Hip-surgery Clinical Trial
Official title:
A Mono-centre, Post CE-mark, Prospective-randomized Clinical Trial to Evaluate the Performance of a Flexible Self-adherent Absorbent Dressing Coated With a Soft Silicone Layer After Hip or Knee Arthroplasty or Primary Spine Surgery in Comparison to a Standard Wound Dressing (Cosmopor E®Steril, Fa. Hartmann)
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:
- the performance of the dressing
- the comfort, conformability and the acceptability of the dressing
- pain before, during and after dressing removal
- the overall cost regarding dressing wear time, time to do dressing change and personal
resources needed
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:
• 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).
Secondary variables:
- Other wound complications (i.e. leakage, inflammation, infection)
- Number of dressing changes
- Pain before, during and after dressing removal (VA scale)
- Performance and acceptability of the dressing (4 point rating scale)
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment