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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Tape Blisters
Hip Surgery
 Device: Dressing of wound
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Reduction of Tape Blisters After Hip Surgery. A Prospective Evaluation of Three Types of Dressings.

Further study details as provided by Hopital de l'Enfant-Jesus:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Enrollment: 150
Study Start Date: February 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
The wound will be dressed using the Hypafix Transparent dressing after hip surgery.
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
The wound will be dressed using the Mepore Pro dressing after hip surgery.
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
The wound will be dressed using the Mepilex Border dressing after hip surgery.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01469871

Locations
Canada
Centre hospitalier affilié universitaire de Quebec - Hopital l'Enfant-Jesus
Quebec, Canada, G1J 1Z4
Sponsors and Collaborators
Hopital de l'Enfant-Jesus
Investigators
Principal Investigator: Stephane Pelet, MD,PhD Hopital l'Enfant-Jésus
  More Information

No publications provided

Responsible Party: Pelet Stephane, Dr Stephane Pelet MD, PhD Orthopedic surgeon, Hopital de l'Enfant-Jesus
ClinicalTrials.gov Identifier: NCT01469871     History of Changes
Other Study ID Numbers: PEJ-481
Study First Received: November 4, 2011
Last Updated: November 9, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Hopital de l'Enfant-Jesus:
Dressing
Blisters
Silicone

Additional relevant MeSH terms:
Blister
Skin Diseases, Vesiculobullous
Skin Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 16, 2013