Post Market Clinical Follow-up Study (MxB Po01)

Molnlycke Health Care

Status and phase: Completed; Phase 4

Conditions: Hip or Knee Surgery

Treatments: Device: Mepilex border post op; Device: Mepilex border post. op

Study type: Interventional

Funder types: Industry

Identifiers

NCT01841567

MxB Po01

Details and patient eligibility

About

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).

Enrollment: 60 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Age 45 years
2. Have an expected total length of stay of 4 or more days
3. Undergoing elective primary arthroplasty of the hip or knee
4. Undergoing hip surgery with a standard access
5. Give their written informed consent to participate

Exclusion Criteria

1. Dressing size does not fit the incision area
2. Known allergy hypersensitivity to any of the components of the dressing
3. Multi-trauma
4. Undergoing arthroplasty due to tumour
5. Fractures
6. Wound at the surgical site prior to surgery
7. Neurological deficit of operated side
8. Subject has documented skin disease at time of enrolment, as judged by the investigator
9. Previously enrolled in the present investigation
10. Subject included in other ongoing investigation at present, as judged by the investigator.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

dressing

Other group

Treatment:

Device: Mepilex border post. op

Device: Mepilex border post op