NCT01469871

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 10, 2011

Completed
Last Updated

November 10, 2011

Status Verified

November 1, 2011

Enrollment Period

11 months

First QC Date

November 4, 2011

Last Update Submit

November 9, 2011

Conditions

Keywords

DressingBlistersSilicone

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 COMPARATOR

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

Device: Dressing of wound

Mepore Pro dressing

ACTIVE COMPARATOR

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

Device: Dressing of wound

Mepilex Border dressing

ACTIVE COMPARATOR

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

Device: Dressing of wound

Interventions

The wound will be dressed using the Hypafix Transparent dressing after hip surgery.

Hypafix Transparent dressing

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Blister

Interventions

Bandages

Condition Hierarchy (Ancestors)

Skin Diseases, VesiculobullousSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Stephane Pelet, MD,PhD

    Hopital l'Enfant-Jésus

    PRINCIPAL INVESTIGATOR

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

Locations