Prolonged Orbital Relaxation by Locally Modified Phonon Density of States for the SiV

Coherent quantum systems are a key resource for emerging quantum technology. Solid-state spin systems are of particular importance for compact and scalable devices. However, interaction with the solid-state host degrades the coherence properties. The negatively charged silicon vacancy center in diamond is such an example. While spectral properties are outstanding, with optical coherence protected by the defects symmetry, the spin coherence is susceptible to rapid orbital relaxation limiting the spin dephasing time. A prolongation of the orbital relaxation time is therefore of utmost urgency and has been tackled by operating at very low temperatures or by introducing large strain. However, both methods have significant drawbacks: the former requires use of dilution refrigerators and the latter affects intrinsic symmetries. Here, a novel method is presented to prolong the orbital relaxation with a locally modified phonon density of states in the relevant frequency range, by restricting the diamond host to below 100 nm. Subsequently measured coherent population trapping shows an extended spin dephasing time compared to the phonon-limited time in a pure bulk diamond. The method works at liquid helium temperatures of few Kelvin and in the low-strain regime.

Intermediate to long-term clinical outcomes and survival analysis of the Salto Mobile Bearing total ankle prothesis.

INTRODUCTION: Osteoarthritis of the ankle is a major burden to affected patients. While tibio-talar arthrodesis has been the gold-standard regarding the treatment of osteoarthritis of the ankle joint for many years, at present total ankle arthroplasty (TAA) provides appealing clinical outcomes and is continually gaining popularity. The aim of this study was to evaluate the intermediate- to long-term clinical outcome including the survival rate of Salto Mobile Bearing TAA (Tonier SA, Saint Ismier, France). MATERIAL AND METHODS: In this retrospective study intermediate- to long-term outcomes measures [Ankle Range of Motion (ROM), American Orthopaedic Foot and Ankle Score (AOFAS score) and survival rate] of 171 consecutive TAA were analysed and compared before and after surgery. Revision was defined as secondary surgery with prothesis component removal, while reoperation was defined as a non-revisional secondary surgery involving the ankle. RESULTS: At a mean follow-up (FU) period of 7.2 ± 2.7 years (range 2.0 to 14.1 years) there was a significant improvement in ankle ROM (total ROM improved from 25.0° ± 15.0° to 28.7° ± 11.3°, p = 0.015; plantarflexion improved from 18.4° ± 11.7° to 20.6° ± 8.2°, p = 0.044; dorsiflexion improved from 6.6° ± 5.7° to 8.1° ± 4.9°, p = 0.011). AOFAS score increased significantly by 41 ± 15 points after surgery (43.3 ± 11.1 before and 84.3 ± 12.0 after surgery, p < 0.001). Overall survival rate within the FU was 81.3% (95% CI 75.3% to 87.3%) with any secondary surgery, 89.9% (95% CI 84.1% to 93.6%) with revision and 93.6% (95% CI 89.8% to 97.3%) with reoperation as endpoint. CONCLUSION: This study endorses the previously reported appealing intermediate- to long-term outcomes of the Salto Mobile Bearing TAA. There was a significant increase in ROM and AOFAS score as well as decent implant survival at final FU.

Results after spica cast immobilization following hip reconstruction in 95 cases: is there a need for alternative techniques?

INTRODUCTION: Developmental dysplasia of the hip (DDH), neurogenic dysplasia of the hip (NDH), and Perthes disease often require surgical treatment. Spica casting is a common postoperative immobilization. The purpose of this study was to evaluate the complications related to the immobilization. MATERIALS AND METHODS: In a retrospective analysis, we included 83 patients (95 hips), who underwent hip reconstructive surgery between 2008 and 2018. We had 43 female and 40 male patients. Age reached from 3 months to 19 years. All patients were treated with a spica cast postoperatively for a 6-week protocol. Complications were analyzed using the full medical documentation and classified according to Clavien-Dindo. RESULTS: We had complications in 23 patients (27.7%). We counted superficial skin lesions in seven, deep skin lesions in three, spasticity of adductors in three, subluxation in two, infection of the plate in one, fracture of the plate in one, compliance problem in one, dislocations of the cast in two, reluxation in one, delayed bone healing in one and spasticity of knee flexors in one case. According to the classification of Clavien-Dindo, we were able to count ten type I, four type II, nine type III, zero type IV and zero type V adverse events. CONCLUSION: The usage of a spica cast after hip reconstructive surgery is still the most popular way of aftertreatment. It has a low complication rate, which may be lowered by well-applied casts and foam padding. Known complications such as spasticity in patients with cerebral palsy, skin lesions, and pressure sores should be observed and avoided. Shorter protocols for immobilization with the usage of foam padding and foam splints lead to less complications. CLINICAL RELEVANCE: Evidence level level IV, case series.

Straight stem and threaded cup in patients under 60 years of age: 28.8-30.2 years of follow-up.

PURPOSE: The aim of this retrospective observational study of one cohort was to evaluate the long-term outcome in patients younger than 60 years after total hip arthroplasty using a straight uncemented stem and an uncemented threaded cup. METHODS: Between 1986 and 1987, 75 hips of 75 patients (mean age, 53.35 ± 6.17 years) were consecutively implanted with an Alloclassic Zweymüller/Alloclassic SL stem and an Alloclassic CSF cup. Forty-four patients had died over the last 30 years. The remaining 31 patients (mean age, 82.9 ± 6.4 years) were reinvited for follow-up examinations. Clinical and radiographic evaluations were carried out. RESULTS: At a mean follow-up of 29.5 (28.8-30.2), 4 patients (5.3%) were lost to follow-up. For the endpoint aseptic loosening (defined as the removal of stem or the cup for 2 cases), the overall survival rate is 97.3%. For the endpoint revision for any reason (22 patients), the survival rate is 70.6%. Eleven patients needed an exchange of head and liner, caused by wear. The average time from implantation until change of head and liner was 21.44 years (SD 5.92). Other reasons for revision surgery were septic loosening (3 cases), aseptic loosening of stem and cup (1 case), aseptic loosening of stem (1 case), periprosthetic calcification (2 cases), implant fracture (1 case), periprosthetic fracture (1 case), intraoperative fissure of stem (1 case), and total wear of liner including cup (1 case). CONCLUSION: The combination of a straight stem (Alloclassic) and a screw cup (CSF) shows excellent results in young patients under the age of 60 at ultra-long-term follow-up at 30 years. Revisions due to wear of the polyethylene liner are more likely than in the older patients.

Importance of the biofilm matrix for the erosion stability of Bacillus subtilis NCIB 3610 biofilms.

Production and secretion of biomolecules can provide new emergent functionalities to the synthesizing organism. In particular, the secretion of extracellular polymeric substances (EPS) by biofilm forming bacteria creates a biofilm matrix that protects the individual bacteria within the biofilm from external stressors such as antibiotics, chemicals and shear flow. Although the main matrix components of biofilms formed by Bacillus subtilis are known, it remains unclear how these matrix components contribute to the erosion stability of B. subtilis biofilms. Here, we combine different biophysical techniques to assess this relation. In particular, we quantify the importance of specific biofilm matrix components on the erosion behavior of biofilms formed by the well-studied Bacillus subtilis NCIB 3610. We find that the absence of biofilm matrix components decreases the erosion stability of NCIB 3610 biofilms in water, largely by abolishing the hydrophobic surface properties of the biofilm and by reducing the biofilm stiffness. However, the erosion resistance of NCIB 3610 biofilms is strongly increased in the presence of metal ions or the antibiotic ciprofloxacin. In the first case, unspecific ionic cross-linking of biofilm components or individual bacteria seems to be responsible for the observed effect, and in the second case there seems to be an unspecific interaction between the antibiotic and the biofilm matrix. Taken together, our results emphasize the importance of the biofilm matrix to reduce biofilm erosion and give insights into how the specific biomolecules interact with certain chemicals to fulfill this task.

