Post Market Clinical Follow-up Study

Study Overview
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Brief Summary
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The overall rationale for this study is to evaluate the clinical performance potential for Mepilex Border Post-Op in the ability to minimise the risk of blistering, maceration and less dressing change due to high absorption capacity. This study is a part of Post Market Clinical Follow-Up (PMCF).

Official Title
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A Multi-centre, Post CE-mark, Open Investigation to Evaluate the Performance of a Flexible Self-adherent Absorbent Dressing Coated With a Soft Silicone Layer After Hip or Knee Arthroplasty

Conditions
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Hip or Knee Surgery

Intervention / Treatment
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* Device: Mepilex border post. op
* Device: Mepilex border post op


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Age 45 years Have an expected total length of stay of 4 or more days Undergoing elective primary arthroplasty of the hip or knee 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 tumour Fractures Wound at the surgical site prior to surgery Neurological deficit of operated side Subject has documented skin disease at time of enrolment, as judged by the investigator Previously enrolled in the present investigation Subject included in other ongoing investigation at present, as judged by the investigator.

Ages Eligible for Study
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Minimum Age: 45 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: dressing<br> | Device: Mepilex border post. op<br> <br> Device: Mepilex border post op<br> <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 | 

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 |  | 7 days | 
| Pain Evaluation |  | 7 days | 
| Overall Cost Regarding Dressing Wear Time |  | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hip, knee