Ignite Creation Date:
2025-12-25 @ 4:34 AM
Ignite Modification Date:
2026-02-23 @ 1:09 PM
Study NCT ID:
NCT01988818
Status:
COMPLETED
Last Update Posted:
2016-05-11
First Post:
2013-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective, Randomized Study of 2 Different Wound Dressings
Sponsor:
University of Cologne
Organization:
Study Overview
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)
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Close
Brief 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
* 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)
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)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| University Hospital Cologne | OTHER | University Hospital Cologne | View |