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

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ClinicalTrials.gov Identifier: NCT01988818
Recruitment Status : Completed
First Posted : November 20, 2013
Last Update Posted : May 11, 2016
Sponsor:
Information provided by (Responsible Party):

November 13, 2013
November 20, 2013
May 11, 2016
April 2014
December 2015   (Final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01988818 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
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)

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

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)
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Hip-surgery
  • Knee-surgery
  • Spinal-surgery
  • 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
  • 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)
  • 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
    Intervention: Device: standard wound dressing
  • Experimental: Mepilex® Border Post-Op
    wound dressing with Mepilex® Border Post-Op with Safetac®Technology, self-adherent soft silicone surgical dressing
    Intervention: Device: Mepilex® Border Post-Op
Bredow J, Oppermann J, Hoffmann K, Hellmich M, Wenk B, Simons M, Eysel P, Zarghooni K. Clinical trial to evaluate the performance of a flexible self-adherent absorbent dressing coated with a soft silicone layer compared to a standard wound dressing after orthopedic or spinal surgery: study protocol for a randomized controlled trial. Trials. 2015 Mar 7;16:81. doi: 10.1186/s13063-015-0599-z.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
May 2016
December 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01988818
Uni-Köln_2013-02
University Hospital Cologne ( Other Identifier: University Hospital Cologne )
No
Not Provided
Not Provided
Jan Bredow, University of Cologne
University of Cologne
Not Provided
Principal Investigator: Jan Bredow, physician University Hospital of Cologne
University of Cologne
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP