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Compare the efficacy of using an absorbent foam silver dressing (Mepilex Ag) versus the equivalent dressing without silver in subjects suffering from venous leg ulcer or mixed ulcer with an ABPI ≥ 0.8 and with inflammatory signs. Efficacy will be defined as absolute wound size reduction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mepilex product | Placebo Comparator |
| |
| Mepilex Ag | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepilex Ag | Device | Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Will be Defined as Absolute Wound Size Reduction. | Efficacy will be defined as absolute wound size reduction. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Inflammatory Signs | Change in inflammatory signs | 4 weeks |
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Inclusion Criteria:
Subjects with colonised/ local infection in a venous leg ulcer or mixed leg ulcer with an ABPI ≥ 0,8 and < 1.3
A history of an appropriate compression therapy for at least 2 weeks prior to randomisation
Subjects with colonised/local infection presenting with three of five following specified signs:
An ulcer size of at least 4 cm2 and a maximum size witch could be covered by one investigational product of 15x15 cm.
Ulcer duration 6 weeks to 1 year
In case of multiple ulcers: target ulcer must be at least 3 cm distant from other ulcers.
Both gender with an age ≥ 18 years
Signed informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sylvie Meaume, Dr | Hopital Rotchild - Jean Rostand, Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemocnice Jihlava | Jihlava | Jihlava | 586 01 | Czechia | ||
| Krajská nemocnice Liberec |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mepilex Product | Mepilex without Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds. |
| FG001 | Mepilex Ag |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Mepilex without Ag | Device | Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds. |
|
| Liberec |
| Liberec |
| 46063 |
| Czechia |
| chirugické oddělení, Fakultní nemocnice Královské Vinohrady | Prague | Prague | 10 PSČ 100 34 | Czechia |
| Nemocnice Podlesí a.s. | Třinec | Třinec | 73961 | Czechia |
| Uherskohradišťská nemocnice a. s. | Uherské Hradiště | Uherské Hradiště | 68668 | Czechia |
| Fakultní nemocnice U svate Anny, St. Anne´s University Hospital | Brno | 65691 | Czechia |
| Dermatovenerologická klinika, University Hospital Bohunice, | Brno | Czechia |
| Dermatovenerologická klinike, Univerzita Karlova | Pilsen | 305 99 | Czechia |
| Fakultní nemocnice Na Bulovce | Prague | 180 00 | Czechia |
| Masarykova Hospital, Dermatology dept. | Ústí nad Labem | 401 13 | Czechia |
| Dermatovenerologie Rendlová s.r.o. | České Budějovice | České Budějovice | 37001 | Czechia |
| Polyclinique de Picardie Service d'Angiologie Phlébologie | Amiens | Amiens | 80000 | France |
| Hôpital privé d'Antony Service de Dermatologie | Antony | Antony | 92160 | France |
| Hôpital Saint Jacques - CHU Besançon | Besançon | Besançon | 25030 | France |
| Résidence le Bristol | Boulogne-sur-Mer | Boulogne-sur-mer | 62200 | France |
| CHU Le Bocage Service Dermatologie | Dijon | Dijon Cedex | 21079 | France |
| Hôpital Albert Michallon Service de médecine vasculaire | Grenoble | Grenoble Cedex 9 | 38 043 | France |
| CHG La Roche-sur-Yon Service de D'Angiologie,Les Oudairies | La Roche-sur-Yon | La Roche-sur-Yon | 85925 | France |
| Centre Hospitalier le Mans Service de Dermatologie | Le Mans | Le Mans Cedex 9 | 72037 | France |
| Pharmacie Centrale-Service Arsenal | Nantes | Nantes | 44093 | France |
| APHP Hôpital Lariboisère | Paris | Paris | 75010 | France |
| Hôpital Saint Joseph | Paris | Paris | 75014 | France |
| Cabinet d'Angiologie, 1 bis rue de Salgareda | Saint-Alban | Saint Alban | 31140 | France |
| Dermatology Department, University Hospital, Hopital Sud | Amiens | 80054 | France |
| Service de Dermatologie, Centre Hospitalier Regional Universitaire | Caen | 140 33 | France |
| Cabinet D'Angeiologie | Lille | 690 00 | France |
| Hopital Maringer-Villemin- Fournier | Nancy | France |
| Hôpital Rotchild - Jean Rostand | Paris | 75012 | France |
| Hopital Robert Debré Service de Dermatologie | Reims | France |
| Hopital Charles Nicolle | Rouen | France |
| Maison de Santé Protestante de Bordeaux-Bagatelle | Talence | France |
| Hopital Beauregard / Secrétariat de Dermatologie | Thionville | 57100 | France |
| Service de dermatologie | Toulon | France |
| Clinique Pasteur | Toulouse | 31076 | France |
| Universitätsklinikum Schleswig-Holstein Campus Lübeck | Lübeck | Germany | 23538 | Germany |
| Universtätsmedizin Charité Klinik für Dermatologie, Allergologie und Venerologie | Berlin | 10117 | Germany |
| Venenzentrum der Dermatologischen und Gefäßchirurgischen Kliniken - | Bochum | 44805 | Germany |
| Universitätsklinikum Hamburg-Eppedorf | Hamburg | 20246 | Germany |
| Bramfelder Chaussee 200 | Hamburg | 22177 | Germany |
| Universität klinikum Jena, Klinik für dermatologie und dermatologische | Jena | 07740 | Germany |
| University Hospital Regensburg | Regensburg | Germany |
| Universitäts-Hautklinik | Tübingen | 72076 | Germany |
| Dermatology department | Amsterdam | 1081 | Netherlands |
| St. Antonius Ziekenhuis | Utrecht | Netherlands |
Mepilex Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mepilex Product | Mepilex without Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds. |
| BG001 | Mepilex Ag | Mepilex Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Efficacy Will be Defined as Absolute Wound Size Reduction. | Efficacy will be defined as absolute wound size reduction. | Posted | Mean | Standard Deviation | cm2 | 8 weeks |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Change in Inflammatory Signs | Change in inflammatory signs | Not Posted | 4 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mepilex Product | Mepilex without Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds. | 2 | 101 | 28 | 101 | ||
| EG001 | Mepilex Ag | Mepilex Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds. | 4 | 100 | 20 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aggravation of ulcus | Skin and subcutaneous tissue disorders | Aggravation of ulcus, no antibiotics, mailfunktion of dressing. |
| ||
| Erysephilas needing hospitalisation | Skin and subcutaneous tissue disorders | Erysephilas needing hospitalisation, |
| ||
| Pain on left arm /shoulder | Musculoskeletal and connective tissue disorders |
| |||
| Acute exacerbation of psoriasis vulgaris | Skin and subcutaneous tissue disorders |
| |||
| Pneumonia | Respiratory, thoracic and mediastinal disorders |
| |||
| Cardiac decompensation | Cardiac disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse event related to the ulcer | Skin and subcutaneous tissue disorders |
| |||
| Other Adverse Event not related to the ulcer | Investigations |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ann Larkö | Molnlycke Health Care AB | +46 722 3338 | ann.larko@molnlycke.com |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Czech Republic |
|
| Netherlands |
|
| Germany |
|