Pressure Incidence PreventionPUP16_01NCT02962882
Pressure Injury Prevention in the ICU With Multi-Layer Foam Dressings
A study testing Mepilex Border in people with Pressure Incidence Prevention, run by Molnlycke Health Care AB at 2 sites in United States.
Trial summary
A Multi-Centre, Open, Non-controlled, Clinical Investigation to Evaluate the User Friendliness and Wear Time of Multi-layer Foam Dressings With Safetac® for Pressure Injury Prevention in the Intensive Care Unit Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Incidence Prevention
- What is being tested?
- Mepilex Border
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Sep 2016to 4 May 2017
- 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
Who may be able to join
- Patient is at risk for developing a pressure injury to the heels and/or sacrum
- Aged ≥ 18 years
- Patient or his/her legal representative is able to understand and voluntarily sign the informed consent
- Estimated treatment period in ICU for patient at least 4-6 days
Who cannot join
- Patient has a pressure injury or blistering on sacrum and/or heels
- Patient with known or suspected sensitivity to any of the components of the products being evaluated
- Patient included in other clinical investigations at present or within the last 30 days
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Anmed Health
Anderson, South Carolina, 29621
Roper Hospital
Charleston, South Carolina, 29401
About this study
Official title: A Multi-Centre, Open, Non-controlled, Clinical Investigation to Evaluate the User Friendliness and Wear Time of Multi-layer Foam Dressings With Safetac® for Pressure Injury Prevention in the Intensive Care Unit
A Multi-Centre, Open, Non-controlled, Clinical Investigation to Evaluate the User Friendliness and Wear Time of Multi-layer Foam Dressings With Safetac® for Pressure Injury Prevention in the Intensive Care Unit
Read the detailed description
This was a multi-centre, open, non-comparative, prospective, clinical investigation involving 50 enrolled subjects using competitive enrolment at two sites in the United States of America (USA). The study was conducted on subjects at risk of developing PIs according to investigators' judgment and facility protocol being treated in ICUs. The target subjects were male and female, 18 years and above, with an expected hospital stay of 4-6 days. An evaluable subject was defined as a subject that was enrolled and had data for at least one visit after the baseline visit. There were two parts to the study: Part A: Mepilex Border/Protect Sacrum; Part B: Mepilex Border/Protect Heel (on both left and right heels), used within intended use and according to IFU.
- Conditions
- Pressure Incidence Prevention
- Being tested
- Mepilex Border
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepilex BorderDevice
Multi-layer Foam Dressings
| Study group | Role | What they receive |
|---|---|---|
| A. Mepilex Border Sacrum (Safetac) | Experimental | A dressing that is a flexible, self-adherent, profylactic, absorbent pad in three layers to be used on the sacrum area at pressure points in patients in the ICU, prone to get pressure injuries (PI). Receives: Device: Mepilex Border |
| B. Mepilex Border Heel (Safetac) | Experimental | A dressing that is a flexible, self-adherent, profylactic, absorbent pad in three layers to be used on the heels (on both left and right heels), in patients in the ICU, prone to get pressure injuries (PI). Receives: Device: Mepilex Border |
What is being measured
The primary outcome is the main question the study is designed to answer.
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
User friendliness judged by site staff, with the following variables; Ability to stay in place Facilitation of inspection Ease of reapplication Conformability to the body Overall impression of dressing
*NOTE: Since subjects typically left the ICU earlier than expected (the study protocol stipulated that the test dressing should be left in place for 3 days or longer, however typically the subjects left the ICU department after one day), not all subjects completed the full study period/all study visits.
Furthermore, since not all assessment visits were completed for each subject or a dressing change was not required, the total number of all visits exceeds the total number for each variable. This was because the subject did not undergo a dressing application/removal or that the question was not relevant at a given visit (some questions were only relevant for dressing applications, some questions were only relevant for dressing removals or only relevant for dressing inspections).
Measured: 4-6 days
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
User friendliness judged by site staff, with the following variables; How do you prefer this dressing to your current dressing?
*NOTE: Since subjects typically left the ICU earlier than expected (the study protocol stipulated that the test dressing should be left in place for 3 days or longer, however typically the subjects left the ICU department after one day), not all subjects completed the full study period/all study visits.
Furthermore, since not all assessment visits were completed for each subject or a dressing change was not required, the total number of all visits exceeds the total number for each variable. This was because the subject did not undergo a dressing application/removal or that the question was not relevant at a given visit (some questions were only relevant for dressing applications, some questions were only relevant for dressing removals or only relevant for dressing inspections).
Measured: 4-6 days
Secondary outcomes (1)
Wear Time (Days) for First Dressing
Maximum length of wear time/stay on ability of dressings in ICU.
