Prospective, Randomized Study of 2 Different Wound Dressings

Study Overview
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Brief Summary
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The primary objective of this investigation is to evaluate the performance of a self-adhesive absorbent post-operative dressing coated with a soft silicone layer in minimize the risk of the development of blistering in subjects after hip or knee arthroplasty or spinal surgery in comparison to a standard wound dressing The secondary objectives are to evaluate: the performance of the dressing the comfort, conformability and the acceptability of the dressing pain before, during and after dressing removal the overall cost regarding dressing wear time, time to do dressing change and personal resources needed

Detailed Description
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A monocentre, post CE-mark, randomized clinical trial will be conducted at the University of Cologne, Department of Orthopedics and Trauma Surgery. 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). AEs/ADEs/unexpected events with the device may be documented by relevant photos at time. All photos shall include a sticker marked with subject code, visit number/date and time. Outcome Measures Primary variable: • Development of blistering from day 0 to day 6 post surgery Photo documentation will be evaluated in a blinded manner by the Clinical Evaluation Committee (CEC). Secondary variables: Other wound complications (i.e. leakage, inflammation, infection) Number of dressing changes Pain before, during and after dressing removal (VA scale) Performance and acceptability of the dressing (4 point rating scale)

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-surgery, Knee-surgery, Spinal-surgery

Intervention / Treatment
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* Device: Mepilex® Border Post-Op
* Device: standard wound dressing


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 or spine surgery due to tumour or infection? 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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard wound dressing<br>As comparator will be used a standard Cosmopor E®adhesive, island wound dressing (Paul Hartmann LTD)after hip or knee arthroplasty or spinal surgery | Device: standard wound dressing<br>* standard wound dressing after hip-knee or spinal surgery<br>* Other names: As comparator will be used a standard Cosmopor E®adhesive, island wound dressing (Paul Hartmann LTD);|
| Experimental: Mepilex® Border Post-Op<br>wound dressing with Mepilex® Border Post-Op with Safetac®Technology, self-adherent soft silicone surgical dressing | Device: Mepilex® Border Post-Op<br>* wound dressing with Mepilex® Border Post-Op with Safetac®Technology, self-adherent soft silicone surgical dressing<br>* Other names: Mepilex® Border Post-Op with Safetac®Technology;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blistering | Development of blistering from day 0 to day 6 post surgery Photo documentation will be evaluated in a blinded manner by the Clinical Evaluation Committee (CEC). | 0-6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound complications | Other wound complications (i.e. leakage, inflammation, infection) | 0-6 days | 
| dressing changes | Number of dressing changes | 0-6 days | 
| pain | Pain before, during and after dressing removal (VA scale) | 0-6 days | 
| performance and acceptability | Performance and acceptability of the dressing (4 point rating scale) | 0-6 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wound dressing, silicone, standard wound dressing