The Dimorphos ejecta plume properties revealed by LICIACube.

The Double Asteroid Redirection Test (DART) had an impact with Dimorphos (a satellite of the asteroid Didymos) on 26 September 20221. Ground-based observations showed that the Didymos system brightened by a factor of 8.3 after the impact because of ejecta, returning to the pre-impact brightness 23.7 days afterwards2. Hubble Space Telescope observations made from 15 minutes after impact to 18.5 days after, with a spatial resolution of 2.1 kilometres per pixel, showed a complex evolution of the ejecta3, consistent with other asteroid impact events. The momentum enhancement factor, determined using the measured binary period change4, ranges between 2.2 and 4.9, depending on the assumptions about the mass and density of Dimorphos5. Here we report observations from the LUKE and LEIA instruments on the LICIACube cube satellite, which was deployed 15 days in advance of the impact of DART. Data were taken from 71 seconds before the impact until 320 seconds afterwards. The ejecta plume was a cone with an aperture angle of 140 ± 4 degrees. The inner region of the plume was blue, becoming redder with increasing distance from Dimorphos. The ejecta plume exhibited a complex and inhomogeneous structure, characterized by filaments, dust grains and single or clustered boulders. The ejecta velocities ranged from a few tens of metres per second to about 500 metres per second.

Fracture of a triple-polished tapered cemented femoral stem at the Morse taper after metal-on-metal primary total hip arthroplasty.

Total hip arthroplasty, one of the most successful orthopaedic procedures, is influenced by several variables. Corrosion at the modular junction is known as trunnionosis. Despite being reported infrequently, corrosion between the femoral head and the Morse taper can result in severe complications. Fracture of the femoral component in primary metal-on-metal (MoM) total hip arthroplasty at the Morse taper is an extremely rare event and can be associated with several risk factors. We report a case of corrosion at the Morse taper in a hybrid primary MoM total hip arthroplasty, resulting in Morse taper fracture with consequent femoral head entrapment inside the acetabular component. We hypothesise that some risk factors, such as age over 60years, active male patients, body mass index above 30kg/m2, large femoral heads, high-offset stems, 9/10 Morse taper and MoM-bearing surfaces, are associated with this mode of failure.

Gait instability may indicate liner failure in patients with total hip arthroplasty. A report of three cases.

Total hip arthroplasty is one of the most common and successful orthopaedic procedures performed worldwide. Uncemented modular acetabular components and highly cross-linked polyethylene liners are the implants of choice for most arthroplasty surgeons. However, despite their well-known benefits, highly cross-linked polyethylene liners are not without complications, such as rim fracture, rupture and dissociation. We report three patients with gait instability and radiographic subluxation due to highly cross-linked polyethylene liner failures evidenced during stage one revision surgery. The three patients were symptoms free, with no new instability episodes, and the radiographs showed no evidence of implant loosening at the most recent follow-up. Although it is a rare complication, these three cases highlight the importance of suspecting and evaluating highly cross-linked polyethylene liner failures in patients referred for gait instability with no history of previous trauma.

Six-stage revision surgery of a triple periprosthetic joint infection due to a delayed diagnosis of a bilateral psoas abscess: a case report.

CASE: We present a case of a 70-year-old woman with simultaneous periprosthetic joint infection (PJI) of both hips and left knee due to a bilateral psoas abscess. The patient underwent debridement and implants removal with the consequent reimplantation in a sequential six-stage revision surgery. At four years of follow-up and in spite of the patient's comorbidities and current PJI presentation, she maintains full activities of daily living without restrictions. CONCLUSION: Accurate and early diagnosis of a psoas abscess is crucial. This case report provides experience of a complex scenario, the decision-making involved and the outcomes of an underdiagnosed complication.

Is hip arthroscopy useful in the treatment of borderline dysplasia?: a case-control study. / ¿Es útil la artroscopia de cadera para el tratamiento de la displasia limítrofe?: análisis de casos y controles.

