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Molnlycke

Molnlycke Mepilex XT 20x20 cm 5s (211400)

Molnlycke Mepilex XT 20x20 cm 5s (211400)

常规价格 $167.17 SGD
常规价格 促销价 $167.17 SGD
促销 售罄
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Clinical Summary: Mölnlycke Mepilex XT (REF 211400, 20×20 cm, box of 5) is a CE-marked (EU MDR 2017/745) three-layer absorbent foam dressing incorporating Safetac® soft silicone wound contact technology, a flexible polyurethane foam absorbent core with vertical exudate-transfer channels, and a breathable outer polyurethane film, indicated for low-to-moderately exuding acute and chronic wounds including venous leg ulcers, pressure injuries (EPUAP/NPUAP stages 1–4), diabetic foot ulcers, surgical wounds, and traumatic wounds. Its Safetac adhesive layer seals wound edges while minimising adhesion to wound bed tissue, enabling atraumatic dressing changes with documented reduction in patient pain; more than 450 peer-reviewed publications support Safetac technology. The product is sterilised by ethylene oxide (ETO) per ISO 11135, with a three-year shelf life, and is manufactured under ISO 13485:2016 quality management; registration under Singapore HSA Health Products (Medical Devices) Regulations 2010 applies.

Product Overview

Mepilex XT is a non-bordered absorbent foam dressing designed for the management of low-to-moderately exuding wounds across all clinical settings. The wound contact layer consists of Safetac® soft silicone, a proprietary adhesive technology in which soft silicone polymer seals against the intact perilesional skin to prevent lateral exudate leakage and maceration, while maintaining minimal, atraumatic adhesion to the moist wound surface. Upon dressing removal, the Safetac layer releases from the wound bed without disrupting newly formed granulation tissue or epithelium, eliminating the mechanical stripping injury associated with acrylic-adhesive foam dressings that is a documented cause of pain, wound trauma, and delayed healing. Clinical evidence from the Safetac portfolio encompasses more than 30 randomised controlled trials and over 450 peer-reviewed publications, with Safetac dressings consistently demonstrating superiority to conventional foam and gauze in patient-reported pain scores at dressing change and time to wound healing endpoints.

The absorbent core of Mepilex XT is a flexible polyurethane foam with vertically oriented exudate-transfer channels that rapidly wick wound fluid away from the wound surface into the foam matrix, preventing fluid pooling at the wound-dressing interface that promotes bacterial proliferation and perilesional maceration. The outer layer is a moisture-vapour permeable (MVP) polyurethane film that permits transcutaneous gas exchange while providing a bacterial and liquid barrier, maintaining the moist wound microenvironment that optimises epithelialisation velocity per the moist wound healing principles established by Winter (1962) and supported by subsequent Cochrane evidence synthesis. The dressing can be cut to wound shape without compromising edge integrity or Safetac adhesive function, providing clinical versatility for irregular wound contours and difficult anatomical locations. The product is distributed in Singapore by EMIS Singapore (emis.asia) and is available in standard stocked quantities for both hospital and community wound care procurement.

Product Specifications

Parameter Details
Manufacturer Mölnlycke Health Care AB (Sweden)
Product Name Mepilex XT Absorbent Foam Dressing
Reference (REF) 211400
Size 20 × 20 cm
Thickness 5.6 mm
Packaging Box of 5 sterile dressings
Construction (layers) Layer 1: Safetac® soft silicone wound contact; Layer 2: Flexible polyurethane foam with vertical exudate channels; Layer 3: Moisture-vapour permeable (MVP) polyurethane outer film
Wound Contact Layer Safetac® soft silicone — seals perilesional skin, atraumatic wound bed release
Exudate Capacity Low-to-moderate; handles both low and high-viscosity exudate via vertical channel absorption
Can Be Cut Yes — maintains integrity and Safetac function when trimmed to wound shape
Sterility Sterile (ethylene oxide sterilisation per ISO 11135 / EN 550)
Shelf Life 3 years (unopened packaging; store below 35°C in dry environment)
Latex Content Latex-free
CE Marking Yes — EU Medical Device Regulation (MDR) 2017/745
Manufacturing Quality ISO 13485:2016 (Medical Devices Quality Management System)
Biocompatibility ISO 10993 series (biocompatibility evaluation for medical devices)
Regulatory – Singapore Medical device; registration under HSA Health Products (Medical Devices) Regulations 2010; Class B device eligible; CE marking supports abridged evaluation pathway via Singapore Medical Device Register (SMDR)
Retail Price (Singapore) SGD $167.17 per box of 5 (SGD ~$33.43 per dressing)

