Oral session 2: Diabetic foot infection O2.1 Predictors of lower-extremity amputation in patients with an infected diabetic foot ulcer Kristy Pickwell, University Hospital Maastricht, Maastricht, Netherlands Volkert Siersma, The Research Unit for General Practice and Section of General Practice, Copenhagen, Denmark Marleen Kars, University Hospital Maastricht, Maastricht, Netherlands Eurodiale Consortium, University Hospital Maastricht, Maastricht, Netherlands Nicolaas Schaper, University Hospital Maastricht, Maastricht, Netherlands Aim: Infection commonly complicates diabetic foot ulcers and is associated with a poor outcome. In a cohort of individuals with an infected diabetic foot ulcer we aimed to determine independent predictors of lower-extremity amputation, the predictive value for amputation of the International Working Group on the Diabetic Foot (IWGDF) classification system and, to develop a risk score for predicting amputation. Methods: We prospectively studied 575 patients with an infected diabetic foot ulcer presenting to one of 14 diabetic foot clinics in 10 European countries. Results:, Among these patients 159 (28%) underwent an amputation. Independent risk factors for amputation were: periwound edema, foul smell, (non)-purulent exudate, deep ulcer, positive probing to bone test, pretibial edema, fever, and elevated CRP-levels. Increasing IWGDF severity of infection also independently predicted amputation. We developed a risk score for any amputation and for amputations excluding the lesser toes (including the variables sex, pain on palpation, periwound edema, ulcer size, ulcer depth and PAD) that predicted amputation better than the IWGDF system (area under the ROC-curves 0.80, 0.78 and 0.67, respectively). Conclusions: In individuals with an infected diabetic foot ulcer we identified independent predictors of amputation, validated the prognostic value of the IWGDF classification system and developed a new risk score for amputation that can be readily used in daily clinical practice. Our risk score may have better prognostic accuracy than the IWGDF system, the only currently available system, but our findings need to be validated in other cohorts. www.diabeticfoot.nl Page 1 of 5 O2.2 Percutaneous isolated limb perfusion versus intravenous antibiotics for management of infected diabetic foot ulcers Paul Wraight, The Royal Melbourne Hospital, Melbourne, Australia Steve Christov, The Royal Melbourne Hospital, Melbourne, Australia McCann Jane, The Royal Melbourne Hospital, Melbourne, Australia Melissa Byrne, 2Baker IDI Heart and Diabetes Institute, Melbourne, Australia Rick Dowling, The Royal Melbourne Hospital, Melbourne, Australia Peter Mitchell, The Royal Melbourne Hospital, Melbourne, Australia David Kaye, 2Baker IDI Heart and Diabetes Institute, Melbourne, Australia Aim: A first in human study of five individuals suggested that antibiotics administered by percutaneous isolated limb perfusion (PILP) was safe and demonstrated significant reductions in quantitative bacterial levels within 6 hours. This study compares antibiotic concentrations in subjects with diabetes and lower limb infection, randomised to receive ticarcillin/clavulanic acid (Timentin) delivered by PILP procedure or via intravenous delivery alone. Methods: Twenty individuals with a significant diabetes-related foot infection are to be recruited. Individuals will be randomised 1:1 to receive Timentin either as a single 30 minute episode of PILP in addition to standard intravenous Timentin or intravenous Timentin alone. Individuals undergoing PILP will have an antegrade femoral artery catheter, retrograde Venous Recovery Catheter and Venous Support Device inserted under local anaesthetic. The catheters will be connected with an oxygenator, heater and cardiac perfusion pump to create a lower limb circuit, with a proximal external tourniquet to isolate the limb circulation., Biochemistry, antibiotic levels and microbiology samples will be collected. Results: Fifteen (of the planned 20) individuals have been recruited; 6 PILP, 7 Control and 2 withdrawals., All were male with Type 2 diabetes and mean age 63 years. No alteration in vital signs or biochemical parameters from the limb or systemic circulation were recorded during the 28 day follow-up. Ticarcillin concentrations in the limb circulation were on average 2.3 fold greater in the PILP group vs. control group at 15mins into antibiotic delivery (142.21 vs 61.02mcg/ml). At 1 hour post antibiotic infusion, Ticarcillin concentrations were 8.1 fold greater in the control group vs PILP group (86.37 vs 10.63mcg/ml) despite both groups receiving the same total dose of Timentin. Conclusions: The results of this randomised study suggest that the early high peak in antibiotic concentration in the lower limb circulation with PILP is likely to be contributing to higher tissue absorption, thus explaining the lower systemic concentrations 1 hour after antibiotic infusion., The antibiotic results however need to be correlated with the clinical and microbiological results in order to assess the full benefit of PILP. www.diabeticfoot.nl Page 2 of 5 O2.3 Negative pressure with instillation in the management of severely infected diabetic foot ulceration Chiara Goretti, University of Pisa, Pisa, Italy Alberto Coppelli, University of Pisa, Pisa, Italy Carlo Tascini, University of Pisa, Pisa, Italy Elisabetta Iacopi, University of Pisa, Pisa, Italy Alberto Piaggesi, University of Pisa, Pisa, Italy Aim: To evaluate the safety and effectiveness of Negative Pressure Wound Therapy with Instillation (i-NPWT), in the management of the severely infected ulceration of the diabetic foot (DF) Method: A group of consecutive type 2 diabetic inpatients with acutely infected