Pressure UlcerNCT02295735
Effectiveness of Two Silicone Dressings for Sacral and Heel Pressure Ulcer Prevention
A study testing Mepilex® Border Sacrum and Mepilex® Border Heel in people with Pressure Ulcer, run by PD Dr. Jan Kottner at 1 site in Germany.
Trial summary
The aim of this randomized controlled trial is to test the efficacy of preventive dressings for pressure ulcer prevention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- Mepilex® Border Sacrum and Mepilex® Border Heel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 475 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2015to Jul 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Major trauma patients and/or critically ill patients (e.g. with cardiac arrest) admitted to the emergency department and being transferred and/or admitted directly to a surgical or internal ICU
- Being at "high" or "very high" PU risk according to the Charité PU prevention standard:
- Category 3 (= partly care dependent/limited mobility in bed), 4A (= care depended, limited mobility in bed), 4B (= totally immobile) according to the Jones classification modified by Charité
- Expected minimum length of stay at least three days
- Informed consent (or by legal representative)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Parallel-group Trial to Investigate the Effectiveness of Two Silicone Dressings for Sacral and Heel Pressure Ulcer Prevention Compared to no Dressings
The aim of this randomized controlled trial is to test the efficacy of preventive dressings for pressure ulcer prevention.
Read the detailed description
Patients of intensive acute care and residents of institutional long-term care facilities are at high risk for developing pressure ulcers (PUs). PU standard prevention includes repositioning, early mobilization and the use of special support surfaces. The use of prophylactic dressings might reduce friction and shear forces and/or modify the microclimate of the skin and might therefore protect the skin and underlying tissues from pressure/deformation injury. The primary objective of this study is to determine if preventive silicone dressings (Mepilex® border) applied to the heels and to the sacrum in addition to PU standard prevention reduces PU incidence category II, III, IV, and deep tissue injury compared to PU standard alone in at risk hospital patients.
- Conditions
- Pressure Ulcer
- Being tested
- Mepilex® Border Sacrum and Mepilex® Border Heel
- Keywords
- Skin, safety, wounds, intensive care
- Medical subject headings
- Pressure Ulcer, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepilex® Border Sacrum and Mepilex® Border HeelDevice
| Study group | Role | What they receive |
|---|---|---|
| Mepilex® Border | Experimental | If a patient is assigned to the intervention group the dressings Mepilex® Border Sacrum and Mepilex® Border Heel will be applied onto the respective intact skin areas in addition to standard pressure ulcer prevention Receives: Device: Mepilex® Border Sacrum and Mepilex® Border Heel |
| Control | No intervention | Standard pressure ulcer prevention according to hospital standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion)
The primary outcome was the cumulative incidence of Pressure ulcer category II, III, IV, unstageable and DTI at heels or sacrum. Pressure ulcers were categorized according to the NPUAP/EPUAP 2014 classification System. The occurrence of a new pressure ulcer of any category was assessed and documented daily during the study period. The Categories are defined as follows: Category I (nonblanchable erythema); Category II (Partial thickness Skin loss); Category III (Full Thickness Skin loss); Category IV (Full Thickness tissue loss); Unstageable (Depth unknown); Deep tissue injury (suspected Deep tissue injury, Depth unknown)
Measured: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days
Secondary outcomes (11)
Density Rate of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion Per 1000 Bed Days, Rate)
The Incidence density of Pressure Ulcer category II, III, IV, unstageable and DTI at heels or sacrum was measured. Pressure ulcer were categorized according to the NPUAP/EPUAP 2014 classification system. The occurrence of a new Pressure ulcer of any category was assessed and documented daily during the study period. The Categories are defined as follows: Category I (nonblanchable erythema); Category II (Partial thickness Skin loss); Category III (Full Thickness Skin loss); Category IV (Full Thickness tissue loss); Unstageable (Depth unknown); Deep tissue injury (suspected Deep tissue injury, Depth unknown)
Measured: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days
Number of Pressure Ulcer Category I (Non-blanchable Erythema) II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion)
The the cumulative incidence of Pressure ulcer category I, II, III, IV, unstageable and DTI at heels or sacrum. Pressure ulcer were categorized according to the NPUAP/EPUAP 2014 classification system. The occurrence of a new Pressure ulcer of any category was assessed and documented daily during the study period. The Categories are defined as follows: Category I (nonblanchable erythema); Category II (Partial thickness Skin loss); Category III (Full Thickness Skin loss); Category IV (Full Thickness tissue loss); Unstageable (Depth unknown); Deep tissue injury (suspected Deep tissue injury, Depth unknown)
Measured: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days
Number of Pressure Ulcers Category I (Non-blanchable Erythema) II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion Per 1000 Bed Days, Rate)
The Incidence density of Pressure Ulcer category I, II, III, IV, unstageable and DTI at heels or sacrum was measured. Pressure ulcer were categorized according to the NPUAP/EPUAP 2014 classification system. The occurrence of a new Pressure ulcer of any category was assessed and documented daily during the study period. The Categories are defined as follows: Category I (nonblanchable erythema); Category II (Partial thickness Skin loss); Category III (Full Thickness Skin loss); Category IV (Full Thickness tissue loss); Unstageable (Depth unknown); Deep tissue injury (suspected Deep tissue injury, Depth unknown)
Measured: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days
Number of Preventive Sacrum Dressings Used for Pressure Ulcer Prevention
Number of preventive sacrum dressings used for pressure ulcer prevention
Measured: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days
Numbers of Support Surface Used for Pressure Ulcer Prevention (Total)
Support surface categories were recorded. Please see the different types in the Outcome measure data table
Measured: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days
Time to Pressure Ulcer Development of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum
- Time to Pressure ulcer development in days
Measured: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days
Number of Preventive Heel Dressings Used for Pressure Ulcer Prevention
