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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Molnlycke Health Care AB
ClinicalTrials.gov Identifier:
NCT01036438
First received: December 18, 2009
Last updated: December 10, 2013
Last verified: December 2013
  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 ≥ 0.8 and with inflammatory signs. Efficacy will be defined as absolute wound size reduction.


Condition Intervention Phase
Venous Leg Ulcers
Mixed Leg Ulcers
Device: Mepilex Ag
Device: Mepilex without Ag
Phase 4

Study Type: Interventional
Study 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

Resource links provided by NLM:


Further study details as provided by Molnlycke Health Care AB:

Primary Outcome Measures:
  • Efficacy will be defined as absolute wound size reduction. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in inflammatory signs [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 201
Study Start Date: December 2009
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01036438

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

No publications provided

Responsible Party: Molnlycke Health Care AB
ClinicalTrials.gov Identifier: NCT01036438     History of Changes
Other Study ID Numbers: PUMA 416
Study First Received: December 18, 2009
Last Updated: December 10, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Leg Ulcer
Ulcer
Varicose Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes
Varicose Veins
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014