A New Transcutaneous Method for Breast Cancer Detection with Dogs.

We developed a new transcutaneous method for breast cancer detection with dogs: 2 dogs were trained to sniff skin secretion samples on compresses that had been worn overnight by women on their breast, and to recognize a breast cancer sample among 4 samples. During the test, the dogs recognized 90.3% of skin secretion breast cancer samples. This proof-of-concept study opens new avenues for the development of a reliable cancer diagnostic tool integrating olfactory abilities of dogs.

Biomodulation induced by fluorescent light energy versus standard of care in venous leg ulcers: a retrospective study.

OBJECTIVE: The recently completed EUREKA study confirmed the efficacy and safety profile of fluorescent light energy (FLE) in treating hard-to-heal wounds. To supplement the EUREKA prospective, observational, uncontrolled trial results, researchers selected one of the EUREKA clinical centres to conduct a retrospective analysis of matching wound care data for 46 venous leg ulcers (VLU) patients who had received standard wound care over a five-year period, compared with 10 EUREKA VLU subjects. METHOD: The study centre selected 46 patients with VLUs based on the matching criteria (wound age and size, patient's age and gender). They compared the healing rates of these matching VLUs with 10 VLU patients treated at the same centre during the EUREKA study. RESULTS: The EUREKA patients had larger and significantly older wounds (p<0.05) and significantly more risk factors (p<0.05) than the matching wounds. However, they had better outcomes (EUREKA: 40% versus matching group: 7% for full wound closure by 16 weeks). No wound breakdown was observed at 16 weeks in the EUREKA group, compared with 25% in the matching group. No EUREKA patient developed infections requiring antibiotics, compared with 37% in the matching group. EUREKA wounds had a mean relative wound area regression (RWAR) of 32% at week six and 50% at week 16, compared with -3% at week six and -6% at week 16 for the matching group. CONCLUSION: These findings show that the system based on FLE was well-tolerated and efficacious, with better clinical outcome results compared with the wounds analysed in this retrospective matching study and treated with standard of care alone.

Optimal wound closure of diabetic foot ulcers with early initiation of TLC-NOSF treatment: post-hoc analysis of Explorer.

OBJECTIVE: In March 2018, the Explorer study, an international, double-blind, randomised controlled trial (RCT), established that adding a TLC-NOSF (UrgoStart Contact, Laboratoires Urgo, France) dressing to good local standard of care (SoC) significantly and substantially increases wound closure and reduces the healing time of neuroischaemic diabetic foot ulcers (DFU). Besides the TLC-NOSF treatment, the wound duration was the only other covariate that had an influence on the wound closure rate in the regression model used in the original study. The purpose of this work was to further document the impact of wound duration on the healing outcomes of the DFUs included in the Explorer study and to discuss complementary pragmatic observations on the TLC-NOSF effect. METHOD: In this post-hoc analysis of the Explorer data, the wound closure rates by week 20 are reported for the global cohort (n=240, Intention-to-treat population) and for the treated (n=126) and control groups (n=114) according to DFU duration and location. RESULTS: For the combined group, wound closure rates decreased with the increase of wound duration at baseline (from 57% in wounds ≤2 months to 19% in wounds >11 months). Whatever the wound duration subgroups analysed, higher closure rates were reported in the TLC-NOSF group than in the control group. However, the maximal difference between the two treatments was reported in wounds with a duration of ≤2 months (71% versus 41%, 30 percentage points difference, Relative Risk 1.7, 95% Confidence Interval 1.1 to 2.8). Regarding wound location subgroup analyses, the outcomes were always in favour of the TLC-NOSF treatment, with closure rates ranging between 43% and 61% within the TLC-NOSF group, and between 25% and 40% within the control group. CONCLUSION: This clinical evidence supports that treating DFUs with TLC-NOSF dressing and good SoC results in higher wound closure rates than with a neutral dressing and the same good standard of care, whatever the duration and the location of the treated wounds. However, the earlier the TLC-NOSF dressing is initiated in DFU treatment, the greater the benefits.

A randomised, controlled, non-inferiority trial comparing the performance of a soft silicone-coated wound contact layer (Mepitel One) with a lipidocolloid wound contact layer (UrgoTul) in the treatment of acute wounds.