Number of preventive heel dressings used for pressure ulcer prevention
Measured: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days
Time to Pressure Ulcer Development of Pressure Ulcers Category I, II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum
- Time to Pressure ulcer development in days
Measured: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days
Event Free Survival Time of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Days, Kaplan Meier Analysis)
- Estimation of the Survival function and measure of the length of time the ICU patients remained Pressure ulcer free in days
Measured: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days
Event Free Survival Time of Pressure Ulcers Category I, II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Days, Kaplan Meier Analysis)
- Estimation of the Survival function and measure of the length of time the ICU patients remained Pressure ulcer free in days
Measured: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days
Follow up Period of Included ICU Patients (Days)
Follow up period of included ICU patients in mean (days)
Measured: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startJun 2015
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 475 participants (actual)
Sponsor and investigators
- Lead sponsor
- PD Dr. Jan Kottner
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, PD Dr. Jan Kottner, Charite University, Berlin, Germany
- Investigators
- Jan Kottner, PhD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295735
- Sponsor's protocol ID
- CRC-PU-A-16
- Status last verified
- Jun 2020
- First submitted
- 10 Nov 2014
- Last updated
- 2 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Parallel-group Trial to Investigate the Effectiveness of Two Silicone Dressings for Sacral and Heel Pressure Ulcer Prevention Compared to no Dressings
- ClinicalTrials.gov ID
- NCT02295735
- Acronym / sponsor ID
- CRC-PU-A-16
- Conditions
- Pressure Ulcer
- Keywords
- Skin, safety, wounds, intensive care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 475 participants (actual)
- Lead sponsor
- PD Dr. Jan KottnerUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 20 Nov 2014 (estimated)
- Results
- Posted 2 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this randomized controlled trial is to test the efficacy of preventive dressings for pressure ulcer prevention.
Detailed description
Patients of intensive acute care and residents of institutional long-term care facilities are at high risk for developing pressure ulcers (PUs). PU standard prevention includes repositioning, early mobilization and the use of special support surfaces. The use of prophylactic dressings might reduce friction and shear forces and/or modify the microclimate of the skin and might therefore protect the skin and underlying tissues from pressure/deformation injury. The primary objective of this study is to determine if preventive silicone dressings (Mepilex® border) applied to the heels and to the sacrum in addition to PU standard prevention reduces PU incidence category II, III, IV, and deep tissue injury compared to PU standard alone in at risk hospital patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mepilex® Border | Experimental | Device: Mepilex® Border Sacrum and Mepilex® Border HeelIf a patient is assigned to the intervention group the dressings Mepilex® Border Sacrum and Mepilex® Border Heel will be applied onto the respective intact skin areas in addition to standard pressure ulcer prevention |
| Control | No intervention | –Standard pressure ulcer prevention according to hospital standard |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 and Mepilex® Border Heel | Device | Mepilex® Border |
Primary outcome
Number of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion)
Time frame: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days
The primary outcome was the cumulative incidence of Pressure ulcer category II, III, IV, unstageable and DTI at heels or sacrum. Pressure ulcers were categorized according to the NPUAP/EPUAP 2014 classification System. The occurrence of a new pressure ulcer of any category was assessed and documented daily during the study period. The Categories are defined as follows: Category I (nonblanchable erythema); Category II (Partial thickness Skin loss); Category III (Full Thickness Skin loss); Category IV (Full Thickness tissue loss); Unstageable (Depth unknown); Deep tissue injury (suspected Deep tissue injury, Depth unknown)
11 secondary outcomes
Density Rate of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion Per 1000 Bed Days, Rate)
Time frame: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days
Number of Pressure Ulcer Category I (Non-blanchable Erythema) II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion)
Time frame: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days
Number of Pressure Ulcers Category I (Non-blanchable Erythema) II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion Per 1000 Bed Days, Rate)
Time frame: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days
Number of Preventive Sacrum Dressings Used for Pressure Ulcer Prevention
Time frame: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days
Numbers of Support Surface Used for Pressure Ulcer Prevention (Total)
Time frame: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days
Time to Pressure Ulcer Development of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum
Time frame: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days
Number of Preventive Heel Dressings Used for Pressure Ulcer Prevention
Time frame: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days
Time to Pressure Ulcer Development of Pressure Ulcers Category I, II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum
Time frame: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days
Event Free Survival Time of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Days, Kaplan Meier Analysis)
Time frame: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days
Event Free Survival Time of Pressure Ulcers Category I, II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Days, Kaplan Meier Analysis)
Time frame: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days
Follow up Period of Included ICU Patients (Days)
Time frame: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jan Kottner, PhD principal investigator
Charite University, Berlin, Germany
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 and Mepilex® Border Heel in people with Pressure Ulcer, run by PD Dr. Jan Kottner at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 2 Jul 2020. 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 Germany. 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?
Yes. Results are posted in the registry (first posted 2 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion) (time frame: Duration of hospital stay, an average of 12.6 (SD +/-12.7) 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 2 Jul 2020.