An interventional study of Mepilex® Border Post-Op and standard wound dressing in Hip-surgery, Knee-surgery and Spinal-surgery, sponsored by University of Cologne. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-11.
Sponsored by University of Cologne · Not applicable, Interventional, and Treatment
The primary objective of this investigation is to evaluate the performance of a self-adhesive absorbent post-operative dressing coated with a soft silicone layer in minimize the risk of the development of blistering in subjects after hip or knee arthroplasty or spinal surgery in comparison to a standard wound dressing The secondary objectives are to evaluate:
A monocentre, post CE-mark, randomized clinical trial will be conducted at the University of Cologne, Department of Orthopedics and Trauma Surgery.
Male or female subjects, 18 years and above, undergoing hip, knee or spinal surgery with an expected hospital stay for 4 days or more will be included in the trial. Individual trial duration will be for 7 days (follow-up).
Two hundred subjects will be included in the trial, i.e. 100 subjects per arm. The treatment arm (either new or standard wound dressing) will be assigned by randomization stratified by type of surgery (i.e. hip, knee or spine).
AEs/ADEs/unexpected events with the device may be documented by relevant photos at time. All photos shall include a sticker marked with subject code, visit number/date and time.
Outcome Measures
Primary variable:
Secondary variables:
University of Cologne is the lead sponsor of 199 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
As comparator will be used a standard Cosmopor E®adhesive, island wound dressing (Paul Hartmann LTD)after hip or knee arthroplasty or spinal surgery
Device: standard wound dressing
wound dressing with Mepilex® Border Post-Op with Safetac®Technology, self-adherent soft silicone surgical dressing
Device: Mepilex® Border Post-Op
wound dressing with Mepilex® Border Post-Op with Safetac®Technology, self-adherent soft silicone surgical dressing
Also known as: Mepilex® Border Post-Op with Safetac®Technology
standard wound dressing after hip-knee or spinal surgery
Also known as: As comparator will be used a standard Cosmopor E®adhesive, island wound dressing (Paul Hartmann LTD)
Blistering
Development of blistering from day 0 to day 6 post surgery Photo documentation will be evaluated in a blinded manner by the Clinical Evaluation Committee (CEC).
Time frame: 0-6 days
wound complications
Other wound complications (i.e. leakage, inflammation, infection)
Time frame: 0-6 days
dressing changes
Number of dressing changes
Time frame: 0-6 days
pain
Pain before, during and after dressing removal (VA scale)
Time frame: 0-6 days
performance and acceptability
Performance and acceptability of the dressing (4 point rating scale)
Time frame: 0-6 days
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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University of Cologne