NCT01988818

Prospective, Randomized Study of 2 Different Wound Dressings

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: University of Cologne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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)

Conditions

• Hip-surgery
• Knee-surgery
• Spinal-surgery

Interventions

Type	Name	Description
DEVICE	Mepilex® Border Post-Op	wound dressing with Mepilex® Border Post-Op with Safetac®Technology, self-adherent soft silicone surgical dressing
DEVICE	standard wound dressing	standard wound dressing after hip-knee or spinal surgery

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-12-01
• Completion: 2016-05-01
• First posted: 2013-11-20
• Last updated: 2016-05-11

Locations

1 site across 1 country: Germany