Self-adherent Absorbent Silver Dressing in Adults After Hip or Knee Arthroplasty

Study Overview
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Brief Summary
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The overall rationale for this investigation is to evaluate the clinical performance potential for Mepilex Border Post-Op Ag in the ability to minimize the risk of skin related post-operative wound complications such as blistering, maceration and redness at the incision and surrounding skin.

Detailed Description
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This was a descriptive, open, prospective, non-controlled clinical investigation conducted on 21 enrolled subjects at one site in the United states of America (USA). The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty with a possibility to participate in a follow-up visit 7 days after surgery. The primary purpose was to investigate if there was any skin damage under the dressing from operation day to last visit. Performance of the dressing as well as comfort, conformability, acceptability and pain at dressing removal was also followed-up until post-op day 7.

Official Title
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A Single Center, Open, Non-controlled Investigation to Evaluate the Performance of a Flexible, Self-adherent Absorbent Silver Dressing Coated With a Soft Silicone Layer After Elective Primary Total Hip or Knee Arthroplasty

Conditions
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Arthroplasties, Hip Replacement, Arthroplasties, Knee Replacement

Intervention / Treatment
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* Device: Mepilex Border Post-Op Ag


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Available for a follow-up visit including dressing change 7 days after surgery Plan for elective primary hip or knee arthroplasty Plan for incision size ≤18 cm Provision of informed consent i.e. subject must be able to understand and sign the Patient Information and Consent Form Undergoing elective primary arthroplasty of the hip or knee. Exclusion Criteria Known allergy/hypersensitivity to any of the components of the dressing Multi-trauma Undergoing arthroplasty due to tumor Previous incision at the same knee or same side of the hip Wound at the surgical site prior to surgery Neurological deficit of operated side (hemiplegia, etc.) Documented skin disease at time of enrollment, as judged by the investigator Previously enrolled in the present investigation Inclusion in other ongoing investigations at present that would preclude the subject from participating in this investigation as judged by the investigator Involvement in the planning and conduct of the clinical investigation (applies to all MHC staff, investigational site staff and third party vendor) Dressing size does not fit the incision area (>18 cm) Complications that would increase wound risks if investigational dressing is applied

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Mepilex Border Post-Op Ag Dressing<br>A soft silicone foam dressing that absorbs wound exudate maintains a moist wound healing environment and has antimicrobial properties | Device: Mepilex Border Post-Op Ag<br>* To investigate if there was any skin damage under the dressing from operation day to last visit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Damage to the Incision and Surrounding Skin | The primary outcome is damage to the incision and surrounding skin from operation day to last visit in terms of: Blistering (Yes/No) by visit Redness under dressing (Yes/No) by visit Redness outside dressing (Yes/No) by visit Maceration under dressing (Yes/No) by visit Maceration outside dressing (Yes/No) by visit | Daily visits, up to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Leakage of the Dressing | Nurse/ Investigator evaluate: Leakage (No/Yes) | Daily visits, up to 7 days | 
| Number of Participants With Dressing Sticking to the Staples/Sutures | Nurse/ Investigator evaluate: Dressing sticks to the staples/sutures (No/Yes) | Daily visits, up to 7 days | 
| Number of Participants With Bleeding Caused by Dressing Removal | Nurse/ Investigator evaluate: Bleeding caused by dressing removal (No/Yes) | Daily visits, up to 7 days | 
| Participants' Dressing Wear Time (Days) | The number of days the dressing can stay on are evaluated | 7 days | 
| Number of Dressing Changes Per Subject | To evaluate the number of dressing changes per subject | Daily visits, up to 7 days | 
| Evaluation of the Dressing Capacity of Handling Blood | Nurse or Investigator evaluate: Poor, Good, Very Good,Very Good, Excellent on a Likert scale. | Daily visits, up to 7 days | 
| Residuals of the Dressing Material in the Wound or Surrounding Skin at Any Visit (for Patients With at Least One Dressing Change) | Residuals of the dressing material in the wound or surrounding skin at any visit (for patients with at least one dressing change). Nurse/ Investigator evaluate with No/Yes | Daily visits, up to 7 days |