Secondary Evaluation Criteria Research Articles

A modified sling mid-urethral suspension + subcutaneous tunnel-double point fixation technique for male stress urinary incontinence: a pilot study.

The aim of this study was to demonstrate the feasibility of a modified sling mid-urethral suspension + subcutaneous tunnel-double point fixation technique for the treatment of male urinary incontinence and to preliminarily evaluate the short-term clinical efficacy of this technique. The clinical data of patients treated with the modified sling mid-urethral suspension + subcutaneous tunnel-double point fixation technique using a Pelvimesh pelvic floor repair patch as a sling were collected. The primary evaluation criteria were surgery-related indicators and daily urinal pad usage before and after treatment, and the secondary evaluation criteria were the corresponding incontinence scores and the results of surgery-related questionnaires. After 1-12months of follow-up, seven patients were clinically cured. Follow-up 1 month after surgery showed that one patient (14.3%) used one pad daily, and six patients (85.7%) did not need pads. The incontinence quality of life questionnaire (I-QOL) scores at 3 days and 1 month postoperatively were 89.4 ± 2.5 and 88.1 ± 6.7, respectively, which were significantly higher than the preoperative scores (31.5 ± 18.9) (P < 0.05). The scores of the International Continence Control Association Incontinence Questionnaire Short Form (ICI-Q-SF) at 3 days and 1 month postoperatively were 3.2 ± 0.9 and 4.2 ± 1.7, respectively, which were significantly lower than the preoperative scores of 19.4 ± 5.0 (P < 0.05). In addition, the results of the surgery-related questionnaires were positive. No serious complications occurred in any of the patients. The modified sling mid-urethral suspension + subcutaneous tunnel-double point fixation technique for the treatment of male urinary incontinence patients is safe, effective, minimally invasive, and has few complications. However, further validation in large sample, randomized, comparative, and longer-term follow-up studies is still needed.

Modified Sling Midurethral Suspension + Hemolock Fixation Technique for Male Urinary Incontinence: A Pilot Study

To demonstrate the feasibility of a modified midurethral sling+hemolock fixation technique for treating male urinary incontinence. This study aims to provide a preliminary assessment of the short-term clinical efficacy of this technique. We collected the clinical data of patients treated with modified sling midurethral suspension+hemolock fixation technique. The primary evaluation criteria were surgery-related indicators and daily urinal pad usage by patients before and after treatment, and the secondary evaluation criteria were the corresponding incontinence scores and the results of surgery-related questionnaires. Follow-up 1-7months, eight patients achieved a clinical cure. Follow-up 1month after surgery showed that two patients (25.0%) used one pad daily and six patients (75.0%) did not need pads. The incontinence quality of life questionnaire (I-QOL) scores were (86.0±7.0) and (89.0±3.0) at three postoperative days and one postoperative month, respectively, which were significantly higher than the preoperative scores (26.0±6.0) (P<.05). The scores of the International Continence Control Association Incontinence Questionnaire Short Form (ICI-Q-SF) at three postoperative days and one postoperative month were (4.0±2.0) and (4.0±1.0), respectively, which were significantly lower than the preoperative scores of (18.0±1.0) (P<.05). Besides, the results of the surgery-related questionnaires were positive. The short-term efficacy of the modified sling midurethral suspension+hemolock fixation technique for the treatment of male urinary incontinence patients is safe, effective, minimally invasive, and has few complications. However, further validation in large samples, randomized, comparative, and longer-term follow-up studies is still needed.

의과대학 역량중심교육과정 평가준거 구안

Objectives The purpose of this study was to propose evaluation criteria for assessing competency-based medical education curriculum, which are currently the main educational programs in medical schools in South Korea. The ultimate goal was to enhance the quality of medical education by establishing evaluation criteria that reflect the characteristics of competency-based medical education curriculum.&#x0D; Methods To achieve this, the study conducted a literature review to identify the characteristics of competencybased medical education curriculum and analyzed existing evaluation models and criteria used in medical education. Based on this analysis, primary evaluation criteria were identified. Subsequently, interviews were conducted with five experts to derive practical elements that should be included in the evaluation criteria, considering the current reality of medical education curriculum in South Korean medical schools. Through the literature review and expert interviews, the final evaluation criteria were developed.&#x0D; Results Through literature analysis, we have developed a framework for evaluation criteria by combining evaluation models that are commonly used in medical education. By analyzing previous studies that mentioned evaluation criteria in the field of medical education, we initially derived 8 evaluation areas, 31 evaluation items, and 73 evaluation indicators. Subsequently, incorporating the secondary evaluation criteria factors derived from expert interviews, we organized them to finalize 5 evaluation areas, 19 evaluation items, and 61 evaluation indicators.&#x0D; Conclusions This study contributes to the development of evaluation criteria and models that reflect the theoretical and practical characteristics of competency-based medical education curriculum in medical schools. Additionally, through the investigation process, it provided in-depth insights into the challenges and areas for improvement faced in implementing competency-based medical education curriculum in current medical schools.

Effect of hormonal treatment on evolution of endometriomas: An observational study

ObjectiveTo evaluate the evolution of endometriomas with or without medical treatment. MethodsThis retrospective observational study was performed at the Gynaecological Center, Hôpital La Conception (Assistance Publique Hopitaux de Marseille). We reviewed clinical data of patients with at least one endometrioma diagnosed by magnetic resonance imaging (MRI) and at least one other MRI exam after more than three months. Patients were divided into groups receiving medical treatment and without medical treatment (high-dose progestins, low-dose progestins or combined contraceptives). The primary objective was to evaluate the evolution of endometriomas with or without hormonal treatment. The primary evaluation criterion was the diameter of the endometriomas, and the secondary evaluation criterion was the number of endometriomas for each patient observed. The secondary objective was to evaluate whether different categories of hormonal treatment have different efficacity in the evolution of endometriomas. ResultsWe included 68 patients, 39 (57,4%) with hormonal treatment and 29 (42,6%) without hormonal treatment. There were 105 total endometriomas identified at the first MRI, 52 in patients with hormonal treatment and 53 in patients without treatment. The mean diameter of the endometriomas in patients with hormonal treatment was 31,48 ± 18,1 mm at the first MRI and 23,60 ± 15,3 mm at the second MRI. The mean diameter of the endometriomas in patients without treatment was 33,57 ± 19,7 mm at the first MRI and 40,11 ± 25,7 mm at the second MRI (statistically significant difference, p = 0.01). The mean number of endometriomas in patients with treatment was 1,79 ± 1,1 at the first MRI and 1,18 ± 0,9 at the second MRI, while the mean number of endometriomas in patients without hormonal treatment was 1,38 ± 0,6 at the first MRI and 1,97 ± 1,5 at the second MRI (difference not statistically significant, p = 0.38). The subgroup analysis differentiated by category of hormonal treatment did not show statistically significant results. ConclusionsThe present study shows that there is a positive effect of hormonal treatment on reducing the diameter of endometriomas and also a significative increase in endometrioma size in the absence of treatment. There is no evidence of an advantage of a single category of hormonal treatment on this effect on endometriomas. Thus, any medical treatment could be proposed as a first-line therapy for endometriomas that would reduce the size of the endometrioma and thereby help to avoid surgical intervention.

Impact of Sarcopenia on Patients with Localized Pancreatic Ductal Adenocarcinoma Receiving FOLFIRINOX or Gemcitabine as Adjuvant Chemotherapy.

Despite its toxicity, modified FOLFIRINOX is the main chemotherapy for localized, operable pancreatic adenocarcinomas. Sarcopenia is known as a factor in lower overall survival (OS). The purpose of this study was to assess the impact of sarcopenia on OS in patients with localized pancreatic ductal adenocarcinoma (PDAC) who received modified FOLFIRINOX or gemcitabine as adjuvant chemotherapy. Patients with operated PDAC who received gemcitabine-based (GEM group) or oxaliplatin-based (OXA group) adjuvant chemotherapy between 2008 and 2021 were retrospectively included. Sarcopenia was estimated on a baseline computed tomography (CT) examination using the skeletal muscular index (SMI). The primary evaluation criterion was OS. Secondary evaluation criteria were disease-free survival (DFS) and toxicity. Seventy patients treated with gemcitabine-based (n = 49) and oxaliplatin-based (n = 21) chemotherapy were included, with a total of fifteen sarcopenic patients (eight in the GEM group and seven in the OXA group). The median OS was shorter in sarcopenic patients (25 months) compared to non-sarcopenic patients (158 months) (p = 0.01). A longer OS was observed in GEM non-sarcopenic patients (158 months) compared to OXA sarcopenic patients (14.4 months) (p &lt; 0.01). The median OS was 157.7 months in the GEM group vs. 34.1 months in the OXA group (p = 0.13). No differences in median DFS were found between the GEM group and OXA group. More toxicity events were observed in the OXA group (50%) than in the GEM group (10%), including vomiting (p = 0.02), mucositis (p = 0.01) and neuropathy (p = 0.01). Sarcopenia is associated with a worse prognosis in patients with localized operated PDAC whatever the delivered adjuvant chemotherapy.

Therapeutic effectiveness and safety of sintilimab-dominated triple therapy in unresectable hepatocellular carcinoma

Immune checkpoint inhibitor therapy has shown promising results in patients with unresectable hepatocellular carcinoma. This study aimed to evaluate the effectiveness and safety of sintilimab, a programmed cell death protein-1 (PD-1) blockade, combined with sorafenib and transhepatic arterial chemotherapy and embolization in this patient population, compared with sintilimab monotherapy and sintilimab-sorafenib duotherapy. This was a 22 months single center retrospective cohort study in China. 80 patients with unresectable hepatocellular carcinoma were included, with diagnosis confirmed by either histologic, cytologic or diagnostic imaging analysis. The patients were divided into three groups based on therapeutic regimen: sintilimab monotherapy (sintilimab group, n = 22), sintilimab-sorafenib duotherapy (duplex group, n = 23), sintilimab-sorafenib and transcatheter arterial chemoembolization combined therapy (triple group, n = 35). The principal evaluation criteria were overall survival and progression free survival in the population, assessed according to response evaluation criteria in solid tumors, version 1.1 (RECIST 1.1). Secondary evaluation criteria were safety, objective response rate and disease control rate. From March 1st, 2019 to December 31, 2020, 80 patients with unresectable hepatocellular carcinoma were included and divided into three treatment groups (22 received sintilimab monotherapy, 23 received sintilimab-sorafenib duotherapy, and 35 received sintilimab-sorafenib combined with transcatheter arterial chemoembolization). The median overall survival of all patients was 11.0 months (95% CI 7.7–14.3). Median overall survival was 13.0 months (95% CI NE–NE), 9.0 months(95% CI 6.3–11.7)and 3.0 months (95% CI 1.9–4.1, p < 0.0001) in the triple therapy, duplex and sintilimab groups respectively, while the corresponding median progression-free survival were 5.0 months (95% CI 2.9–7.1, p < 0.001), 4.0 months (95% CI 2.8–5.2) and 2.0 months (95% CI 1.7–2.3). Disease control and clinical benefits rates were higher in the triple therapy group (80%, 95% CI 63.1–91.6, p < 0.001; 54.3%, 95% CI 36.6–71.2, p < 0.01) compared to the sintilimab group. Median duration of disease control was 4.0 months (95% CI NE–NE, p < 0.01) in the triple therapy group, longer than that of the duplex group (2.0 months, 95% CI 0.9–3.1) and sintilimab group (2.0 months, 95% CI 0.8–3.2). Grade 3 or 4 treatment-related adverse events occurred in 26.3% of 80 patients with hypertension was the most common event observed (38, 47.5%), however, other severe toxic effects were infrequent. Sintilimab combined with sorafenib and transcatheter arterial chemoembolization might have more beneficial effects on overall and progression-free survival and on the duration of disease control outcomes than both sintilimab monotherapy and sintilimab-sorafenib duotherapy in patients with unresectable hepatocellular carcinoma. This triple therapy model might represent an innovative and effective option for inoperable liver cancer.

A study of patients\u2019 quality of life more than 5\xa0years after trauma: a prospective follow-up

BackgroundThe long-term fate of severely injured patients in terms of their quality of life is not well known. Our aim was to assess the quality of life of patients who have suffered moderate to severe trauma and to identify primary factors of long-term quality of life impairment.MethodsA prospective monocentric study conducted on a number of patients who were victims of moderate to severe injuries during the year 2012. Patients were selected based on an Injury Severity Score (ISS) more than or equal to 9. Quality of life was assessed by the MOS SF-36 and NHP scores as a primary evaluation criterion. The secondary evaluation criteria were the determination of the socio-economic impact on quality of life and the identification of factors associated with disability.ResultsTwo hundred and eight patients were contacted by e-mail or telephone. Fifty-five patients participated in this study (with a participation level of 26.4%), including 78.2% men, with a median age of 46. Significant alterations in quality of life were observed with the NHP and MOS SF-36 scale, including physical and psychological components. This resulted in a major socio-economic impact as 26% of the patients could not resume their professional activities (n = 10), 20% required retraining in other lines of work, and 36.4% had a disability status. The study showed that scores ≤ 85 on the physical functioning variable of the MOS SF 36 scale was associated with disability.ConclusionMore than five years after a moderate to severe injury, patients’ quality of life was significantly impacted, resulting in significant socio-economic consequences. Disability secondary to major trauma seems to be associated with a score ≤ 85 on the physical functioning dimension of the MOS SF-36 scale. This study raises the question of whether or not early rehabilitation programs should be implemented in order to limit the long-term impact of major trauma.