First isolation of Mycoplasma canis from human tissue samples after a dog bite.

Mycoplasma canis is an opportunistic bacterial pathogen that may colonize dogs and cattle. In the present case, we report for the first time the isolation of M. canis from a wound tissue specimen of a 62-year-old woman after a dog bite.

Does additional patella tendon shortening influence the effects of multilevel surgery to correct flexed knee gait in cerebral palsy: A randomized controlled trial.

BACKGROUND: The aims of this study were to investigate if patellar tendon shortening (PTS) as a part of SEMLS (single event multilevel surgery) is effective for reduction of flexed knee gait in children with cerebral palsy (CP) and, if PTS leads to stiff knee gait. METHODS: In a randomized controlled study 22 children with flexed knee gait (age: 10.4 ±â€¯2.6 years, GMFCS Level I-III) were randomized and allocated to two groups (1: SEMLS + PTS; 2: SEMLS no PTS): SEMLS was performed for correction of flexed knee gait either with or without additional PTS. Before and after surgery (follow up: 12.7 ±â€¯1.6 months) kinematics (3-D motion analysis) and clinical parameters were compared. RESULTS: Two children were lost to follow up. Maximum knee extension improved significantly in both groups after SEMLS while the patients with additional PTS showed much more correction (SEMLS + PTS: 37.6° to 11.4°, p = 0.007; SEMLS no PTS: 35.1° to 21.8°, p = 0.016). After surgery peak knee flexion decreased significantly (14.6°, p = 0.004) in the "SEMLS + PTS" group while there was no relevant change in the other group. There was a trend of increase in anterior pelvic tilt after surgery in both groups, but no statistical significant difference. After surgery knee flexion contracture (15.9°, p < 0.001) and popliteal angle (27.2, p = 0.009) measured on clinical examination only decreased significantly in the "SEMLS + PTS" group. CONCLUSION: PTS is effective for correction of flexed knee gait and knee flexion contracture leading to superior stance phase knee extension. However, additional PTS may lead to stiff knee gait and a higher increase of anterior pelvic tilt.

Detection of MET mRNA in gastric cancer in situ. Comparison with immunohistochemistry and sandwich immunoassays.

Determination of predictive biomarkers by immunohistochemistry (IHC) relies on antibodies with high selectivity. RNA in situ hybridization (RNA ISH) may be used to confirm IHC and may potentially replace it if suitable antibodies are not available or are insufficiently selective to discriminate closely related protein isoforms. We validated RNA ISH as specificity control for IHC and as a potential alternative method for selecting patients for treatment with MET inhibitors. MET, the HGF receptor, is encoded by the MET proto-oncogene that may be activated by mutation or amplification. MET expression and activity were tested in a panel of control cell lines. MET could be detected in formalin fixed paraffin, embedded (FFPE) samples by IHC and RNA ISH, and this was confirmed by sandwich immunoassays of fresh frozen samples. Gastric cancer cell lines with high MET expression and phosphorylation of tyrosine-1349 respond to the MET inhibitor, BAY-853474. High expression and phosphorylation of MET is a predictive biomarker for response to MET inhibitors. We then analyzed MET expression and activity in a matched set of FFPE vs. fresh frozen tumor samples consisting of 20 cases of gastric cancer. Two of 20 clinical samples investigated exhibited high MET expression with RNA ISH and IHC. Both cases were shown by sandwich immunoassays to exhibits strong functional activity. Expression levels and functional activity in these two cases were in a range that predicted response to treatment. Our findings indicate that owing to its high selectivity, RNA ISH can be used to confirm findings obtained by IHC and potentially may replace IHC for certain targets if no suitable antibodies are available. RNA ISH is a valid platform for testing predictive biomarkers for patient selection.

Freezing-induced self-assembly of amphiphilic molecules.