Measured: 4-6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study start9 Sep 2016
- Primary completion21 Nov 2016
- Study completion4 May 2017
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 Incidence PreventionStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kelli Potter, BSN, RN, Principal investigator, AnMed Health Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02962882
- Sponsor's protocol ID
- PUP16_01
- Acronym
- PUP16_01
- Status last verified
- Mar 2018
- First submitted
- 23 Aug 2016
- Last updated
- 26 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre, Open, Non-controlled, Clinical Investigation to Evaluate the User Friendliness and Wear Time of Multi-layer Foam Dressings With Safetac® for Pressure Injury Prevention in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT02962882
- Acronym / sponsor ID
- PUP16_01 / PUP16_01
- Conditions
- Pressure Incidence Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2016 (actual)
- Primary completion
- 21 Nov 2016 (actual)
- Study completion
- 4 May 2017 (actual)
- First posted
- 15 Nov 2016 (estimated)
- Results
- Posted 26 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Multi-Centre, Open, Non-controlled, Clinical Investigation to Evaluate the User Friendliness and Wear Time of Multi-layer Foam Dressings With Safetac® for Pressure Injury Prevention in the Intensive Care Unit
Detailed description
This was a multi-centre, open, non-comparative, prospective, clinical investigation involving 50 enrolled subjects using competitive enrolment at two sites in the United States of America (USA). The study was conducted on subjects at risk of developing PIs according to investigators' judgment and facility protocol being treated in ICUs. The target subjects were male and female, 18 years and above, with an expected hospital stay of 4-6 days. An evaluable subject was defined as a subject that was enrolled and had data for at least one visit after the baseline visit. There were two parts to the study: Part A: Mepilex Border/Protect Sacrum; Part B: Mepilex Border/Protect Heel (on both left and right heels), used within intended use and according to IFU.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A. Mepilex Border Sacrum (Safetac) | Experimental | Device: Mepilex BorderA dressing that is a flexible, self-adherent, profylactic, absorbent pad in three layers to be used on the sacrum area at pressure points in patients in the ICU, prone to get pressure injuries (PI). |
| B. Mepilex Border Heel (Safetac) | Experimental | Device: Mepilex BorderA dressing that is a flexible, self-adherent, profylactic, absorbent pad in three layers to be used on the heels (on both left and right heels), in patients in the ICU, prone to get pressure injuries (PI). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is at risk for developing a pressure injury to the heels and/or sacrum
- Aged ≥ 18 years
- Patient or his/her legal representative is able to understand and voluntarily sign the informed consent
- Estimated treatment period in ICU for patient at least 4-6 days
Key exclusion criteria (3 listed)
- Patient has a pressure injury or blistering on sacrum and/or heels
- Patient with known or suspected sensitivity to any of the components of the products being evaluated
- Patient included in other clinical investigations at present or within the last 30 days
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 BorderMulti-layer Foam Dressings | Device | A. Mepilex Border Sacrum (Safetac), B. Mepilex Border Heel (Safetac) |
Primary outcome
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Time frame: 4-6 days
User friendliness judged by site staff, with the following variables; Ability to stay in place Facilitation of inspection Ease of reapplication Conformability to the body Overall impression of dressing *NOTE: Since subjects typically left the ICU earlier than expected (the study protocol stipulated that the test dressing should be left in place for 3 days or longer, however typically the subjects left the ICU department after one day), not all subjects completed the full study period/all study visits. Furthermore, since not all assessment visits were completed for each subject or a dressing change was not required, the total number of all visits exceeds the total number for each variable. This was because the subject did not undergo a dressing application/removal or that the question was not relevant at a given visit (some questions were only relevant for dressing applications, some questions were only relevant for dressing removals or only relevant for dressing inspections).
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Time frame: 4-6 days
User friendliness judged by site staff, with the following variables; How do you prefer this dressing to your current dressing? *NOTE: Since subjects typically left the ICU earlier than expected (the study protocol stipulated that the test dressing should be left in place for 3 days or longer, however typically the subjects left the ICU department after one day), not all subjects completed the full study period/all study visits. Furthermore, since not all assessment visits were completed for each subject or a dressing change was not required, the total number of all visits exceeds the total number for each variable. This was because the subject did not undergo a dressing application/removal or that the question was not relevant at a given visit (some questions were only relevant for dressing applications, some questions were only relevant for dressing removals or only relevant for dressing inspections).
1 secondary outcome
Wear Time (Days) for First Dressing
Time frame: 4-6 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Pressure Incidence Prevention
Enrolling by invitationObservational study
Evaluation of Commercially Available Heel Pads for the Prevention of Pressure Ulcers: An Observational Study of Incidence and Usability in Adult Surgical Patients.
Pressure Injury Prevention
Not yet recruiting
Combined Strategy Using Automated Subglottic Secretion Drainage and Continuous Cuff Pressure Monitoring to Prevent Microaspiration: a Multicenter Randomized Controlled Trial.
Pneumonia, Ventilator-Associated Healthcare-associated Pneumonia Respiration, Artificial
Recruiting
The Effect of Different Support Surface Applications
Pressure Incidence Prevention, Pain
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.
Kelli Potter, BSN, RN principal investigator
AnMed Health Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mepilex Border in people with Pressure Incidence Prevention, run by Molnlycke Health Care AB at 2 sites in United States.
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 3 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 26 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 26 Mar 2018). 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?
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication (time frame: 4-6 days). The study lists 2 primary outcomes in all. 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 26 Mar 2018.