Antimicrobial Dressings

Mepilex Border Ag

Self-adherent antimicrobial soft silicone foam dressing

  • Sterile
  • Antimicrobial
  1. Mepilex Border Ag should be used by or under the supervision of a qualified health care professional.
    Note that local hygiene procedures should be followed prior to and following the dressing change.
    1. Cleanse the wound with saline solution or water according to standard clinical practice.
    2. Dry the surrounding skin thoroughly.
    3. Select appropriate dressing size. For best clinical outcomes, ensure that the absorbent pad covers the wound bed and overlaps the wound edges.
    4. Remove the release films and apply the adherent side to the wound. Do not stretch.
    Each Mepilex Border Ag dressing may be left in place for up to 7 days depending on the patient, condition of the wound and surrounding skin, or as indicated by accepted clinical practice.
    Initially it might be necessary to change Mepilex Border Ag more frequently. This is due to a change in treatment regime, which can often result in an initial increase in exudation.
    Mepilex Border Ag is intended for short-term use up to 4 weeks. For continued use, a re-assessment by a physician is recommended. In case of clinical infection Mepilex Border Ag does not replace the need for systemic or other adequate infection treatment.
    The interaction of Mepilex Border Ag together with cleansing agents, oxidising agents such as hypochlorite solutions/hydrogen peroxide and topical treatments has not been demonstrated.
    Prior to commencing radiation therapy, remove Mepilex Border Ag if product is present in the treatment area. A new dressing can be applied following treatment. Avoid contact with electrodes or conductive gels during electronic measurements, e.g. electrocardiograms
    (ECG) and electroencephalograms (EEG).

    Precautions

    Mepilex Border Ag should be stored in dry conditions below 25°C/77°F and protected from direct sunlight.
    Disposal should be handled according to local environmental procedures.

  2. Mepilex Border Ag consists of a Safetac® soft silicone wound contact layer, an absorbent polyurethane foam pad containing silver sulphate and coloured by activated carbon, a layer with super absorbent fibres, a nonwoven and a breathable and water proof film. Safetac® is a proprietary adhesive technology developed by Mölnlycke that minimises pain to patients and trauma to intact skin or wounds. Mepilex Border Ag is a soft silicone foam dressing that absorbs exudate, maintains a moist wound healing environment and has antimicrobial properties. Mepilex Border Ag contains silver sulphate to create an effective bacterial barrier and inactivate a wide range of wound related pathogens (bacteria and fungi), as shown in vitro. By reducing the number of microorganisms, Mepilex Border Ag may also reduce odour. Mepilex Border Ag has been shown to inactivate wound related pathogens up to 7 days in vitro.

    1. 01

      Fast (as from 30 min, in vitro), sustained (up to 7 days, in vitro) and broad range antimicrobial action (in vitro)

    2. 02

      Efficient exudate handling by minimising leakage and a high absorption, retention and MVTR. This could help support a reduced number of dressing changes

    1. Mölnlycke Health Care. NAMSA reference 10C_39972_01. (Modified) ISO 20743:2007 Determination of antibacterial activity of antibacterial finished products. Data on file, 2010. Mölnlycke Health Care. NAMSA references 09C_29253_01, 09C_29252_01, 09C_29253_02. ASTM E2149-01 Determining the antimicrobial activity of immobilized antimicrobial agents under dynamic contact conditions. Data on file, 2009. Mölnlycke Health Care. T- 1050 Shake flask method for determination of antimicrobial effect of material and products. Data on file, 2009. Mölnlycke Health Care. T- 1050 Shake flask method for determination of antimicrobial effect of material and products. Data on file, 2009.
    2. Huss, F., Thorfinn, J. An open, non-controlled, postmarketing investigation evaluating the experience of using a self-adherent antimicrobial soft silicone, silver containing, foam dressing, Mepilex Border Ag, in second degree burns. PMCF study MxB Ag 02 from Mölnlycke Health Care. Unpublished data, 2011. Latenser, B., Alvarez, OM., Treadwell, T. Open multicentre investigation to evaluate signs and symptoms of local inflammation/infection on chronic ulcers and partial thickness burns when using Mepilex Border Ag as an anti-microbial wound dressing. PMCF study MxB Ag 01 from Mölnlycke Health Care. Unpublished data, 2012. Kles C.L., Murrah, C.P., Smith, K., Baugus- Wellmeier, E., Hurry, T., Morris, C.D. Achieving and sustaining zero. Preventing surgical site infections after isolated coronary artery bypass with saphenous vein harvest through implementation of a staffdriven quality improvement process. Dimensions of Critical Care Nursing 2015;34(5):265-272.
  3. Packaging levelQuantityGTIN code
    Consumer pack17332551895198
    Dispenser box57332551895181
    Transport box257332551895174

    Class: CFR Unclassified

    Manufacturer: Molnlycke Health Care AB, Gamlestadsvagen 3c, Box 13080, SE-402 52 Goteborg Sweden

    Notified Body: FDA CDRH