Oral rehabilitation after squamous cell carcinoma mandibular resection

Introduction:Squamous cell carcinoma of the oral cavity is the most common cause of mandibular defect. The functional and aesthetic impacts of this surgery must be considered. The number of mandibular resections depends on the TNM classification of the tumor. Mandibular reconstruction by a fibula free flap has become the gold standard. Unfortunately, not all mandibular resections are rehabilitated. The purpose of this study is to evaluate oral rehabilitation after mandibular resection in patients with squamous cell carcinoma.Materials and methods:A retrospective study was conducted to evaluate oral rehabilitations according to the type of surgical resection and reconstruction. The secondary evaluation criteria were type of rehabilitation, implant success rate, post-radiotherapy delay, rehabilitation success rate, and causes of non-rehabilitation.Results:The study included 157 patients with mandibular resection. Of the patients, 26.7 percent received oral rehabilitation. All rehabilitation with implants was functional. The main causes of non-rehabilitation were death or recurrences related to the progression of the disease, postoperative anatomical difficulties, and cost of oral rehabilitation.Conclusion:Oral rehabilitation after mandibular resection surgery is insufficient. A rehabilitation unit including a maxillofacial surgeon, oral surgeon, and dentist is essential. Implementation of the unit should be considered as soon as possible. The cost of rehabilitation should not be a limiting factor.

Ten-year Evaluation of a Large Retrospective Cohort Treated by Sacral Nerve Modulation for Fecal Incontinence: Results of a French Multicenter Study.

The aim of this study was to assess the effectiveness of sacral nerve modulation (SNM) in a large cohort of patients implanted for at least 10 years, quantify adverse event rates, and identify predictive factors of long-term success. Few studies have evaluated the long-term success of SNM. Data collected prospectively from patients implanted for fecal incontinence (FI) in 7 French centers between January 1998 and December 2008 were retrospectively analyzed. Patient FI severity scores were assessed before and 10 years after implantation. The main evaluation criterion was the success of SNM defined by the continuation of the treatment without additional therapies. The secondary evaluation criteria were the rate of device revisions and explantations. Preoperative predictors of success at 10 years were sought. Of the 360 patients (27 males, mean age: 59 ± 12 years) implanted for FI, 162 (45%) had a favorable outcome 10 years post-implantation, 115 (31.9%) failed, and 83 (23.1%) were lost to follow-up. The favorable outcome derived from the time-to-event Kaplan-Meier curve at 10 years was 0.64 (95% CI 0.58-0.69). FI severity scores were significantly better 10 years post-implantation compared to preimplantation (7.4 ± 4.3 vs 14.0 ± 3.2; P < 0.0001). During the 10-year follow-up, 233 patients (64.7%) had a surgical revision and 94 (26.1%) were explanted. A history of surgery for FI and sex (male) were associated with an increased risk of an unfavorable outcome. Long-term efficacy was maintained in approximately half of the FI patients treated by SNM at least 10 years post-implantation.

Preoperative Osteopathic Manipulative Therapy Improves Postoperative Pain and Reduces Opioid Consumption After Total Knee Arthroplasty: A Prospective Comparative Study.

