A desiccation compound as a biofilm- and necrosis-removing agent: a case series.

OBJECTIVE: A new compound, Debrichem (DEBx Medical BV, the Netherlands), a topical desiccation agent (TDA), is an active gel that contains an acidic species with a potent hygroscopic action. When in contact with microorganisms and necrosis, rapid desiccation and carbonisation of the proteins in these microorganisms, as well as of the extracellular matrix of biofilms and necrosis, occurs. The resulting 'precipitate' rapidly dislodges from the wound bed, resulting in a clean wound which granulates, which is a prerequisite for healing by secondary intention. METHOD: In a retrospective study, a series of mostly large and hard-to-heal lesions of different aetiologies were treated with a one-time application of the TDA, followed by weekly dressing changes. RESULTS: Of the total of 54 lesions included in this case series, 22 were diagnosed as venous leg ulcers (VLUs), 20 as diabetic foot ulcers (DFUs), nine as post-traumatic, hard-to-heal lesions, two as vascular ulcers and one as an ischaemic ulcer. All of the VLUs, 75% of the DFUs and all of the other lesions reached complete granulation. CONCLUSION: The use of a TDA may contribute to the consistent, fast and easy removal of both biofilms and necrosis, and hence to wound healing.

Real-World Treatment of Complicated Skin and Soft Tissue Infections with Daptomycin: Results from a Large European Registry (EU-CORE).

INTRODUCTION: The objective of this analysis was to describe in real-life settings the clinical outcomes and safety associated with daptomycin treatment in a cohort of patients with complicated skin and soft tissues infection (cSSTI). METHODS: All patients with cSSTI who had received at least one dose of daptomycin between January 2006 and April 2012 were identified from a non-interventional, multicenter, retrospective registry (European Cubicin(®) Outcome Registry and Experience; EU-CORE(SM)). RESULTS: Of the 6075 patients included in the EU-CORE registry, 1927 (31.7%) were diagnosed with cSSTI (male, 63.8%; median age, 63 years). The most frequent underlying diseases were cardiovascular disease (58.1%) and diabetes mellitus (40.7%). The most frequent cSSTIs included surgical site infections (34.9%), wound infections (20.2%) and diabetic foot infections (19.9%). The most frequently prescribed doses of daptomycin were 4 mg/kg/day (38.9%) and 6 mg/kg/day (35.2%). A total of 1126 (58.4%) patients received antibiotics prior to daptomycin treatment; treatment failure (53.7%) was the most common reason for switching to daptomycin. The majority of hospitalized patients (61.8%) were treated with concomitant antibiotics. Among patients with positive cultures, Staphylococcus aureus (51.9%; 673/1297) was the most common pathogen. The overall clinical success rate was 84.6%; for infections caused by S. aureus, the success rate was 87.2% (methicillin susceptible, 87.8%; methicillin resistant, 87.0%). Adverse events possibly related to daptomycin treatment were reported in 2.4% of patients and adverse events led to drug discontinuation in 2.4% of patients. CONCLUSION: Daptomycin treatment resulted in high clinical success rates in patients with different cSSTI subtypes, the majority of whom having failed previous antibiotic therapy. Daptomycin was well tolerated and there were no new or unexpected safety findings.

Daptomycin for methicillin-resistant Staphylococcus aureus diabetic foot infections.

BACKGROUND: Diabetic foot infection (DFI) is a serious, difficult-to-treat infection, especially when caused by methicillin-resistant Staphylococcus aureus (MRSA). Vancomycin has been the standard treatment for MRSA infection, but lower response rates in MRSA skin infections have been reported. This analysis assessed the outcome and safety of daptomycin therapy in patients with a DFI caused by MRSA. METHODS: Using the Cubicin Outcomes Registry and Experience and the European Cubicin Outcomes Registry and Experience (2006-2009), 79 patients with MRSA DFI were identified and included in this analysis. RESULTS: In the 74 evaluable patients, daptomycin was administered at a median dose of 4.8 mg/kg primarily every 24 hours (85.1%) and for a median of 15.0 days. Overall, 77.0% of the patients (57 of 74) received initial therapy with activity against MRSA; however, of patients receiving daptomycin as second-line therapy (n = 31), only 45.2% were treated with an antibiotic agent active against MRSA. The overall clinical success and treatment failure rates were 89.2% and 10.8%, respectively. Success with daptomycin therapy was higher in patients who had surgery and in those whose initial therapy was daptomycin. Eleven patients had 14 adverse events, two of which were possibly related to daptomycin use and led to discontinuation. CONCLUSIONS: In a large real-world cohort of patients with MRSA DFI, daptomycin therapy was shown to be generally well tolerated and effective. The use of an anti-MRSA antibiotic agent should be considered when implementing first-line antibiotic drug therapy for DFI in countries where MRSA is common to avoid inappropriate empirical treatment and potential negative effects on outcomes.

Clinical experience with daptomycin in Italy: results from a registry study of the treatment of Gram-positive infections between 2006 and 2009.

The purpose of this study was to evaluate post-marketing efficacy and safety data for therapy with daptomycin (DAP) in Italy. Data from patients treated with DAP at 30 centres between January 2006 and July 2009 were analysed according to the protocol of the EU-CORE(SM). In 359 patients, DAP was most commonly prescribed for skin and skin-structure infections (55%), infective endocarditis (13%), and bacteraemia (12.5%). DAP was associated with rapid improvement, and clinical success rates ranging from 77 to 91%, despite almost half of the patient population being ≥65 years of age, 86% having significant underlying disease, and many being affected by drug-resistant pathogens. Staphylococcus aureus represented 35% of all pathogens isolated. Success rates for all staphylococcal and enterococcal infections were >80%, including methicillin-resistant S. aureus (MRSA) and methicillin-susceptible S. aureus (MSSA). Clinical outcomes were similar for DAP whether used as first- or second-line therapy. DAP was well tolerated even with prolonged treatment.

Serial 2-point ultrasonography plus D-dimer vs whole-leg color-coded Doppler ultrasonography for diagnosing suspected symptomatic deep vein thrombosis: a randomized controlled trial.

CONTEXT: Patients with suspected deep vein thrombosis (DVT) of the lower extremities are usually investigated with ultrasonography either by the proximal veins (2-point ultrasonography) or the entire deep vein system (whole-leg ultrasonography). The latter approach is thought to be better based on its ability to detect isolated calf vein thrombosis; however, it requires skilled operators and is mainly available only during working hours. No randomized comparisons are yet available evaluating the relative values of these 2 strategies. OBJECTIVE: To assess if the 2 diagnostic strategies are equivalent for the management of symptomatic outpatients with suspected DVT of the lower extremities. DESIGN, SETTING, AND PATIENTS: A prospective, randomized, multicenter study of consecutive symptomatic outpatients (n = 2465) with a first episode of suspected DVT of the lower extremities who were randomized to undergo 2-point or whole-leg ultrasonography. Data were taken from ultrasound laboratories of 14 Italian universities or civic hospitals between January 1, 2003, and December 21, 2006. Patients with normal ultrasound findings were followed up for 3 months, with study completion on March 20, 2007. MAIN OUTCOME MEASURE: Objectively confirmed 3-month incidence of symptomatic venous thromboembolism in patients with an initially normal diagnostic workup. RESULTS: Of 2465 eligible patients, 345 met 1 or more exclusion criteria and 22 refused to participate; therefore, 2098 patients were randomized to either 2-point (n = 1045) or whole-leg (n = 1053) ultrasonography. Symptomatic venous thromboembolism occurred in 7 of 801 patients (incidence, 0.9%; 95% confidence interval [CI], 0.3%-1.8%) in the 2-point strategy group and in 9 of 763 patients (incidence, 1.2%; 95% CI, 0.5%-2.2%) in the whole-leg strategy group. This met the established equivalence criterion (observed difference, 0.3%;95% CI, -1.4% to 0.8%). CONCLUSION: The 2 diagnostic strategies are equivalent when used for the management of symptomatic outpatients with suspected DVT of the lower extremities. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00353093.

Infective endocarditis due to Capnocytophaga canimorsus.

We report the case of a 41-year-old woman with severe mitral regurgitation due to infective endocarditis caused by a rare zoonotic microorganism (Capnocytophaga canimorsus). She had had a rheumatic mitral endocarditis successfully treated with antibiotics when she was 13 years old. She arrived to our attention for a fever of unknown origin. She had been bitten by her dog and medicated the wound herself. About 2 weeks later she developed a fever with values up to 39.5 degrees C. Blood cultures were initially negative but in view of her particular history (dog bite), the samples were sent to a specialized center where a Capnocytophaga canimorsus (a commensal bacterium contained in the saliva of dogs and cats) infection sensitive to ceftriaxone was detected. The antibiotic therapy was consequently modified and the patient's fever resolved. At echocardiography a mild mitral stenosis with severe regurgitation (3-4+/4+) was detected. We planned surgical mitral repair but the operative findings clearly showed the need for mitral replacement and a 29 mm size bileaflet mechanical prosthesis was implanted. The postoperative course was regular and the patient was discharged on the fifth day. We highlight the importance of a careful history and correct work-up for the diagnosis and treatment of false negative blood culture endocarditis.

Using hyaluronic acid derivatives and cultured autologous fibroblasts and keratinocytes in a lower limb wound in a patient with diabetes: a case report.

Patients with diabetes have an impaired wound healing process that contributes to the pathophysiology that may lead to amputation. In this case study, an extensive (103.49 cm2) full-thickness cutaneous wound with exposure of a necrotic Achilles' tendon in a patient with diabetes, neuropathy, and infrapopliteal vascular disease of the lower limbs was healed using a two-stage autologous skin substitute technique. The scaffolds on which the autologous fibroblasts and keratinocytes were grown comprised an ester derivative of hyaluronic acid. Two applications of the cultured autologous fibroblasts and one of the cultured autologous keratinocytes were placed on the wound at 7-day intervals. The ulcer healed completely 60 days following the first fibroblast graft application. After 16 months of follow-up, no recurrence was noted and the patient can walk without ancillary support. This novel tissue engineering technique is a promising treatment for wound healing.