NCT01469871CompletedPhase 4
Reduction of Tape Blisters After Hip Surgery. A Prospective Evaluation of Three Types of Dressings.
Hopital de l'Enfant-Jesus2 sites in 1 country150 target enrollmentStarted: February 1, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- The prevalence of tape blisters after hip fracture surgery
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
- 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)
Investigators
Pelet Stephane
Dr Stephane Pelet MD, PhD Orthopedic surgeon
Hopital de l'Enfant-Jesus
Study Sites (2)
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