Evaluation of Three Types of Dressings After Hip Surgery
Reduction of Tape Blisters After Hip Surgery. A Prospective Evaluation of Three Types of Dressings.
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Feb 2009
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 4, 2011
CompletedFirst Posted
Study publicly available on registry
November 10, 2011
CompletedNovember 10, 2011
November 1, 2011
11 months
November 4, 2011
November 9, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The prevalence of tape blisters after hip fracture surgery
Participants will be followed for the duration of hospital stay, an expected average of 8 days
Secondary Outcomes (4)
Length of hospital stay
Participants will be followed for the duration of hospital stay, an expected average of 8 days
The correlation between risk factors and tape blisters
Participants will be followed for the duration of hospital stay, an expected average of 8 days
The possible link between the presence of tape blisters and hospital morbidity.
Participants will be followed for the duration of hospital stay, an expected average of 8 days
The costs related to a tape blister.
Participants will be followed for the duration of hospital stay, an expected average of 8 days
Study Arms (3)
Hypafix Transparent dressing
ACTIVE COMPARATORThe Hypafix Transparent dressing, a stretchable dressing, will be used to treat the patients in this group
Mepore Pro dressing
ACTIVE COMPARATORThe Mepore Pro dressing, a self-adhesive perforated dressing, will be used to treat the patients in this group
Mepilex Border dressing
ACTIVE COMPARATORThe Mepilex Border dressing, a self-adherent soft silicone dressing, will be used to treat the patients in this group
Interventions
The wound will be dressed using the Hypafix Transparent dressing after hip surgery.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Allergy to dressing
- Polytrauma / high energy trauma
- Wound at the surgical site prior to surgery
- Neurological deficit of operated side (hemiplegia, etc.)
- Bilateral fracture
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre hospitalier affilié universitaire de Quebec - Hopital l'Enfant-Jesus
Québec, Quebec, G1J 1Z4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephane Pelet, MD,PhD
Hopital l'Enfant-Jésus
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr Stephane Pelet MD, PhD Orthopedic surgeon
Study Record Dates
First Submitted
November 4, 2011
First Posted
November 10, 2011
Study Start
February 1, 2009
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
November 10, 2011
Record last verified: 2011-11