Pain is a therapeutic challenge after total knee arthroplasty (TKA), and it could lead to the overuse of opioids. Few methodologically robust clinical studies have been performed to assess the effectiveness of osteopathic manipulative therapy (OMTh; manipulative care performed by non-US-trained osteopaths) for postsurgical pain. To evaluate the effectiveness of standardized preoperative OMTh on early postoperative pain and opioid consumption after TKA. This comparative, nonrandomized study took place from 2013 to 2015 and included patients who had primary unilateral TKA for osteoarthritis in a knee that had not undergone any previous surgery. Patients were divided into 2 consecutive groups: 1 group received traditional preoperative management, and the other group received associated preoperative OMTh (general OMTh [rhythmic mobilization of all the body joints, from the ankles to the skull, using long-lever manipulation] and myofascial relaxation). The primary evaluation criterion was knee pain at rest 1 month after surgery: 0 (no pain) to 100 (the worst imaginable pain). The secondary evaluation criteria were: (1) knee pain while walking 1 month after surgery, (2) average weekly knee pain during the first month after surgery, (3) the presence of night pain and the consumption of sleeping pills and opioids or morphine at least once per week, (4) the International Knee Society scores and the Western Ontario and McMaster University Osteoarthritis index at postoperative 6 months and 1 year. The number of patients needed for a superiority trial was determined. No eligible patient refused OMTh when proposed. Seventy patients were evaluated (mean [SD] age, 75 [8] years; 47 women and 23 men). The 2 treatment groups contained 35 patients each. At postoperative month 1, the OMTh group had significantly less pain at rest (mean [SD], 6.8 [6] vs 20.9 [17.3]; P=.00001) and while walking (7.9 [9.4] vs 23.5 [20.6]; P=.0001) compared with the group that received traditional preoperative management. The consumption of opioids during the first postoperative week was significantly lower in the OMTh group (P=.0001). No statistically significant difference was found in the International Knee Society or Western Ontario and McMaster University Osteoarthritis scores between the 2 groups at 6 months and 1 year of follow-up. Standardized preoperative OMTh was found to be effective in reducing pain in the first month after TKA for osteoarthritis and significantly reduced opioid consumption during the first postoperative week.

Influence of operative technique on anterior cruciate ligament reconstruction in patients older than 50 years

BackgroundA consequence of the steady growth in the worldwide population of elderly individuals who remain in good health and continue to engage in sports is an increase in the incidence of anterior cruciate ligament (ACL) rupture occurring after 50 years of age. ACL reconstruction was formerly reserved for young athletes but now seems to produce good outcomes in over 50s. The type of graft and graft fixation method were selected empirically until now, given the absence of investigations into potential relationships of these two parameters with the outcomes. The objective of this study was to assess associations linking the type of graft and the method of femoral graft fixation to outcomes in patients older than 50 years at ACL reconstruction. HypothesisThe operative technique is not associated with the clinical outcomes or differential laxity. Material and methodsA multicentre retrospective cohort of 398 patients operated between 1 January 2011 and 31 December 2015 and a multicentre prospective cohort of 228 patients operated between 1 January 2016 and 30 June 2017 were conducted. Mean follow-up was 42.7 months in the retrospective cohort and 14.2 months in the prospective cohort. The primary evaluation criterion was the clinical outcome as assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Tegner Activity Score (TAS). Differential laxity was the secondary evaluation criterion. The Wilcoxon rank sum test and Kruskal-Wallis test were used to compare groups, and p-values<0.05 were considered significant. ResultsIn the retrospective and prospective cohorts, hamstring tendons were used in 269 (67.6%) and 197 (86.4%) patients and extensor apparatus tendons in 124 (31.2%) and 31 (13.6%) patients. Femoral fixation in the retrospective cohort was cortical in 81 (20.4%) cases, by press-fit in 112 (28.1%) cases, and by interference screw in 205 (51.5%) cases; corresponding figures in the prospective cohort were 135 (59.2%), 17 (7.5%), and 76 (33.3%). The multivariate analysis of the retrospective data identified no significant associations of graft type or femoral fixation type with the KOOS, TAS, or differential laxity values. In the prospective cohort, hamstring grafts were associated with 0.6mm of additional laxity (p=0.007); compared to cortical fixation, press-fit fixation of patellar tendon grafts was associated with 0.3mm of additional laxity (p=0.029) and a 0.5-point lower TAS value (p=0.033), with no difference in KOOS values. None of these differences were clinically significant. DiscussionThe various ACL reconstruction techniques used in patients older than 50 years produce similar outcomes. The technique can be chosen based on surgeon preference without regard for patient age. Level of evidenceIV.

Femoral neck shortening after internal fixation of Garden I fractures increases the risk of femoral head collapse

