Cluster-randomized crossover trial of chlorhexidine-alcohol versus iodine-alcohol for prevention of surgical-site infection (SKINFECT trial).

Background: Surgical-site infection (SSI) is a serious surgical complication that can be prevented by preoperative skin disinfection. In Western European countries, preoperative disinfection is commonly performed with either chlorhexidine or iodine in an alcohol-based solution. This study aimed to investigate whether there is superiority of chlorhexidine-alcohol over iodine-alcohol for preventing SSI. Methods: This prospective cluster-randomized crossover trial was conducted in five teaching hospitals. All patients who underwent breast, vascular, colorectal, gallbladder or orthopaedic surgery between July 2013 and June 2015 were included. SSI data were reported routinely to the Dutch National Nosocomial Surveillance Network (PREZIES). Participating hospitals were assigned randomly to perform preoperative skin disinfection using either chlorhexidine-alcohol (0·5 per cent/70 per cent) or iodine-alcohol (1 per cent/70 per cent) for the first 3 months of the study; every 3 months thereafter, they switched to using the other antiseptic agent, for a total of 2 years. The primary endpoint was the development of SSI. Results: A total of 3665 patients were included; 1835 and 1830 of these patients received preoperative skin disinfection with chlorhexidine-alcohol or iodine-alcohol respectively. The overall incidence of SSI was 3·8 per cent among patients in the chlorhexidine-alcohol group and 4·0 per cent among those in the iodine-alcohol group (odds ratio 0·96, 95 per cent c.i. 0·69 to 1·35). Conclusion: Preoperative skin disinfection with chlorhexidine-alcohol is similar to that for iodine-alcohol with respect to reducing the risk of developing an SSI.

Antecedentes: La infección del sitio quirúrgico (surgical site infection, SSI) es una complicación quirúrgica grave que se puede prevenir mediante una desinfección cutánea preoperatoria. En los países de Europa occidental, la desinfección preoperatoria se realiza habitualmente usando clorhexidina o yodo en una solución a base de alcohol. Nuestro objetivo fue investigar si la clorhexidina alcohólica es superior al yodo con alcohol para prevenir la SSI. Métodos: Este ensayo prospectivo aleatorizado por conglomerados y de grupos cruzados se realizó en cinco hospitales docentes. Se incluyeron todos los pacientes que se sometieron a cirugía mamaria, vascular, colorrectal, biliar y ortopédica entre julio de 2013 y junio de 2015. Los datos de SSI se presentaron de manera rutinaria a la Red Nacional Holandesa de Vigilancia Nosocomial (PREZIES). Los hospitales participantes fueron asignados al azar para realizar una desinfección cutánea preoperatoria con clorhexidina alcohólica (0,5%/70%) o yodo con alcohol (1%/70%) durante los primeros tres meses del estudio; cada 3 meses a partir de entonces, cambiaron a usar el otro agente antiséptico, durante un total de 2 años. El criterio de valoración principal fue el desarrollo de SSI. Resultados: Se incluyeron un total de 3.665 pacientes; 1.835 y 1.830 de estos pacientes recibieron desinfección cutánea preoperatoria con clorhexidina alcohólica o yodo con alcohol, respectivamente. La incidencia global de SSI fue del 3,8% entre los pacientes en el grupo de clorhexidina alcohólica y del 4,0% entre los pacientes en el grupo de yodo con alcohol (razón de oportunidades, odds ratio, OR 0,96; i.c. del 95%: 0,69­1,35). Conclusión: La desinfección cutánea preoperatoria con clorhexidina alcohólica es similar al yodo con alcohol con respecto a la reducción del riesgo de desarrollar una SSI.

Thromboembolic complications after Zenith® Low Profile Endovascular Graft for infrarenal abdominal aneurysms.

PURPOSE: The purpose of this study was to objectify and evaluate risk factors for thromboembolic complications after treatment with a Zenith(®) Low Profile Endovascular Graft (Zenith LP). Results were compared with those in the recent literature on endovascular aortic repair (EVAR) and with the thromboembolic complications in the patient group treated with a Zenith Flex Endovascular Graft in our institute in the period before the use of the Zenith LP. MATERIALS AND METHODS: All consecutive patients who were suitable for treatment with a Zenith LP endograft between October 2010 and December 2011 were included. The preprocedural computed tomography scan (CT), procedural angiographic images, and the postprocedural CT scans were evaluated for risk factors for and signs of thromboembolic complications. All patients treated between December 2007 and November 2012 with a Zenith Flex endograft were retrospectively evaluated for thromboembolic complications. RESULTS: In the study period 17 patients were treated with a LP Zenith endograft. Limb occlusion occurred in 35 % of the patients. Limb occlusions occurred in 24 % of the limbs at risk (one limb occluded twice). In one patient two risk factors for limb occlusion were identified. Between December 2007 and November 2012, a total of 43 patients were treated with a Zenith Flex endograft. No limb occlusion or distal embolization occurred. CONCLUSION: Despite that this was a small retrospective study, the Zenith LP endograft seems to be associated with more frequent thromboembolic complications compared with the known limb occlusion rates in the literature and those of the patients treated with a Zenith Flex endograft in our institute.

[Embolisation in spontaneous haemopneumothorax]. / Embolisatie bij een spontane hematopneumothorax.

BACKGROUND: Spontaneous haemopneumothorax is a rare disorder and is defined as spontaneous pneumothorax associated with the accumulation of more than 400 ml of blood in the pleural cavity. CASE DESCRIPTION: A 32-year-old male presented at the emergency department following sudden onset of right-sided stinging chest pain and difficulty in breathing. The chest X-ray showed right-sided hydropneumothorax. A tube thoracostomy was performed, which immediately drained 1500 ml of sanguinolent fluid. The first CT-scan showed no active bleeding. Several hours later the patient became haemodynamically unstable and an additional CT-angiogram was performed. This revealed an extravasation in the area of the second posterior intercostal artery, which was successfully embolised subsequently. This resulted in a haemodynamically stable patient, allowing elective video-assisted thoracic surgery. CONCLUSION: Spontaneous haemopneumothorax is a life-threatening disorder. After initial drainage video-assisted thoracic surgery is to be preferred to conservative treatment or thoracotomy. However, it is necessary for the patient to be haemodynamically stable. In this case intervention radiology contributed to a minimally invasive approach. This therefore also merits consideration as a therapeutic option.

[Diagnostic policy in patients with a suspected ruptured abdominal aortic aneurysm]. / Diagnostisch beleid bij klinische aanwijzingen voor een geruptureerd aneurysma van de aorta abdominalis.

The clinical diagnosis of a ruptured aortic aneurysm is unreliable, and in haemodynamically stable patients both ultrasound and CT are used to improve diagnostic accuracy. In any patient with a suspected ruptured aneurysm, ultrasound is done upon arrival of the patient in the hospital to confirm or exclude the presence of an aortic aneurysm. If facilities for endovascular reconstruction are available at the hospital, an immediate CT scan with intravenous contrast follows, to find out if and how endovascular treatment should be performed. If endovascular reconstruction is not available, a CT scan without using contrast is carried out. If the CT scan shows a ruptured aneurysm, the patient is transported to the Operating Department without further delay. If the CT scan does not show any signs of rupture, there is time for further investigation. If no alternative condition to explain the patient's symptoms is found, further diagnostic tests such as repeat ultrasound, CT with contrast material and laboratory tests can be performed. If no other serious condition emerges, the aortic aneurysm should be considered symptomatic. In this case, the patient should undergo a rapid, but thorough pre-operative work-up, and go for operation as soon as possible by a rested and experienced operating team as part of the regular day programme.

[Acute abdominal and back pain in a patient with an aortic aneurysm and a duodenum perforation on CT-scan]. / Acute buik- en rugpijn bij een aneurysma van de aorta, en een duodenumperforatie op de CT-scan.

An 82-year old man with a known aneurysm of the abdominal aorta (AAA) presented with a history of acute onset abdominal and back pain of a few hours. He was haemodynamically stable and had pain on pressure over the aneurysm. Ultrasound confirmed the AAA, but could not demonstrate or exclude rupture. Subsequent CT-scan confirmed a non-ruptured AAA and demonstrated a small, curvilinear, hyperdense structure thought to be a fish bone or chicken bone which had perforated the duodenum. On gastroduodenoscopy, a fish bone was found and removed. The patient's symptoms resolved completely within two days. In patients with a possible ruptured AAA, echographic or CT-scan investigations can confirm or exclude the condition thus avoiding unnecessary surgery. These investigations also gather preoperative data for potential endovascular reconstruction. Before the introduction of new visualization techniques a duodenum perforation resulting from the unnoticed swallowing of a sharp object could only be diagnosed by explorative laparotomy. Delay in diagnosis leads to high mortality.

