Post Market Clinical Follow-up Study (MxB Po01)

September 26, 2014 updated by: Molnlycke Health Care AB

A 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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Köln, Germany, 50924
        • Universitatsklinikum Koln

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: dressing
Device: Mepilex border post. op
Device: Mepilex border post op

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minimize the Risk of the Development of Blistering.
Time Frame: 7 days
Number of participants without blisters at study visit
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Rated 'Very Good to Excellent' for Comfort, Conformability and the Acceptability of the Dressing.
Time Frame: 7 days
The comfort, conformability and the acceptability of the dressing were measured on all visit in the study, by a study nurses. The patient had to answer questions regarding, the size of the dressing, shape of the dressing, Visibility beneath the dressing, ease of the application of the dressing, ease of removal of the dressing, overall experience of the use of the dressing, notice any pain at dressing change, Comfort of their dressing, overall experience of their dressing. The patient could chose between 1 Good, 2 Very good, 3 Excellent.In most cases, the patient chose very good to excellent for both hip and knee surgery
7 days
Comfort, Comformability, Acceptability of the Dressing
Time Frame: 7 days
7 days
Pain Evaluation
Time Frame: 7 days
7 days
Overall Cost Regarding Dressing Wear Time
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Molnlycke Health Care AB

Investigators

  • Principal Investigator: Kourosh Zarghooni, Dr. Med, University Hospital Köln

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

April 23, 2013

First Submitted That Met QC Criteria

April 25, 2013

First Posted (Estimate)

April 26, 2013

Study Record Updates

Last Update Posted (Estimate)

September 30, 2014

Last Update Submitted That Met QC Criteria

September 26, 2014

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MxB Po01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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