Evaluation of Three Types of Dressings After Hip Surgery

Hip Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01469871
• Other study ID #: PEJ-481
• Status: Completed
• Phase: Phase 4
• First received: November 4, 2011
• Last updated: November 9, 2011
• Start date: February 2009
• Est. completion date: January 2010

Study information

• Verified date: November 2011
• Source: Hopital de l'Enfant-Jesus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Blister
• Hip Surgery
• Tape Blisters

Intervention

Device:
• Dressing of wound
The wound will be dressed using the Hypafix Transparent dressing after hip surgery.
• Dressing of wound
The wound will be dressed using the Mepore Pro dressing after hip surgery.
• Dressing of wound
The wound will be dressed using the Mepilex Border dressing after hip surgery.

Locations

Country	Name	City	State
Canada	Centre hospitalier affilié universitaire de Quebec - Hopital l'Enfant-Jesus	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Hopital de l'Enfant-Jesus

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Length of hospital stay		Participants will be followed for the duration of hospital stay, an expected average of 8 days	No
Secondary	The correlation between risk factors and tape blisters		Participants will be followed for the duration of hospital stay, an expected average of 8 days	No
Secondary	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	No
Secondary	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	No