The self-assembly of amphiphilic molecules usually takes place in a liquid phase, near room temperature. Here, using small angle X-ray scattering (SAXS) experiments performed in real time, we show that freezing of aqueous solutions of copolymer amphiphilic molecules can induce self-assembly below 0 °C.

[Femoral Derotation in Children with Cerebral Palsy - Does the Result Depend on the Age at Operation and the Kind of Surgery?]. / Derotation des Femurs bei Patienten mit infantiler Zerebralparese - ist das Ergebnis abhängig vom Alter zum Zeitpunkt der Operation und der OP-Technik?

INTRODUCTION: Patients with spastic cerebral palsy GMFCS I-III often develop gait dysfunctions. One of the most prevalent gait dysfunctions is the intoeing gait. Femoral derotation osteotomy is the common treatment for internal rotation gait in cerebral palsy. We now present 3D-gait analysis data of the hip rotation in gait before and after femoral derotation osteotomy. We analysed the influence of the age at the index operation on the risk of recurrence and the surgical technique. METHODS: We included 48 patients treated with femoral derotation osteotomy during a single event of multi-level surgery. Mean hip rotation in standing was measured before and after femoral derotation osteotomy (FDO). The patients were divided into two groups of different age and in a second analysis into two groups with the osteotomy in different locations, either inter-trochanteric (DO proximal) or supracondylar (DO distal). RESULTS: Age at FDO and surgical technique had no influence on the results. However, the variance of the results was very high. Differences were found in the walking speed between the DO proximal and DO distal groups. The walking speed in the group of distal femoral osteotomy was higher. This difference was not significant, but there was a trend to proximal osteotomy in slower walkers. Significant improvements in IRG after FDO were found in our investigation. Our results indicate that FDO as a part of single-event multilevel surgery SEMLS provides a satisfactory mean overall correction of IRG. The results were independent of the age at the index operation and the location of the osteotomy.

Factors associated with recurrence after femoral derotation osteotomy in cerebral palsy.

Femoral derotation osteotomy (FDO) as gold standard treatment for internal rotation gait in cerebral palsy (CP) leads to satisfying short-term results, whereas rates of recurrence up to 33% are reported in long-term outcome studies. The purpose of this study was therefore to identify factors contributing to recurrence of internal rotation gait in patients with CP who were treated with FDO in childhood. 70 patients (age: 10 (± 3.3) years at surgery) with bilateral CP and internal rotation gait were examined pre-, one year and at least five years (mean 8 ± 2 years) postoperatively after distal or proximal FDO, using standardized clinical examination and 3D gait-analysis. 27 patients had a good hip rotation one year postoperatively (between 5° external and 15° internal for both limbs) and were considered for the analysis of factors contributing to recurrence of internal rotation gait. Regarding all included patients both mean hip rotation and foot progression angle improved significantly (p < 0.001) from pre- to postoperative. A significant deterioration in hip rotation (more involved side) (p < 0.001) from one year postoperatively to the long-term follow-up can be observed. Younger age, reduced hip joint impulse, increased plantar flexion and internal foot progression angle postoperatively could be identified as factors for recurrence. FDO on average leads to a satisfactory correction of internal rotation gait. In order to improve the long-term outcome after FDO the time of multilevel surgery should be indicated as late as possible and the different factors leading to potential recurrence should be considered.

Asymmetric pelvic and hip rotation in children with bilateral cerebral palsy: uni- or bilateral femoral derotation osteotomy?

