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| 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 |
| Link to the ClinicalTrials.gov record | Information obtained from ClinicalTrials.gov on February 23, 2012 |
| Title of trial/grant title | 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 |
| Current status of trial | Recruiting |
| Sponsors and collaborators | Molnlycke Health Care AB |
| Information provided by | Molnlycke Health Care AB |
| ClinicalTrials.gov identifier | NCT01036438 |
| Purpose | 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 â¿¥ 0.8 and with inflammatory signs. Efficacy will be defined as absolute wound size reduction. |
| Condition(s) | Venous Leg Ulcers Mixed Leg Ulcers |
| Intervention(s) | Device: Mepilex Ag Device: Mepilex without Ag |
| Phase | Phase IV |
| Study type and design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| Official title | A Double-blind, Comparative, Superiority, Multi-centre Investigation 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 |
| Primary outcome | Efficacy will be defined as absolute wound size reduction. 4 weeks No |
| Secondary outcome | Change in inflammatory signs 4 weeks No |
| Study start | December 2009 |
| Minimum age | 18 Years |
| Maximum age | N/A |
| Gender | Both |
| Eligibility criteria | 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: - 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 Exclusion Criteria: - > 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 |
| Overall contact | Ann Larkö tel: +46 31 7223338 ann.larko@molnlycke.com |
| Study chairs or principal investigators | Sylvie Meaume, Dr, Principal Investigator, Hopital Rotchild - Jean Rostand, Paris |
| Locations | Czech Republic Fakultnà nemocnice U svate Anny, St. Anne´s University Hospital Brno 65691 Status: Recruiting Contact: Hana Kostková hana.kostkova@fnusa.cz Investigator: Veronika Slonkova, MD, Principal Investigator Czech Republic Dermatovenerologická klinika, University Hospital Bohunice, Brno Status: Not yet recruiting Contact: Drahomira Corbova, MD drahushka@gmail.com Investigator: Sabina Svestkova, MD, Principal Investigator Czech Republic Hospital (Nemocnice) Dermatological Dpt. (Kozni oddeleni) Ceské Budejovice Status: Withdrawn Czech Republic Dermatovenerologická klinike, Univerzita Karlova Plzen 305 99 Status: Recruiting Contact: Adisa Duranovic duranovic@fnplzen.cz Investigator: Petra Cetkovska, MUDr, Principal Investigator Czech Republic Fakultnà nemocnice Na Bulovce Prague 180 00 Status: Active, not recruiting Czech Republic Masarykova Hospital, Dermatology dept. Usti nad Labem 401 13 Status: Recruiting Contact: Hana Malikova, MD hana.malikova@mnul.cz Investigator: Olga Filipovská, MD, Principal Investigator France Dermatology Department, University Hospital, Hopital Sud Amiens cedex 80054 Status: Recruiting Contact: Alicia Playe playe.alicia@chu-amiens.fr Investigator: Catherine Lok, MD, Principal Investigator France Service de Dermatologie, Centre Hospitalier Regional Universitaire Caen cedex 9 140 33 Status: Recruiting Contact: Bénédicte Mourgeon bmourgeon@me.com Investigator: Anne Dompmartin, MD, Principal Investigator France Cabinet D'Angeiologie Lille 690 00 Status: Active, not recruiting France Hopital Maringer-Villemin- Fournier Nancy Status: Recruiting Contact: Jean-Francois Cuny, Dr tel: +33 383 85 24 66 jf.cuny@chu-nancy.fr Investigator: Jean-Francois Cuny, Dr, Principal Investigator France Hôpital Rotchild - Jean Rostand Paris 75012 Status: Recruiting Investigator: Sylvie Meaume, Dr, Principal Investigator France Hopital Robert Debré Service de Dermatologie Reims Status: Recruiting Contact: Géraldine Perceau, Dr gperceau@chu-reims.fr Investigator: Géraldine Perceau, Dr, Principal Investigator France Hopital Charles Nicolle Rouen cedex Status: Recruiting Contact: Priscille Carvalho, MD tel: +33 2 32888855 priscille.carvalho@chu-rouen.fr Investigator: Priscille Carvalho, Dr, Principal Investigator France Maison de Santé Protestante de Bordeaux-Bagatelle Talence Cedex Status: Active, not recruiting France Hopital Beauregard / Secrétariat de Dermatologie Thionville 57100 Status: Recruiting Contact: Antoine Claeys, Dr a.claeys@chr-metz-thionville.fr Investigator: Francois Truchetet, Dr, Principal Investigator France Service de dermatologie Toulon cedex Status: Active, not recruiting France Clinique Pasteur Toulouse 31076 Status: Recruiting Contact: Frédéric Petit tel: +33 5 62 21 16 99 F.Petit@clinique-pasteur.com Investigator: Philippe Léger, Dr, Principal Investigator France CH de valenciennes / Service de cardiologie Valenciennes 59300 Status: Withdrawn Germany Universtätsmedizin Charité Klinik für Dermatologie, Allergologie und Venerologie Berlin 10117 Status: Recruiting Contact: Iris Hübner iris.huebner@charite.de Investigator: Bernhard Lange-Asschenfeldt, MD, Principal Investigator Germany Venenzentrum der Dermatologischen und Gefäÿchirurgischen Kliniken - Bochum 44805 Status: Recruiting Contact: Elke Esser tel: +49 234 8792 377 E.Esser@klinikum-bochum.de Investigator: Markus Stücker, prof, Principal Investigator Germany Bramfelder Chaussee 200 Hamburg 22177 Status: Recruiting Contact: Ulrike Gravenhorst-Münter tel: +49 40 64220562 Ulrike.muenter@t-online.de Investigator: . Karl-Christian Münter, Dr, Principal Investigator Germany Universitätsklinikum Hamburg-Eppedorf Hamburg 20246 Status: Recruiting Contact: Katharina Herberger, Dr tel: +49 40 42803 5428 k.herberger@uke.uni-hamburg.de Investigator: Matthias Augustin, Dr, Principal Investigator Germany Universität klinikum Jena, Klinik für dermatologie und dermatologische Jena 07740 Status: Recruiting Contact: Nancy Schmidt tel: +49 3641 820523 nancy.schmidt@med.uni-jena.de Investigator: Sabine Sell, Dr, Principal Investigator Germany Universitätsklinikum Schleswig-Holstein Campus Lübeck Lübeck 23538 Status: Active, not recruiting Germany University Hospital Regensburg Regensburg Status: Recruiting Contact: Sigrid Karrer, Prof. Dr. tel: +49 172 814 08 09 Sigrid.karrer@klinik.uni.regensburg.de Investigator: Sigrid Karrer, Prof. MD, Principal Investigator Germany Universitäts-Hautklinik Tübingen 72076 Status: Recruiting Contact: Martina Hommel tel: +49 7071 2985124 Investigator: Anke Stroelin, Dr, Principal Investigator Netherlands Dermatology department Amsterdam 1081 Status: Active, not recruiting Netherlands Academisch Medich Centrum / University of Amsterdam Amsterdam 1105 AZ Status: Active, not recruiting Netherlands St. Antonius Ziekenhuis Utrecht Status: Recruiting Contact: Rita Ditzhuijzen r.van.ditzhuijzen@antoniusziekenhuis.nl Investigator: R Tupker, Principal Investigator |
| Study ID numbers | PUMA 416 |
| Last updated | December 16, 2011 |
| Record first received | December 18, 2009 |
| ClinicalTrials.gov identifier | NCT01036438 |
| Download date | Information obtained from ClinicalTrials.gov on February 23, 2012 |
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