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Article: A 2023 update of choosing wisely "Chemical or thermal occlusion treatments in saphenous vein insufficiency and recurrence": What objectives for what impact?

Blaise, Sophie

Journal de medecine vasculaire

2023 Volume 48, Issue 2, Page(s) 53–54

MeSH term(s)	Humans ; Saphenous Vein/diagnostic imaging ; Saphenous Vein/surgery ; Varicose Veins/therapy
Language	English
Publishing date	2023-06-28
Publishing country	France
Document type	Editorial
ISSN	2542-4513
ISSN	2542-4513
DOI	10.1016/j.jdmv.2023.06.003
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Article: Diagnosis of a chronic wound in the special case of a vascular malformation: A proposal of the Wound and Healing Group of the French Society of Vascular Medicine.

Blaise, Sophie / Malloizel-Delaunay, Julie / Nou, Monira

Journal de medecine vasculaire

2024 Volume 49, Issue 2, Page(s) 103–111

Abstract: Vascular malformations can present with a variety of symptoms and an unpredictable course with the occurrence of wounds. Ulcerations in patients with vascular malformations are fortunately rare. Although few data exist, complications may involve a ... ...

Abstract	Vascular malformations can present with a variety of symptoms and an unpredictable course with the occurrence of wounds. Ulcerations in patients with vascular malformations are fortunately rare. Although few data exist, complications may involve a variety of mechanistic or hemodynamic factors. A rigorous etiological and vascular assessment is therefore essential. In view of the paucity of recommendations, the Wound and Healing Group of the French Society of Vascular Medicine, based on the literature on the subject, presents a number of suggestions for the diagnosis and management of wounds associated with vascular malformations.
MeSH term(s)	Humans ; Vascular Malformations/complications ; Vascular Malformations/diagnostic imaging ; Vascular Malformations/therapy ; Wound Healing ; Chronic Disease
Language	English
Publishing date	2024-04-17
Publishing country	France
Document type	Journal Article ; Practice Guideline ; Review
ISSN	2542-4513
ISSN	2542-4513
DOI	10.1016/j.jdmv.2024.03.003
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Article ; Online: La rétention trophoblastique hypervascularisée peut-elle être considérée comme une malformation vasculaire acquise ?

Zenati, Nora / Seinturier, Christophe / Blaise, Sophie

Gynecologie, obstetrique, fertilite & senologie

2023 Volume 51, Issue 7-8, Page(s) 387–389

Title translation	Can retained products of conception be considered as an unclassified acquired vascular malformation?
MeSH term(s)	Humans ; Female ; Uterus ; Fertilization ; Vascular Diseases ; Vascular Malformations ; Retrospective Studies
Language	French
Publishing date	2023-03-15
Publishing country	France
Document type	Letter
ZDB-ID	2887456-0
ISSN	2468-7189
ISSN (online)	2468-7189
DOI	10.1016/j.gofs.2023.03.006
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Article: Negative pressure wound therapy with instillation and dwell time in debridement of fibrinous leg ulcers.

Achiti, Alexandru / Zenati, Nora / Seinturier, Christophe / Cracowski, Jean-Luc / Blaise, Sophie

Journal of wound care

2024 Volume 33, Issue 3, Page(s) 166–170

Abstract: Objective: In conjunction with appropriate wound care, negative pressure wound therapy with instillation and dwell time (NPWTi-d) may be used as an adjunct therapy for acute or hard-to-heal (chronic) wounds, especially when infected. However, there are ... ...