Internal rotation gait is common among children with bilateral cerebral palsy. However, despite bilaterally increased femoral anteversion asymmetric internal rotation gait is often found. Femoral derotation osteotomy (FDO) is commonly performed bilaterally. Variable functional outcomes are reported especially in cases with mild internal hip rotation during gait and abnormal preoperative pelvic rotation. A major question is if a unilateral treatment of the more involved side in asymmetric cases leads to a comparable or even superior outcome. One hundred and nine children with spastic bilateral CP treated with FDO with pre- and 1-year postoperative 3D gait analysis were retrospectively collected. The asymmetry was calculated from the preoperative difference between both limbs in hip rotation obtained by 3D gait analysis. Twenty-eight children with asymmetry larger than 20° were selected and classified into two groups, according to whether they obtained a unilateral or bilateral FDO. Preoperative clinical examination and pre- and postoperative hip and pelvic rotation in gait analysis on the more and the less involved side did not differ significantly between both groups. Interestingly, in both groups, hip rotation did not change significantly in less-involved limbs, although intraoperative derotation averaged 25°. After unilateral FDO a significant change in pelvic rotation resulted, whereas this was not found after bilateral FDO. The results of this study suggest that unilateral FDO in children with asymmetric internal rotation gait leads to a comparable functional outcome compared to bilateral treatment. Furthermore, it was shown for the first time that considering the asymmetry has a positive effect on pelvic rotation.

Can reverse shoulder arthroplasty in post-traumatic revision surgery restore the ability to perform activities of daily living?

BACKGROUND: Failed shoulder arthroplasty and failed internal fixation in fractures of the proximal humerus can benefit from implantation of a reverse total shoulder arthroplasty (RSA). While there is some evidence that RSA can improve function regarding range of motion (ROM), pain, satisfaction, and strength, there is sparse data how this translates into activities of daily living (ADLs). A marker-based 3D video motion analysis system has recently been designed that can measure changes of ROM in dynamic movements in every plane. The hypothesis was that a gain of maximum ROM also translates into the ability to perform ADLs and into a significant increase of ROM in ADLs. MATERIALS AND METHODS: Six consecutive patients (5 women, 1 man; 2× failed arthroplasty, 4× failed open reduction and internal fixation) who received RSA were examined the day before and 1 year after shoulder replacement. A 3D motion analysis system using a novel upper extremity model measured active maximum values and ROM in four ADLs. RESULTS: Comparing the pre- to the 1-year postoperative status, RSA resulted in a significant increase in mean maximum values for active flexion (humerus to thorax) of 37° (S.D. ±23°), from 50 to 87° [P=0.005], and for active abduction averaging of 17° (S.D. ±13°), from 52 to 69° [P=0.027]. The extension decreased significantly by about 8° (S.D. ±16°), from a mean of 39 to 31° [P=0.009]. For active adduction and internal and external rotation, there were trends for improvements, but no significant changes. Only three additional tasks of the ADL (out of 13/24 preoperatively) could be performed after revision surgery. Comparing the preoperative to the postoperative ROM in the ADLs in flexion/extension, ROM improved significantly in one ("tying an apron") of four ADLs. There were no significant changes in the abduction/adduction and internal/external rotation in any ADLs. CONCLUSION: RSA in revision cases significantly improved maximum active flexion and abduction, but decreased extension in this series. However, the patients were only able to use this greater ROM to their benefit in one of four ADLs.

Prevalence of Scedosporium species and Lomentospora prolificans in patients with cystic fibrosis in a multicenter trial by use of a selective medium.

OBJECTIVE: Detection of hyphomycetes of the Scedosporium apiospermum complex and Lomentospora prolificans (Sac-Lp) is not yet standardized. Prevalence rates in patients with cystic fibrosis (CF) and the resistance pattern of these pathogens in Germany are unknown. METHODS: In a one-year prospective study 11 laboratories used a selective medium for isolation of Sac-Lp, examining >11,600 respiratory samples from 2346 patients with CF. Isolates were identified by molecular methods and tested for susceptibility to antifungal drugs. RESULTS: The prevalence of Sac-Lp in patients with CF in Germany varied from 0.0 to 10.5% (mean: 3.1%) among the clinical centres. The benefit of the selective medium SceSel(+) compared to standard media for fungi was documented for >5000 samples. High antifungal resistance was detected in the S. apiospermum complex, and the multiresistance of L. prolificans was confirmed. CONCLUSION: Microbiology laboratories should be aware of these resistant species in patients with CF and consider using a selective medium.