INTRODUCTION: Since arthroscopy remains a controversial treatment of hip dysplasia, our objective was to analyse its clinical and radiological results in a cohort of patients with dysplasia and compare them to controls with femoroacetabular impingement (FAI). MATERIAL AND METHODS: We retrospectively analysed a series of patients who underwent hip arthroscopy for the treatment of labral pathology; 29 of them with borderline hip dysplasia and 197 with FAI, comparing reoperations and joint survival. The diagnosis of borderline dysplasia was made with a lateral centre-edge angle greater than 18° but less than 25°. The average follow-up was 43 months. We performed a multivariate regression analysis to evaluate the association of reoperations with different demographic, radiological and intraoperative variables. RESULTS: Seven complications were registered in the FAI group (1 medically treated superficial wound infection, 3 pudendal nerve paraesthesias, 1 deep vein thrombosis and 2 heterotopic ossifications) and none in the dysplasia group. While 5 patients from the FAI group required a new surgery, none of the dysplasia group was re-operated (p=.38). After adjusting for confounders, reoperation showed a very strong association with the finding of osteochondral lesions during index surgery, with a coefficient of .12 (p<.001, 95%CI=.06-.17). CONCLUSION: Hip arthroscopy was useful in the treatment of borderline dysplasia, without non-inferior survival compared to the FAI group. We suggest indicating it carefully in dysplasia cases, whenever the symptoms of femoroacetabular friction prevail over those of instability.

Interceptive use of pendulum for advance resolution of class II patient: a guided eruption plan to reduce stress on permanent teeth root.

Use of the so-called distalizing mechanics is a common treatment to correct class II malocclusion. One of the first appliances made for molar distalization was the pendulum, which resulted immediately efficient. The knowledge of pendulum efficacy, in regards to distalizing treatment in adolescence, has guided the research to analyze pendulum effect in childhood: checking the pre-eruptive, natural and distal movement of upper second premolar following first upper molar distalization in order to obtain an advance resolution on Angle's Class II patient, limited treatment time, reduced periodontal inflammation and stress on permanent teeth root. A pilot study testing the possibility of a prospective study was necessary on 6 patients treated following an accurate protocol (6 months and 1-year Rx control) and 6 patient control after one year. Statistical analysis by T-Test was done. Oral hygiene controls every month were done. Second upper bicuspid vertical (1.6mm) and sagittal (2.5mm) movement mean values allow to emphasize a distal variation of tooth axis inclination of treatment group than control group, and a second upper bicuspid distal departure from "gubernaculus dentis" of second deciduous molar in treated patients. Periodontal inflammation appears inexistent on second and first upper premolar germs after the comparison between RX exam of treatment and control groups because of exploiting deciduous teeth. Besides periodontal inflammation and teeth root stress on first upper molar of treatment group, after RX analysis, results were limited compared to control groups because of the advanced orthodontic interceptive treatment during a previous stage of first upper molar root development.

Ketamine in dentistry: a useful way for non-compliant pediatric patients.

The infant, like the young un-cooperative or odontophobic patient, constitute the most complex type of patient to be treated and it is frequent in modern society. The treatment of these patients is necessary to resolve the infectious-antalgic urgency and subsequently to build the patient/doctor relationship for continuing general dental care. Conscious sedation is the only way to approach this type of patient. Where therapeutic success with traditional sedation techniques is not achieved, as frequently happens in these patients, sedation with ketamine is the extreme ratio for the purpose of effective resolution of the dental problem, obviously carried out within facilities authorized for these anesthesiological modalities such as private outpatient surgery structures where, when necessary, it is possible to carry out the treatments also under general anesthesia as well as with ketamine.

Laser lingual frenectomy: basal eutonia achievement by natural homeostatis.

The aim of present study is a macro evaluation of adjustment to allow homeostasis before and after frenectomy. Macro analysis was done on 7 pediatric patients tested firstly simple surface elettromyography (EMG) to evaluate masticatory muscles, secondly the Romberg's test to assess the posture and thirdly cephalometric analysis according to Giannì and Rocabado to assess orthodontic variations. The frenectomy was performed with diode laser (wavelength 890 nm). Pre-frenectomy EMG outcomes indicate a clear masticatory muscular imbalance with a different electrical activity compared to physiological standard values and functional basal balance. Results after frenectomy EMG show a normalization of basal values with an improvement of mandibular posture. Depending on cephalometric analysis, outcomes reveal a tendency to normalize the cervical lordosis, previously altered. Ultimately, pre-frenectomy Romberg's test shows initial instability in the static posture, which decreases after frenectomy. In conclusion, the short lingual fraenum not only has static correlations with the oral cavity but also dynamic connections with the cervical posture and muscular basal organization. So, homeostasis includes macro alterations involving muscular tone and bone position. Frenectomy could favor the restoration of the basal eutonia achieved by a natural homeostasis.