BackgroundArthroplasty has not been proven superior over internal fixation for the treatment of non-displaced femoral neck fractures. However, internal fixation has been followed by high rates of revision for mechanical complications and of femoral neck impaction within the first postoperative year. The objective of this study was to determine whether femoral neck impaction was associated with avascular necrosis (AVN). HypothesisFracture healing with femoral neck shortening by impaction after internal fixation of a femoral neck fracture is associated with AVN. Material and methodsA single-centre retrospective study in patients with Garden I fractures managed by screw fixation was performed to compare outcomes in the groups with and without femoral neck impaction. Follow-up radiographs were assessed for evidence of the femoral neck impaction during fracture healing. The occurrence of AVN was the primary evaluation criterion. The secondary evaluation criteria were risk factors for impaction and complications. ResultsOf the 75 included patients, 9 (12%) experienced AVN. Impaction was significantly associated with AVN (p=0.02; relative risk, 4.38). Significant risk factors for impaction were a higher body mass index (p=0.0003) and valgus-impacted fracture reduction between the radiographs at baseline and immediately after surgery (p=0.0001). DiscussionFemoral neck impaction was a significant risk factor for AVN after screw fixation of Garden I fractures. Valgus-impacted fracture reduction must receive careful attention during fixation. We suggest static internal fixation if the impaction is reduced on a traction table and advise caution when using parallel screws. The diagnostic and therapeutic strategy proposed here deserves to be evaluated in a prospective study. Level of evidenceIII, retrospective comparative study.

Quality, Non-clinical and Clinical Considerations for Biosimilar Monoclonal Antibody Development: EU, WHO, USA, Canada, and BRICS-TM Regulatory Guidelines.

Objective: The aim was to critically evaluate well-established regulatory agencies mAb biosimilar guidelines for development and marketing authorization about quality, efficacy and safety and compare to BRICS-TM regulations to identify challenges.Materials and Methods: The current valid guidelines of EMA, WHO, USFDA, BGTD/HC, ICH, and BRICS-TM were obtained from official websites and comparative qualitative review was performed.Results: The review revealed that Health Canada uses mAb specific guidelines from EMA or USFDA when necessary. The BRICS agencies (except Russia) have incorporated some or most of the WHO SBP TRS and related annexes in similar national biotechnological/biological guidelines; however, gaps or insufficient information have been identified. The Russian Federation has issued general product registration guideline/s with very brief information about mAbs. The TMMDA (Turkey) has published an updated biosimilar guideline which parallels those of the EMA and the ones from WHO; however, no mAb specific guidelines are published. COFEPRIS (Mexico) has published a biotechnological/biological product registration guideline with no information about mAb. The SAHPRA biosimilar guideline has an annex on mAbs which focuses on non-clinical and clinical aspects.The comparative evaluation of BRICS-TM agencies indicates a gap pertaining to clarification for physico-chemical characterization, manufacturing process, overages and compatibility requirements between biological substances and excipients specifically on mAbs. In vitro assay requirements seem quite aligned with those of WHO, whereas in vivo studies mostly have disparity in terms of necessity, type of studies as well as design and criteria. Clinical safety and efficacy studies are indicated in emerging regulatory agencies, however detailed information pertaining to design, size of populations, requirements for primary and secondary endpoints, clarity and evaluation criteria differ. In general, BRICS-TM agencies allow extrapolation of indications provided that pre-defined conditions are met. Interchangeability, switching and substitution of biosimilars are not defined in most of BRIC-TM guidelines whereas South Africa, by law, allows neither interchangeability nor substitution. Pediatric research remains questionable across BRICS-TM.Conclusions: EMA, USFDA guidelines are broadly aligned with WHO and in addition, they also contain specific requirements pertaining to their own region. BRICS-TM has considerably less defined mAb specific biosimilar development and comparability parameters in their published guidelines.

Use of Cellutome for the healing of venous or mixed ulcers

Venous or mixed ulcers are common and invalidating. Cutaneous transplants may be necessary if conventional treatment is ineffective. We evaluated the performance of Cellutome in promoting the healing of venous or mixed ulcers 2 months after grafting. This was a retrospective, multi-centric, descriptive study of patients who had a venous or mixed ulcer for at least several months and who received an autologous skin graft using the Cellutome system at least 2 months before. The principle evaluation criterion was the state of the wound after 2 months (completely healed vs not healed). The secondary evaluation criterion was the percentage of wound healing after 2 months. A total of 47 patients were included in the study. The ulcers had evolved over an average of 18 months. The average surface area was 13.37 cm2 . After 2 months, the grafts of 26 of 47 patients (55.3%) were completely healed. The grafts of 21 patients (44.6%) were not completely healed but showed an average rate of healing of 51%. Use of the Cellutome system for epidermal transplants promoted complete or improved healing after 2 months for 55.3% of patients with chronic venous or mixed ulcers. The limited data on the rate of healing of conventional transplants in the literature report rates of approximately 50%. The Cellutome system may therefore be of interest as the healing rate is similar to that of conventional techniques, but using a much simpler, painless procedure on an outpatient basis.