Abstract	Objective: In conjunction with appropriate wound care, negative pressure wound therapy with instillation and dwell time (NPWTi-d) may be used as an adjunct therapy for acute or hard-to-heal (chronic) wounds, especially when infected. However, there are very few data on the use of NPWTi-d in the treatment of fibrinous wounds that are difficult to debride mechanically. The main objective of this study was to describe changes in the fibrin area of such wounds, before and after treatment with NPWTi-d. Method: This was a monocentric, observational, prospective pilot study evaluating the NPWTi-d medical device. Eligible patients included in the study were those with hard-to-heal lower limb ulcers who had previously undergone unsuccessful specific debridement treatment for their wound, with failure of manual mechanic debridement for at least six weeks' duration, and whose wounds had a fibrinous surface area of >70% of the total wound surface area. The primary endpoint was the difference in the percentage of fibrinous surface area before and after treatment. Results: A total of 14 patients who received treatment for lower limb ulcers between October 2017 and August 2019 were included in the study. There was a significant shrinkage rate of the fibrinous wound surface between the start and end of treatment (83.6±14.5% and 32.2±19.7%, respectively; p<0.001). Conclusion: This study showed a significant decrease in fibrin area in wounds treated with NPWTi-d, with good tolerance. We believe that NPWTi-d has its place in the multidisciplinary management of patients with hard-to-heal ulcers. Additional randomised studies are required to confirm these findings. Declaration of interest: The authors have no conflicts of interest.
MeSH term(s)	Humans ; Debridement ; Wound Infection/therapy ; Negative-Pressure Wound Therapy ; Ulcer ; Pilot Projects ; Prospective Studies ; Leg Ulcer/therapy ; Fibrin ; Therapeutic Irrigation
Chemical Substances	Fibrin (9001-31-4)
Language	English
Publishing date	2024-03-11
Publishing country	England
Document type	Observational Study ; Journal Article
ZDB-ID	1353951-6
ISSN	0969-0700
ISSN	0969-0700
DOI	10.12968/jowc.2024.33.3.166
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Article ; Online: A randomised, open-label, parallel-group, multicentre, comparative study to compare the efficacy and safety of Exufiber® with Aquacel® Extra™ dressings in exuding venous and mixed aetiology leg ulcers.

Joergensen, Bo / Blaise, Sophie / Svensson, Ann-Sofie

International wound journal

2022 Volume 19 Suppl 1, Page(s) 22–38

Abstract: The performance and safety of Exufiber® gelling fibre and Aquacel® Extra™ Hydrofiber® wound dressings were compared for the management of chronic, exuding leg ulcers. The 6-week study (≤ 24 weeks in a subgroup of subjects) was a randomised, open-label, ... ...

Abstract	The performance and safety of Exufiber® gelling fibre and Aquacel® Extra™ Hydrofiber® wound dressings were compared for the management of chronic, exuding leg ulcers. The 6-week study (≤ 24 weeks in a subgroup of subjects) was a randomised, open-label, parallel-group, multicentre, non-inferiority design. Adults (n = 248, 30-97 years of age) were randomised to either Exufiber® or Aquacel® Extra™ dressing. The dressings were applied at baseline and evaluations of wound condition and performance of the dressing were recorded at 1, 2, 3, 4, and 6 weeks. The primary efficacy endpoint was the percentage reduction in wound area at 6 weeks relative to baseline, in the per protocol (PP) population. A median relative reduction of 50% for Exufiber® (n = 100) vs 42% for Aquacel® Extra™ (n = 107) was demonstrated in the PP population (P = 0.093) and confirmed in the intention-to-treat population. As the mean and 95% confidence interval for the difference in relative wound area reduction between groups at 6 weeks was -29.4% (-63.5; 3.2), and the lower limit did not exceed 12%, non-inferiority of Exufiber® was concluded. Both dressings were well tolerated and no safety concerns were identified in both groups. Clinicians' satisfaction with the dressings was higher for Exufiber® than for Aquacel® Extra™ in terms of ease of use and management of exudate, slough, and blood.
MeSH term(s)	Adult ; Bandages ; Carboxymethylcellulose Sodium ; Humans ; Leg Ulcer/therapy ; Prospective Studies ; Treatment Outcome ; Wound Healing
Chemical Substances	Carboxymethylcellulose Sodium (K679OBS311)
Language	English
Publishing date	2022-09-16
Publishing country	England
Document type	Journal Article ; Multicenter Study ; Randomized Controlled Trial
ZDB-ID	2170920-8
ISSN	1742-481X ; 1742-4801
ISSN (online)	1742-481X
ISSN	1742-4801
DOI	10.1111/iwj.13913
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Article: Skin necrosis and calcifications after extravasation of vancomycin: a localised form of calciphylaxis?

Zenati, Nora / Khouri, Charles / Schwebel, Carole / Blaise, Sophie

Journal of wound care

2021 Volume 30, Issue 5, Page(s) 390–393

Abstract: Vancomycin is a tricyclic glycopeptide antibiotic produced ... ...

Abstract	Vancomycin is a tricyclic glycopeptide antibiotic produced from
MeSH term(s)	Anti-Bacterial Agents/adverse effects ; Calcinosis/chemically induced ; Calciphylaxis/chemically induced ; Humans ; Male ; Methicillin-Resistant Staphylococcus aureus ; Middle Aged ; Necrosis/chemically induced ; Vancomycin/adverse effects
Chemical Substances	Anti-Bacterial Agents ; Vancomycin (6Q205EH1VU)
Language	English
Publishing date	2021-05-12
Publishing country	England
Document type	Case Reports ; Journal Article
ZDB-ID	1353951-6
ISSN	0969-0700
ISSN	0969-0700
DOI	10.12968/jowc.2021.30.5.390
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Article: Comparative evaluation of socioeconomic insecurity in peripheral and coronary artery disease patients.

Joly, Marion / Gillois, Pierre / Satger, Bernadette / Blaise, Sophie / Pernod, Gilles

Journal de medecine vasculaire

2022 Volume 47, Issue 5-6, Page(s) 220–227

Abstract: Background: Cardiovascular disease represents the leading cause of death worldwide. Socioeconomic deprivation is a risk factor for cardiovascular disease. We have previously shown that precariousness was more frequent in symptomatic peripheral artery ... ...

Abstract	Background: Cardiovascular disease represents the leading cause of death worldwide. Socioeconomic deprivation is a risk factor for cardiovascular disease. We have previously shown that precariousness was more frequent in symptomatic peripheral artery disease (PAD) patients than in the general population. According to a previous study, coronary artery disease (CAD) patients have a higher level of education than CAD with PAD, but no study directly compared the level of precariousness in PAD and CAD patients. Aim: To measure and compare the level of socioeconomic insecurity in patients suffering from symptomatic PAD with those suffering from isolated CAD, i.e without symptomatic PAD. Methods: We conducted an observational, cohort, prospective, multicenter study. Patients suffering from symptomatic PAD or CAD were recruited through the medical or surgical vascular or cardiology departments, or the vascular rehabilitation center. The EPICES score and the INSEE parameters were used for analysis. The individual is considered precarious when his or her score is greater than or equal to 30. Cardiovascular risk factors and peripheral arterial disease stages were also collected. Results: In total, 230 patients were included. According to the EPICES score, 47.8% [95%CI, 38.7-56.7] of patients with symptomatic PAD were in a precarious situation compared to 17.4% [95%CI, 10.5-24.3] of patients suffering from isolated CAD (P<0.001). The mean EPICES score was 33.3 (SD 22.5) in the PAD and 16.9 (SD 17.02) in the CAD population, respectively (P<0.001). In the PAD population, the level of education was low, with an under-representation of patients with a baccalaureate or higher education degree: 21.7% [95%CI, 14.2-29.3] vs. 41.7% [95%CI, 32.7-50.7] in the PAD and CAD populations, respectively. There was also an under-representation of executives and intellectual and intermediate professions in the PAD population, 18.3% [95%CI, 11.2-25.3], compared to the CAD population, 31.3% [95%CI, 22.8-39.8]. Conclusion: PAD patients are more precarious than patients suffering from CAD. A better detection of socioeconomic deprivation in patients suffering from peripheral arterial disease could allow comprehensive care and thus hope for an improvement in terms of morbidity and mortality.
MeSH term(s)	Female ; Male ; Humans ; Coronary Artery Disease/epidemiology ; Prospective Studies ; Peripheral Arterial Disease/diagnosis ; Peripheral Arterial Disease/epidemiology ; Risk Factors ; Educational Status
Language	English
Publishing date	2022-10-19
Publishing country	France
Document type	Observational Study ; Multicenter Study ; Journal Article
ISSN	2542-4513
ISSN	2542-4513
DOI	10.1016/j.jdmv.2022.10.001
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Article ; Online: Localised intravascular coagulation complicating venous malformations: Clinical characterisation.

