Study on Pressure Ulcers Prevention With Mepilex® Border Sacrum Dressing in Scheduled Cardiovascular Surgery

Prevention Clinical Trial

— MEPICARD  

Official title:

A Monocentric, Comparative and Randomized Study on Pressure Ulcers Prevention With Mepilex® Border Sacrum Dressing in Scheduled Cardiovascular Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03823963
• Other study ID #: CHU-418
• Secondary ID: 2018-A00694-51
• Status: Recruiting
• Phase: Phase 4
• Start date: December 10, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: January 2019
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise LACLAUTRE
• Phone: 04 73 75 49 63
• Email: drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is a randomised controlled trial of patients admitted for a scheduled cardiac surgery at the Clermont-Ferrand hospital.

Patients meeting the study inclusion criteria will be allocated to either the control group that will receive pressure ulcer prevention standard care or the intervention group that will receive pressure ulcer prevention standard care plus have a Mepilex® Border dressing applied to their sacrum.

Description:

The main objective of this research is to evaluate the impact of Mepilex Border® dressing applied in addition to standard pressure ulcer prevention protocol, in a French hospital setting, in at-risk patients in a cardiovascular surgery unit with full hospitalisation including block operation and ICU.

Hypothesis: Patients treated with Mepilex® Border dressings will have a lower incidence rate of sacral pressure ulcer development than patients receiving standard care.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 478
• Est. completion date: January 31, 2020
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject over 18 years of age,

• Subject programmed to benefit from cardiac surgery with sternotomy,

• Subject capable and willing to comply with the protocol and willing to give his written consent,

• Subject affiliated to a social security system

Exclusion Criteria:

• Subject with a skin lesion in the sacral area upon admission,

• Subject admitted for emergency cardiovascular surgery (unscheduled subject),

• Subject admitted for heart transplant surgery,

• Subject participating in another clinical study or in a period of exclusion from a study previous,

• Subject with a linguistic or psychological disability to sign informed consent,

• Subject refusing to give written consent,

• Subject deprived of liberty by administrative or judicial decision, under guardianship or curatorship.

Related Conditions & MeSH terms

• Pressure Ulcer
• Pressure Ulcers
• Prevention
• Skin Ulcer
• Ulcer

Intervention

Combination Product:
• Mepilex® Border dressing
Soft silicone self-adherent dressing (5-layers)

Other:
• Standard care
The control group will receive pressure ulcer prevention standard care

Locations

Country	Name	City	State
France	Chu Clermont-Ferrand	Clermont-Ferrand

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Molnlycke Health Care AB

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure ulcer incidence	Incidence of sacral pressure ulcers acquired during patients' hospital stay	0-20 days