Performance of Flexible Self-adherent Absorbent Dressing Coated With a Soft Silicone Layer After Hip -,Knee- Arthroplasty,Primary Spine Surgery in Comparison to a Standard Wound Dressing

Study Overview
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Brief Summary
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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).

Detailed Description
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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

Official Title
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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)

Conditions
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Hip-arthroplasty, Knee-arthroplasty, Spine Surgery

Intervention / Treatment
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* Device: Mepilex Border®
* Device: Cosmopor steril®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mepilex Border®<br>Mepilex Border® wound dressing at patients after hip-knee or primary spine surgery | Device: Mepilex Border®<br>* randomization<br>|
| Active Comparator: Cosmopor steril®<br>Standard wound dressing at patients after hip-knee or primary spine surgery | Device: Cosmopor steril®<br>* randomization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimize the Risk of the Development of Blistering | Number of participants without blisters at study visit | 7 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Rated 'Very Good to Excellent' for Comfort, Conformability and the Acceptability of the Dressing | The comfort, conformability and the acceptability of the dressing were measured on all visit in the study, by a study nurses. The patient had to answer questions regarding, the size of the dressing, shape of the dressing, Visibility beneath the dressing, ease of the application of the dressing, ease of removal of the dressing, overall experience of the use of the dressing, notice any pain at dressing change, Comfort of their dressing, overall experience of their dressing. The patient could chose between 1 Good, 2 Very good, 3 Excellent.In most cases, the patient chose very good to excellent for both hip and knee surgery | 7 days | 
| Comfort, Comformability, Acceptability of the Dressing | The comfort, conformability and the acceptability of the dressing were measured on all visit in the study, by a study nurses. The patient had to answer questions regarding, the size of the dressing, shape of the dressing, Visibility beneath the dressing, ease of the application of the dressing, ease of removal of the dressing, overall experience of the use of the dressing, notice any pain at dressing change, Comfort of their dressing, overall experience of their dressing. The patient could chose between 1 Good, 2 Very good, 3 Excellent | 7 days | 
| Change From Baseline in Pain on the visual analog scale | Scores range from 0 [no pain] to 10 [worst possible pain] | 7 days | 
| the overall cost regarding dressing wear time | bill of material costs | 7 days |