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

Molnlycke Health Care

Status: Completed

Conditions: Arthroplasties, Hip Replacement; Arthroplasties, Knee Replacement

Treatments: Device: Mepilex Border Post-Op Ag

Study type: Interventional

Funder types: Industry

Identifiers

NCT03016078

MxB Po Ag 01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Age ≥ 18 years
2. Available for a follow-up visit including dressing change 7 days after surgery
3. Plan for elective primary hip or knee arthroplasty
4. Plan for incision size ≤18 cm
5. Provision of informed consent i.e. subject must be able to understand and sign the Patient Information and Consent Form
6. Undergoing elective primary arthroplasty of the hip or knee.

Exclusion Criteria

1. Known allergy/hypersensitivity to any of the components of the dressing
2. Multi-trauma
3. Undergoing arthroplasty due to tumor
4. Previous incision at the same knee or same side of the hip
5. Wound at the surgical site prior to surgery
6. Neurological deficit of operated side (hemiplegia, etc.)
7. Documented skin disease at time of enrollment, as judged by the investigator
8. Previously enrolled in the present investigation
9. Inclusion in other ongoing investigations at present that would preclude the subject from participating in this investigation as judged by the investigator
10. Involvement in the planning and conduct of the clinical investigation (applies to all MHC staff, investigational site staff and third party vendor)
11. Dressing size does not fit the incision area (>18 cm)
12. Complications that would increase wound risks if investigational dressing is applied

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Mepilex Border Post-Op Ag Dressing

Other group

Description:

A soft silicone foam dressing that absorbs wound exudate maintains a moist wound healing environment and has antimicrobial properties

Treatment:

Device: Mepilex Border Post-Op Ag