Blood Tests Predict Arteriovenous Fistula Maturation?

BACKGROUND: To evaluate the association between inflammatory markers expressed as neutrophil-lymphocyte ratio (NLR) and process of arteriovenous fistula (AVF) maturation. METHODS: A retrospective review of patients with end-stage renal disease referred for formation of a new AVF in one center. Patients referred to the vascular service in the University Hospital of Limerick for creation of vascular access between 2009 and 2013. The association between NLR, calculated from preoperative blood tests, and functional fistula maturation, as determined by successful use of the AVF for 6 consecutive hemodialysis sessions, was investigated using univariate and logistic regression analyses. A logistic regression analysis was carried out to assess potential influence from other factors related to AVF maturation. Stepwise regression test was performed including the NLR. RESULTS: Overall AVF functional maturation rate in our study was 53.7% (66/123). Patients with matured AVFs had an NLR of 4.850 (1.8-15.7) compared with 3.554 (1.7-15.0); this difference was found to be significant (P = 0.024). Female gender (P = 0.008) and a history of kidney transplant (P = 0.004) were the only independent factors of fistula maturation outcome in a logistic regression model. CONCLUSION: Increased level of NLR was found to be associated with fistula maturation; however, more studies are needed to validate this finding.

Remote ischemic conditioning and renal function after contrast-enhanced CT scan: A randomized trial.

PURPOSE: Remote ischemic conditioning has been shown to protect against kidney injury in animal and human studies of ischemia-reperfusion. Recent evidence suggests that conditioning may also provide protection against kidney injury caused by contrast medium. The purpose of this study was to determine if conditioning protected against increases in serum creatinine (SCr) after contrast-enhanced computed tomography (CECT). METHODS: A randomised controlled trial (NCT 01741896) was performed with institutional review board approval and informed patient consent. Adult in-patients undergoing abdomino-pelvic CECT were allocated to conditioned or control groups. Conditioning consisted of four cycles of five minutes of cuff-induced arm ischemia with three minutes of reperfusion applied ~40 minutes before CECT. The primary outcome was SCr change after CECT. RESULTS: Baseline characteristics were similar in both groups. For all patients, conditioning reduced the risk ratio (RR) of increased SCr; RR 0.65 (95% confidence intervals 0.41 to 1.04). The protective effect was greater and the evidence for protection stronger when analysis was restricted to patients with pre-scan reduced renal function (eGFR.

Preconditioning Shields Against Vascular Events in Surgery (SAVES), a multicentre feasibility trial of preconditioning against adverse events in major vascular surgery: study protocol for a randomised control trial.

BACKGROUND: Patients undergoing vascular surgery procedures constitute a 'high-risk' group. Fatal and disabling perioperative complications are common. Complications arise via multiple aetiological pathways. This mechanistic redundancy limits techniques to reduce complications that target individual mechanisms, for example, anti-platelet agents. Remote ischaemic preconditioning (RIPC) induces a protective phenotype in at-risk tissue, conferring protection against ischaemia-reperfusion injury regardless of the trigger. RIPC is induced by repeated periods of upper limb ischaemia-reperfusion produced using a blood pressure cuff. RIPC confers some protection against cardiac and renal injury during major vascular surgery in proof-of-concept trials. Similar trials suggest benefit during cardiac surgery. Several uncertainties remain in advance of a full-scale trial to evaluate clinical efficacy. We propose a feasibility trial to fully evaluate arm-induced RIPC's ability to confer protection in major vascular surgery, assess the incidence of a proposed composite primary efficacy endpoint and evaluate the intervention's acceptability to patients and staff. METHODS/DESIGN: Four hundred major vascular surgery patients in five Irish vascular centres will be randomised (stratified for centre and procedure) to undergo RIPC or not immediately before surgery. RIPC will be induced using a blood pressure cuff with four cycles of 5 minutes of ischaemia followed by 5 minutes of reperfusion immediately before the start of operations. There is no sham intervention. Participants will undergo serum troponin measurements pre-operatively and 1, 2, and 3 days post-operatively. Participants will undergo 12-lead electrocardiograms pre-operatively and on the second post-operative day. Predefined complications within one year of surgery will be recorded. Patient and staff experiences will be explored using qualitative techniques. The primary outcome measure is the proportion of patients who develop elevated serum troponin levels in the first 3 days post-operatively. Secondary outcome measures include length of hospital and critical care stay, unplanned critical care admissions, death, myocardial infarction, stroke, mesenteric ischaemia and need for renal replacement therapy (within 30 days of surgery). DISCUSSION: RIPC is novel intervention with the potential to significantly improve perioperative outcomes. This trial will provide the first evaluation of RIPC's ability to reduce adverse clinical events following major vascular surgery. TRIAL REGISTRATION: www.clinicaltrials.gov NCT02097186 Date Registered: 24 March 2014.