[Epiploic appendagitis: an underestimated self-limiting acute abdominal condition]. / Appendagitis epiploica: een onderbelichte zelflimiterende acute buikaandoening.

OBJECTIVE: To describe the clinical findings in patients with epiploic appendagitis and to evaluate its natural course. DESIGN: Retrospective. METHOD: A review of the medical records was carried out for all patients who were diagnosed with epiploic appendagitis using ultrasonography and computed tomography (CT), during the period June 1988-October 2001, at the Haaglanden Medical Centre (Westeinde site), The Hague, the Netherlands. RESULTS: The study group consisted of 49 patients, 38 men and 11 women, with a median age of 41 years. The main symptom was focal abdominal pain, with a median diagnostic delay in the patients of 2 days, located in the left lower quadrant (n = 34), right lower quadrant (n = 8), right upper quadrant (n = 6) or left upper quadrant (n = 1) of the abdomen. No other complaints were present with the exception of nausea and vomiting in two patients. Leucocytosis was found in 21% of patients, the erythrocyte sedimentation rate was elevated in 26% of the patients, and signs of peritoneal irritation were found in 53% of the patients. Epiploic appendagitis was correctly included in the clinical differential diagnosis of 2 patients. All of the patients made a complete and uncomplicated recovery under conservative treatment; the majority were symptom-free within 9 days. CONCLUSION: Due to the increased use of diagnostic imaging in patients with acute abdominal symptoms, epiploic appendagitis is much more frequently diagnosed than before. Presenting symptoms of epiploic appendagitis are non-specific, leading to misdiagnosis in most cases. Epiploic appendagitis has a benign natural course and if patients are correctly diagnosed using ultrasonography and CT, unnecessary surgery and medical treatment may be avoided.

[Primary venous mesenterial thrombosis in three patients]. / Primaire veneuze mesenteriale trombose bij 3 patiënten.

Three patients, a woman aged 72, a man aged 25 and a woman aged 42 years, presented at the casualty department with a subacute form of primary venous mesenterial thrombosis. As symptoms and laboratory findings are aspecific, CT scan is the gold standard for the diagnosis of this condition. In these patients no cause or predisposing factor was detected, so the disease was considered to be primary. Treatment generally consists of anticoagulant therapy and if peritonitis is present operation is indicated. Hyperdynamic circulation and inotropica are indicated after surgery and in cases of critical illness. Based on clinical findings the third patient was treated successfully with anticoagulants only. The other two also underwent partial small intestinal resection. All three patients were discharged in good health and were prescribed lifelong anticoagulants. If a cause of venous mesenterial thrombosis can be found, this must first be treated before deciding on whether lifelong treatment with anticoagulants is indicated.

Amaurosis fugax and stenosis of the ophthalmic artery--a case report.

Amaurosis fugax has many causes. Its most common cause is transient hypoperfusion of the eye, caused by thromboemboli from atherosclerotic carotid arteries. Thromboembolism from carotid arteries is a risk factor for cerebral infarction, and preventive endarterectomy could be performed. This report describes a patient with a rare ophthalmic artery stenosis, which was the probable origin of thromboemboli. This finding prevented surgical intervention.

The potential of simple clinical information and electrocardiogram to predict mortality of primary elective abdominal aortic reconstruction.

OBJECTIVE: To assess the importance of simple clinical information to predict mortality after primary elective aortic reconstruction. DESIGN: Retrospective clinical study. MATERIALS: Four hundred-three consecutive patients (206 with aortic occlusive disease (51%) and 197 with aneurysmal disease of the abdominal aorta (49%) who underwent primary elective aortic reconstruction during an 8 year study period. METHODS: Eight potential clinical risk variables and six electrocardiogram related risk variables were studied. The predictive value for postoperative mortality was evaluated univariately for all separate variables by calculation of the odds ratio (OR). Determination of the most predictive sets of risk factors was performed by stepwise logistic regression. RESULTS: Five clinical risk factors showed significant odds ratio's: > 70 years (OR: 4.1), aortic aneurysm (OR: 9.0), myocardial infarction (OR: 8.6), angina pectoris (OR: 4.6), congestive heart failure (OR: 8.1), all p < 0.01. Furthermore, four electrocardiogram related factors showed significant odds ratio's: infarction pattern (OR: 4.3, p = 0.003), ischaemic changes (OR: 6.2, p < 0.001), conductance disturbances (OR: 3.2, p = 0.04), and non-sinus rhythm (OR: 6.2, p = 0.003). Stepwise logistic regression analysis demonstrated that 3 clinical risk factors (aneurysm (OR: 6.1, p = 0.02), myocardial infarction (OR: 3.7, p = 0.01), and congestive heart failure (OR: 5.3, p = 0.006)) contributed significantly to mortality. Addition of any of the electrocardiogram risk factors did not contribute to the prediction of mortality in the presence of these factors. CONCLUSIONS: The patients' history and clinical examination provides the most useful information for further selection of additional cardiac tests before elective primary aortic reconstruction. The additional value of the electrodiogram is somewhat overestimated.

