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CompletedNCT01469871Updated Nov 10, 2011

Evaluation of Three Types of Dressings After Hip Surgery

A Phase 4 interventional study of Dressing of wound and Dressing of wound in Tape Blisters and Hip Surgery, sponsored by Hopital de l'Enfant-Jesus. Completed at 1 site in Canada. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2011-11-10.

Sponsored by Hopital de l'Enfant-Jesus · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
45 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine if one of the new types of dressings (MEPORE PRO and/or MEPILEX BORDER ) will reduce the blister rate compared to the currently used HYPAFIX.

02

Conditions studied

  • Tape Blisters
  • Hip Surgery

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Keywords

  • Dressing
  • Blisters
  • Silicone
03

In context

Blister

36 studies on the registry are indexed under Blister; 3 are open to participants now.

This study's enrollment of 150 is above the median of 65 across 24 interventional studies indexed under Blister.

Browse Blister studies →

Lead sponsor

Hopital de l'Enfant-Jesus is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or Female 45 years old or older
  • Hip surgery at Hopital de l'Enfant-Jesus between 02/2009 and 01/2010 (THR,rTHR, DHS, screw fixation, hemiarthroplasty, resurfacing)
  • Signed consent form

Exclusion criteria

Exclusion Criteria:

  • Allergy to dressing
  • Polytrauma / high energy trauma
  • Wound at the surgical site prior to surgery
  • Neurological deficit of operated side (hemiplegia, etc.)
  • Bilateral fracture
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (actual)

Study arms

  • Active comparator
    Hypafix Transparent dressing

    The Hypafix Transparent dressing, a stretchable dressing, will be used to treat the patients in this group

    Device: Dressing of wound

  • Active comparator
    Mepore Pro dressing

    The Mepore Pro dressing, a self-adhesive perforated dressing, will be used to treat the patients in this group

    Device: Dressing of wound

  • Active comparator
    Mepilex Border dressing

    The Mepilex Border dressing, a self-adherent soft silicone dressing, will be used to treat the patients in this group

    Device: Dressing of wound

Interventions

  • DeviceDressing of wound

    The wound will be dressed using the Hypafix Transparent dressing after hip surgery.

  • DeviceDressing of wound

    The wound will be dressed using the Mepore Pro dressing after hip surgery.

  • DeviceDressing of wound

    The wound will be dressed using the Mepilex Border dressing after hip surgery.

06

What researchers measure

Primary outcomes

  1. The prevalence of tape blisters after hip fracture surgery

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 8 days

Secondary outcomes

  1. Length of hospital stay

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 8 days

  2. The correlation between risk factors and tape blisters

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 8 days

  3. The possible link between the presence of tape blisters and hospital morbidity.

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 8 days

  4. The costs related to a tape blister.

    The actual costs related to a tape blister will be calculated by adding the costs of additional dressings, the costs associated with an extended hospital stay and the additional costs associated with the use of external resources.

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 8 days

07

Study locations

1 site
  • Centre hospitalier affilié universitaire de Quebec - Hopital l'Enfant-Jesus
    Quebec, G1J 1Z4, Canada
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2009, a primary completion of Jan 2010 and a completion of Jan 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 4, 2011
First posted
Nov 10, 2011
Start
Feb 2009
Primary completionActual
Jan 2010
CompletionActual
Jan 2010
Last update
Nov 10, 2011
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 10, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01469871
Lead sponsor
Hopital de l'Enfant-Jesus
Responsible party
Pelet Stephane (Dr Stephane Pelet MD, PhD Orthopedic surgeon, Hopital de l'Enfant-Jesus) — Principal investigator
First posted
Nov 10, 2011
Start date
Feb 2009
Primary completion
Jan 2010
Completion
Jan 2010
Last update
Nov 10, 2011

Study contacts

Stephane Pelet, MD,PhD
principal investigator · Hopital l'Enfant-Jésus

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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