Predictive parameters of arteriovenous fistula functional maturation in a population of patients with end-stage renal disease.

INTRODUCTION: With increasing numbers of patients diagnosed with ESRD, arteriovenous fistula (AVF) maturation has become a major factor in improving both dialysis related outcomes and quality of life of those patients. Compared to other types of access it has been established that a functional AVF access is the least likely to be associated with thrombosis, infection, hospital admissions, secondary interventions to maintain patency and death. AIM: Study of demographic factors implicated in the functional maturation of arteriovenous fistulas. Also, to explore any possible association between preoperative haematological investigations and functional maturation. METHODS: We performed a retrospective chart review of all patients with ESRD who were referred to the vascular service in the University Hospital of Limerick for creation of vascular access for HD. We included patients with primary AVFs; and excluded those who underwent secondary procedures. RESULTS: Overall AVF functional maturation rate in our study was 53.7% (52/97). Female gender showed significant association with nonmaturation (P = 0.004) and was the only predictor for non-maturation in a logistic regression model (P = 0.011). Patients who had history of renal transplant (P = 0.036), had relatively lower haemoglobin levels (P = 0.01) and were on calcium channel blockers (P = 0.001) showed better functional maturation rates. CONCLUSION: Female gender was found to be associated with functional non-maturation, while a history kidney transplant, calcium channel-blocker agents and low haemoglobin levels were all associated with successful functional maturation. In view of the conflicting evidence in the literature, large prospective multi-centre registry-based studies with well-defined outcomes are needed.

One-stage vs. two-stage brachio-basilic arteriovenous fistula for dialysis access: a systematic review and a meta-analysis.

INTRODUCTION: A brachiobasilic arteriovenous fistula (BB-AVF) can provide access for haemodialysis in patients who are not eligible for a more superficial fistula. However, it is unclear whether one- or two-stage BB-AVF is the best option for patients. AIM: To systematically assess the difference between both procedures in terms of access maturation, patency and postoperative complications. METHODS: Online search for randomised controlled trials (RCTs) and observational studies that compared the one-stage versus the two-stage technique for creating a BB-AVF. RESULTS: Eight studies were included (849 patients with 859 fistulas), 366 created using a one-stage technique, while 493 in a two-stage approach. There was no statistically significant difference between the two groups in the rate of successful maturation (Pooled risk ratio = 0.95 [0.82, 1.11], P = 0.53). Similarly, the incidence of postoperative haematoma (Pooled risk ratio = 0.73 [0.34, 1.58], P = 0.43), wound infection (Pooled risk ratio = 0.77 [0.35, 1.68], P = 0.51) and steal syndrome (Pooled risk ratio = 0.65 [0.27, 1.53], P = 0.32) were statistically comparable. CONCLUSION: Although more studies seem to favour the two-stage BVT approach, evidence in the literature is not sufficient to draw a final conclusion as the difference between the one-stage and the two-stage approaches for creation of a BB-AVF is not statistically significant in terms of the overall maturation rate and postoperative complications. Patency rates (primary, assisted primary and secondary) were comparable in the majority of studies. Large randomised properly conducted trials with superior methodology and adequate sub-group analysis are needed before making a final recommendation.