Blaise, Sophie / Soya, Esaie / Nou, Monira / Malloizel-Delaunay, Julie / Thiel, Hélène / Bisdorff-Bresson, Annouk / Seinturier, Christophe

Phlebology

2023 Volume 39, Issue 3, Page(s) 169–173

Abstract: Objective: The International Union of Phlebology recommends measuring at least D-dimer and fibrinogen levels in the diagnosis of extensive extra-truncular venous malformations, with a surface area of 10 cm: Method: This study was an observational and ...

Abstract	Objective: The International Union of Phlebology recommends measuring at least D-dimer and fibrinogen levels in the diagnosis of extensive extra-truncular venous malformations, with a surface area of 10 cm Method: This study was an observational and multicentre study. The objective was to explore the presence of a possible coagulation disorder among patients with venous malformation. The primary endpoint was to characterise venous malformations with increased D-dimer levels. Results: The majority of the 72 venous malformations were located in the trunk region, mostly in intramuscular or subcutaneous locations. There were 72 venous malformations with increased D-dimer levels including 3 with biological disseminated intravascular coagulation (elevated D-dimer and fibrinogen <1 g/L). The anticoagulant treatments administered were very heterogeneous in class and dosage, and at the end of the treatment, 17 elevated D-dimers were persistent, 9 venous malformations remained painful and 27 showed thrombotic regression. Conclusion: Venous vascular malformations are probably underestimated and should probably be explored more systematically in terms of coagulation disorder regardless of size or symptomatology. The therapeutic recommendations to treat localised intravascular coagulation with low-molecular weight are not widely applied. Studies are needed, in particular to assess the role of oral anticoagulants in the management of coagulation disorder among patients with venous malformation.
MeSH term(s)	Humans ; Anticoagulants/therapeutic use ; Vascular Malformations/diagnosis ; Blood Coagulation Disorders ; Veins/abnormalities ; Fibrinogen/therapeutic use ; Fibrin Fibrinogen Degradation Products
Chemical Substances	Anticoagulants ; Fibrinogen (9001-32-5) ; Fibrin Fibrinogen Degradation Products
Language	English
Publishing date	2023-11-18
Publishing country	England
Document type	Observational Study ; Multicenter Study ; Journal Article
ZDB-ID	645172-x
ISSN	1758-1125 ; 0268-3555
ISSN (online)	1758-1125
ISSN	0268-3555
DOI	10.1177/02683555231216349
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Article ; Online: Assessment of digital perfusion as a surrogate outcome in Raynaud's phenomenon clinical trials.

Guigui, Alicia / Liaigre, Léa / Manceau, Marc / Gaget, Olivier / Cracowski, Jean-Luc / Blaise, Sophie / Khouri, Charles / Roustit, Matthieu

Rheumatology (Oxford, England)

2023

Abstract: Objectives: Measurement of digital perfusion, sometimes coupled with a cold challenge, has been widely used as an objective outcome in trials evaluating drug therapies in Raynaud's Phenomenon (RP), in addition to patient-reported outcomes or to ... ...