Bi-layered collagen nano-structured membrane prototype collagen matrix CM-10826 for oral soft tissue regeneration: an in vivo ultrastructural study on 13 patients.

A new developed collagen matrix CM-10826 (CM) of porcine origin designed to be used as oral soft tissue substitute was investigated before and after implantation by light microscopy (LM), scanning electron microscopy (SEM), and transmission electron microscopy (TEM). In a case series biopsy specimens were harvested from thirteen patients at 10, 20, 30, 43 days after abutment surgery for uncovering dental implants. The in vivo histological evaluations of each patient were performed via micro-coring of newly formed oral mucosa in the area covered by CM (test side) or left uncovered (control). Results showed that CM can be integrated in connective and epithelial tissues within 10 days, can be completely resorbed within 20 days and it is able to reduce inflammatory infiltrates and to stimulate both fibroblast/epithelial cell proliferation and neo-angiogenesis. Generally it seems to be superior in promoting soft tissue healing compared to that induced by secondary intention healing. Furthermore, it is able to act as a scaffold for soft-tissue regeneration, allowing the proliferation of keratinocytes from the wound edges and favoring neovascularization and growth of connective tissue in the mesh of porous layer. It appears that a CM might function in oral surgery as a substitute for autologous grafts and to avoid secondary intention healing in soft tissue defects.

Agenesis: pilot case report by 2.9 mm implant.

The agenesis of the upper lateral incisor is one of the most frequent aesthetic-functional problems in dentistry. The reported case concerns a 49 years old male patient with bilateral agenesis of teeth 1.2-2.2 and a root stump of tooth 5.2 temporarily rehabilitated through a Maryland bridge. Without orthodontic treatment, the only solution for implant-prosthetic rehabilitation of tooth 1.2 results therefore in the use of a 2.9 mm diameter implant. The clinical and radiographic control of the implant and the gingival stability at a distance of 1 year gives a positive result both clinically and radiographically. The use of the implant with a 2.9 mm diameter is therefore indicated in extreme cases of limited bone availability.

Adjuvant sunitinib in patients with high-risk renal cell carcinoma: safety, therapy management, and patient-reported outcomes in the S-TRAC trial.

Background: Adjuvant sunitinib has significantly improved disease-free survival versus placebo in patients with renal cell carcinoma at high risk of recurrence post-nephrectomy (hazard ratio 0.76; 95% confidence interval, 0.59-0.98; two-sided P = 0.03). We report safety, therapy management, and patient-reported outcomes for patients receiving sunitinib and placebo in the S-TRAC trial. Patients and methods: Patients were stratified by the University of California, Los Angeles Integrated Staging System and Eastern Cooperative Oncology Group performance status score, and randomized (1 : 1) to receive sunitinib (50 mg/day) or placebo. Single dose reductions to 37.5 mg, dose delays, and dose interruptions were used to manage adverse events (AEs). Patients' health-related quality of life, including key symptoms typically associated with sunitinib, were evaluated with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Results: Patients maintained treatment for 9.5 (mean, SD 4.4) and 10.3 (mean, SD 3.7) months in the sunitinib and placebo arms, respectively. In the sunitinib arm, key AEs occurred ∼1 month (median) after start of treatment and resolved within ∼3.5 weeks (median). Many (40.6%) AEs leading to permanent discontinuation were grade 1/2, and most (87.2%) resolved or were resolving by 28 days after last treatment. Patients taking sunitinib showed a significantly lower EORTC QLQ-C30 overall health status score versus placebo, although this reduction was not clinically meaningful. Patients reported symptoms typically related to sunitinib treatment with diarrhea and loss of appetite showing clinically meaningful increases. Conclusions: In S-TRAC, AEs were predictable, manageable, and reversible via dose interruptions, dose reductions, and/or standard supportive medical therapy. Patients on sunitinib did report increased symptoms and reduced HRQoL, but these changes were generally not clinically meaningful, apart from appetite loss and diarrhea, and were expected in the context of known sunitinib effects. Clinical trial registration: ClinicalTrials.gov, NCT00375674.