Effects of neck radiation therapy on extra-cranial carotid arteries atherosclerosis disease prevalence: systematic review and a meta-analysis.

INTRODUCTION: Radiation arteritis following neck irradiation as a treatment for head and neck malignancy has been well documented. The long-term sequelae of radiation exposure of the carotid arteries may take years to manifest clinically, and extra-cranial carotid artery (ECCA) stenosis is a well-recognised vascular complication. These carotid lesions should not be regarded as benign and should be treated in the same manner as standard carotid stenosis. Previous studies have noted increased cerebrovascular events such as stroke in this cohort of patients because of high-grade symptomatic carotid stenosis resulting in emboli. AIM: To evaluate the effect of radiation therapy on ECCA atherosclerosis progression. METHODS: Online search for case-control studies and randomised clinical trials that reported on stenosis in extra-cranial carotid arteries in patients with neck malignancies who received radiation therapy (RT) comparing them to patients with neck malignancies who did not receive RT. RESULTS: Eight studies were included in the final analysis with total of 1070 patients - 596 received RT compared to 474 in the control group. There was statistically significant difference in overall stenosis rate (Pooled risk ratio  =  4.38 [2.98, 6.45], P  =  0.00001) and severe stenosis (Pooled risk ratio  =  7.51 [2.78, 20.32], P <0.0001), both being higher in the RT group. Pooled analysis of the five studies that reported on mild stenosis also showed significant difference (Pooled risk ratio  =  2.74 [1.75, 4.30], 95% CI, P  =  0.0001). CONCLUSION: The incidence of severe ECCA stenosis is higher among patients who received RT for neck malignancies. Those patients should be closely monitored and screening programs should be considered in all patients who receive neck RT.

Remote ischaemic preconditioning as a method for perioperative cardioprotection: concepts, applications and future directions.

Remote ischaemic preconditioning (RIPC) is a phenomenon whereby brief episodes of non-lethal ischaemia in one organ or tissue can render a distant organ or tissue resistant to subsequent longer ischaemic insults. It represents an exciting perioperative risk reduction strategy as it allows cardioprotection (and organ protection in general) from injuries that are caused by multiple mechanisms. Several proof of concept studies show benefits in cardiovascular interventions and in a variety of other procedures. However convincing and consistent evidence of benefits in patient important outcomes is lacking but may emerge with the completion of large scale studies. This article aims to provide a concise review of the origins and concepts of RIPC. It will revisit the biological theories of RIPC and the clinical applications thus far. The article concludes by discussing the current status of multi-centre cardiovascular RIPC research and the future challenges that investigators must overcome.

Role of far infra-red therapy in dialysis arterio-venous fistula maturation and survival: systematic review and meta-analysis.

INTRODUCTION: A well-functioning arteriovenous fistula (AVF) is the best modality for vascular access in patients with end-stage renal disease (ESRD) requiring haemodialysis (HD). However, AVFs' main disadvantage is the high rate of maturation failure, with approximately one third (20%-50%) not maturing into useful access. This review examine the use of Far-Infra Red therapy in an attempt to enhance both primary (unassisted) and secondary (assisted) patency rates for AVF in dialysis and pre-dialysis patients. METHOD: We performed an online search for observational studies and randomised controlled trials (RCTs) that evaluated FIR in patients with AVF. Eligible studies compared FIR with control treatment and reported at least one outcome measure relating to access survival. Primary patency and secondary patency rates were the main outcomes of interest. RESULTS: Four RCTs (666 patients) were included. Unassisted patency assessed in 610 patients, and was significantly better among those who received FIR (228/311) compared to (185/299) controls (pooled risk ratio of 1.23 [1.12-1.35], p = 0.00001). In addition, the two studies which reported secondary patency rates showed significant difference in favour of FIR therapy--160/168 patients--compared to 140/163 controls (pooled risk ratio of 1.11 [1.04-1.19], p = 0.003). CONCLUSION: FIR therapy may positively influence the complex process of AVF maturation improving both primary and secondary patency rates. However blinded RCTs performed by investigators with no commercial ties to FIR therapy technologies are needed.