ulceration (Group A - N. 22; age 68.4±12.1 yrs, duration of diabetes 21.7±12.3 yrs, HbA1c 8.8±2.1%, BMI 28.6±2.9 kg/m2), was treated with i-NPWT on top of standard treatment consisting in surgical debridement, revascularization if needed, offloading and systemic antibiotic, while admitted. Instillation of a polyhexanide solution was delivered for 15' every three hours on a continuous NPWT application scheme. Patients, compared with a matched control group with the same clinical characteristics treated with NPWT without instillation (Group B), were followed up for 6 months to evaluate Healing Rate (HR), Healing Time (HT), Negativization of Coltural Exams (NCE), Duration of Antibiotic Therapy (DAT) and adverse events. Results: HR was of 91% in Group A and 85% in Group B (n.s.); HT in Group A was 68.5±18.4days vs 97.4±29.1 days in Group B (p<0.05)., NCE during he observation period was reached in 95% of Group A patients vs 45% in Group B (p<0.01), DAT was 12.4±5.9 days in Group A vs 28.9±11.6 days in Group B, respevctively. No difference in adverse events, was observed throughout the study period between the two groups. Conclusion: On top of standard treatment ì-NPWT proved to be as safe and more effective than NPWT, in the management of the infected lesions of the diabetic foot. www.diabeticfoot.nl Page 3 of 5 O2.4 Biofilm in diabetic patients with foot infection Barcin Ozturk, University of Adnan Menderes School of Medicine, Aydin, Turkey Bulent Ertugrul, University of Adnan Menderes School of Medicine, Aydin, Turkey Esra Corekli, University of Adnan Menderes School of Medicine, Aydin, Turkey Background: Chronic wounds remain open for a long time, thus increase the possibility of bacterial infection. Polymicrobial, infections, predominate among causes of severe diabetic foot infections. The existence of biofilms in acute partial-thickness and chronic wounds has been documented. Methods: A total of one Turkish medical centre was included in this prospective study conducted from 2013 to 2014. The data on enrolled subjects were recorded in patient followup forms. On admission, specimens for culture were obtained following cleansing and the debridement of the wound by swabbing the ulcer base, curettage, needle aspiration or biopsy, depending on the wound depth. Biofilm, production, was assessed by the method of O’Toole and Kolter. Biofilms formed in 96-well microtitre plates. For biofilm growth, the Tryptic Soy Broth (TSB), medium with 0.25 % glucose was used. Slime formation at 48 hours was evaluated with crystal violet, using a spectrophotometer at a wavelength of 595 nm . Wells with optical density ≥ 1 000 were considered as slime positive. Results: We included a total of 48 diabetic foot infections from 37 patients., A total of 59 causative bacteria were isolated from soft and/or bone tissue samples. Fourty seven (80%) of 59 isolates produced biofilm. The most frequently isolated species was Meticillin resistant CoN Staphylococcus, (n=13, 22%)., Comments: An important obstacle during the healing of chronic wounds is that the formation of biofilm by the growing, infective organisms. There are very few studies indicating the presence of a biofilm in the diabetic foot ulcers. Our study showed that biofilm formation rates in diabetic foot infections are very high. Managing the biofilm in chronic wounds effectively is an important component of wound healing therapy., Treatment methods like debritment and use of quorum sensing inhibitors (QSI) which provide biofilm elimination, might be able to eliminate the infecting bacteria and recreate a normal healing process www.diabeticfoot.nl Page 4 of 5 O2.5 KPC-producing Klebsiella pneumoniae rectal colonization is a risk factor for mortality in patients with diabetic foot infections Carlo Tascini, U.O.Malattie Infettive - Azienda Ospedaliera Universitaria Pisana, Pisa, Italy Elisabetta Iacopi, University of Pisa, Pisa, Italy Alberto Coppelli, University of Pisa, Pisa, Italy Chiara Goretti, University of Pisa, Pisa, Italy Alberto Piaggesi, University of Pisa, Pisa, Italy Aim: The incidence of infection with strains of Klebsiella pneumoniae-producing carbapenemases (KPC-Kp) has been increasing worldwide. To identify if KPC-Kp colonization and infection in diabetic patients with foot infection (DFI) is associated with increased mortality we conducted a retrospective, matched case-control study. Methods: Cases consisted of adult inpatients with a DFI who had a documented isolation of a KPC-Kp strain from a rectal swab. For each case we selected at least one matched control with no KPC-Kp-positive cultures on a rectal swab. Results: Between 1 December 2010 and 31 March 2014 we identified 21 patients with DFI with rectal colonization by KPC-Kp. In 6/21 (28%) of these patients KPC-Kp was also isolated from the diabetic foot wound. Comparing the 21 patients colonized with KPC-Kp with the 25 controls, matched by time period, we found the groups were not significantly different with regard to their mean age, gender, Charlson score, University of Texas score, number of negative outcomes or number of previous admissions. Compared to patients in the control group, who had an overall mortality of 4%, mortality was significantly higher in patients with rectal colonization by KPC-Kp (40%, p= 0.013) and in KPC-Kp DFI patients (67%; p= 0.002). Using multivariate logistic regression analysis we found that colonization with KPC-Kp was the only independent risk factor significantly associated with mortality (OR=22.41, 95%CI: 3.43 – 455.28, p= 0.006). Conclusion: Colonization and foot infection with KPC-Kp is associated with a significant, increased mortality in DF patients. www.diabeticfoot.nl Page 5 of 5
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