Evaluation of Three Types of Dressings After Hip Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pelet Stephane, Hopital de l'Enfant-Jesus
ClinicalTrials.gov Identifier:
NCT01469871
First received: November 4, 2011
Last updated: November 9, 2011
Last verified: November 2011

November 4, 2011
November 9, 2011
February 2009
January 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01469871 on ClinicalTrials.gov Archive Site
  • Length of hospital stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 8 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The costs related to a tape blister. [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 8 days ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
Evaluation of Three Types of Dressings After Hip Surgery
Reduction of Tape Blisters After Hip Surgery. A Prospective Evaluation of Three Types of Dressings.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Tape Blisters
  • Hip Surgery
  • Device: Dressing of wound
    The wound will be dressed using the Hypafix Transparent dressing after hip surgery.
  • Device: Dressing of wound
    The wound will be dressed using the Mepore Pro dressing after hip surgery.
  • Device: Dressing of wound
    The wound will be dressed using the Mepilex Border dressing after hip surgery.
  • Active Comparator: Hypafix Transparent dressing
    The Hypafix Transparent dressing, a stretchable dressing, will be used to treat the patients in this group
    Intervention: 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
    Intervention: 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
    Intervention: Device: Dressing of wound
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
January 2010
January 2010   (final data collection date for primary outcome measure)

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:

  • Allergy to dressing
  • Polytrauma / high energy trauma
  • Wound at the surgical site prior to surgery
  • Neurological deficit of operated side (hemiplegia, etc.)
  • Bilateral fracture
Both
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01469871
PEJ-481
No
Pelet Stephane, Hopital de l'Enfant-Jesus
Hopital de l'Enfant-Jesus
Not Provided
Principal Investigator: Stephane Pelet, MD,PhD Hopital l'Enfant-Jésus
Hopital de l'Enfant-Jesus
November 2011

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