Real-world patient- and caregiver-reported outcomes in advanced breast cancer.

Background: Advanced breast cancer (abc) represents a substantial burden for patients and caregivers. In the present study, we aimed to estimate quality of life (qol), utility, productivity loss, pain, health care resource utilization, and costs for patients with abc, and qol, utility, and productivity loss for their caregivers. Methods: This multicentre prospective non-interventional study was conducted in Canada. Eligible participants were postmenopausal women with estrogen receptor-positive, her2-negative unresectable abc and their caregivers. Validated questionnaires were used to measure qol, utility, productivity loss, and pain. Patients and caregivers were classified into 4 health states typically used in oncology economic modelling: first-line progression-free (1l-pf), first-line progressive disease (1l-pd), second- or subsequent-line progression-free (≥2l-pf), and second- or subsequent-line progressive disease (≥2l-pd). Results: Most patients and caregivers accepted to participate, with total recruitment of 202 patients and 78 caregivers. Compared with patients in pf, patients in pd had lower mean qol scores (52.9 ± 29.9 for 1l-pd vs. 68.2 ± 23.2 for 1l-pf, and 54.0 ± 23.6 for ≥2l-pd vs. 66.0 ± 22.1 for ≥2l-pf), lower mean utility values (0.64 ± 0.22 for 1l-pd vs. 0.73 ± 0.20 for 1l-pf, and 0.65 ± 0.25 for ≥2l-pd vs. 0.74 ± 0.18 for ≥2l-pf), and greater productivity loss (39.4 ± 27.7 for 1l-pd vs. 27.5 ± 30.1 for 1l-pf, and 37.6 ± 29.2 for ≥2l-pd vs. 32.0 ± 29.0 for ≥2l-pf). Compared with caregivers of patients in pf, caregivers of patients in pd had lower qol scores and utility values, and greater productivity loss. Conclusions: Study results indicate that, for patients and caregivers, pd health states are associated with a deterioration of qol and utility and a decrease in productivity in both 1l and ≥2l.

Real-world evidence analysis of palbociclib prescribing patterns for patients with advanced/metastatic breast cancer treated in community oncology practice in the USA one year post approval.

BACKGROUND: Rapidly evolving understanding of cancer biology has presented novel opportunities to translate that understanding into clinically relevant therapy. Palbociclib, a novel, first-in-class cyclin-dependent kinase (CDK) 4/6 inhibitor was approved in the USA in February 2015 for the treatment of advanced/metastatic breast cancer. We examined real-world evidence in the first year post approval to understand the clinical and demographic characteristics of patients treated with palbociclib in community oncology practices and the dosing, treatment, and complete blood count (CBC) monitoring patterns. METHODS: This was a retrospective observational study of structured data from a US electronic medical record (EMR) database. Female patients receiving palbociclib after 31 January 2015 were followed through 31 March 2016. Our methodological rules were constructed to aggregate drugs received according to the order in which they are given, i.e., identify the line of therapy as first, second, or third line, etc., using treatment order and course description fields from the EMR. RESULTS: There were 763 patients initiating palbociclib who met the selection criteria. Of those, 612 (80.2%) received palbociclib concomitantly with letrozole. Mean follow up was 6.4 months and mean age at palbociclib initiation was 64 years. Of patients with a known starting dose (n = 417), 79.9% started on palbociclib 125 mg. Dose reductions were observed in 20.1% of patients. Percentages of patients according to line of therapy at initiation of palbociclib were first-line, 39.5%; second-line, 15.7%; third-line, 13.1%; and fourth-line therapy or later, 31.7%. On average, two CBC tests were conducted during the first cycle of palbociclib treatment. Overall, 74.6% of patients had a neutropenic event during follow up including 47.3% and 8.0% of patients with a grade 3 or 4 occurrence, respectively. CONCLUSIONS: Real-world palbociclib use one year post US approval demonstrates a more heterogeneous patient population than that studied in the clinical trials with more than half of the patients receiving palbociclib plus letrozole in later lines of therapy. CBC testing rates suggested good provider compliance with monitoring guidelines in the USA prescribing information. The occurrence of grade 3 and 4 neutropenia (based on laboratory results) was consistent with the rates of grade 3 and 4 neutropenia in two phase-III studies (PALOMA-2, 56% and 10%; PALOMA-3, 55% and 11%, respectively). Understanding palbociclib utilization in real-world patients and how drug dosing and monitoring are performed aids in the understanding of safe and effective use of the drug.