Efficacy of cloxacillin versus cefazolin for methicillin-susceptible Staphylococcus aureus bacteraemia (CloCeBa): study protocol for a randomised, controlled, non-inferiority trial

IntroductionMethicillin-susceptible Staphylococcus aureus (MSSA) bacteraemia is a common and severe disease responsible for approximately 65 000 deaths every year in Europe. Intravenous antistaphylococcal penicillins (ASP) such as cloxacillin are the...

Oxygen equimolar mixture of nitrous oxide during post-operative physiotherapy in patients with cerebral palsy: A randomised double-blind placebo-controlled study

The administration of an equimolar mixture of nitrous oxide-oxygen (N 2 O) is recommended during painful procedures. However, the evaluation of its use during physiotherapy after surgery has not been reported, although pain may hamper physiotherapy efficiency. This study investigated whether the use of N 2 O improves the efficacy of post-operative physiotherapy after multilevel surgery in patients with cerebral palsy. It was a randomised 1:1, double-blind, placebo-controlled study. Sixty-four patients were enrolled. All patients had post-operative physiotherapy starting the day after surgery. Patients received either N 2 O or placebo gas during the rehabilitation sessions. All patients had post-operative pain management protocol, including pain medication as needed for acute pain. The primary objective was to reach angles of knee flexion of 110° combined with hip extension of 10°, with the patient lying prone, within 6 or less physiotherapy sessions. Secondary evaluation criteria were the number of sessions required to reach the targeted angles, the session-related pain intensity, and the analgesics consumption for managing post-operative pain. Targeted angles were achieved more often in the N 2 O group (23/32, 72%, vs. Placebo: 13/32, 41%; P = 0.01). Patients treated with N 2 O tended to require less often level III analgesic agents for managing post-operative pain, compared to those receiving placebo: 18/32 (58%) vs. 24/32 (75%). The administration of N 2 O during post-operative physiotherapy can help to achieve more quickly an improved range of motion, and, although not significant in our study, to alleviate the need for pain medication. Further studies evaluating the administration of N 2 O in various settings are warranted.

MSPMI study: Medical spastic patient machine interface MSPMI: Preliminary results

Spasticity scales present poor metrologic qualities, especially concerning reliability. It allows qualitative assessement without distinction of neural and non-neural component. In 2005, the SPASM consortium published recommandations for promoting the developpement of instrumented devices devoted to spasticity assessment, recommandations renewed recently in an european consensus. The MSPMI ( Medical Spastic Patient Machine Interface MSPMI ) has been created in the UMR 7338 in Compiègne, designed for the study of triceps surae spasticity. The study MSPMI aims to measure the metrologic properties of this new tool. We present here the preliminary results on the first 15 patients. Interventional monocentric study with minimal risks and constraints conducted on the Nantes University Hospital. The inclusion criterion was spasticity defined as a minimal score of 1 on the modified Ashworth scale. 25 ankles were evaluated (15 subjects). Each patient was evaluated by two raters during the same session. The evaluation included passive stretch of the triceps surae according to 6 experimental conditions. The collected parameters were the Ashworth and Modified Tardieu scales and 25 kinematic, kinetic, electromyographic and mechanical parameters given by the MSPMI. Inter-observer reliability was evaluated by measuring an intra-class correlation coefficient (ICC) and the concurrent validity by a Spearman correlation test with a significance threshold set at 5% Sixteen of the 25 parameters have good inter-rater reliability (ICC > 0.6) and 7 of them have an ICC > 0.8. At intermediate speed, 56% of the parameters are significantly correlated to the modified modified Ashworth and Tardieu scales. Correlations are mostly moderate to good. The work variability index has an ICC of 0.85 and a good to moderate significant correlation at the clinical scales. The preliminary results of the IIMPS study are encouraging. The rest of this work will complete the study of the secondary evaluation criteria.

The role of Dexamethasone in clinical pharmaceutical treatment for patients with cataract surgery.

