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Evaluation of Three Types of Dressings After Hip Surgery

Primary Purpose

Tape Blisters, Hip Surgery

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Dressing of wound
Dressing of wound
Dressing of wound
Sponsored by
Hopital de l'Enfant-Jesus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tape Blisters focused on measuring Dressing, Blisters, Silicone

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre hospitalier affilié universitaire de Quebec - Hopital l'Enfant-Jesus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Hypafix Transparent dressing

Mepore Pro dressing

Mepilex Border dressing

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

The prevalence of tape blisters after hip fracture surgery

Secondary Outcome Measures

Length of hospital stay
The correlation between risk factors and tape blisters
The possible link between the presence of tape blisters and hospital morbidity.
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.

Full Information

First Posted
November 4, 2011
Last Updated
November 9, 2011
Sponsor
Hopital de l'Enfant-Jesus
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1. Study Identification

Unique Protocol Identification Number
NCT01469871
Brief Title
Evaluation of Three Types of Dressings After Hip Surgery
Official Title
Reduction of Tape Blisters After Hip Surgery. A Prospective Evaluation of Three Types of Dressings.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hopital de l'Enfant-Jesus

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tape Blisters, Hip Surgery
Keywords
Dressing, Blisters, Silicone

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypafix Transparent dressing
Arm Type
Active Comparator
Arm Description
The Hypafix Transparent dressing, a stretchable dressing, will be used to treat the patients in this group
Arm Title
Mepore Pro dressing
Arm Type
Active Comparator
Arm Description
The Mepore Pro dressing, a self-adhesive perforated dressing, will be used to treat the patients in this group
Arm Title
Mepilex Border dressing
Arm Type
Active Comparator
Arm Description
The Mepilex Border dressing, a self-adherent soft silicone dressing, will be used to treat the patients in this group
Intervention Type
Device
Intervention Name(s)
Dressing of wound
Intervention Description
The wound will be dressed using the Hypafix Transparent dressing after hip surgery.
Intervention Type
Device
Intervention Name(s)
Dressing of wound
Intervention Description
The wound will be dressed using the Mepore Pro dressing after hip surgery.
Intervention Type
Device
Intervention Name(s)
Dressing of wound
Intervention Description
The wound will be dressed using the Mepilex Border dressing after hip surgery.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Length of hospital stay
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 8 days
Title
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
Title
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
Title
The costs related to a tape blister.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephane Pelet, MD,PhD
Organizational Affiliation
Hopital l'Enfant-Jésus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre hospitalier affilié universitaire de Quebec - Hopital l'Enfant-Jesus
City
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada

12. IPD Sharing Statement

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Evaluation of Three Types of Dressings After Hip Surgery

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