No lower bacterial adhesion for ceramics compared to other biomaterials: An in vitro analysis.

BACKGROUND: Although there is some clinical evidence of ceramic bearings being associated with a lower infection rate after total hip arthroplasty (THA), available data remains controversial since this surface is usually reserved for young, healthy patients. Therefore, we investigated the influence of five commonly used biomaterials on the adhesion potential of four biofilm-producing bacteria usually detected in infected THAs. HYPOTHESIS: Ceramic biomaterials exhibit less bacterial adherence than other biomaterials. MATERIAL AND METHODS: In this in vitro research, we evaluated the ability of Staphylococcus aureus, Staphylococcus epidermidis ATCC 35984, Escherichia coli ATCC 25922 and Pseudomonas aeruginosa to adhere to the surface of a cobalt-chromium metal head, a fourth-generation ceramic head, a fourth-generation ceramic insert, a highly-crossed linked polyethylene insert and a titanium porous-coated acetabular component. After an initial washing step, bacterial separation from the surface of each specimen was done with a vortex agitator. The colony-forming units were counted to determine the number of viable adherent bacteria. RESULTS: We found no differences on global bacterial adhesion between the different surfaces (p=0.5). E. coli presented the least adherence potential among the analysed pathogens (p<0.001). The combination of E. coli and S. epidermidis generated an antagonist effect over the adherence potential of S. epidermidis individually (58±4% vs. 48±5%; p=0.007). The combination of P. aeruginosa and S. aureus presented a trend to an increased adherence of P. aeruginosa independently, suggesting an agonist effect (71% vs. 62%; p=0.07). DISCUSSION: Ceramic bearings appeared not to be related to a lower bacterial adhesion than other biomaterials. However, different adhesive potentials among bacteria may play a major role on infection's inception. LEVEL OF EVIDENCE: IV, in vitro study.

Reply to the 'Comment on "Metal-organic green dye: chemical and physical insight into a modified Zn-benzoporphyrin for dye-sensitized solar cells"' by R. Steer, RSC Advances, 2018, DOI: 10.1039/c8ra00213d.

The authors reply to the comment by R. P. Steer discussing the reasons for their incorrect assignment of the luminescence decay of the novel compound 5,10,15-(triphenyl),20-[ethynyl-(4-carboxy)phenyl]tetrabenzoporphyrinate Zn(ii) (PETBP). Further DFT and TDDFT calculations have been performed on the compound to investigate the possibility of a direct S2-S0 decay instead of a S2-S1 conversion with a subsequent emission to the ground state. In addition, the presence of traces of very luminescent contaminants of the ring-opened type has been considered on the grounds of calculated absorption and fluorescence spectra. The results of these investigations confirm that the S2-S0 emission reported in the commented paper is not attributable to the target molecule but rather to a neglected luminescent impurity.

Metaphyseal debonding of the Corail collarless cementless stem: report of 18 cases and case-control study.

