Evaluating the Efficacy of an Absorbent Foam Dressing Containing Silver (Mepilex Ag) Versus the Same Dressing Without Silver Used on Subjects With Venous Leg Ulcers or Mixed Ulcers
- Conditions
- Venous Leg UlcersMixed Leg Ulcers
- Interventions
- Device: Mepilex AgDevice: Mepilex without Ag
- Registration Number
- NCT01036438
- Lead Sponsor
- Molnlycke Health Care AB
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 201
-
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:
- pain between dressing changes
- exuding wounds
- erythema on peri-wound skin
- oedema
- odour
-
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
- > 10% necrotic (black) or fibrinous (yellow) tissue covering the wound bed
- Infected wounds in need of systemic antibiotic treatment
- Use of anti-microbial dressings or topical agents such as antiseptics, local antibiotics and steroids within 7 days from inclusion on the wound intended to be included
- Previous treatment with silver product 2 weeks prior to inclusion
- Previous treatment with MepilexAg® on the target ulcer
- Use of systemic antibiotics for any reason during the previous 7 days
- Venous surgery 2 weeks prior to inclusion or planned surgery within 8 weeks after inclusion
- Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer/malignancy and severe anaemia) judged by the investigator to be a potential interference in the wound evaluation
- Subjects with poorly controlled diabetes mellitus i.e. HbA1c >8%
- Subjects treated with systemic immunosuppressive or glucocorticosteroids, except subjects taking occasional doses or doses less than 10mg prednisolon/day or equivalent. Subjects inhaling glucocorticosteroids for asthma should not be excluded.
- Known allergy/hypersensitivity to any of the components of the investigation products.
- Subjects with physical and/or mental conditions that are not expected to comply with the investigation due to poor medical condition
- Participation in other clinical investigation(s) within 1 month prior to start of the investigation.
- Previously randomised to this investigation.
- Life expectance of the subject less than 3 months
- Pregnant or breast-feeding women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mepilex Ag Mepilex Ag - Mepilex product Mepilex without Ag -
- Primary Outcome Measures
Name Time Method Efficacy Will be Defined as Absolute Wound Size Reduction. 8 weeks Efficacy will be defined as absolute wound size reduction.
- Secondary Outcome Measures
Name Time Method Change in Inflammatory Signs 4 weeks Change in inflammatory signs
Trial Locations
- Locations (44)
Dermatology Department, University Hospital, Hopital Sud
🇫🇷Amiens cedex, France
Nemocnice Podlesí a.s.
🇨🇿Třinec, Czech Republic
Krajská nemocnice Liberec
🇨🇿Liberec, Czech Republic
Uherskohradišťská nemocnice a. s.
🇨🇿Uherské Hradiště, Czech Republic
CHU Le Bocage Service Dermatologie
🇫🇷Dijon Cedex, France
Hôpital Saint Joseph
🇫🇷Paris, France
APHP Hôpital Lariboisère
🇫🇷Paris, France
CHG La Roche-sur-Yon Service de D'Angiologie,Les Oudairies
🇫🇷La Roche-sur-Yon, France
Hôpital Saint Jacques - CHU Besançon
🇫🇷Besançon, France
Résidence le Bristol
🇫🇷Boulogne-sur-mer, France
Fakultní nemocnice Na Bulovce
🇨🇿Prague, Czech Republic
Service de Dermatologie, Centre Hospitalier Regional Universitaire
🇫🇷Caen cedex 9, France
Hôpital privé d'Antony Service de Dermatologie
🇫🇷Antony, France
Centre Hospitalier le Mans Service de Dermatologie
🇫🇷Le Mans cedex 9, France
Cabinet D'Angeiologie
🇫🇷Lille, France
Hopital Maringer-Villemin- Fournier
🇫🇷Nancy, France
Pharmacie Centrale-Service Arsenal
🇫🇷Nantes, France
Clinique Pasteur
🇫🇷Toulouse, France
Universtätsmedizin Charité Klinik für Dermatologie, Allergologie und Venerologie
🇩🇪Berlin, Germany
Maison de Santé Protestante de Bordeaux-Bagatelle
🇫🇷Talence Cedex, France
Polyclinique de Picardie Service d'Angiologie Phlébologie
🇫🇷Amiens, France
Hôpital Albert Michallon Service de médecine vasculaire
🇫🇷Grenoble Cedex 9, France
Hopital Robert Debré Service de Dermatologie
🇫🇷Reims, France
Hôpital Rotchild - Jean Rostand
🇫🇷Paris, France
Hopital Beauregard / Secrétariat de Dermatologie
🇫🇷Thionville, France
St. Antonius Ziekenhuis
🇳🇱Utrecht, Netherlands
Bramfelder Chaussee 200
🇩🇪Hamburg, Germany
University Hospital Regensburg
🇩🇪Regensburg, Germany
Venenzentrum der Dermatologischen und Gefäßchirurgischen Kliniken -
🇩🇪Bochum, Germany
Universität klinikum Jena, Klinik für dermatologie und dermatologische
🇩🇪Jena, Germany
Dermatology department
🇳🇱Amsterdam, Netherlands
Nemocnice Jihlava
🇨🇿Jihlava, Czech Republic
Fakultní nemocnice U svate Anny, St. Anne´s University Hospital
🇨🇿Brno, Czech Republic
Dermatovenerologická klinika, University Hospital Bohunice,
🇨🇿Brno, Czech Republic
Dermatovenerologická klinike, Univerzita Karlova
🇨🇿Plzen, Czech Republic
Masarykova Hospital, Dermatology dept.
🇨🇿Usti nad Labem, Czech Republic
Dermatovenerologie Rendlová s.r.o.
🇨🇿České Budějovice, Czech Republic
Cabinet d'Angiologie, 1 bis rue de Salgareda
🇫🇷St Alban, France
Universitätsklinikum Hamburg-Eppedorf
🇩🇪Hamburg, Germany
Universitäts-Hautklinik
🇩🇪Tübingen, Germany
Hopital Charles Nicolle
🇫🇷Rouen cedex, France
Service de dermatologie
🇫🇷Toulon cedex, France
Universitätsklinikum Schleswig-Holstein Campus Lübeck
🇩🇪Lübeck, Germany
chirugické oddělení, Fakultní nemocnice Královské Vinohrady
🇨🇿Praha, Czech Republic