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

Phase 4

• Conditions: Ulcer; Pressure Ulcers; Skin Ulcer; Prevention
• Interventions: Combination Product: Mepilex® Border dressing; Other: Standard care

• Registration Number: NCT03823963
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

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 Timeline

• Study Start: 2018-12-10
• Status Verified: 2019-01
• Study First Submitted: 2019-01-11
• Study First Submitted QC: 2019-01-29
• Last Update Submitted: 2019-01-29
• Study First Posted: 2019-01-31
• Last Update Posted: 2019-01-31
• Primary Completion: 2019-08-31
• Study Completion: 2020-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 478

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard care + Mepilex® Border	Mepilex® Border dressing	pressure ulcer prevention standard care + Mepilex® Border applied on sacrum
Standard care	Standard care	pressure ulcer prevention standard care
standard care + Mepilex® Border	Standard care	pressure ulcer prevention standard care + Mepilex® Border applied on sacrum

Primary Outcome Measures

Name	Time	Method
Pressure ulcer incidence	0-20 days	Incidence of sacral pressure ulcers acquired during patients' hospital stay

Trial Locations

Locations (1)

Chu Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France