The advent of telemedicine has significantly transformed the healthcare landscape, offering enhanced accessibility to specialised wound care. By integrating digital health solutions, complementary to face-to-face care, in a personalised care pathway telemedicine facilitates timely interventions, reduces unnecessary hospital visits and optimises medical resources. Developing recommendations on the effective use of telemedicine in wound care can encourage good practice. The model proposed by the Haute Autorité de Santé (the French National Authority of Health) consists of developing recommendations for good clinical practice through formal consensus. To this end, and following a Delphi process, a panel of wound care experts was convened, including physicians and nurses of various disciplines involved in wound management (wound healing; dermatology; geriatrics; vascular medicine; vascular surgery; physical and rehabilitation medicine; and plastic and reconstructive surgery); and from a range of organisations (public/state, private, collaborative, independent). As a first step, an extensive review of the evidence-based literature was conducted on the use of telemedicine. Questions were developed by the strategic committee (formed of 10 experts) and proposed to a scoring committee composed of 20 experts in wound healing who established a consensus agreement. Levels of consensus were determined through two successive rounds of consultation. The resulting document was proposed to the lecture committee, composed of 50 experts and non-experts, which reviewed and amended the proposed text. This document reflects the importance of e-health technologies which have emerged since the COVID-19 pandemic in complex wounds.
OBJECTIVE:Chronic wounds, such as venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs), remain a major healthcare challenge, particularly in France, where their management is complex and resource-intensive. Technology lipido-colloid nano-oligosaccharide factor (TLC-NOSF) dressings have demonstrated the ability to modulate the wound microenvironment, inhibit excessive matrix metalloproteinase activity and accelerate healing. Despite strong evidence and national recommendations, their use in routine practice remains limited. The STARTLIFE study aimed to generate additional real-life evidence on the effectiveness of TLC-NOSF dressings in VLUs and DFUs across diverse care settings. METHOD:STARTLIFE was a prospective, multicentre, non-interventional French observational study. TLC-NOSF dressings (UrgoStart Plus Border/Pad, UrgoStart Contact, Laboratoires Urgo, France) were used according to clinical practice. The primary endpoint was complete healing within 12 weeks; secondary outcomes included wound healing progression and dressing performance. RESULTS:From June 2022-July 2024, 229 VLUs and 138 DFUs were included at 53 French sites. Among patients with VLUs, 44.5% achieved complete healing after 72 days, with a median healing time of 60 days. In patients with DFUs, 36.8% achieved complete closure after 78 days, with a median healing time of 64 days. Earlier initiation of TLC-NOSF treatment was associated with better outcomes in both groups. Both patient and clinician satisfaction with comfort and efficacy were high. CONCLUSION:The findings of the STARTLIFE study provide real-life evidence demonstrating the effectiveness, safety and high acceptability of TLC-NOSF dressings in the management of VLUs and DFUs when associated with appropriate standard of care. The diverse range of TLC-NOSF dressings supports personalised wound care and reinforces its use as a first-line intervention throughout the healing process.
OBJECTIVE:Pain induced by dressing removal is an important clinical problem in the management of acute wounds. Contact layer dressings are intended to protect the wound and minimise pain. This study was designed to compare two dressings of this type in terms of pain induced at the first dressing removal. METHOD:Patients with acute wounds were randomly assigned to treatment with either an investigational product (n=78) or a comparator (n=81), and received treatment until their wound healed, or for a maximum period of 23 days. RESULTS:By the first dressing change (day 3±2), minimal pain (<30mm on a 100mm visual analogue scale) was observed by 97.4% of patients in the intervention group and 97.5% of patients in the control group (modified intention-to-treat population (mITT)). For both mITT and per protocol populations, the lower bound of the unilateral 97.5% confidence interval did not exceed the prespecified -10.0% non-inferiority margin; thus, the non-inferiority of the investigational product to comparator was confirmed. In total, 64.8% of patients achieved wound healing by day 21±2. Time to wound closure, estimated for 50% of the patients using the Kaplan-Meier model, was 20±1.9 days for the intervention group and 19±2.7 days for the control group. The re-epithelialisation area doubled from baseline to day 21±2 in both groups. The opposite trend was observed for granulation, fibrin and necrosis areas. The number of periwound skin abnormalities significantly decreased in both groups. A good safety profile was demonstrated. CONCLUSION:The results of this study showed that the investigational product supported healing and was non-inferior to the comparator in minimising dressing-associated pain in acute wounds.
