A Post-Market Clinical Investigation on Mepilex Border Post-Op
ARCTIS
A Retrospective, Observational, Post-Market Clinical Investigation on Safety and Performance of Mepilex Border Post-Op for Post-Operative Wounds
1 other identifier
observational
560
1 country
1
Brief Summary
This is a retrospective, observational (non-interventional), single-arm, single-centre, post-market clinical investigation designed to verify clinical performance and safety of Mepilex Border Post-Op when used according to clinical practice for post-operative wounds in a large and broad population. The clinical investigation will consist of a retrospective medical record review, which will be completed with data from up to 450 female and male adult subjects who were treated with Mepilex Border Post-Op following elective hip or knee replacement at one clinic in Belgium between January 2016 and February 2021.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2021
CompletedFirst Posted
Study publicly available on registry
August 6, 2021
CompletedStudy Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2021
CompletedDecember 20, 2021
December 1, 2021
4 months
July 7, 2021
December 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dressing wear time
Dressing wear time from day of surgery to end of dressing use
From day of surgery to end of dressing use (up to one month)
Secondary Outcomes (10)
Total number of dressings per subject
From day of surgery to end of dressing use (up to one month)
Time to dressing strikethrough
From day of surgery to end of dressing use (up to one month)
Change in physical activity level
Pre-surgery to end of dressing use (up to one month)
Change in the EQ-5D
Pre-surgery to day 83 post surgery
Change in KOOS or HOOS pain subscale score
pre-surgery to day 42 and day 83 post surgery
- +5 more secondary outcomes
Eligibility Criteria
Eligible subjects/medical records will be identified from a population of adults patients who have had elective hip or knee replacement surgery at the Medisch Centrum Latem, Belgium.
You may qualify if:
- Underwent elective knee or hip surgery between January 2016 and February 2021 at the Medisch Centrum Latem, Belgium.
- Post-operative wound treated with Mepilex Border Post-Op
- Documented consent in moveUP Therapy
- Documented consent at Medisch Centrum Latem during pre-op consultation
You may not qualify if:
- \. Subject missing all answers to the moveUP Therapy question "Is the dressing dry?"
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medisch Centrum Latem
Sint-Martens-Latem, 9830, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2021
First Posted
August 6, 2021
Study Start
September 1, 2021
Primary Completion
December 15, 2021
Study Completion
December 15, 2021
Last Updated
December 20, 2021
Record last verified: 2021-12