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Locally applied vancomycin is increasingly being used in primary hip and knee arthroplasty to reduce the risk of infection. Despite encouraging initial results, considerable debate remains on the basis of the data currently available. In particular, it has been unclear up to now whether local vancomycin is suitable to further reduce the risk of infection even if the rate of infection is already low (< 1%). In this monocentric retrospective cohort study, all primary total hip and knee arthroplasties performed between 2013 and 2018 were included. After a change in procedure at the hospital, 1 g vancomycin powder was applied intraarticularly before wound closure. The remaining perioperative procedure was constant over the investigation period. The follow-up was one year. The presence of an infection according to the currently valid MSIS criteria was defined as the endpoint. In patients with TKA two infections (0.3%) were observed under vancomycin prophylaxis in contrast to 44 infections (1.3%) in the control group ( p  = 0.033). In patients with THA two infections (0.5%) were observed under vancomycin prophylaxis and 48 infections (1.1%) in the control group without local vancomycin but this difference was statistically not significant. No wound complications requiring revision were observed as a result of the vancomycin. On the basis of the results of this study, intraarticular application of vancomycin powder in total hip and knee arthroplasty may be considered. Prospective randomized studies have to confirm this promising results prior a common recommendation. Level of Evidence III Retrospective cohort study.

Procedure-related cardiac electronic implantable device (CIED) infections have high morbidity and mortality, highlighting the urgent need for infection prevention efforts to include electrophysiology procedures. We developed and validated a semi-automated algorithm based on structured electronic health records data to reliably identify CIED infections. A sample of CIED procedures entered into the Veterans’ Health Administration Clinical Assessment Reporting and Tracking program from FY 2008–2015 was reviewed for the presence of CIED infection. This sample was then randomly divided into training (2/3) validation sets (1/3). The training set was used to develop a detection algorithm containing structured variables mapped from the clinical pathways of CIED infection. Performance of this algorithm was evaluated using the validation set. 2,107 unique CIED procedures from a cohort of 5,753 underwent manual review; 97 CIED infections (4.6%) were identified. Variables strongly associated with true infections included presence of a microbiology order, billing codes for surgical site infections and post-procedural antibiotic prescriptions. The combined algorithm to detect infection demonstrated high c-statistic (0.95; 95% confidence interval: 0.92–0.98), sensitivity (87.9%) and specificity (90.3%) in the validation data. Structured variables derived from clinical pathways can guide development of a semi-automated detection tool to surveil for CIED infection.

PurposeTo evaluate preoperative asymptomatic bacteriuria (ASB) treatment to reduce early-periprosthetic joint infections (early-PJIs) after hip hemiarthroplasty (HHA) for fracture.MethodsOpen-label, multicenter RCT comparing fosfomycin-trometamol versus no intervention with a parallel follow-up cohort without ASB. Primary outcome: early-PJI after HHA.ResultsFive hundred ninety-four patients enrolled (mean age 84.3); 152(25%) with ASB (77 treated with fosfomycin-trometamol/75 controls) and 442(75%) without. Despite the study closed without the intended sample size, ASB was not predictive of early-PJI (OR: 1.06 [95%CI: 0.33–3.38]), and its treatment did not modify early-PJI incidence (OR: 1.03 [95%CI: 0.15–7.10]).ConclusionsNeither preoperative ASB nor its treatment appears to be risk factors of early-PJI after HHA. ClinicalTrials.gov Identifier: Eudra CT 2016-001108-47

BackgroundThe avascular capsule around the generator of the cardiac implantable electronic device (CIED) could be susceptible to bacterial colonization and source of infection. Capsulectomy during CIED generator replacement may be beneficial in preventing device infection, but there is a lack of evidence.MethodsThis prospective randomized trial, conducted from December 2013 to December 2019, included 195 patients divided equally into two groups. In the intervention group (n = 97), capsule removal was performed on the floor of the pocket, while it was not performed in the control group (n = 98). In both groups, swab culture was performed in the pocket. The primary outcome was the occurrence of device infection requiring pocket revision.ResultsA total of 195 patients were included (mean age 70.2 ± 13.6 years, 55.4% women), with an average follow-up period of 54.3 ± 28.9 months. Among 182 patients undergoing microbiological cultures of pockets, 19 (10.4%) were confirmed positive, and Staphylococcus species were identified most frequently. The primary outcome occurred in 4 (2.1%), and there was no significant difference between the two groups (3.1% vs. 1.0%, p = 0.606). Hematoma has occurred in 10 patients (3.1% vs. 7.1%, p = 0.338), one of them required wound revision. In multivariable analysis, the occurrence of hematoma was the only independent risk factor associated with device infection (HR 13.6, 95% CI 1.02–181.15, p = 0.048).ConclusionsIn this long-term prospective study, capsulectomy during the replacement of the generator did not reduce the incidence of device infection. There was no association between bacterial colonization in the capsule around the generator and CIED infection.

Background Despite significant progress in orthopaedic surgery, the prevalence of periprosthetic joint infections (PJIs) remains persistent, and future increases are expected due to the increasing number of joint arthroplasties. PJIs are intricately connected to biofilm-producing bacteria, which encase infected prostheses, impairing the effectiveness of antibiotics and the immune system. Acute PJIs with immature biofilms are traditionally managed with debridement, antibiotics, and implant retention (DAIR). However, to date, there has not been a conclusive direct clinical comparison (in vivo) demonstrating the superiority of one irrigation solution over others. Recently, there has been a growing interest in irrigation solutions with antibiofilm properties demonstrated in in vitro studies, exemplified by the preformulated Bactisure® irrigation solution, which contains ethanol, acetic acid, sodium acetate, benzalkonium chloride, and sterile water. The main objective of this study was to evaluate the effectiveness (infection cure rate) of preformulated Bactisure® irrigation solution in vivo compared with saline solution in a control group of patients with acute knee and/or hip periprosthetic infections treated with DAIR. Methods Prospective single-centre randomized controlled trial involving patients with acute or haematogenous PJI who received standard DAIR surgery from December 2022 to December 2024. The type of irrigation solution used during surgery will include two groups allocated at a 1:1 ratio: a control group ( n  = 25) with saline solution and an experimental group ( n  = 25) receiving the Bactisure® preformulated solution. The sample size was calculated based on an expected reduction in reinfection rates from 45% in the control group to 10% in the experimental group. Data on baseline patient characteristics, clinical and radiological information, and healthcare questionnaires will be recorded. All patients will be followed for minimum of 12 months. The infection cure rate at 1 year will be the primary outcome. Discussion This study is the first to compare the effectiveness of preformulated Bactisure® irrigation solution with that of saline solution in real clinical practice (in vivo) in patients with acute knee and/or hip periprosthetic infections treated with DAIR. Our main hypothesis is that, compared with saline solution, Bactisure® provides a better infection cure rate at 1 year post-DAIR. Trial registration International Standard Randomized Controlled Trial Number (ISRCTN): https://doi.org/10.1186/ISRCTN10873696 . Registered on December 19, 2023.

