Grade I to Grade IV Pressure Ulcers in Higher Risk PatientsSACRESSNCT01640418
Prevention of Sacral Pressure Ulcers With Preventive Dressings
A study testing Mepilex® Border Sacrum dressings in people with Grade I to Grade IV Pressure Ulcers in Higher Risk Patients, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
In this study we would like to find a way to prevent sacral pressure ulcers in high-risk patients by the use of a Mepilex sacral dressing. The research question we would like to answer is the following: Is the Mepilex sacral dressing a cost-effective dressing for the prevention of grade I to grade IV pressure ulcers… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Grade I to Grade IV Pressure Ulcers in Higher Risk Patients
- What is being tested?
- Mepilex® Border Sacrum dressings
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 253 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2012to Oct 2013
- Phase
- Interventional
- 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
- Age: ≥18 years
- Admission in one of the ten high-risk departments of the azM
- Suspected hospital stay of 5 days or more after admission
- Braden score 19 or less
Who cannot join
- Age: <18 years
- Pre-existing sacral pressure ulcer
- Pre-existing trauma to the sacrum
- Patient is unable to speak Dutch
- Patients with an inability to give informed consent
- Patients who are unable to give informed consent within 24h after admission
- Patients who are unable to give informed consent before surgery
Trial locations and contacts
1 site in 1 country.
About this study
In this study we would like to find a way to prevent sacral pressure ulcers in high-risk patients by the use of a Mepilex sacral dressing. The research question we would like to answer is the following: Is the Mepilex sacral dressing a cost-effective dressing for the prevention of grade I to grade IV pressure ulcers in the sacral region in higher-risk hospitalized patients?
- Being tested
- Mepilex® Border Sacrum dressings
- Keywords
- pressure ulcer, dressing, prevention, higher risk patients
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepilex® Border Sacrum dressingsDevice
Mepilex® Border Sacrum dressings
| Study group | Role | What they receive |
|---|---|---|
| Mepilex® Border Sacrum dressings | Experimental | Mepilex® Border Sacrum dressings Receives: Device: Mepilex® Border Sacrum dressings |
| Standard Care | No intervention | Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the number of patients who develop sacral pressure ulcers between the group with the Mepilex® Border Sacrum dressings (Group A) and the group without any sacral dressings (Group B).
till hospital release, max 8 weeks
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2012 (estimated)
- Study startSep 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Grade I to Grade IV Pressure Ulcers in Higher Risk PatientsStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole Bouvy, Principal investigator, Academic Hospital of Maastricht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640418
- Sponsor's protocol ID
- NL40299.068.12
- Acronym
- SACRESS
- Status last verified
- Jul 2015
- First submitted
- 11 Jul 2012
- Last updated
- 21 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Sacral Pressure Ulcers With Preventive Dressings
- ClinicalTrials.gov ID
- NCT01640418
- Acronym / sponsor ID
- SACRESS / NL40299.068.12
- Keywords
- pressure ulcer, dressing, prevention, higher risk patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 13 Jul 2012 (estimated)
- 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.
In this study we would like to find a way to prevent sacral pressure ulcers in high-risk patients by the use of a Mepilex sacral dressing. The research question we would like to answer is the following: Is the Mepilex sacral dressing a cost-effective dressing for the prevention of grade I to grade IV pressure ulcers in the sacral region in higher-risk hospitalized patients?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mepilex® Border Sacrum dressings | Experimental | Device: Mepilex® Border Sacrum dressingsMepilex® Border Sacrum dressings |
| Standard Care | No intervention | –Standard Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: ≥18 years
- Admission in one of the ten high-risk departments of the azM
- Suspected hospital stay of 5 days or more after admission
- Braden score 19 or less
Key exclusion criteria (7 listed)
- Age: <18 years
- Pre-existing sacral pressure ulcer
- Pre-existing trauma to the sacrum
- Patient is unable to speak Dutch
- Patients with an inability to give 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 Sacrum dressingsMepilex® Border Sacrum dressings | Device | Mepilex® Border Sacrum dressings |
Primary outcome
To compare the number of patients who develop sacral pressure ulcers between the group with the Mepilex® Border Sacrum dressings (Group A) and the group without any sacral dressings (Group B).
Time frame: 8 weeks
till hospital release, max 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2015.
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.
Nicole Bouvy principal investigator
Academic Hospital of Maastricht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mepilex® Border Sacrum dressings in people with Grade I to Grade IV Pressure Ulcers in Higher Risk Patients, run by Maastricht University Medical Center at 1 site in Netherlands.
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: finished, as of the sponsor's last update on 21 Jul 2015. 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 Netherlands. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the number of patients who develop sacral pressure ulcers between the group with the Mepilex® Border Sacrum dressings (Group A) and the group without any sacral dressings (Group B). (time frame: 8 weeks). 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 21 Jul 2015.