Perioperative mortality of elective abdominal aortic aneurysm surgery. A clinical prediction rule based on literature and individual patient data.

BACKGROUND: Abdominal aortic aneurysm surgery is a major vascular procedure with a considerable risk of (mainly cardiac) mortality. OBJECTIVE: To estimate elective perioperative mortality, we developed a clinical prediction rule based on several well-established risk factors: age, gender, a history of myocardial infarction, congestive heart failure, ischemia on the electrocardiogram, pulmonary impairment, and renal impairment. METHODS: Two sources of data were used: (1) individual patient data from 246 patients operated on at the University Hospital Leiden (the Netherlands) and (2) studies published in the literature between 1980 and 1994. The Leiden data were analyzed with univariate and multivariate logistic regression. Literature data were pooled with meta-analysis techniques. The clinical prediction rule was based on the pooled odds ratios from the literature, which were adapted by the regression results of the Leiden data. RESULTS: The strongest adverse risk factors in the literature were congestive heart failure and cardiac ischemia on the electrocardiogram, followed by renal impairment, history of myocardial infarction, pulmonary impairment, and female gender. The literature data further showed that a 10-year increase in age more than doubled surgical risk. In the Leiden data, most multivariate effects were smaller than the univariate effects, which is explained by the positive correlation between the risk factors. In the clinical prediction rule, cardiac, renal, and pulmonary comorbidity are the most important risk factors, while age per se has a moderate effect on mortality. CONCLUSIONS: A readily applicable clinical prediction rule can be based on the combination of literature data and individual patient data. The risk estimates may be useful for clinical decision making in individual patients.

The effects of aortic reconstruction and collagen impregnation of Dacron prostheses on the complement system.

Complement activation has been associated with numerous clinical hazards such as platelet aggregation, adult respiratory distress syndrome, and renal dysfunction. The complement system is activated by exposure of different biomaterials to blood. Recently a watertight knitted Dacron aortic prosthesis impregnated with bovine collagen has been developed. One potential disadvantage is that this bovine collagen may activate the complement system and evoke the production of inflammatory mediators. We conducted a prospective randomized trial to study the systemic effects of collagen-impregnated prostheses and of aortic surgery with implantation of Dacron prosthesis on the complement system in the perioperative period and at 3 months after operation. Forty-one patients randomly received either a collagen-impregnated (n = 20) or a nonimpregnated prosthesis (n = 21). Twelve patients who had cholecystectomy served as controls. CH50 consumption and C3a generation were determined to study overall complement activation. Furthermore, C3a/C3 fractions were calculated. Finally, C4 and factor B consumption were determined to evaluate the complement stimulation via the classic and the alternative pathways, respectively. We found significant activation of the complement system during the operation in both the collagen group (CH50 consumption: 40%, p = 0.03; C4 consumption: 74%, p < 0.0001; factor B consumption: 73%, p < 0.0001; C3a/C3 fraction increase: 173%,p = 0.04), and the nonimpregnated group (CH50 consumption: 40%, p < 0.0001; C4 consumption: 71%, p < 0.0001; factor B consumption: 76%, p < 0.0001; C3a/C3 fraction increase: 165%, p = 0.025), with no statistically significant differences between the groups of prostheses. Activation was initiated via both the classic and the alternative pathway. This indicates aortic implantation significantly activates the complement system, but that collagen-impregnated prostheses do not stimulate the complement system any more than its nonsealed substrate. Comparing results in patients with vascular disease with controls, a significantly increased complement activation was observed in the vascular group (CH50 consumption: 40%, p < 0.0001; C4 consumption: 74%, p < 0.0001; factor B consumption: 75%, p < 0.0001; C3a/C3 fraction: 169%, p = 0.002), compared with the controls (CH50 consumption: 71%; C4 consumption: 104%; factor B consumption: 94%; C3a/C3 fraction: 119%, all p = NS), with statistical significant differences between the vascular group and cholecystectomies (CH50: p = 0.005; C4: p = 0.002; factor B: p < 0.0001, and C3a/C3 fraction: NS). This observation demonstrates that aortic surgery with the implantation of a Dacron prosthesis significantly activates the complement system.