OBJECTIVES:Deep dissecting hematomas (DDHs) represent severe acute wounds, predominantly affecting older patients. This study aimed to identify DDH risk factors and analyze factors associated with good wound-healing prognosis. DESIGN:Retrospective, multicenter, case-control study from January 2016 to March 2022. SETTING AND PARTICIPANTS:A total of 240 patients, 60 patients with DDH and 180 controls with venous or arterial ulcers. METHODS:Primary endpoint was analysis of demographic and clinical parameter differences between patients and controls to identify DDH risk factors. Secondary endpoint was analysis of DDH-wound healing to identify factors associated with good prognosis defined as ≥40% healing of the initial wound 1 month after debridement. RESULTS:Patients were mainly female (n = 47, 78%), 63% misdiagnosed, median age: 87 years, and median Cumulative Illness Rating Scale (CIRS) score: 20/56. The low limb was the main DDH localization. Thirty-three (55%) patients had dermatoporosis, 53 (88%) were malnourished, and 51 (85%) had peripheral vascular disease. DDH developed post-trauma in 42 (70%) patients, with 29 (48%) of them resulting from falls. Half of the patients experienced DDH complications: acute anemia (n = 31, 52%) and local infection requiring oral antibiotics (n = 22, 37%). Time to starting appropriate care was significantly longer when the first DDH consultation was outside our expert center. DDH was significantly associated [adjusted OR (95% CI)] with low-molecular-weight heparin [1.95 (5.12-92.1); P < .001], dermatoporosis [3.75 (1.63-9.04); P = .002], age [1.09 (1.02-1.17); P = .02], and CIRS score [1.08 (1.01-1.17); P = .05]. Chemotherapy was significantly associated with delayed wound healing (P = .03) and age (P = .04) and skin grafting within 1 month (P = .003) were significantly associated with good wound healing. CONCLUSIONS AND IMPLICATIONS:This analysis of DDH risk factors based on a case-control study of a large geriatric cohort identified novel results on prognostic factors for DDH healing. Larger prospective studies are needed to extend our findings.
OBJECTIVE:The aim of this clinical trial was to evaluate the performance and local tolerance of an innovative mesh-free contact layer (healing matrix) made of lipidocolloid technology (TLC) in the management of various wounds. This dressing is made highly flexible by the absence of textile mesh in its core. METHOD:A four-week, prospective, multicentre clinical trial was conducted on the evaluated dressing (UrgoFit, Laboratoires Urgo, France) in 23 centres in France. Eligible patients were adults with a cutaneous wound of acute or chronic origin or due to epidermolysis bullosa (EB) in the granulation stage. The primary endpoint was the relative wound area reduction (RWAR) at week 4. Secondary endpoints included wound closure rate and time-to-heal, as well as dressing change frequency, pain at dressing removal, local tolerance and acceptability of the dressing. RESULTS:A total of 78 adult patients (23-95 years old) were treated with the dressing over a period of 24±8 days. Wound aetiologies included: postoperative or traumatic finger wounds; skin graft donor sites; dermabrasions/skin tears; burns; leg ulcers (LUs) of predominantly venous origin; a stage 3 pressure injury; and EB lesions. The median RWAR at week 4 was 98.2% (ranging between 61.5-100.0%, depending on wound types). Complete closure was achieved in 49% of patients (59% in acute wounds, 60% in EB lesions and 16% in chronic wounds) with a median time-to-heal of 16.5 days (ranging between 14.5-27.0 days, depending on wound types). Half of LUs reached a RWAR ≥40% at week 4, a predictive indicator of complete wound healing at week 24. Dressings were changed every 2±1 days on average (and left in place for a maximum of 10 days). Since the first application, the dressing was judged by healthcare professionals (HCPs) to be 'very easy' or 'easy' to apply on 96% of wounds, with a 'very good' or 'good' conformability to 94% of wound beds. Similar results were reported in cases of finger/hand wounds. Since the first week of treatment, the dressing removal was also judged 'very easy' or 'easy' in 95-98% of the cases, protecting and preserving newly formed tissue in 100% of cases. At the first follow-up visit, patients reported the dressing changes to be painless in 95% of cases. This represented a significant improvement over the previous dressings they received (p<0.0001). In all, seven non-serious adverse events related to the dressing were reported during the study period. CONCLUSION:In this clinical trial, the innovative mesh-free TLC dressing was shown to promote wound healing, to be well tolerated and well accepted by patients and HCPs, in line with the evidence available on other TLC dressings; however, its enhanced conformability may provide an additional benefit for the management of wounds.
Nous effectuerons une sélection non exhaustive d’innovations technologiques (dispositifs médicaux – électrothérapie – plasmas froids – pansements – TPN – nouveaux antiseptiques…) en rapport avec la prise en charge des plaies et, en particulier des ulcères de jambe et des plaies du pied diabétique.Dans la littérature médicale la plus récente (2024) : des travaux de recherche, des articles originaux, des études cliniques, des revues générales ou méta-analyses actualisant le niveau des connaissances et la diffusion des différentes technologies au service des patients porteurs de plaie seront sélectionnés. Dans les rapports d’industriels, à travers des cas cliniques réalisés dans le cadre d’études observationnelles, nous découvrirons des produits innovants qui seront peut-être le traitement de demain de toute ou partie des plaies.Le niveau de preuve n’est pas toujours celui que nous espérons, et tout n’est pas encore codifié de façon très scientifique tant la diversité des technologies et celle des plaies est grande et tant souvent elle échappe, en tout cas au début, à la méthodologie rigoureuse que les autorités de santé espèrent voir se développer dans ce domaine.
Introduction et objectifs Les plaies chroniques représentent un défi majeur en raison de leur prévalence élevée et des coûts associés. Bien que plusieurs recommandations nationales et internationales recommandent l’utilisation des pansements TLC-NOSF (« pansement d’intérêt », Laboratoires Urgo Medical, France) pour le traitement des plaies chroniques, ces pansements sont encore souvent utilisés en deuxième intention. Cette revue systématique vise à évaluer l’efficacité et le coût des pansements d’intérêts en tant que traitement en première intention pour les plaies chroniques, en se basant sur les données de la littérature. Méthodologie La recherche de littérature a été effectuée le 01/02/2024 (dernière consultation) dans les bases de données ProQuest (Medline, Embase, Emcare) et Google Scholar. Les mots clés de base utilisés dans la recherche étaient « UrgoStart » ou « TLC-NOSF » ou « sucrose octasulfate » et « first-line » ou « 2 months ». Les critères d’inclusion comprenaient des essais cliniques contrôlés randomisés, des études comparatives et des séries de cas cliniques. Les données extraites ont été analysées pour évaluer les résultats cliniques. Résultats Dix-sept études incluant 10 196 patients ont été analysées. Les pansements à l’étude, utilisés en première intention, sont associés à des taux de cicatrisation plus élevés (le plus grand delta de cicatrisation est obtenu lorsque les pansements d’intérêts sont utilisés sur des plaies du pied diabétique récentes [≤2 mois]) : 71 % pour le pansement à l’étude vs 41 % avec le pansement contrôle, des temps de cicatrisation plus courts et des économies de coûts significatives par rapport aux pansements sans TLC-NOSF utilisés dans des conditions similaires. Les bénéfices sont moindres, mais toujours significatifs, lorsque les pansements d’intérêts sont utilisés plus tard. Les preuves en vie réelle confirment ces résultats : elles montrent que l’utilisation des pansements d’intérêts en première intention permet d’obtenir un taux de fermeture des plaies plus élevé (entre 54 et 64 % à 12 semaines, selon l’étiologie) et de réduire les temps de cicatrisation de 31 à 33 %, comparé à une utilisation plus tardive. Discussion Les pansements d’intérêts sont plus efficaces et moins coûteux que les pansements contrôles dans la gestion des plaies chroniques, quelle que soit leur ancienneté. Les bénéfices sont plus importants lorsque les pansements à l’étude sont utilisés comme traitement de première intention.