AIMS: The Corail stem has good long-term results. After four years of using this stem, we have detected a small group of patients who have presented with symptomatic metaphyseal debonding. The aim of this study was to quantify the incidence of this complication, to delineate the characteristics of patients presenting with this complication and to compare these patients with asymptomatic controls to determine any important predisposing factors. PATIENTS AND METHODS: Of 855 Corail collarless cementless stems implanted for osteoarthritis, 18 presented with symptomatic metaphyseal debonding. A control group of 74 randomly selected patients was assembled. Clinical and radiological parameters were measured and a logistic regression model was created to evaluate factors associated with metaphyseal debonding. RESULTS: The prevalence of this complication was 2.1% in our series. In the multivariable model, the presence of a Dorr B-type proximal femur was associated with metaphyseal debonding (odds ratio (OR) 10.73, 95% confidence interval (CI) 2.31 to 49.97, p = 0.002), as was a body mass index > 25 kg/m2 (OR 6.85, 95% CI 1.06 to 44.28, p = 0.04). Smaller stems and the use of a polyethylene acetabular liner appeared to be protective when compared with metal and ceramic setting hard-on-hard bearings. CONCLUSION: We have described an uncommon but important mode of failure of the Corail stem. Surgeons should be aware of this phenomenon; overweight patients with Dorr B-type femurs and in whom hard bearings are used appear to be particularly at risk. Cite this article: Bone Joint J 2017;99-B:1435-41.

Outcomes using wedge stem with full hydroxiapatite coverage with a minimum of 5 years' follow-up. / Resultados de un vástago con cobertura completa de hidroxiapatita con un seguimiento mínimo de 5 años.

INTRODUCTION: Total Hip Arthroplsty (THA) using uncemented stems is a popular practice in the last decades. The implant survivorship is crtitical and a less than 10% revision at 10 years is been propesed for commercialization and use. OBJECTIVE: To analyse the clinicoradiological results of an uncemented hydroxiapatite covered wedge stem with a 5 years minimum follow up. MATERIAL AND METHODS: Prospective study, patients aged from 21-75years were included. All patients received an Element stem (Exactech) and uncemented cup with crosslink poly and 32 mm metal head, and posterior approach with piriformis retention was used. Scheduled clinical and radiographic evaluation at 3 weeks, 3-6 month, year and subsequent years using Harris Hip Score and Merle d'Aubigné Postel. Intraoperative and during follow up complications were recorded. RESULTS: One hundred and fourteen total hip replacements in 104 patients: 54 females and 50 males (52%/48%). Follow-up of 5.7 years (range, 5-6.2years). Average age 56.8years (range, 42-75years). Clinical evaluation the Merle d'Aubigné score improved 6.8 points and from the initianl Harris Hip Score 47.3 to 93.1 points at last follow up. Radiographic evaluation shows osteointegration in all stems. And in 6 cases (5.3% at 3 months subsidence was detected, average 1.4 mm (range 0-2.6 mm) with no clinical manifestation, 3 cases of subsidence were associated to intraoperative fractures (1 greater trochanter and 2 in the calcar area, all resolved with wire cerclaje). Subjective evaluation: 86 cases (82.6%) excellent, 9 patients (8.6%) good, 6 cases (5.9%) satisfactory and 3 cases (2.9%) poor. All poor results linked to the intraoperative complications. No patient lost during follow up period. No femoral pain dislocation or aseptic or loosening detected. All implants were in situ at last follow up. CONCLUSIONS: The radiological results confirm the benefits of this type of stem with good osteointegration. The clinical and subjective results are promising. With good surgical technical and without complications the risk of aseptic loosening should be absent or minimal.

Treatment of skin defects with growth factors and biodegradable collagen carrier: histological evaluation in animal model.

The aim of the present study is to evaluate the effects on skin regeneration of a new collagen matrix (CM-10826) when used in different combination with or without growth factors, using skin regeneration without membrane as control. An area of 10x15 cm on rabbit back was shaved and three circular wounds on test side were covered with a differently soaked membrane. The first wound was soaked with Epidermal Growth Factor (EGF, 26mg/130mL) (Test EGF), the second with Platelet-Derived Growth Factor (PDGF, 6mg/120mL) (Test PDGF) and the third with EGF (13mg/65mL) and PDGF (3mg/60mL) (Test EGF+PDGF). On the control side, there was a dry membrane. After 7 days, the experiment was concluded. Healing process was evaluated at day 2 and 6 postoperatively. Analysis was made clinically and with light microscopy (LM), transmission electron microscopy (TEM) and scanning electron microscopy (SEM). Analyses with LM of Test EGF showed evidence of neoangiogenesis and good epithelium growth. Test PDGF resulted in moderate angiogenesis, less evident epithelial growth and more evident mesenchymal growth than Test EGF. Test EGF+PDGF showed rich angiogenesis, massive growth of epithelium and mesenchymal tissue. Control side showed weak angiogenesis, regenerating wound margin with normal epithelium and less dense mesenchymal layer. Analysis at TEM and SEM confirmed what was noticed at LM. In vivo studies on rabbits have shown that membrane CM10826 is well tolerated, it gives neither inflammation nor foreign body reactions and does not disturb healing process. CM10826 is safe, modulates angiogenesis and induces migration and proliferation of keratinocytes.