The aim of the present study is to determine the efficacy of dexamethasone (DEX) vs. indomethacin (IND) and ciprofloxacin (CIP) in modulating immediate inflammation following cataract surgery. A total of 644 patients with cataract were recruited and inflammation was investigated during the perioperative period. The management protocol was similar in both groups. Each drug was given four times a day for 30 days starting 7 days prior to surgery. The primary efficacy criteria for evaluation were the reduction in anterior chamber (AC) flare and AC inflammation score, in addition, a different secondary efficacy and safety evaluation criteria were maintained. The results demonstrated that the average inflammation score was 1.2±0.8 in the DEX group, which was significantly lower compared with the IND (1.9±0.7) and CIP (1.8±0.6) groups. Intra-ocular pressure was decreased following treatment with DEX, while intra-ocular pressure was slightly increased in the IND (1.9±0.7) and CIP (1.8±0.6) groups. The final visual outcomes for patients postcataract surgery were clinically superior in the DEX group compared with that of the IND and CIP groups (P=0.034 and P=0.042, respectively), but there was no significant difference between the ND and CIP groups (P=0.78). Outcomes indicated that AC inflammation, conjunctival hyperaemia, corneal and lid oedema, ocular infection, pain, photophobia, and tearing were significantly improved in each group. No significant poor local tolerance or adverse reaction was observed in the DEX, IND and CIP groups. In conclusion, the outcomes of the present study suggest that DEX serves an important role in the clinical pharmaceutical treatment of patients with cataract surgery.

Equimolar mixture of nitroux oxyde and oxygen during post-operative physiotherapy in patients with cerebral palsy: A randomized, double-blind, placebo-controlled study.

The administration of an equimolar mixture of nitrous oxide and oxygen (N2O) is recommended during painful procedures. However, the evaluation of its use during physiotherapy after surgery has not been reported, although pain may hamper physiotherapy efficiency. This study investigated whether the use of N2O improves the efficacy of post-operative physiotherapy after multilevel surgery in patients with cerebral palsy. It was a randomized 1:1, double-blind, placebo-controlled study. All patients had post-operative physiotherapy starting the day after surgery. Patients received either N2O or placebo gas during the rehabilitation sessions. All patients had post-operative pain management protocol, including pain medication as needed for acute pain. The primary objective was to reach angles of knee flexion of 110° combined with hip extension of 10°, with the patient lying prone, within six or less physiotherapy sessions. Secondary evaluation criteria were the number of sessions required to reach the targeted angles, the session-related pain intensity and the analgesics consumption for managing post-operative pain. Sixty-four patients were enrolled. Targeted angles were achieved more often in the N2O group (23 of 32, 72%, vs. Placebo: 13/ of 32, 41%; p=0.01). The administration of N2O during post-operative physiotherapy can help to achieve more quickly an improved range of motion, and, although not significant in our study, to alleviate the need for pain medication. Further studies evaluating the administration of N2O in various settings are warranted. During this randomized placebo-controlled double-blind study, children receiving nitrous oxide and oxygen (N2O) achieved more often the targeted range of motion during physiotherapy sessions after multilevel surgery. Compared to placebo, nitrous oxide and oxygen (N2O) enabled a better management of acute pain related to physiotherapy procedures.

Cadaver study of anatomic landmark identification for placing ankle arthroscopy portals

BackgroundArthroscopy-assisted surgery is now widely used at the ankle for osteochondral lesions of the talus, anterior and posterior impingement syndromes, talocrural or subtalar fusion, foreign body removal, and ankle instability. Injuries to the vessels and nerves may occur during these procedures. ObjectiveTo determine whether ultrasound topographic identification of vulnerable structures decreased the risk of iatrogenic injuries to vessels, nerves, and tendons and influenced the distance separating vulnerable structures from the arthroscope introduced through four different portals. HypothesisUltrasonography to identify vulnerable structures before or during arthroscopic surgery on the ankle may be useful. Material and methodTwenty fresh cadaver ankles from body donations to the anatomy institute in Strasbourg, France, were divided into two equal groups. Preoperative ultrasonography to mark the trajectories of vessels, nerves, and tendons was performed in one group but not in the other. The portals were created using a 4-mm trocar. Each portal was then dissected. The primary evaluation criterion was the presence or absence of injuries to vessels, nerves, and tendons. The secondary evaluation criterion was the distance between these structures and the arthroscope. ResultsNo tendon injuries occurred with ultrasonography. Without ultrasonography, there were two full-thickness tendon lesions, one to the extensor hallucis longus and the other to the Achilles tendon. Furthermore, with the anterolateral, anteromedial, and posteromedial portals, the distance separating the vessels and nerves from the arthroscope was greater with than without ultrasonography (P=0.041, P=0.005, and P=0.002), respectively; no significant difference was found with the anterior portal. DiscussionPreoperative ultrasound topographic identification decreases the risk of iatrogenic injury to the vessels, nerves, and tendons during ankle arthroscopy and places these structures at a safer distance from the arthroscope. Our hypothesis was confirmed. Level of evidenceIV, cadaver study.