Delphi Study to Reach International Consensus Among Vascular Surgeons on Major Arterial Vascular Surgical Complications

Background: The complications discussed with patients by surgeons prior to surgery vary, because no consensus on major complications exists. Such consensus may improve informed consent and shared decision-making. This study aimed to achieve consensus among vascular surgeons on which complications are considered ‘major’ and which ‘minor,’ following surgery for abdominal aortic aneurysm (AAA), carotid artery disease (CAD) and peripheral artery disease (PAD). Methods: Complications following vascular surgery were extracted from Cochrane reviews, national guidelines, and reporting standards. Vascular surgeons from Europe and North America rated complications as major or minor on five-point Likert scales via an electronic Delphi method. Consensus was reached if ≥ 80% of participants scored 1 or 2 (minor) or 4 or 5 (major). Results: Participants reached consensus on 9–12 major and 6–10 minor complications per disease. Myocardial infarction, stroke, renal failure and allergic reactions were considered to be major complications of all three diseases. All other major complications were treatment specific or dependent on disease severity, e.g., spinal cord ischemia, rupture following AAA repair, stroke for CAD or deep wound infection for PAD. Conclusion: Vascular surgeons reached international consensus on major and minor complications following AAA, CAD and PAD treatment. This consensus may be helpful in harmonizing the information patients receive and improving standardization of the informed consent procedure. Since major complications differed between diseases, consensus on disease-specific complications to be discussed with patients is necessary

Which dressing do donor site wounds need?: study protocol for a randomized controlled trial

Donor site wounds after split-skin grafting are rather 'standard' wounds. At present, lots of dressings and topical agents for donor site wounds are commercially available. This causes large variation in the local care of these wounds, while the optimum 'standard' dressing for local wound care is unclear. This protocol describes a trial in which we investigate the effectiveness of various treatment options for these donor site wounds. A 14-center, six-armed randomized clinical trial is being carried out in the Netherlands. An a-priori power analysis and an anticipated dropout rate of 15% indicates that 50 patients per group are necessary, totaling 300 patients, to be able to detect a 25% quicker mean time to complete wound healing. Randomization has been computerized to ensure allocation concealment. Adult patients who need a split-skin grafting operation for any reason, leaving a donor site wound of at least 10 cm2 are included and receive one of the following dressings: hydrocolloid, alginate, film, hydrofiber, silicone dressing, or paraffin gauze. No combinations of products from other intervention groups in this trial are allowed. Optimum application and changes of these dressings are pursued according to the protocol as supplied by the dressing manufacturers. Primary outcomes are days to complete wound healing and pain (using a Visual Analogue Scale). Secondary outcomes are adverse effects, scarring, patient satisfaction, and costs. Outcome assessors unaware of the treatment allocation will assess whether or not an outcome has occurred. Results will be analyzed according to the intention to treat principle. The first patient was randomized October 1, 2009. This study will provide comprehensive data on the effectiveness of different treatment options for donor site wounds. The dressing(s) that will prevail in effectiveness, satisfaction and costs will be promoted among clinicians dealing with such patients. Thus, we aim to contribute a well-designed trial, relevant to all clinicians involved in the care for donor site wounds, which will help enhance uniformity and quality of care for these patients. http://www.trialregister.nl, NTR1849. Date registered: June 9, 200

Topical haemostatic agents for skin wounds: a systematic review

Background: Various agents and techniques have been introduced to limit intra-operative blood loss from skin lesions. No uniformity regarding the type of haemostasis exists and this is generally based on the surgeon's preference. To study the effectiveness of haemostatic agents, standardized wounds like donor site wounds after split skin grafting (SSG) appear particularly suitable. Thus, we performed a systematic review to assess the effectiveness of haemostatic agents in donor site wounds. Methods. We searched all randomized clinical trials (RCTs) on haemostasis after SSG in Medline, Embase and the Cochrane Library until January 2011. Two reviewers independently assessed trial relevance and quality and performed data analysis. Primary endpoint was effectiveness regarding haemostasis. Secondary endpoints were wound healing, adverse effects, and costs. Results: Nine relevant RCTs with a fair methodological quality were found, comparing epinephrine, thrombin, fibrin sealant, alginate dressings, saline, and mineral oil. Epinephrine achieved haemostasis significantly faster than thrombin (difference up to 2.5 minutes), saline or mineral oil (up to 6.5 minutes). Fibrin sealant also resulted in an up to 1 minute quicker haemostasis than thrombin and up to 3 minutes quicker than placebo, but was not directly challenged against epinephrine. Adverse effects appeared negligible. Due to lack of clinical homogeneity, meta-analysis was impossible. Conclusion: According to best available evidence, epinephrine and fibrin sealant appear superior to achieve haemostasis when substantial topical blood loss is anticipated, particularly in case of (larger) SSGs and burn debridement

Parametric Investigations of the Induced Shear Stress by a Laser-Generated Bubble

The present paper focuses on the simulation of the growth and collapse of a bubble in the vicinity of a wall. Both liquid and gas phases are assumed compressible, and their interaction is handled with the volume-of-fluid method. The main interest is to quantify the influence of the induced shear stress and pressure pulse in the vicinity of the wall for a variety of bubble sizes and bubble–wall distances. The results are validated against prior experimental results, such as the measurements of the bubble size, induced pressure field, and shear stress on the wall. The simulation predictions indicate that the wall in the vicinity of the bubble is subjected both to high shear stresses and large pressure pulses because of the growth and collapse of the bubble. In fact, pressure levels of 100 bar or more and shear stresses up to 25 kPa have been found at localized spots on the wall surface, at the region around the bubble. Moreover, the simulations are capable of providing additional insight to the experimental investigation, as the inherent limitations of the latter are avoided. The present work may be considered as a preliminary investigation in optimizing bubble energy and wall generation distance for ultrasound cleaning applications

Manual versus automatic bladder wall thickness measurements: a method comparison study

Purpose To compare repeatability and agreement of conventional ultrasound bladder wall thickness (BWT) measurements with automatically obtained BWT measurements by the BVM 6500 device. Methods Adult patients with lower urinary tract symptoms, urinary incontinence, or postvoid residual urine were urodynamically assessed. During two subsequent cystometry sessions the infusion pump was temporarily stopped at 150 and 250 ml bladder filling to measure BWT with conventional ultrasound and the BVM 6500 device. For each method and each bladder filling, repeatability and variation was assessed by the method of Bland and Altman. Results Fifty unselected patients (30 men, 20 women) aged 21–86 years (median 62.5 years) were prospectively evaluated. Invalid BWT measurements were encountered in 2.1–14% of patients when using the BVM 6500 versus 0% with conventional ultrasound (significant only during the second measurement at 150 ml bladder filling). Mean difference in BWT values between the measurements of one technique was -0.1 to +0.01 mm. Measurement variation between replicate measurements was smaller for conventional ultrasound and the smallest for 250 ml bladder filling. Mean difference between the two techniques was 0.11–0.23 mm and did not differ significantly. The BVM 6500 device was not able to correctly measure BWTs above 4 mm. Conclusions Both BWT measurements are repeatable and agree with each other. However, conventional ultrasound measurements have a smaller measurement variance, can measure BWT in all patients, and BWTs above 4 mm

A tool to balance benefit and harm when deciding about adjuvant therapy

Adjuvant therapy aims to prevent outgrowth of residual disease but can induce serious side effects. Weighing conflicting treatment effects and communicating this information with patients is not elementary. This study presents a scheme balancing benefit and harm of adjuvant therapy vs no adjuvant therapy. It is illustrated by the available evidence on adjuvant pelvic external beam radiotherapy (RT) for intermediate-risk stage I endometrial carcinoma patients. The scheme comprises five outcome possibilities of adjuvant therapy: patients who benefit from adjuvant therapy (some at the cost of complications) vs those who neither benefit nor contract complications, those who do not benefit but contract severe complications, or those who die. Using absolute risk differences, a fictive cohort of 1000 patients receiving adjuvant RT is categorised. Three large randomised clinical trials were included. Recurrences will be prevented by adjuvant RT in 60 patients, a majority of 908 patients will neither benefit nor suffer severe radiation-induced harm but 28 patients will suffer severe complications due to adjuvant RT and an expected four patients will die. This scheme readily summarises the different possible treatment outcomes and can be of practical value for clinicians and patients in decision making about adjuvant therapies

Normohomocysteinaemia and vitamin-treated hyperhomocysteinaemia are associated with similiar risks of cardiovascular events in patients with premature peripheral arterial occlusive disease. A prospective cohort study

Objectives. Mild hyperhomocysteinaemia (HHC), fasting or after methionine loading, is associated with an increased risk and severity of atherosclerotic vascular disease. Post-methionine and fasting HHC are responsive to treatment with vitamin