Wound contact layer (WCL) dressings are intended to protect tissue during the healing process. A randomised controlled trial was undertaken to compare 2 such dressings. Outpatients with acute wounds were randomly allocated to treatment with either a soft silicone-coated WCL (intervention group, n = 59) or a lipidocolloid-impregnated WCL (control group, n = 62). At the first dressing removal (day 3), 89.8% of patients in the intervention group experienced non-painful dressing removal (defined as a pain rating <30 mm on a 100 mm visual analogue scale), compared with 73.6% of patients in the control group (P = .017) (per protocol population). At day 21, wounds were considered as healed in 66.1% of patients in the intervention group compared with 43.5% in the control group (P = .012) (intention-to-treat population). Both dressings were well tolerated and rated highly in terms of in-use characteristics, although the soft silicone-coated WCL was rated significantly higher than the lipidocolloid-impregnated WCL in terms of its ability to remain in place (P= .016). The results indicate that the soft silicone-coated WCL is suitable for the management of acute wounds as it can minimise dressing-associated pain and support healing.

Prospective, Split-Face, Randomized, Long-Term Blinded Objective Comparison of the Performance and Tolerability of Two New Hyaluronic Acid Fillers.

BACKGROUND: There are requirements for long-term, objective comparisons of hyaluronic acid (HA) dermal fillers. OBJECTIVE: To compare efficacy and tolerability of ART FILLER Universal (AFU) and ART FILLER Fine lines (AFFL) with the existing HA fillers for the treatment of nasolabial folds and crow's feet. MATERIALS AND METHODS: Prospective, randomized, rater- and patient-blind, split-face comparison of AFU with JUVEDERM Ultra 3 (JUV) and AFFL with FIRST LINES PureSense (FLPS). The severity of nasolabial folds and crow's feet was assessed by independent blinded evaluators using the Lemperle scale at baseline, day (D) 30/D45, D90, and D180. Tolerability, Global Aesthetic Improvement Scale (GAIS), wrinkle volumes, and skin thickness and density were also measured at D30/D45, D90, and D180. RESULTS: At D30 and D180 respectively, 61 and 57 patients were assessed. Scores for nasolabial folds and crow's feet showed statistically significant improvements at D30, D90, and D180. AFU and AFFL were noninferior to JUV and FLPS, respectively. Most patients showed GAIS improvements, maintained until at least D180 and significant increases of collagen synthesis in crow's feet and nasolabial folds. Treatments were well tolerated. CONCLUSION: AFU and AFFL are noninferior to comparators. The methodology used represents a novel approach to augment existing clinical assessment of HA fillers.

Topical Erythropoietin Accelerates Wound Closure in Patients with Diabetic Foot Ulcers: A Prospective, Multicenter, Single-Blind, Randomized, Controlled Trial.

The diabetic foot ulcer (DFU) is a major disabling complication of diabetes mellitus. Growing evidence suggests that topical erythropoietin (EPO) can promote wound healing. The aim of this study is to clinically assess the efficacy of a proprietary topical EPO-containing hydrogel for treating DFUs. We conducted a randomized, controlled trial in 20 patients with DFUs. After a 14-day screening period, the DFUs of 20 eligible participants who fulfilled the inclusion criteria were randomly assigned (1:1) to either a 12-week of daily treatment with topical EPO and standard-of-care (SOC) or SOC treatment alone. The DFUs were assessed weekly until week 12. The primary outcome was 75% ulcer closure or higher. After 12 weeks of treatment, 75% ulcer closure was achieved in 6 of the 10 patients whose DFUs were treated with topical EPO and in one of the 8 patients whose DFUs were treated with SOC alone. The mean area of the DFUs that were treated with topical EPO and SOC was significantly smaller than those treated with SOC alone (1.2 ± 1.4 cm2 vs. 4.2 ± 3.4 cm2; p = 0.023). Re-epithelialization was faster in the topically EPO-treated DFUs than in the SOC-treated DFUs. There were no treatment-related adverse events. We conclude that topical EPO is a promising treatment for promoting the healing of DFUs. Clinical Trial Registration number: NCT02361931.

