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

May 10, 2016 updated by: Jan Bredow, University of Cologne

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Cologne, Germany, 50937
        • University Hospital Cologne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard wound dressing
As comparator will be used a standard Cosmopor E®adhesive, island wound dressing (Paul Hartmann LTD)after hip or knee arthroplasty or spinal surgery
Device: standard wound dressing
standard wound dressing after hip-knee or spinal surgery
Other Names:
  • As comparator will be used a standard Cosmopor E®adhesive, island wound dressing (Paul Hartmann LTD)
Experimental: Mepilex® Border Post-Op
wound dressing with Mepilex® Border Post-Op with Safetac®Technology, self-adherent soft silicone surgical dressing
Device: Mepilex® Border Post-Op
wound dressing with Mepilex® Border Post-Op with Safetac®Technology, self-adherent soft silicone surgical dressing
Other Names:
  • Mepilex® Border Post-Op with Safetac®Technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blistering
Time Frame: 0-6 days
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).
0-6 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
wound complications
Time Frame: 0-6 days
Other wound complications (i.e. leakage, inflammation, infection)
0-6 days
dressing changes
Time Frame: 0-6 days
Number of dressing changes
0-6 days
pain
Time Frame: 0-6 days
Pain before, during and after dressing removal (VA scale)
0-6 days
performance and acceptability
Time Frame: 0-6 days
Performance and acceptability of the dressing (4 point rating scale)
0-6 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Investigators

  • Principal Investigator: Jan Bredow, physician, University Hospital of Cologne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

November 13, 2013

First Submitted That Met QC Criteria

November 13, 2013

First Posted (Estimate)

November 20, 2013

Study Record Updates

Last Update Posted (Estimate)

May 11, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Uni-Köln_2013-02
  • University Hospital Cologne (Other Identifier: University Hospital Cologne)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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