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: September 11, 2014
Last verified: December 2013

December 18, 2009
September 11, 2014
December 2009
October 2013   (final data collection date for primary outcome measure)
Efficacy Will be Defined as Absolute Wound Size Reduction. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Efficacy will be defined as absolute wound size reduction.
Efficacy will be defined as absolute wound size reduction. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01036438 on ClinicalTrials.gov Archive Site
Change in Inflammatory Signs [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Change in inflammatory signs
Change in inflammatory signs [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Venous Leg Ulcers
  • Mixed Leg Ulcers
  • 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.
  • 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.
  • Placebo Comparator: Mepilex product
    Intervention: Device: Mepilex without Ag
  • Active Comparator: Mepilex Ag
    Intervention: Device: Mepilex Ag
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
201
October 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   France,   Germany,   Netherlands
 
NCT01036438
PUMA 416
No
Molnlycke Health Care AB
Molnlycke Health Care AB
Not Provided
Principal Investigator: Sylvie Meaume, Dr Hopital Rotchild - Jean Rostand, Paris
Molnlycke Health Care AB
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP