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

Tracking Information

First Received Date ^ICMJE

November 4, 2011

Last Updated Date

November 9, 2011

Start Date ^ICMJE

February 2009

Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01469871 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Evaluation of Three Types of Dressings After Hip Surgery

Official Title ^ICMJE

Reduction of Tape Blisters After Hip Surgery. A Prospective Evaluation of Three Types of Dressings.

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Tape Blisters
Hip Surgery

Intervention ^ICMJE

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.

Study Arm (s)

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

Intervention: Device: Dressing of wound
Active Comparator: Mepore Pro dressing
The Mepore Pro dressing, a self-adhesive perforated dressing, will be used to treat the patients in this group

Intervention: Device: Dressing of wound
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

Intervention: Device: Dressing of wound

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

150

Completion Date

January 2010

Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

45 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT01469871

Other Study ID Numbers ^ICMJE

PEJ-481

Has Data Monitoring Committee

Responsible Party

Pelet Stephane, Hopital de l'Enfant-Jesus

Study Sponsor ^ICMJE

Hopital de l'Enfant-Jesus

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Stephane Pelet, MD,PhD

Hopital l'Enfant-Jésus

Information Provided By

Hopital de l'Enfant-Jesus

Verification Date

November 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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