Venous leg ulcers (VLUs) affect 1% of individuals in developed countries, posing a significant public health challenge due to complications, patient disability and healthcare costs. While high compression (>40mmHg) is the gold standard, delays in vascular assessment often postpone the adapted treatment. The ankle-brachial pressure index (ABPI) is recommended to exclude peripheral arterial disease, but its availability and reliability may vary, particularly in patients with diabetes. Given these challenges, immediate mild compression (≤20mmHg) has been proposed as a first and safe interim approach before confirming venous aetiology through an assessment performed by a vascular physician. Studies show that mild compression prevents worsening venous hypertension and improves patient adherence compared to stronger compression. In this position paper, written by a group of expert physicians in the field of compression therapy, we propose a pragmatic approach to compression during the initial phase of leg ulcer management to optimise patient care and wound healing outcomes. Guidelines support early mild compression in the absence of arterial 'red flags' (most notably chronic limb-threatening ischaemia, CLTI), followed by an increase in compression once venous pathology is confirmed. In France, where only 6.5% of general practitioners perform ABPI, timely vascular assessment is often impractical, leading to delayed interventions. After clinical elimination of any contraindication(s) (such as CLTI, severe neuropathy and/or atypical ulcers with a lack of healing despite hypergranulation), an effective strategy should involve the immediate initiation of mild compression, conducting vascular assessment within 4-6 weeks, and transitioning to high compression if needed and if the patient is able to tolerate it. Hence, mild compression can also be beneficial for patients who do not tolerate high compression. Given the need to balance safety, efficacy and tolerance, mild compression can be a valuable first-line strategy before specialised intervention, and while waiting for ABPI measurement availability as part of a complete vascular assessment.
PURPOSE: The aim of the study was to determine the clinical value of using a powered alternating pressure air mattress (P-APAM) in the prevention of pressure injury (PI) in patients at medium to high risk. DESIGN: Noncomparative, observational study. SUBJECTS AND SETTING: The sample comprised 86 patients who were >18 years old, were classified as having medium to high risk of PI, had no PI at baseline, and were lying more than 15 hours a day on a specific P-APAM. Data were collected between September 2018 and July 2019, in 4 nursing homes, and 1 long-term care geriatrics hospital department in France. METHODS: In addition to guideline-based care for PI prevention, patients were followed up for 35 days following placement on the P-APAM. The main outcome was the percentage of patients who developed between day 0 and day 35 at least 1 PI of at least stage 2 on the sacrum, spine, or heel. Secondary outcomes were patient assessments of comfort, caregiver satisfaction, mattress noise level, and mattress safety. RESULTS: No patients experienced a PI (incidence = 0%; 95% confidence interval, 0.00%-4.28%). Patients were satisfied or very satisfied with the mattress in most cases in terms of comfort (77.9%) and stability (73.0%). Patients also rated the noise level of the mattress as satisfactory or very satisfactory in all cases (100%). CONCLUSION: When combined with guideline-based PI prevention measures, use of the P-APAM was associated with a low incidence of PI.
OBJECTIVE:Several national and international guidelines recommend lipidocolloid technology with a nano-oligosaccharide factor (TLC-NOSF) dressings (UrgoStart dressing range, Laboratoires Urgo, France) for treating patients with chronic wounds. However, these dressings are still often reported as second-line options, potentially leading to loss of opportunity for patients and additional costs for payers. This review aimed to explore the reported wound healing and patient outcomes as well as the related costs when the dressings were used as first-line treatment in patients with different types of chronic wounds. METHOD:A systematic review of the literature was conducted. Databases (MEDLINE, Embase, Emcare, and Google Scholar) were searched up to 1 February 2024, without any language or time period limitations. Studies were eligible if the evaluated dressings had been used as a first-line treatment for chronic wounds, that is, as an integral part of the standard of care (SoC) at the patient's first presentation and/or in recent wounds. The main evaluation criteria included: wound healing rate; time to reach wound closure; change in patients' quality of life (QoL); and associated costs. The quality of evidence of the included studies was appraised using well-recognised risk-of-bias tools suitable for different study designs. A narrative synthesis describes the findings in three sections depending on the type of comparison. This report followed the principles of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. RESULTS:A total of 17 studies published between 2017 and 2024 met the eligibility criteria. A comparative analysis between TLC-NOSF dressings and standard dressings, both of which were used as first-line treatment, was reported in nine studies. A comparative analysis between the use of TLC-NOSF dressings as first-line and second-line treatments was reported in eight studies, and five studies reported a systematic use of the TLC-NOSF dressing as first-line treatment without a control group. Overall, the included studies had a relatively low risk of bias for the respective types of evidence. Data of 10,191 patients of both sexes and different age groups with a total of 10,203 wounds (diabetic foot ulcers, leg ulcers, pressure injuries, and other types of chronic wounds) were included in the analysis: 7775 treated with the evaluated dressing and 2428 treated with a comparator dressing. The data suggested that using TLC-NOSF as a first-line treatment for chronic wounds consistently resulted in significantly higher healing rates, shorter healing times, and cost savings compared with standard dressings used under similar conditions. Real-life evidence confirmed the results obtained in clinical trials and economic models, within similar ranges, regardless of the settings involved or of the characteristics of the patients and wounds treated. The wound healing rates ranged around 70-80% by week 20/24 and time-to-heal was reported on average around seven weeks, with slightly longer times reported in wounds with a more severe prognosis. Furthermore, the dressings were shown to improve patient QoL, and were well tolerated and accepted, supporting a wider adoption approach. CONCLUSION:The results of this review are aligned with the current guidelines recommending the use of TLC-NOSF dressings in the treatment of patients with chronic wounds. They support its wider implementation as a first-line treatment and as an integral part of SoC for these wounds in the daily practice of all centres involved in their management.
En raison d'une incidence importante, d'une durée de cicatrisation longue, d'un fort impact sur le coût de prise en charge, les ulcères veineux de jambe (UVJ) représentent un fardeau pour la collectivité et les patients. Les données du Système national des données de santé (SNDS) ont été utilisées pour estimer les taux, délais et coûts associés à la cicatrisation complète des UVJ traités par des systèmes de compression recommandés par la HAS. La première analyse a démontré l'efficacité supérieure des systèmes multitypes (MT) par rapport aux bandes à allongement court. Une analyse complémentaire a été menée afin d'évaluer l'impact du pansement utilisé (TLC-NOSF ou neutre) en association à la compression MT. L'étude est réalisée pour tous les patients présentant un premier épisode d'ulcère entre 2018 et 2020. La durée minimum de suivi est de 9 mois. La durée de traitement correspond au délai de cicatrisation. Les taux de cicatrisation sont calculés à 1, 3, 6 et 12 mois. Les coûts étudiés sont ceux liés à la pathologie et remboursés par la sécurité sociale pour les patients cicatrisés. Les résultats sont ajustés selon un appariement sur score de propension. Au total, 12 507 patients traités par un système MT et un même type de pansement, du début à la fin de leur traitement, ont été inclus. À 3 mois, le taux de cicatrisation ajusté était significativement plus élevé dans le groupe TLC-NOSF (52,4 %) que dans le groupe neutre (36,7 %) (p < 0,001). Le délai médian de cicatrisation des UVJ est de 87 jours dans le groupe TLC-NOSF vs 125,5 jours dans le groupe neutre. Enfin, grâce à la réduction du délai de cicatrisation, les pansements TLC-NOSF permettent de réduire significativement le coût moyen de traitement par ulcère guéri de 23,7 % par rapport aux neutres (2099 € et 2751 €, respectivement, p < 0,001). L'accès au SNDS est strictement réglementé : la méthodologie de l'étude doit être approuvée par un comité d'éthique et l'intérêt de santé publique doit être démontré. Ces nouvelles données de vie réelle ont permis d'évaluer l'impact du traitement local associé à la compression MT dans l'UVJ. Cependant, comme toutes les analyses basées sur le SNDS, celle-ci comporte des limites inhérentes aux bases médico-administratives et au design observationnel de l'étude. Ces données confirment l'efficacité supérieure de l'association d'une compression MT avec les pansements TLC-NOSF : meilleurs taux et délai de cicatrisation, ainsi que les économies générées par rapport aux pansements neutres.
Objective: Multicomponent bandages (MCBs) are recommended by the French Authority for Health (Haute Autorité de Santé) as first-line treatment for venous leg ulcers (VLUs). A first analysis of the data collected from the French administrative healthcare database (Système National des Données de Santé (SNDS)) on 25,255 patients with a VLU supported superiority of MCBs versus short stretch bandages when considering the healing outcomes and costs associated with closure of these wounds. The aim of this study was to assess how beneficial the primary dressing (technology lipido-colloid nano-oligosaccharide factor (TLC NOSF) or control dressing group (CDG)) could be, when used in combination with MCBs in the treatment of VLUs. Method: Data from the SNDS were collected for patients meeting the following inclusion criteria: treatment for a VLU with MCBs and with the same dressing type (TLC-NOSF or CDG) during the whole treatment period. Healing outcomes were documented on the global cohorts and propensity score-matched cohorts. The mean healthcare cost and the ecological impact were calculated for those patients healed within the study period. Results: In total, 12,507 patients met the criteria for treatment with both MCBs and TLC-NOSF dressings (n=1134) versus MCBs and CDG (n=11,373); with 1134 and 2268 patients per group following propensity score matching. Healing outcomes were favourable for the TLC-NOSF group in the global cohort and were enhanced in the propensity score-matched cohorts. At every point of the analysis, the adjusted healing rates were significantly higher in the TLC-NOSF group than in the CDG group (p<0.001). In the propensity score-matched cohorts (n=3402), the healing rate at three months was 52% in the TLC-NOSF group versus 37% in the CDG group (p<0.001). The median healing time was 87 days versus 125.5 days in the TLC-NOSF and CDG groups, respectively (p<0.0001). TLC-NOSF dressings significantly reduced the average treatment cost per healed ulcer (€2099) by 23.7% compared with dressings without TLC-NOSF (€2751) (p<0.001), as well as the resources used. Conclusion: This SNDS analysis confirms, in the largest real-life study performed in VLU management, the superiority of the TLC-NOSF dressings versus those not impregnated with the NOSF compound. Better clinical outcomes associated with cost savings and a positive ecological impact support the combination of MCBs and TLC-NOSF dressings and should be considered as an optimal standard of care for the global management of VLUs. These outcomes reinforce the current positions of the international guidelines on the use of NOSF impregnated dressings (UrgoStart range; Laboratoires Urgo, France) in this pathology.
PURPOSE: The aim of the study was to determine the clinical value of using a powered alternating pressure air mattress (P-APAM) in the prevention of pressure injury (PI) in patients at medium to high risk. DESIGN: Noncomparative, observational study. SUBJECTS AND SETTING: The sample comprised 86 patients who were >18 years old, were classified as having medium to high risk of PI, had no PI at baseline, and were lying more than 15 hours a day on a specific P-APAM. Data were collected between September 2018 and July 2019, in 4 nursing homes, and 1 long-term care geriatrics hospital department in France. METHODS: In addition to guideline-based care for PI prevention, patients were followed up for 35 days following placement on the P-APAM. The main outcome was the percentage of patients who developed between day 0 and day 35 at least 1 PI of at least stage 2 on the sacrum, spine, or heel. Secondary outcomes were patient assessments of comfort, caregiver satisfaction, mattress noise level, and mattress safety. RESULTS: No patients experienced a PI (incidence = 0%; 95% confidence interval, 0.00%-4.28%). Patients were satisfied or very satisfied with the mattress in most cases in terms of comfort (77.9%) and stability (73.0%). Patients also rated the noise level of the mattress as satisfactory or very satisfactory in all cases (100%). CONCLUSION: When combined with guideline-based PI prevention measures, use of the P-APAM was associated with a low incidence of PI.
OBJECTIVE:To evaluate the healing outcomes and costs associated with the aetiological management of venous leg ulcers (VLUs) treated with recommended multicomponent bandages (MCBs) and short-stretch bandages (SSBs).METHOD:This observational study is a retrospective comparative study (Level 2b), based on the French administrative healthcare database (Système National des Données de Santé, SNDS). It includes patients treated from onset with reimbursed MCBs and SSBs for a VLU episode, between July 2018 and September 2020. Although other compression systems, such as long-stretch bandages, are commonly used for the treatment of VLUs, they are not recommended by health authorities in France and thus, were not considered for this study. A binomial regression model was performed to estimate the adjusted relative risk of wound closure rates at three months for each group, based on potential confounding factors including, notably, age, sex, key comorbidities, and wound dressing size. The mean healthcare cost was calculated for patients whose VLUs healed within the study period.RESULTS:The reimbursement data (including prescribed compression systems and nursing care) of the 25,255 selected patients were analysed in the study. There were no significant differences between the MCBs and SSBs groups when considering patient characteristics. The healing rates after three months' treatment, were 42% and 35% (p<0.001) in the MCBs and SSBs groups, respectively. When adjusting the statistical model, the chance of healing at three months was still 12% higher with MCBs compared with SSBs (p<0.0001). The median healing time was estimated at 115 (interquartile range (IQR): 60-253) days in the MCB group versus 137 (IQR: 68-300) days in the SSBs group. The average treatment cost per patient with a healed ulcer was €2875±3647 in the MCB group and €3580±5575) in the SSBs group (p=0.0179), due to lower hospital stay and nursing costs in the MCB group. Differences in wound characteristics between the two groups cannot be totally excluded, due to the limited content of the database in terms of clinical data, but should have been addressed, to some extent, through the study selection criteria and the chosen regression model.CONCLUSION:In this study, this SNDS analysis seemed to confirm that the healing outcomes achieved in real-life with MCBs were in line with those reported in clinical trials, and superior to SSBs, which reinforces the current position from the guidelines.