Sucrose octasulfate dressing versus control dressing in patients with neuroischaemic diabetic foot ulcers (Explorer): an international, multicentre, double-blind, randomised, controlled trial.

BACKGROUND: Diabetic foot ulcers are serious and challenging wounds associated with high risk of infection and lower-limb amputation. Ulcers are deemed neuroischaemic if peripheral neuropathy and peripheral artery disease are both present. No satisfactory treatment for neuroischaemic ulcers currently exists, and no evidence supports one particular dressing. We aimed to assess the effect of a sucrose octasulfate dressing versus a control dressing on wound closure in patients with neuroischaemic diabetic foot ulcers. METHODS: We did a randomised, double-blind clinical trial (Explorer) in 43 hospitals with specialised diabetic foot clinics in France, Spain, Italy, Germany, and the UK. Eligible participants were inpatients or outpatients aged 18 years or older with diabetes and a non-infected neuroischaemic diabetic foot ulcer greater than 1 cm2 and of grade IC or IIC (as defined by the University of Texas Diabetic Wound Classification system). We excluded patients with a severe illness that might lead to them discontinuing the trial and those who had surgical revascularisation in the month before study entry. We randomly assigned participants (1:1) via a computer-generated randomisation procedure (concealed block size two); stratified by study centre and wound area (1-5 cm2 and 5-30 cm2), to treatment with either a sucrose octasulfate wound dressing or a control dressing (the same dressing without sucrose octasulfate) for 20 weeks. Both groups otherwise received the same standard of care for a 2-week screening period before randomisation and throughout the 20-week trial. Dressings were applied by nursing staff (or by instructed relatives for some outpatients). Frequencies of dressing changes were decided by the investigator on the basis of the clinical condition of the wound. Patients were assessed 2 weeks after randomisation, then monthly until week 20 or occurrence of wound closure. The primary outcome, assessed by intention-to-treat, was proportion of patients with wound closure at week 20. This trial is registered with ClinicalTrials.gov, number NCT01717183. FINDINGS: Between March 21, 2013, and March 31, 2016, we randomly assigned 240 individuals to treatment: 126 to the sucrose octasulfate dressing and 114 to the control dressing. After 20 weeks, wound closure occurred in 60 patients (48%) in the sucrose octasulfate dressing group and 34 patients (30%) in the control dressing group (18 percentage points difference, 95% CI 5-30; adjusted odds ratio 2·60, 95% CI 1·43-4·73; p=0·002). In both groups, the most frequent adverse events were infections of the target wound: 33 wound infections in 25 (20%) patients of 126 in the sucrose octasulfate dressing group and 36 in 32 (28%) patients of 114 in the control dressing group. Minor amputations not affecting the wound site were also reported in one (1%) patient in the sucrose octasulfate dressing group and two (2%) patients in the control dressing group. Three (2%) patients assigned to the sucrose octasulfate dressing and four (4%) assigned to the control dressing died, but none of the deaths were related to treatment, procedure, wound progression, or subsequent to amputation. INTERPRETATION: A sucrose octasulfate dressing significantly improved wound closure of neuroischaemic diabetic foot ulcers without affecting safety after 20 weeks of treatment along with standard care. These findings support the use of sucrose octasulfate dressing as a local treatment for neuroischaemic diabetic foot ulcers. FUNDING: Laboratoires Urgo Medical.

Efficacy of the Stendo Pulsating suit in patients with leg lymphedema: a pilot randomized study.