Background Antibiotic-impregnated bone cement has increased in popularity as an effort to reduce the risk of infection in high-risk TKAs. However, limited data has been reported regarding antibiotic levels achieved when using tobramycin-impregnated bone cement after implanting total knee components. Questions/Purposes We asked: (1) What is the tobramycin serum and knee intraarticular levels in patients undergoing primary TKA using tobramycin cement? (2) What is the intraarticular tobramycin level for patients receiving only intravenous tobramycin? Methods All patients undergoing primary TKA by one of the two study surgeons (GV, JP) during a 6-month period were evaluated for inclusion and invited to participate. The study enrolled 15 patients undergoing primary TKA by one of two surgeons (GV, JP) who met inclusion criteria; treatment allocation was assigned randomly through blinded envelope. The study group consisted of 10 patients whose components were implanted using a commercially prepared low-dose tobramycin bone cement mixture (1 g/40 g). The control group consisted of five patients who received standard weight-based dose intravenous tobramycin. Samples of serum and Hemovac ® drain-collected intraarticular hematoma were analyzed at 6, 24, and 48 hours postoperatively. Tobramycin levels were measured using an immunoassay technique with a low-end sensitivity of 0.28 μg/mL. Mann-Whitney U tests were performed to compare the serum and intraarticular tobramycin concentrations at each time in the independent variable of group (Control and Study). Results The median (interquartile range [IQR]) intraarticular tobramycin concentrations for the study group, with tobramycin-impregnated bone cement, was 31.8 (29.0) μg/mL at 6 hours, 17.1 (13.1) μg/mL at 24 hours, and 6.8 (6.8) μg/mL at 48 hours. The intraarticular tobramycin concentrations of this study group were larger than those for the control group at 6 hours (median = 1.3; IQR = 0.7; p = 0.002), 24 hours (median = 1.3, IQR = 1.0; p = 0.002), and 48 hours (median = 1.4; IQR = 1.0; p = 0.02). The serum concentrations for the tobramycin-impregnated bone cement group were 0.3 μg/mL or less for all samples whereas serum concentrations and median (IQR) for the control group were 1.2 (2.6) μg/mL, 1.6 (4.4) μg/mL, and 2.0 (3.3) μg/mL at 6, 24, and 48 hours respectively. The serum levels for the tobramycin-impregnated cement group were less than those for the control group at 6 hours (p = 0.001), 24 (p = 0.001), and 48 hours (p < 0.001). Conclusions Tobramycin-impregnated bone cement provides a way to deliver antibiotics in patients undergoing TKA. This supratherapeutic short-term prophylactic perioperative antibiotic local delivery can be achieved with limited systemic absorption, whereas joint tobramycin levels were less than therapeutic levels when given intravenously alone. In the control group, with only intravenous tobramycin, a subtherapeutic (< 2.0 μg/mL) level of tobramycin was found in all the intraarticular samples at 6, 24, and 48 hours. Based on the evidence obtained in this study, commercially prepared low-dose tobramycin bone cement can be used to obtain short-term supratherapeutic local concentrations in the knee while maintaining serum tobramycin levels at a minimum. Level of Evidence Level II, therapeutic study.

Background There is a concern regarding the use of a closed-suction drain (CSD) in two-stage exchange arthroplasty for periprosthetic joint infection as it may decrease the antibiotic concentrations in the joint fluids. The purpose of this study was to identify whether the use of a CSD could reduce local antibiotic concentrations following spacer implantation. Methods A prospective, randomized, controlled trial was conducted at our institution between January 2018 and November 2018. We enrolled 32 patients undergoing two-stage exchange arthroplasty for periprosthetic hip infection with an interim cement spacer containing 4-g vancomycin and 2-g meropenem per 40-g methyl-methacrylate cement polymer. Patients were randomized and evenly divided into the study group (non-CSD) and control group (CSD group) by sealed envelopes. Drainage samples of joint fluids ( n  = 160) were collected every 24 h for the first five days following spacer implantation. The antibiotic concentrations of drainage samples were measured by high-performance liquid chromatography, and the bioactivities of the drainage samples against methicillin-sensitive and methicillin-resistant Staphylococcus aureus (MSSA and MRSA) and E. coli were assessed. Results There was no significant difference in the decrease of vancomycin (study group vs. control group: 163.20 ± 77.05 vs. 162.39 ± 36.31; p  = 0.917) and meropenem concentration (123.78 ± 21.04 vs. 117.27 ± 19.38; P  = 0.548) between the two groups during the first five days following spacer implantation. All joint drainage samples in each group exhibited antibacterial activity against MSSA, MRSA and E. coli . Conclusions The use of CSD following the implantation of an antibiotic-loaded cement spacer does not reduce the effectiveness of such a spacer in two-stage exchange arthroplasty. (Chinese Clinical Trial Registry, ChiCTR-INR-17014162. Registered 26 December 2017.)

Our aim was to determine the incidence of occult infection and to examine the role of ultrasound sonication of the implants in cases of presumed aseptic loosening in a prospective trial. Joint swabs, aspirates, and deep tissue samples were obtained from around the prosthesis for routine microbiology. Each prosthesis was sonicated and the sonicate examined with Gram staining and extended cultures. There were 106 joints in the study of which 54 were revised for aseptic loosening and 52 were assigned to the control revision group. There were 9 positive cultures with 8/54 positive cultures in the aseptic loosening group and 1/52 in the control revision group ( p = 0.017 , associated OR 47.7). We found concordant results between sonication fluid culture and conventional samples in 5/9 cultures. Preoperative inflammatory markers were not prognostic for infection. Coagulase-negative Staphylococcus was the most commonly cultured organism (7/9). Previously unrecognised infection was present in 15% of patients undergoing revision for aseptic loosening. Ultrasound sonication of the removed prosthesis was less sensitive than conventional sampling techniques. We recommend routine intraoperative sampling for patients having revision for aseptic loosening, but we do not support the routine use of ultrasound sonication for its detection.

Purpose To investigate the relationship between conjunctival flora and comfort of the socket in anophthalmic patients. Methods A cross-sectional clinical study including 60 patients with unilateral anophthalmia who wear a prosthetic eye. From each patient three microbiological samples were taken from the lower conjunctival sac (healthy eye, pre-prosthesis, and retro-prosthesis space of socket). The 180 samples obtained were cultured. Samples from a randomized subgroup of 29 patients were measured by spectrophotometry at 540 nm after 48 h of growth, to determine their microbial density (MD). The grade of comfort of the socket (GCS) of each patient was established by a questionnaire. Epidemiological and clinical data of the anophthalmic socket and artificial eye care of each patient were also collected. Results MD decreased in healthy eyes (0.213 ± 0.201, P  = 0.004) compared with the pre-prosthesis (0.402 ± 0.323) and retro-prosthesis (0.438 ± 0.268) samples. Pre-prosthesis MD correlated with retro-prosthesis MD ( R  = 0.401, P  = 0.031) and healthy eye MD ( R  = 0.482, P  = 0.008), and it was also related to poor GCS ( P  = 0.017). Aerobic Gram-negative bacteria in retro-prosthesis samples of patients with poor GCS was higher than in patients with good or fair GCS ( P  = 0.008). In the same samples, coagulase-negative staphylococci proportion (excluding S. epidermidis ) increased in patients with good GCS ( P  = 0.030). Conclusions Socket microflora is related to GCS. Increased pathogenic flora, especially Gram-negative bacteria, and high MD are related to discomfort, while coagulase-negative staphylococci (other than S. epidermidis ) are associated with comfort.

Background Pin site infection is a common problem in external fixation. Plain gauze wetted with normal saline is commonly used for a pin site dressing owing to the simplicity and low cost. Evidence to support adding an antimicrobial agent in the dressing material is lacking. Questions/purposes We compared the rate of pin tract infection using plain gauze and gauze impregnated with polyhexamethylene biguanide in patients undergoing limb lengthening procedures. Patients and Methods We included 38 patients (40 limbs) undergoing limb lengthening or deformity correction using an external fixator between July 2009 and June 2010. There were 23 male patients and 15 female patients, with a mean age of 26.3 years (range, 5–68 years). The patients were randomized into two groups: a polyhexamethylene biguanide group (22 limbs) and a control group (18 limbs). The metal-skin interfaces were assessed by a researcher blinded to the type of gauze at 2, 4, 8, and 12 weeks after surgery for the pin site infection based on a predetermined grading system. There were a total of 483 metal-skin interfaces, with 1932 total observations. Infection rates were compared using the chi square test and relative risk with 95% confidence interval. Results The infection rate was lower (χ 2 [1, n = 1932] = 23.00) and the risk for infection was lower (relative risk, 0.228; 95% confidence interval, 0.118, 0.443) for the polyhexamethylene biguanide group (n = 1068; 1.0%) than for the control group (n = 864; 4.5%). Conclusions Use of polyhexamethylene biguanide-impregnated gauze can reduce the risk of pin tract infection in external fixation. Level of Evidence Level I, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.