Pressure UlcersPhase 4MEPICARDNCT03823963
Study on Pressure Ulcers Prevention With Mepilex® Border Sacrum Dressing in Scheduled Cardiovascular Surgery
A Phase 4 study testing Mepilex® Border dressing in people with Pressure Ulcers and Prevention, run by University Hospital, Clermont-Ferrand at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcers, Prevention, Skin Ulcer
- What is being tested?
- Mepilex® Border dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 478 participants
- Where
- 1 siteFrance
- Study dates
- 10 Dec 2018to 31 Jan 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Clermont-Ferrand
Clermont-Ferrand, 63003
Lise LACLAUTRE, 04 73 75 49 63, drci@chu-clermontferrand.fr
Franck HENTZ
About this study
Official title: A Monocentric, Comparative and Randomized Study on Pressure Ulcers Prevention With Mepilex® Border Sacrum Dressing in Scheduled Cardiovascular Surgery
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.
Read the 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.
- Conditions
- Pressure Ulcers, Prevention, Skin Ulcer, Ulcer
- Being tested
- Mepilex® Border dressing, Standard care
- Medical subject headings
- Pressure Ulcer, Skin Ulcer, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepilex® Border dressingCombination product
Soft silicone self-adherent dressing (5-layers)
Standard careOther
The control group will receive pressure ulcer prevention standard care
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Other | pressure ulcer prevention standard care Receives: Other: Standard care |
| standard care + Mepilex® Border | Experimental | pressure ulcer prevention standard care + Mepilex® Border applied on sacrum Receives: Combination Product: Mepilex® Border dressing; Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure ulcer incidence
Incidence of sacral pressure ulcers acquired during patients' hospital stay
Measured: 0-20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start10 Dec 2018
- Primary completion31 Aug 2019 (estimated)
- Study completion31 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcersStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 478 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Molnlycke Health Care AB
- Responsible party
- Sponsor
- Investigators
- Franck HENTZ, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823963
- Sponsor's protocol ID
- CHU-418
- Other IDs
- 2018-A00694-51
- Acronym
- MEPICARD
- Status last verified
- Jan 2019
- First submitted
- 11 Jan 2019
- Last updated
- 31 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Monocentric, Comparative and Randomized Study on Pressure Ulcers Prevention With Mepilex® Border Sacrum Dressing in Scheduled Cardiovascular Surgery
- ClinicalTrials.gov ID
- NCT03823963
- Acronym / sponsor ID
- MEPICARD / CHU-418
- Conditions
- Pressure Ulcers, Prevention, Skin Ulcer, Ulcer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 478 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Molnlycke Health Care AB
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 31 Aug 2019 (estimated)
- Study completion
- 31 Jan 2020 (estimated)
- First posted
- 31 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | Other | Other: Standard carepressure ulcer prevention standard care |
| standard care + Mepilex® Border | Experimental | Combination Product: Mepilex® Border dressing, Other: Standard carepressure ulcer prevention standard care + Mepilex® Border applied on sacrum |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mepilex® Border dressingSoft silicone self-adherent dressing (5-layers) | Combination product | standard care + Mepilex® Border |
| Standard careThe control group will receive pressure ulcer prevention standard care | Other | Standard care, standard care + Mepilex® Border |
Primary outcome
Pressure ulcer incidence
Time frame: 0-20 days
Incidence of sacral pressure ulcers acquired during patients' hospital stay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franck HENTZ principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mepilex® Border dressing in people with Pressure Ulcers and Prevention, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (04 73 75 49 63, drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure ulcer incidence (time frame: 0-20 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2019.