Trial record 8 of 2990 for:    Open Studies | "General Surgery"

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by University of Cologne
Sponsor:
Information provided by (Responsible Party):
Jan Bredow, University of Cologne
ClinicalTrials.gov Identifier:
NCT01988818
First received: November 13, 2013
Last updated: NA
Last verified: November 2013
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 University of Cologne:

Primary Outcome Measures:
  • Blistering [ Time Frame: 0-6 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Other wound complications (i.e. leakage, inflammation, infection)

  • dressing changes [ Time Frame: 0-6 days ] [ Designated as safety issue: No ]
    Number of dressing changes

  • pain [ Time Frame: 0-6 days ] [ Designated as safety issue: No ]
    Pain before, during and after dressing removal (VA scale)

  • performance and acceptability [ Time Frame: 0-6 days ] [ Designated as safety issue: No ]
    Performance and acceptability of the dressing (4 point rating scale)


Estimated Enrollment: 200
Study Start Date: December 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01988818

Locations
Germany
University Hospital Cologne Not yet recruiting
Cologne, Germany, 50937
Contact: Jan Bredow, physician    +49 221 478 87294    jan.bredow@uk-koeln.de   
Contact: Margarete Wicharz, coordinator    +49 221 478 87294    margarete.wicharz@uk-koeln.de   
Principal Investigator: Jan Bredow, physician         
Sub-Investigator: Johannes Oppermann, Dr. med         
Sub-Investigator: Jan Siewe, Dr.med         
Sub-Investigator: Kourosh Zarghooni, Dr.med         
Sub-Investigator: Peer Eysel, Prof.Dr.         
Sub-Investigator: Birte Wenk, physician         
Sponsors and Collaborators
University of Cologne
Investigators
Principal Investigator: Jan Bredow, physician University Hospital of Cologne
  More Information

No publications provided

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
Study First Received: November 13, 2013
Last Updated: November 13, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Cologne:
wound dressing
silicone
standard wound dressing

ClinicalTrials.gov processed this record on July 22, 2014