Completed
MxB Po01A Multi-centre, Post CE-mark, Open Investigation to Evaluate the Performance of a Flexible Self-adherent Absorbent Dressing Coated With a Soft Silicone Layer After Hip or Knee Arthroplasty
What is being tested
Mepilex border post. op
+ Mepilex border post op
Device
Who is being recruted
Over 45 Years
+15 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 4
Interventional
Study Start: April 2013
Summary
Principal SponsorMolnlycke Health Care AB
Last updated: September 30, 2014
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2013
Actual date on which the first participant was enrolled.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).
Principal SponsorMolnlycke Health Care AB
Last updated: September 30, 2014
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 45 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
5 inclusion criteria required to participate
Age 45 years
Give their written informed consent to participate
Have an expected total length of stay of 4 or more days
Undergoing elective primary arthroplasty of the hip or knee
Show More Criteria
10 exclusion criteria prevent from participating
Dressing size does not fit the incision area
Fractures
Known allergy hypersensitivity to any of the components of the dressing
Multi-trauma
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center