Pre-operative ultrasonography and arteriovenous fistulae maturation.

BACKGROUND: Arteriovenous fistulae (AVF) are preferred for haemodialysis access, but maturation is unpredictable. RESULTS: Clinical examination alone is unreliable for AVF planning. Duplex ultrasonography may provide useful anatomical and physiological data to allow more accurate prediction of likely AVF success. CONCLUSION: Selective use of duplex ultrasonography appears to enhance AVF success rates, but there are insufficient data to recommend routine duplex screening of AVF candidates. Agreed vessel criteria are needed.

Randomised controlled trial comparing European standard class 1 to class 2 compression stockings for ulcer recurrence and patient compliance.

The aim of this study was to determine the rate of venous ulcer recurrence and the level of compliance in patients wearing European class 1 or class 2 compression stockings. A total of 100 patients with healed venous leg ulcers were recruited, and were randomised to either class 1 (n = 50) or class 2 (n = 50) compression stockings. Follow-up was at 1 week, 3, 6, 9 and 12 months to monitor ulcer recurrence and compliance. Patients had a duplex scan to identify the source of venous incompetence. The rate of ulcer recurrence after 12 months was 16·1%, and the difference in recurrence rate between classes was not statistically significant (P = 0·287) although greater numbers in class 1 developed a recurrence. Participants (88·9%) were compliant; non-compliant patients were at a significantly greater risk of recurrence (P≤ 0·0001). Thirteen patients had both superficial and deep incompetence; those randomised to class 1 stockings (n = 4) developed ulcer recurrence. Patients with a history of multiple episodes of ulceration were more likely to develop a recurrence (P = 0·001). The lowest venous ulcer recurrence rates were seen in patients who were compliant with hosiery regardless of the compression level. Patients with both superficial and deep incompetence had a lower rate of recurrence with class 2 compression.

Systematic review and meta-analysis of routine total body CT compared with selective CT in trauma patients.

BACKGROUND: Full-body CT scanning is increasingly being used in the initial evaluation of severely injured patients. We sought to analyse the literature to determine the benefits of full-body scanning in terms of mortality and length of time spent in the emergency department (ED). METHODS: A systematic search of the Pubmed and Cochrane Library databases was performed. Eligible studies compared trauma patients managed with selective CT scanning with patients who underwent immediate full-body scanning. Using random effects modelling, the pooled OR was used to calculate the effect of routine full-body CT on mortality while the pooled weighted mean difference was used to analyse the difference in ED time. RESULTS: Five studies (8180 patients) provided mortality data while four studies (6073 patients) provided data on ED time. All were non-randomised cohort studies and were prone to several sources of bias. There was no mortality difference between groups (pooled OR=0.68; 95% CI 0.43 to 1.09, p=0.11). There was a significant reduction in the time spent in the ED when patients underwent full-body CT (pooled effect size of weighted mean difference=-32.39 min; 95% CI -51.78 to -13.00; p=0.001). CONCLUSIONS: We eagerly await the results of randomised controlled trials. Firm clinical outcome data are expected to emerge in the near future, though data on cost and radiation exposure will be needed before definitive conclusions can be made.

Endovascular management of ruptured common iliac mycotic aneurysm in an HIV-positive patient.