[Neurofibromatosis and a tumor of Vater's papilla]. / Neurofibromatosis en een tumor bij de papil van Vater.

A male aged 57 is reported with neurofibromatosis presenting with a tumour in the periampullary region. Pathologic examination revealed a neuroendocrine tumour of the carcinoid type. A review of the literature suggests that neurofibromatosis patients are at significant risk for developing a periampullary tumour which is nearly always of neuroectodermal origin. To date, surgical excision is the only curative therapy. Therefore, early diagnosis is of major importance. In all patients with neurofibromatosis presenting with jaundice, gastrointestinal bleeding or abdominal pain, a periampullary tumour should be considered. A review is presented of the latest developments concerning the DNA-based mutation causing this disorder. In family members, DNA linkage studies should be carried out, and they should be periodically screened, e.g. with gastroduodenoscopy.

Systemic effects of collagen-impregnated aortoiliac Dacron vascular prostheses on platelet activation and fibrin formation.

To minimize intraoperative blood loss a watertight knitted Dacron aortoiliac prosthesis has been developed by impregnation with bovine collagen. A potential disadvantage is that collagen may be associated with an increase in thrombus formation. We conducted a prospective randomized trial to study the systemic effects of collagen-impregnated prostheses and of aortoiliac operation as such on the coagulation mechanism during the first 10 days after operation. Forty-one patients randomly received either a collagen-impregnated (n = 20) or a nonimpregnated prosthesis (n = 21). Twelve patients who underwent cholecystectomies served as controls. Three markers of the coagulation mechanism were monitored: beta-thromboglobulin, fibrinopeptide A, and fibrin/fibrinogen degradation products. We found no significant differences in median beta-thromboglobulin, fibrinopeptide A, and fibrin/fibrinogen degradation product levels between patients in the collagen-impregnated prosthesis group and patients in the nonimpregnated prosthesis group. This indicates that collagen does not stimulate the coagulation cascade any more than conventional Dacron protheses do. In a comparison of patients who underwent aortoiliac reconstruction and patients who underwent cholecystectomies, the results indicated a significant increased platelet activation and fibrin metabolism in aortoiliac reconstruction group compared with the control group. Finally, we observed a significantly higher preoperative fibrin metabolism in patients with vascular disease than in control subjects. This difference is attributable to the high preoperative fibrin/fibrinogen degradation product values in patients with aortic aneurysms.

Randomized study on the effect of collagen impregnation of knitted Dacron velour aortoiliac prostheses on blood loss during aortic reconstruction.

Intraoperative blood loss is an important factor in reconstructive surgery for aortoiliac disease because it is clearly associated with an increase in the operative morbidity and mortality rates. To minimize intraoperative blood loss, a blood-tight vascular prosthesis has been developed by impregnating a knitted Dacron prosthesis with bovine collagen. To study a potential reduction of intraoperative blood loss using these collagen-impregnated prostheses, we conducted a prospective randomized trial involving the collagen-impregnated prosthesis and its non-impregnated substrate, the Dacron knitted non-impregnated prosthesis. During a 2.5-year period, 123 consecutive patients (undergoing 81 procedures for aneurysmal disease and 43 procedures for occlusive disease) were admitted for elective aortic reconstructive surgery. Equal numbers of the two prostheses were randomly implanted. Various parameters were monitored: intraoperative blood loss before aortic cross-clamping (phase 1), during implantation of the prosthesis (phase 2) and after release of aorta cross-clamping (phase 3); the number of intraoperative and postoperative blood transfusions; and, finally, all preoperative and intraoperative factors that might contribute to intraoperative blood loss. A significant overall difference in intraoperative blood loss between the collagen-impregnated (1907 ml) and the non-impregnated (2425 ml) group was found (P = 0.003) [corrected]. However, this difference could not be attributed to collagen impregnation because no statistically significant difference in blood loss was found in the relevant period of operation (phase 3). Similar results were observed in patients operated on for both aneurysmal and occlusive disease (2600 versus 2195 ml and 2105 versus 1344 ml respectively).