Phase 4
Completed N=60
Post Market Clinical Follow-up Study
Hip or Knee Surgery
Source: ClinicalTrials.gov NCT01841567 ↗
Enrolled (actual)
60
Serious AEs
3.3%
Results posted
Sep 2014
Primary outcomePrimary: Minimize the Risk of the Development of Blistering. — 60 participants
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Minimize the Risk of the Development of Blistering. |
60 | — |
| SECONDARY Number of Participants Rated 'Very Good to Excellent' for Comfort, Conformability and the Acceptability of the Dressing. |
60 | — |
| SECONDARY Comfort, Comformability, Acceptability of the Dressing |
— | — |
| SECONDARY Pain Evaluation |
— | — |
| SECONDARY Overall Cost Regarding Dressing Wear Time |
— | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01841567). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.