BACKGROUND: The "shear stress like" effect of pulsating suit sessions at 65 mm Hg (Stendo(®) device), evidenced in healthy volunteers, might stimulate venous return and act as a physiological pump in lymphedema patients. OBJECTIVES: To evaluate the lower limb total volume (TV) decrease induced by a pulsating suit versus intermittent pneumatic compression (IPC) sessions during a five-day complex decongestive physiotherapy (CDP) treatment. MATERIALS & METHODS: Twenty-four leg lymphedema patients were randomized into a CDP group according to the current practices and a CDP group where IPC was replaced by the pulsating suit. Daily care consisted of manual lymphatic drainage (MLD), one hour IPC or Stendo sessions, and bandaging. The Stendo inflatable suit generates heart rate synchronized compression/decompression applied to the lower part of the body. The IPC device was TP05/TP07 (Eureduc Company). Efficacy was assessed by leg TV changes after 5 days' CDP treatment. RESULTS: TV decreases were more pronounced in the Stendo than the IPC group when adjusted to the baseline TV; TV decrease was 14.2 L (11.2%) in the Stendo group, 11.0 L (8.8%) in the IPC group (p = 0.052 - %TV change p = 0.08). A trend in improved quality of life was reported in favor of the Stendo group over the IPC groups (14.2% [SD: 23.4%] and 6.7% [SD:31.5%], respectively). No adverse event related to the Stendo device was reported. CONCLUSION: The promising Stendo results open the way to larger clinical studies targeting CDP maintenance and moderate lymphedema in outpatient settings.

Cost-effective use of silver dressings for the treatment of hard-to-heal chronic venous leg ulcers.

AIM: To estimate the cost-effectiveness of silver dressings using a health economic model based on time-to-wound-healing in hard-to-heal chronic venous leg ulcers (VLUs). BACKGROUND: Chronic venous ulceration affects 1-3% of the adult population and typically has a protracted course of healing, resulting in considerable costs to the healthcare system. The pathogenesis of VLUs includes excessive and prolonged inflammation which is often related to critical colonisation and early infection. The use of silver dressings to control this bioburden and improve wound healing rates remains controversial. METHODS: A decision tree was constructed to evaluate the cost-effectiveness of treatment with silver compared with non-silver dressings for four weeks in a primary care setting. The outcomes: 'Healed ulcer', 'Healing ulcer' or 'No improvement' were developed, reflecting the relative reduction in ulcer area from baseline to four weeks of treatment. A data set from a recent meta-analysis, based on four RCTs, was applied to the model. RESULTS: Treatment with silver dressings for an initial four weeks was found to give a total cost saving (£141.57) compared with treatment with non-silver dressings. In addition, patients treated with silver dressings had a faster wound closure compared with those who had been treated with non-silver dressings. CONCLUSION: The use of silver dressings improves healing time and can lead to overall cost savings. These results can be used to guide healthcare decision makers in evaluating the economic aspects of treatment with silver dressings in hard-to-heal chronic VLUs.

Efficacy of a synbiotic supplementation in the prevention of common winter diseases in children: a randomized, double-blind, placebo-controlled pilot study.

BACKGROUND AND AIMS: The purpose of this study was to investigate the efficacy of a synbiotic supplementation in reducing common winter diseases in children. METHODS: A randomized, double-blind, placebo-controlled, multicentre study was conducted in young school-age children (3-7 years old) during a winter period. Participants were otherwise healthy children who suffered from at least three episodes of ear, nose and throat (ENT), respiratory tract or gastrointestinal illness during the previous winter. They were supplemented daily with either a synbiotic preparation (Lactobacillus helveticus R0052, Bifidobacterium infantis R0033, Bifidobacterium bifidum R0071, and fructooligosaccharide) or a matched placebo for 3 months. Over this period, all emergent health episodes of any type were recorded by parents in a diary. They were checked by investigators at regular monthly visits. The main study outcome was the percentage of children free of any episode during the study course. RESULTS: We randomized 135 children (mean age: 4.1±1.0 years) to the synbiotic group (n = 62) or placebo (n = 73) group. At least one illness episode was reported in 32 children in the synbiotic group and 50 in the placebo group (51.6% versus 68.5%). This corresponded to a significant 25% relative risk reduction (95% CI 0.6-44.3%; p = 0.045). This difference was due to a decrease in the number of children who suffered from at least one ENT, respiratory tract or gastrointestinal disorder (50.0% with synbiotic versus 67.1% with placebo; p = 0.044). At least one sickness school day loss was noted in 25.8% of children with the synbiotic as compared with 42.5% with placebo (p = 0.043). No treatment related side effects were detected in either group. CONCLUSIONS: This study suggests that a 3-month supplementation with this synbiotic preparation can decrease the risk of occurrence of common infectious diseases in children and limits the risk of school day loss.