The stability of the femoral component in the Oxford unicompartmental knee replacement: a comparison of single and twin peg designs.

Aseptic loosening of the femoral component is an important indication for revision surgery in unicompartmental knee replacement (UKR). A new design of femoral component with an additional peg was introduced for the cemented Oxford UKR to increase its stability. The purpose of this study was to compare the primary stability of the two designs of component. Medial Oxford UKR was performed in 12 pairs of human cadaver knees. In each pair, one knee received the single peg and one received the twin peg design. Three dimensional micromotion and subsidence of the component in relation to the bone was measured under cyclical loading at flexion of 40° and 70° using an optical measuring system. Wilcoxon matched pairs signed-rank test was performed to detect differences between the two groups. There was no significant difference in the relative micromotion (p = 0.791 and 0.380, respectively) and subsidence (p = 0.301 and 0.176, respectively) of the component between the two groups at both angles of flexion. Both designs of component offered good strength of fixation in this cadaver study.

[Long-term results of reconstructive surgery in infantile cerebral palsy patients with high hip dislocation: is hip screening necessary?]. / Langzeitergebnisse nach operativer Rekonstruktion hoher Hüftluxationen bei infantiler Zerebralparese: Ist ein Hüftscreening notwendig?

BACKGROUND: Hip dislocation as a result of neurogenic hip displacement is a common focal motor symptom in children with infantile cerebral palsy (ICP). In addition to contracture of the hip joint, in up to 65 % of cases patients suffer from pain which leads to further loss of function and often to limitations in important basic functions, such as lying, care, sitting, standing and transfer. METHODS: In order to avoid hip dislocation and to be able to implement therapy at an early stage, screening programs have been developed in recent years which clearly demonstrate the risks of hip displacement in ICP depending on the ability to walk. An investigation of the natural course is practically impossible because as a rule patients with painful neurogenic hip displacement receive surgical therapy. PATIENTS: In this study 96 patients with high hip dislocation grade IV on the Tönnis classification were included and 68 could be followed up. The average age at the time of surgery was 10.9 years and the mean follow-up period was 7.7 years. In the postoperative course 6 out of 91 reconstructed hips became redislocated and a proximal femoral resection was carried out in one female patient. The migration index according to Reimers was 14.0 % at the time of the follow-up examination. CONCLUSION: Revision procedures can be avoided by screening programs. These should be strived for so that the neuro-orthopedic treatment on operation planning is not first initiated when pain occurs and revision procedures, such as angulation osteotomy or proximal femoral resection can be avoided. The reconstruction should also involve minimal deformation of the femoral head. In order to implement this, the interdisciplinary cooperation between neuropediatricians, social pediatriatricians and neuro-orthopedists should be intensified in the future.

Tibialis posterior tendon transfer corrects the foot drop component of cavovarus foot deformity in Charcot-Marie-Tooth disease.

BACKGROUND: The foot drop component of cavovarus foot deformity in patients with Charcot-Marie-Tooth disease is commonly treated by tendon transfer to provide substitute foot dorsiflexion or by tenodesis to prevent the foot from dropping. Our goals were to use three-dimensional foot analysis to evaluate the outcome of tibialis posterior tendon transfer to the dorsum of the foot and to investigate whether the transfer works as an active substitution or as a tenodesis. METHODS: We prospectively studied fourteen patients with Charcot-Marie-Tooth disease and cavovarus foot deformity in whom twenty-three feet were treated with tibialis posterior tendon transfer to correct the foot drop component as part of a foot deformity correction procedure. Five patients underwent unilateral treatment and nine underwent bilateral treatment; only one foot was analyzed in each of the latter patients. Standardized clinical examinations and three-dimensional gait analysis with a special foot model (Heidelberg Foot Measurement Method) were performed before and at a mean of 28.8 months after surgery. RESULTS: The three-dimensional gait analysis revealed significant increases in tibiotalar and foot-tibia dorsiflexion during the swing phase after surgery. These increases were accompanied by a significant reduction in maximum plantar flexion at the stance-swing transition but without a reduction in active range of motion. Passive ankle dorsiflexion measured in knee flexion and extension increased significantly without any relevant decrease in passive plantar flexion. The AOFAS (American Orthopaedic Foot & Ankle Society) score improved significantly. CONCLUSIONS: Tibialis posterior tendon transfer was effective at correcting the foot drop component of cavovarus foot deformity in patients with Charcot-Marie-Tooth disease, with the transfer apparently working as an active substitution. Although passive plantar flexion was not limited after surgery, active plantar flexion at push-off was significantly reduced and it is unknown whether this reduction was the result of a tenodesis effect or calf muscle weakness.

