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

  Show 44 Study Locations
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 July 22, 2014