Clinical Indications and Key Applications

  • Venous leg ulcers (VLU): Indicated as primary dressing under multi-layer compression bandaging or compression stockings; Safetac wound contact minimises perilesional skin stripping common with adhesive foam dressings in the oedematous, fragile periulcer skin of CVI patients. Compatible with all compression systems including Coban, K-Four, and two-layer systems used in Singapore clinical practice.
  • Pressure injuries (EPUAP/NPUAP Category/Stage 1–4): The flexible foam conforms to body contours at pressure points (sacrum, heel, trochanter, malleolus), distributing interface pressure while managing wound exudate. The MVP outer film maintains skin integrity under the dressing, supporting prevention protocols in addition to treatment of established injury.
  • Diabetic foot ulcers (DFU) — neuropathic and ischaemic/mixed: Indicated for low-to-moderate exudate DFU in off-loading frameworks; Safetac atraumatic removal is particularly important in diabetic patients where wound trauma and perilesional injury risk secondary infection and delayed healing. Mepilex XT is suitable under total contact cast (TCC) systems and removable cast walker (RCW) devices with appropriate offloading.
  • Surgical wounds and post-operative incision management: Suitable for post-surgical wounds healing by secondary intention; the MVP film provides barrier against external contamination while the foam absorbs post-operative haemoserous exudate without strike-through. Reduces dressing change frequency versus gauze, decreasing both material cost and procedural nursing time per Singapore MOH clinical quality metrics.
  • Traumatic wounds and skin tears (Category 1–3 per ISTAP classification): Safetac silicone's low-shear removal mechanism is the standard of care for skin tears in frail and elderly patients; endorsed by the International Skin Tear Advisory Panel (ISTAP) 2018 Best Practice Recommendations as a preferred dressing material for Category 2–3 skin tears.
  • Oncological and neoplastic wound management: Fragile, hypervascular neoplastic wound surfaces benefit from Safetac's non-traumatic wound contact; the foam absorbs variable exudate volumes from tumour wounds while minimising bleeding and patient discomfort at dressing changes, supporting palliative quality-of-life wound management protocols.

Frequently Asked Questions

Q: What clinical evidence supports Safetac® technology and how does it compare to standard foam adhesive dressings?
A: Safetac technology is one of the most extensively evidenced wound dressing adhesive systems in clinical practice. The Safetac evidence base encompasses more than 450 peer-reviewed publications and over 30 randomised controlled trials (RCTs) demonstrating atraumatic dressing removal, reduced patient pain scores at dressing change (measured by VAS and NRS), and superiority in healing rate comparisons versus conventional acrylic-adhesive foam dressings and gauze. A 136-patient, 8-centre German specialist wound care registry study using Mepilex XT reported a mean wound area reduction from 11.8 cm² at baseline to 6.6 cm² at two weeks (44% reduction), with a 31% healing rate at six weeks across heterogeneous wound aetiologies including venous, arterial, diabetic, pressure, and traumatic wounds, with no maceration reported throughout the observation period.

Q: How does Mepilex XT differ from Mepilex Border, Mepilex Transfer, and other products in the Mölnlycke Mepilex range?
A: The Mepilex range shares the Safetac wound contact layer but differs in border configuration, absorption profile, and clinical indication: Mepilex XT is a non-bordered foam dressing suited to wounds requiring dressing fixation with a secondary retention device (e.g., tape, bandage, or compression system). Mepilex Border adds an adhesive foam border for self-adhesion without secondary fixation, suited to wounds on mobile body regions. Mepilex Transfer is an ultra-thin wicking dressing designed to transfer exudate into a secondary absorbent layer, used under compression in high-exudate VLUs. Mepilex Lite is a thin, conformable version for low-exudate wounds and fragile skin. Clinicians should select based on wound exudate level, anatomical location, fixation requirements, and whether compression therapy is being applied concurrently.

Q: Can Mepilex XT 20×20 cm be used under compression therapy for venous leg ulcers?
A: Yes. Mepilex XT is compatible with all forms of compression therapy applied over the dressing, including multi-layer bandaging (K-Four, Coban 2), short-stretch bandaging, and compression stockings. The flexible polyurethane foam conforms to the limb under compression without creating localised pressure ridges or undermining compression gradient delivery. The non-bordered design does not add adhesive bulk that could impair smooth bandage layering. When applying over Mepilex XT under compression, clinicians should ensure the dressing is applied smoothly without folds or edges that could create focal pressure points under the inelastic compression layer. Dressing change frequency under compression should follow wound exudate assessment at each bandage change, typically every 3–7 days for moderate exudate VLUs in the maintenance phase.

Q: What is the Singapore HSA registration status and how should healthcare facilities procure Mepilex XT?
A: Medical devices including wound dressings with therapeutic claims must be registered in Singapore's Medical Device Register (SMDR), maintained by the Health Sciences Authority (HSA) under the Health Products (Medical Devices) Regulations 2010. Mölnlycke Mepilex XT, as a CE-marked Class IIa EU medical device, is eligible for the abridged evaluation pathway in Singapore. Healthcare facilities should request the HSA registration number and Singapore Medical Device Register listing from the authorised distributor (EMIS Singapore, emis.asia) prior to procurement. Singapore-registered healthcare institutions (MOH-licensed hospitals, specialist outpatient clinics, polyclinics) may include Mepilex XT in formulary procurement subject to HSA registration confirmation and compliance with institutional medical device governance requirements.

Q: Are there contraindications or chemical incompatibilities that wound care nurses should be aware of when using Mepilex XT?
A: Absolute contraindication: known hypersensitivity to any component of the dressing, including soft silicone or polyurethane. Critical chemical incompatibility: Mepilex XT must not be used in combination with oxidising wound cleansing agents—specifically hypochlorite solutions (e.g., Dakin's solution, Milton's solution), hydrogen peroxide (H₂O₂), or hypochlorous acid preparations. Oxidising agents degrade the polyurethane foam matrix, compromise Safetac silicone adhesive integrity, and can produce toxic degradation products in the wound environment. If oxidising agents are used for wound bed preparation, allow full irrigation and drying before applying Mepilex XT. There are no documented incompatibilities with iodine-based antiseptics at clinical concentrations or with hydrogel debriding agents. Clinical signs of localised infection (increasing exudate, periwound erythema, warmth, odour, wound stalling) should be assessed at each dressing change; an antimicrobial silver-containing foam dressing (e.g., Mepilex Ag) may be clinically indicated pending microbiological assessment.

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