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

• Sponsor: University Hospital, Clermont-Ferrand (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03823963
• Collaborator: Molnlycke Health Care AB (Industry)
• Enrollment: 478
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 13.7
• Patients Per Site Per Month: 34.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pressure Ulcers; Prevention; Skin Ulcer; Ulcer	Combination Product: Mepilex® Border dressing; Other: Standard care	Phase 4

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 478 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Monocentric, Comparative and Randomized Study on Pressure Ulcers Prevention With Mepilex® Border Sacrum Dressing in Scheduled Cardiovascular Surgery
• Actual Study Start Date: Dec 10, 2018
• Anticipated Primary Completion Date: Aug 31, 2019
• Anticipated Study Completion Date: Jan 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Standard care pressure ulcer prevention standard care	Other: Standard care; The control group will receive pressure ulcer prevention standard care
Experimental: standard care + Mepilex® Border pressure ulcer prevention standard care + Mepilex® Border applied on sacrum	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

Outcome Measures

Primary Outcome Measures

1. Pressure ulcer incidence [0-20 days]

   Incidence of sacral pressure ulcers acquired during patients' hospital stay

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chu Clermont-Ferrand	Clermont-Ferrand		France	63003

Sponsors and Collaborators

• University Hospital, Clermont-Ferrand
• Molnlycke Health Care AB

Investigators

• Principal Investigator: Franck HENTZ, University Hospital, Clermont-Ferrand

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Clermont-Ferrand
• ClinicalTrials.gov Identifier: NCT03823963
• Other Study ID Numbers: CHU-418; 2018-A00694-51
• First Posted: Jan 31, 2019
• Last Update Posted: Jan 31, 2019
• Last Verified: Jan 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pressure Ulcer; Skin Ulcer; Ulcer

Study Results

No Results Posted as of Jan 31, 2019