Isolated iliac artery aneurysms are a rare entity. The majority of cases are asymptomatic and often escape detection. Mortality rates after sudden rupture and emergent surgery for iliac artery aneurysm are very high. We report a case of a 56-year-old man who presented with right hip pain masquerading as septic arthritis or psoas abscess. CT showed ruptured right common iliac artery aneurysm with extensive active extravasation into psoas with a retroperitoneal haematoma. Aneurysm was repaired using an endovascular technique. Postoperative recovery was eventful with the patient experiencing severe back pain radiating down the leg accompanied with fever. CT showed persistent, right iliopsoas haematoma and pelvic haematoma with secondary hydronephrosis. Viral screen for hepatitis B, C and HIV returned positive. The patient was started on intravenous meropenem. Fever and pain settled. Repeated CT scan showed decrease in retroperitoneal pelvic haematoma.

A systematic review of preoperative duplex ultrasonography and arteriovenous fistula formation.

BACKGROUND: Arteriovenous fistula (AVF) formation for dialysis access is a common procedure. Fistula maturation is unpredictable. Preoperative duplex mapping may increase procedural success. We undertook a systematic review to assess the effect of preoperative duplex mapping on subsequent AVF patency. METHODS: The published literature was searched on PubMed and the Cochrane Library using the following keywords: 'arteriovenous fistula,' 'venous mapping,' 'ultrasound,' 'hemodialysis,' 'vascular access,' and 'perioperative vessel mapping.' Conference proceedings were hand searched for otherwise unpublished trials. Only randomized controlled trials in which preoperative duplex mapping was compared with clinical evaluation were eligible. RESULTS: Three trials (402 patients) were identified. More patients who underwent ultrasound successfully started using their fistula for dialysis access, although the difference did not reach statistical significance (174/214 vs 130/188; pooled odds ratio, 1.96; P = .11). CONCLUSIONS: Preoperative duplex mapping may improve fistula maturation rates. However, the results do not reach statistical significance and there are no cost-effectiveness data. Further work is required.

Ultrasound guidance for difficult peripheral venous access: systematic review and meta-analysis.

BACKGROUND: Establishing intravenous access is often vital in an acute hospital setting but can be difficult. Ultrasound-guided cannulation increases success rates in prospective studies. However, these studies have often lacked a comparative group. This systematic review and meta-analysis aimed to determine the clinical effectiveness of Ultrasound-guided peripheral intravenous cannulation compared with the standard technique in patients known to have difficult access. METHODS: Electronic abstract databases, trial registries, article reference lists and internet repositories were searched using the following search terms: 'peripheral venous cannulation', 'peripheral venous access'. Studies meeting the following criteria were included: randomised controlled trial patients of all ages who required peripheral intravenous access; interventions were Ultrasound-guided versus standard cannulation technique; patients were identified as having difficult venous access; inclusion of at least one defined outcome (procedural success time to cannula placement; number of attempts). RESULTS: 7 trials were identified (289 participants). Ultrasound guidance increases the likelihood of successful cannulation (pooled OR 2.42; 95% CI 1.26 to 4.68; p=0.008). There were no differences in time to successful cannulation, or number of percutaneous skin punctures. CONCLUSION: Ultrasound guidance increases the likelihood of successful peripheral cannulation in difficult access patients. We recommend its use in patients who have difficult venous access, and have failed venous cannulation by standard methods. Further randomised controlled trials (RCTs) with larger sample sizes would be of benefit to investigate if Ultrasound has any additional advantages in terms of reducing the procedure time and the number of skin punctures required for successful venous cannulation.

A technique for the computation of lower leg muscle volume from MRI images in the context of venous return.

A technique to automatically calculate the volume of a patient's calf muscle using MRI scans in the context of venous insufficiency is presented. Rather than giving a quantifiable measurement of volume, the technique provides a pixel count which can be used to compare the calf muscle volume of one leg of a patient against the other in the context of unilateral leg ulcers or to compare one patient's calf muscle volume against another patient. A custom MATLAB program reads the MRI scans (in the form of JPEG images) and determines the number of pixels (right and left limbs separately) that fall within a user defined gray-scale band, designated as being muscle. The output from the MATLAB program was compared with a manual counting method. The pixel counting algorithm was found to have an acceptable accuracy with results indicating a percentage difference from the manual method of between 2 and 9.5%.