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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01988818
First Posted: November 20, 2013
Last Update Posted: May 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jan Bredow, University of Cologne
  Purpose

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

Condition Intervention
Hip-surgery Knee-surgery Spinal-surgery Device: Mepilex® Border Post-Op Device: standard wound dressing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Jan Bredow, University of Cologne:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • wound complications [ Time Frame: 0-6 days ]
    Other wound complications (i.e. leakage, inflammation, infection)

  • dressing changes [ Time Frame: 0-6 days ]
    Number of dressing changes

  • pain [ Time Frame: 0-6 days ]
    Pain before, during and after dressing removal (VA scale)

  • performance and acceptability [ Time Frame: 0-6 days ]
    Performance and acceptability of the dressing (4 point rating scale)


Enrollment: 200
Study Start Date: April 2014
Study Completion Date: May 2016
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Mepilex® Border Post-Op with Safetac®Technology

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)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01988818


Locations
Germany
University Hospital Cologne
Cologne, Germany, 50937
Sponsors and Collaborators
University of Cologne
Investigators
Principal Investigator: Jan Bredow, physician University Hospital of Cologne
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jan Bredow, University of Cologne
ClinicalTrials.gov Identifier: NCT01988818     History of Changes
Other Study ID Numbers: Uni-Köln_2013-02
University Hospital Cologne ( Other Identifier: University Hospital Cologne )
First Submitted: November 13, 2013
First Posted: November 20, 2013
Last Update Posted: May 11, 2016
Last Verified: May 2016

Keywords provided by Jan Bredow, University of Cologne:
wound dressing
silicone
standard wound dressing


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