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

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

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.

Study Overview

• Status: Completed
• Conditions: Venous Leg Ulcers; Mixed Leg Ulcers
• Intervention / Treatment: Device: Mepilex without Ag; Device: Mepilex Ag

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Phase 4

Contacts and Locations

Study Locations

• Czech Republic
  • Brno, Czech Republic, 65691
    • Fakultní nemocnice U svate Anny, St. Anne´s University Hospital
  • Brno, Czech Republic
    • Dermatovenerologická klinika, University Hospital Bohunice,
  • Jihlava, Czech Republic, 586 01
    • Nemocnice Jihlava
  • Liberec, Czech Republic, 46063
    • Krajska Nemocnice Liberec
  • Plzen, Czech Republic, 305 99
    • Dermatovenerologická klinike, Univerzita Karlova
  • Prague, Czech Republic, 180 00
    • Fakultni nemocnice Na Bulovce
  • Praha, Czech Republic, 10 PSČ 100 34
    • chirugické oddělení, Fakultní nemocnice Královské Vinohrady
  • Třinec, Czech Republic, 73961
    • Nemocnice Podlesí a.s.
  • Uherské Hradiště, Czech Republic, 68668
    • Uherskohradišťská nemocnice a. s.
  • Usti nad Labem, Czech Republic, 401 13
    • Masarykova Hospital, Dermatology dept.
  • České Budějovice, Czech Republic, 37001
    • Dermatovenerologie Rendlová s.r.o.
• France
  • Amiens, France, 80000
    • Polyclinique de Picardie Service d'Angiologie Phlébologie
  • Amiens cedex, France, 80054
    • Dermatology Department, University Hospital, Hopital Sud
  • Antony, France, 92160
    • Hôpital privé d'Antony Service de Dermatologie
  • Besançon, France, 25030
    • Hôpital Saint Jacques - CHU Besançon
  • Boulogne-sur-mer, France, 62200
    • Résidence le Bristol
  • Caen cedex 9, France, 140 33
    • Service de Dermatologie, Centre Hospitalier Regional Universitaire
  • Dijon Cedex, France, 21079
    • CHU Le Bocage Service Dermatologie
  • Grenoble Cedex 9, France, 38 043
    • Hôpital Albert Michallon Service de médecine vasculaire
  • La Roche-sur-Yon, France, 85925
    • CHG La Roche-sur-Yon Service de D'Angiologie,Les Oudairies
  • Le Mans cedex 9, France, 72037
    • Centre Hospitalier le Mans Service de Dermatologie
  • Lille, France, 690 00
    • Cabinet D'Angeiologie
  • Nancy, France
    • Hopital Maringer-Villemin- Fournier
  • Nantes, France, 44093
    • Pharmacie Centrale-Service Arsenal
  • Paris, France, 75014
    • Hôpital Saint Joseph
  • Paris, France, 75010
    • APHP Hôpital Lariboisère
  • Paris, France, 75012
    • Hôpital Rotchild - Jean Rostand
  • Reims, France
    • Hopital Robert Debré Service de Dermatologie
  • Rouen cedex, France
    • Hopital Charles Nicolle
  • St Alban, France, 31140
    • Cabinet d'Angiologie, 1 bis rue de Salgareda
  • Talence Cedex, France
    • Maison de Santé Protestante de Bordeaux-Bagatelle
  • Thionville, France, 57100
    • Hopital Beauregard / Secrétariat de Dermatologie
  • Toulon cedex, France
    • Service de dermatologie
  • Toulouse, France, 31076
    • Clinique Pasteur
• Germany
  • Berlin, Germany, 10117
    • Universtätsmedizin Charité Klinik für Dermatologie, Allergologie und Venerologie
  • Bochum, Germany, 44805
    • Venenzentrum der Dermatologischen und Gefäßchirurgischen Kliniken -
  • Hamburg, Germany, 20246
    • Universitätsklinikum Hamburg-Eppedorf
  • Hamburg, Germany, 22177
    • Bramfelder Chaussee 200
  • Jena, Germany, 07740
    • Universität klinikum Jena, Klinik für dermatologie und dermatologische
  • Lübeck, Germany, 23538
    • Universitätsklinikum Schleswig-Holstein Campus Lübeck
  • Regensburg, Germany
    • University Hospital Regensburg
  • Tübingen, Germany, 72076
    • Universitäts-Hautklinik
• Netherlands
  • Amsterdam, Netherlands, 1081
    • Dermatology department
  • Utrecht, Netherlands
    • St. Antonius Ziekenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Mepilex product	Device: 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.
ACTIVE_COMPARATOR: Mepilex Ag	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy Will be Defined as Absolute Wound Size Reduction.	Efficacy will be defined as absolute wound size reduction.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Inflammatory Signs	Change in inflammatory signs	4 weeks

Collaborators and Investigators

• Sponsor: Molnlycke Health Care AB
• Investigators: Principal Investigator: Sylvie Meaume, Dr, Hopital Rotchild - Jean Rostand, Paris

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (ACTUAL): October 1, 2013
• Study Completion (ACTUAL): October 1, 2013

Study Registration Dates

• First Submitted: December 18, 2009
• First Submitted That Met QC Criteria: December 18, 2009
• First Posted (ESTIMATE): December 21, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): September 12, 2014
• Last Update Submitted That Met QC Criteria: September 11, 2014
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: PUMA 416