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A Mono-centre, Post CE-mark, Prospective-randomized Clinical Trial to Evaluate the Performance of a Flexible Self-adherent Absorbent Dressing Coated With a Soft Silicone Layer After Hip or Knee Arthroplasty or Primary Spine Surgery in Comparison to a Standard Wound Dressing (Cosmopor E®Steril, Fa. Hartmann) (NCT02771015)

Male or female subjects, 18 years and above, undergoing hip, knee or spinal surgery with an expected hospital stay for 4 days or more will be included in the trial. Individual trial duration will be for 7 days (follow-up). Two hundred subjects will be included in the trial, i.e. 100 subjects per arm. The treatment arm (either new or standard wound dressing) will be assigned by randomization stratified by type of surgery (i.e. hip, knee or spine).
  • Device: Mepilex Border®
    randomization
    • Device: Cosmopor steril®
      randomization
      Ages eligible for Study
      18 Years and older
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      Inclusion Criteria:
      • Age ≥18years
      • Have an expected total length of stay of 4 or more days
      • Undergoing elective primary arthroplasty of the hip or knee or spinal surgery
      • Undergoing hip surgery with a standard access
      • Give their written informed consent to participate
      Exclusion Criteria:
      • Dressing size does not fit the incision area
      • Known allergy/hypersensitivity to any of the components of the dressing
      • Multi-trauma
      • Undergoing arthroplasty due to tumor
      • Fractures
      • Wound at the surgical site prior to surgery
      • Neurological deficit of operated side (hemiplegia, etc.)
      • Subject has documented skin disease at time of enrolment, as judged by the investigator
      At the baseline visit:

      - Subject demographic details

      - Inclusion and exclusion criteria

      - Vital signs

      - Medical and surgical history

      - Skin status at incision site

      - Mobilisation (subject mobility, mobilisation in bed and chair)

      - Medication

      - AE/ADE/ SAE/SADE/DD

      - Informed consent

      - Randomization

      At visit 2:

      - Type of surgery

      - Length of incision

      - Intraoperative antibiotic given

      - Length of anesthesia

      At each visit from visit 3:

      - Surgical incision condition (condition under the dressing, condition outside the dressing, exudates amount, exudates nature, wound odour, dressing capacity of handling blood, signs of systemic infection, systemic antibiotic given for the systematic infection, blistering, skin stripping

      - Skin status at incision site (type of skin, skin temperature, skin perspiration, oedema, tissue consistency, sensation)

      - Mobilisation (subject mobility, mobilisation in bed and chair)

      - Dressing change (application and removal)

      - Drainage (drainage used, application of the drainage)

      - Compression Medication (pain medication and systematic antibiotic treatment)

      - Photo (photo before and after dressing removal and if signs of infection)

      - Investigator/nurse evaluation (ease of application of the dressing, size of the dressing, shape of the dressing, visibility beneath the dressing, notice any pain at dressing change, ease of removal of the dressing, overall experience)

      - Patient evaluation (the patient's overall experience of the dressing, comfort when wearing the dressing).

      - Contentious pain - measured by Visual Analog Scale (VAS) Prüfplan: CLOSE 2.0F 28.10.2013 5(40)

      - Product application (time application start, time application ended, staff involved, material)

      - AE/ADE/SAE/SADE/DD

      1 locations

      Germany (1)
      • University Hospital Cologne
        Not specified
        Cologne, NRW, Germany, 50931
      Status:
      unknown
      Type:
      Interventional
      Phase:
      -
      Start:
      31 July, 2014
      Updated:
      09 May, 2016
      Participants:
      200
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