Abstract	Objectives: Measurement of digital perfusion, sometimes coupled with a cold challenge, has been widely used as an objective outcome in trials evaluating drug therapies in Raynaud's Phenomenon (RP), in addition to patient-reported outcomes or to establish the proof-of-concept in preliminary studies. However, whether digital perfusion is a valid surrogate for clinical outcomes in RP trials has never been explored. The principal aim of this study was to evaluate the potential surrogacy of digital perfusion, by combining individual-level and trial-level data. Methods: We used individual data from a series of n-of-1 trials, and trial data from a network meta-analysis. We estimated individual-level surrogacy through coefficients of determination between digital perfusion and clinical outcomes (R2ind). We further calculated the coefficients of determination between treatment effect on the clinical outcomes and on digital perfusion, at the individual level (R2TEInd) and at the trial level (R2trial), using non-weighted linear regression, with their 95% CI calculated through bootstrapping. Results: Results from 33 patients and 24 trials were included in the final analysis. At the individual level, there was no correlation between digital perfusion and clinical outcomes at rest and in response to various cooling tests (the highest R2ind was 0.03 [-0.07; 0.09]), and R2TEinf was also very low 0.07 [0; 0.29]. At the trial level, the highest value of R2trial was 0.1 [0; 0.477]. Conclusions: Digital perfusion, at rest or in response to a cold challenge, and whatever the method used, does not fulfill the criteria of a valid surrogate for existing patient-reported outcomes in RP trials.
Language	English
Publishing date	2023-07-08
Publishing country	England
Document type	Journal Article
ZDB-ID	1464822-2
ISSN	1462-0332 ; 1462-0324
ISSN (online)	1462-0332
ISSN	1462-0324
DOI	10.1093/rheumatology/kead337
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Article ; Online: Use of Bisphosphonates and the Risk of Skin Ulcer: A National Cohort Study Using Data from the French Health Care Claims Database.

Jambon-Barbara, Clément / Bernardeau, Claire / Bezin, Julien / Roustit, Matthieu / Blaise, Sophie / Cracowski, Jean-Luc / Khouri, Charles

Drug safety

2023 Volume 46, Issue 9, Page(s) 905–916

Abstract: Introduction: Previous pre-clinical and pharmacovigilance disproportionality analyses highlighted a safety signal of cutaneous ulcer with bisphosphonate use. Therefore, our objective is to evaluate this risk and assess whether unmeasured confounding ... ...

Abstract	Introduction: Previous pre-clinical and pharmacovigilance disproportionality analyses highlighted a safety signal of cutaneous ulcer with bisphosphonate use. Therefore, our objective is to evaluate this risk and assess whether unmeasured confounding factors could explain this association. Methods: This study is a population-based cohort study from a representative sample (1/97th) of the French health insurance claims database: Echantillon Généraliste des Bénéficiaires (EGB) from 2006 to 2019. To limit the impact of our study design and methodological choices on any association between skin ulceration and exposure to bisphosphonates, we used several methods: a Cox proportional hazards analysis and a prior event rate ratio (PERR) analysis, using two propensity matched control groups, and either the first episode of incident ulceration or multiple event-time outcomes. Results: There were 7402 individuals newly exposed to bisphosphonates matched to 29,605 unexposed individuals on propensity score. The primary outcome was skin ulcer occurrence assessed by at least 2 deliveries of wound dressing during the period of one month. Among 6911 individuals newly exposed to bisphosphonates and 28,072 unexposed individuals with no previous skin ulcer, the Cox regression yielded a hazard ratio (HR) of 1.40 (95% CI 1.26-1.56) for newly exposed individuals. Among 7402 exposed and 29,605 unexposed individuals, the PERR analysis found a non-significant HR of 1.03 (95% CI 0.87-1.24). Results were similar on the different sensitivity analyses. Conclusion: No association between bisphosphonate and skin ulcers was found in the French population. The association observed in previous pharmacovigilance studies and in the Cox regression analysis is likely due to unmeasured confounding factors.
MeSH term(s)	Humans ; Cohort Studies ; Diphosphonates/adverse effects ; Delivery of Health Care ; Proportional Hazards Models ; Skin Ulcer
Chemical Substances	Diphosphonates
Language	English
Publishing date	2023-08-02
Publishing country	New Zealand
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1018059-x
ISSN	1179-1942 ; 0114-5916
ISSN (online)	1179-1942
ISSN	0114-5916
DOI	10.1007/s40264-023-01336-x
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