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.

Study Overview

• Status: Completed
• Conditions: Tape Blisters; Hip Surgery
• Intervention / Treatment: Device: Dressing of wound; Device: Dressing of wound; Device: Dressing of wound

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1J 1Z4
    • Centre hospitalier affilié universitaire de Quebec - Hopital l'Enfant-Jesus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.; 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: 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 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: 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Participants will be followed for the duration of hospital stay, an expected average of 8 days

Collaborators and Investigators

• Sponsor: Hopital de l'Enfant-Jesus
• Investigators: Principal Investigator: Stephane Pelet, MD,PhD, Hopital L'Enfant-Jesus

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: November 4, 2011
• First Submitted That Met QC Criteria: November 9, 2011
• First Posted (Estimate): November 10, 2011

Study Record Updates

• Last Update Posted (Estimate): November 10, 2011
• Last Update Submitted That Met QC Criteria: November 9, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: Dressing; Blisters; Silicone
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Skin Diseases, Vesiculobullous; Blister
• Other Study ID Numbers: PEJ-481

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No