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Post Market Clinical Follow-up Study (MxB Po01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01841567
Recruitment Status : Completed
First Posted : April 26, 2013
Results First Posted : September 30, 2014
Last Update Posted : September 30, 2014
Information provided by (Responsible Party):
Molnlycke Health Care AB

Brief 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).

Condition or disease Intervention/treatment Phase
Hip or Knee Surgery Device: Mepilex border post. op Device: Mepilex border post op Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Arm Intervention/treatment
dressing Device: Mepilex border post. op
Device: Mepilex border post op

Primary Outcome Measures :
  1. Minimize the Risk of the Development of Blistering. [ Time Frame: 7 days ]
    Number of participants without blisters at study visit

Secondary Outcome Measures :
  1. 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

  2. Comfort, Comformability, Acceptability of the Dressing [ Time Frame: 7 days ]
  3. Pain Evaluation [ Time Frame: 7 days ]
  4. Overall Cost Regarding Dressing Wear Time [ Time Frame: 7 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01841567

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universitätsklinikum Köln
Köln, Germany, 50924
Sponsors and Collaborators
Molnlycke Health Care AB
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Principal Investigator: Kourosh Zarghooni, Dr. Med University Hospital Koln

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Responsible Party: Molnlycke Health Care AB Identifier: NCT01841567    
Other Study ID Numbers: MxB Po01
First Posted: April 26, 2013    Key Record Dates
Results First Posted: September 30, 2014
Last Update Posted: September 30, 2014
Last Verified: December 2013
Keywords provided by Molnlycke Health Care AB: