Prospective, Randomized Study of 2 Different Wound Dressings (Close)

University of Cologne

Status: Completed

Conditions: Hip-surgery; Spinal-surgery; Knee-surgery

Treatments: Device: standard wound dressing; Device: Mepilex® Border Post-Op

Study type: Interventional

Funder types: Other

Identifiers

NCT01988818

Uni-Köln_2013-02

University Hospital Cologne (Other Identifier)

Details and patient eligibility

About

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

Full description

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)

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Standard wound dressing

Active Comparator group

Description:

As comparator will be used a standard Cosmopor E®adhesive, island wound dressing (Paul Hartmann LTD)after hip or knee arthroplasty or spinal surgery

Treatment:

Device: standard wound dressing

Mepilex® Border Post-Op

Experimental group

Description:

wound dressing with Mepilex® Border Post-Op with Safetac®Technology, self-adherent soft silicone surgical dressing

Treatment:

Device: Mepilex® Border Post-Op