Prospective, Randomized Study of 2 Different Wound Dressings

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)

Inclusion criteria

• Age ≥18years
• Have an expected total length of stay of 4 or more days
• Undergoing elective primary arthroplasty of the hip or knee or spinal surgery
• 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 or spine surgery due to tumour or infection?
• Fractures
• Wound at the surgical site prior to surgery
• Neurological deficit of operated side (hemiplegia, etc.)
• Subject has documented skin disease at time of enrolment, as judged by the investigator