NCT01988818

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 20, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 11, 2016

Status Verified

May 1, 2016

Enrollment Period

1.7 years

First QC Date

November 13, 2013

Last Update Submit

May 10, 2016

Conditions

Hip-surgeryKnee-surgerySpinal-surgery

Keywords

wound dressingsiliconestandard wound dressing

Outcome Measures

Primary Outcomes (1)

  • Blistering

    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 Outcomes (4)

  • wound complications

    0-6 days

  • dressing changes

    0-6 days

  • pain

    0-6 days

  • performance and acceptability

    0-6 days

Study Arms (2)

Standard wound dressing

ACTIVE COMPARATOR

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

Mepilex® Border Post-Op

EXPERIMENTAL

wound dressing with Mepilex® Border Post-Op with Safetac®Technology, self-adherent soft silicone surgical dressing

Device: Mepilex® Border Post-Op

Interventions

Mepilex® Border Post-OpDEVICE

wound dressing with Mepilex® Border Post-Op with Safetac®Technology, self-adherent soft silicone surgical dressing

Also known as: Mepilex® Border Post-Op with Safetac®Technology
Mepilex® Border Post-Op
standard wound dressingDEVICE

standard wound dressing after hip-knee or spinal surgery

Also known as: As comparator will be used a standard Cosmopor E®adhesive, island wound dressing (Paul Hartmann LTD)
Standard wound dressing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18years
  • Have an expected total length of stay of 4 or more days
  • Undergoing elective primary arthroplasty of the hip or knee or spinal surgery
  • Undergoing hip surgery with a standard access
  • Give their written informed consent to participate

You may not qualify if:

  • Dressing size does not fit the incision area
  • Known allergy/hypersensitivity to any of the components of the dressing
  • Multi-trauma
  • Undergoing arthroplasty or spine surgery due to tumour or infection?
  • Fractures
  • Wound at the surgical site prior to surgery
  • Neurological deficit of operated side (hemiplegia, etc.)
  • Subject has documented skin disease at time of enrolment, as judged by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Cologne

Cologne, 50937, Germany

Location

Related Publications (2)

  • Bredow J, Hoffmann K, Oppermann J, Hellmich M, Eysel P, Zarghooni K. Evaluation of Absorbent Versus Conventional Wound Dressing. Dtsch Arztebl Int. 2018 Mar 30;115(13):213-219. doi: 10.3238/arztebl.2018.0213.

    PMID: 29669676DERIVED

  • 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.

    PMID: 25873529DERIVED

Study Officials

  • Jan Bredow, physician

    University Hospital of Cologne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jan Bredow

Study Record Dates

First Submitted

November 13, 2013

First Posted

November 20, 2013

Study Start

April 1, 2014

Primary Completion

December 1, 2015

Study Completion

May 1, 2016

Last Updated

May 11, 2016

Record last verified: 2016-05

Locations

DE(1)