[Study of physicochemical and bacteriological impact of a weekly assembly of automated compounding BAXA(®) Exacta-Mix 2400 on parenteral nutrition admixture manufacturing]. / Étude de l'impact physicochimique et bactériologique d'un montage hebdomadaire de l'automate BAXA(®) Exacta-Mix 2400 sur la fabrication des poches de nutrition parentérale.

INTRODUCTION: The parenteral nutrition admixtures are manufactured with an automated compounding BAXA(®) Exacta-Mix 2400. A 48-hour assembly has been validated. To optimize time and cost, a weekly assembly was tested. MATERIALS AND METHODS: Assembly was made on the first day. Ten identical parenteral nutrition admixtures (different volumes and compositions) were produced each day. A macroscopic examination was done at D0, D7 and D14. Physicochemical controls (electrolytes determinations by atomic absorption spectrophotometry, osmolalities measurements) were performed. Microbiological tests included a filtration membrane sterility test (Steritest(®)) and a plate count agar environmental monitoring. RESULTS: All mixtures were considered stable. The 12 Steritest(®) (H24, H48, D7 and D14) did not show any bacterial or fungal contamination. No microorganism has been detected on the plate count agar at D4 and D7. Concerning the physicochemical parameters of each parental nutrition admixture, no significant difference (Wilcoxon test) with the first day was found. DISCUSSION AND CONCLUSIONS: The automated filling system BAXA(®) Exacta-Mix 2400 improves the quality and safety of production. According to these results, the weekly assembly is validated and permit to save time (80hours/year) and cost (40 000 euros on consumable/year).

[Stability and sterility of parenteral nutrition admixture for patients home care manufactured by the automated compounding BAXA® EM 2400]. / Étude de stabilité et de stérilité des poches de nutrition parentérale pour patients à domicile fabriquées à l'aide de l'automate BAXA® EM 2400.

INTRODUCTION: Initially, parenteral nutrition admixtures are produced by sterile filtration with a stability of 14 days This study was conducted to check the stability (physicochemical and microbiological) when automated compounding BAXA(®) EM 2400 is used. MATERIALS AND METHODS: Forty pockets corresponding to 10 patients have been manufactured in according to Good Manufacturing Practice. Macroscopic and physicochemical tests (determination of electrolytes by atomic absorption spectroscopy, osmolality and pH measurements) were performed at different times (D0, D7, D14). To complete these checks, the emulsions were analyzed (size, stability, optical microscopy) at D0 and D14. Finally, microbiological research (Bact-Alert(®), filtration membrane sterility tests Steritest(®) and plate count agar) was performed. RESULTS: No lipid cluster was observed with an optical microscope. Comparison of data observed for all controls showed no significant difference in the production of D0 by the Wilcoxon test. Microbiology (Bact-Alert filtration membrane sterility tests Steritest(®) and plate count agar) was negative for all samples. Consequently, all mixtures were considered stable. DISCUSSION AND CONCLUSIONS: The automated compounding BAXA(®) EM 2400 ensures quality and safety of production. The results of this study have shown stability and sterility of parenteral nutrition admixtures for 14 days.