Bi-layered collagen nano-structured membrane prototype collagen matrix 10826® for soft tissue regeneration in rabbits: an in vivo ultra-structural study of the early healing phase.

Collagen Matrix (CM) 10826 is a nanostructured bi-layered collagen membrane obtained from type I and III porcine collagen, which in vitro has shown to have the potential to be a substitute and/or stimulant for soft oral tissue regeneration. The objective of this study was to evaluate the in vivo potential and safety of this membrane for soft tissue regeneration in the early stage of wound healing. Two soft tissue wounds (test and control) were created on the back skin of 5 rabbits (female New Zealand White Rabbits specific pathogen free). All wounds were protected by a special poly-tetra-fluoro-ethylene (PTFE) healing camera. On each rabbit on the test side CM-10826 was used, while on the control side conventional treatment (an autologous pedicle graft) was performed. The healing process was observed clinically after 2 and 6 days, and Magnetic Resonance Imaging (MRI) was performed after this period. After 7 days, animals were sacrificed and specimens were analyzed with light optic microscopy (LM), Transmission Electron Microscopy (TEM) and Scanning Electron Microscopy (SEM). These in vivo trials on rabbits confirmed that CM-10826 is well tolerated, without signs of histological inflammatory reaction and proved to be able to accelerate the spontaneous repair of the skin defect taken as the control. The light-optic and ultra-microscopy of serial biopsies showed that the new matrix is biocompatible and is able to function as a scaffold inducing soft tissue regeneration. In conclusion this study demonstrates that CM-10826 promote early soft tissue regeneration and suggests it is a potential constituent for human autologous keratinocytes seeded derma bioequivalent. It protects the wound from injuries and bacterial contamination accelerating healing process. As a clinical relevance, we consider that the quality of life of patients will be improved avoiding the use of major autologous grafts, reducing the hospitalization time and morbidity.

Impact of palbociclib plus letrozole on pain severity and pain interference with daily activities in patients with estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer as first-line treatment.

Background Palbociclib is a recently approved drug for use in combination with letrozole as initial endocrine-based therapy for the treatment of postmenopausal women with advanced estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer. This report assesses the impact of palbociclib in combination with letrozole versus letrozole alone on patient-reported outcomes of pain. Methods Palbociclib was evaluated in an open-label, randomized, phase II study (PALOMA-1/TRIO-18) among postmenopausal women with advanced ER+/HER2- breast cancer who had not received prior systemic treatment for their advanced disease. Patients received continuous oral letrozole 2.5 mg daily alone or the same letrozole dose and schedule plus oral palbociclib 125 mg, given once daily for 3 weeks followed by 1 week off over repeated 28-day cycles. The primary study endpoint was investigator-assessed progression-free survival in the intent-to-treat population, and these results have recently been published (Finn et al., Lancet Oncol 2015;16:25-35). One of the key secondary endpoints was the evaluation of pain, as measured using the Brief Pain Inventory (BPI) patient-reported outcome tool. The BPI was administered at baseline and on day 1 of every cycle thereafter until disease progression and/or treatment discontinuation. Clinical trial registration This study is registered with ClinicalTrials.gov (NCT00721409). Results There were no statistically significant differences in Pain Severity or Pain Interference scores of the BPI between the two treatment groups for the overall population or among those with any bone disease at baseline. A limitation of the study is that results were not adjusted for the concomitant use of opioids or other medications used to control pain. Conclusions The addition of palbociclib to letrozole was associated with increased efficacy without negatively impacting pain severity or pain interference with daily activities.