Status:
COMPLETED
Post Market Clinical Follow-up Study
Lead Sponsor:
Molnlycke Health Care AB
Conditions:
Hip or Knee Surgery
Eligibility:
All Genders
45+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01841567
Start Date
April 1 2013
End Date
September 1 2013
Last Update
September 30 2014
Active Locations (1)
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1
universitätsklinikum Köln
Cologne, Köln, Germany, 50924