Pressure Ulcer RiskMultischiumeNCT03900455
Prevention of Pressure Ulcer on the Sacrum
A study testing Hydrocellular polyurethane foam multilayer dressing and Standard preventive care in people with Pressure Ulcer Risk, run by Istituto Ortopedico Rizzoli at 9 sites in Italy.
Trial summary
The aim of the present study was to assess whether the application of a multilayered dressing made of hydrocellular polyurethane foam conformed to the sacral area (MSP) in addition to standard preventive care reduces the rate of pressure ulcer (PU) and their severity in population at risk admitted in acute care… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer Risk
- What is being tested?
- Hydrocellular polyurethane foam multilayer dressing and Standard preventive care
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 711 participants
- Where
- 9 sitesItaly
- Study dates
- 21 Oct 2019to 19 Mar 2020
- 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
- Patients at risk to develop Pressure Ulcer (Braden scale <17)
- without sacrum Pressure Ulcer
- Patients or legal guardians who give their consent to take part in the study
Who cannot join
- Patients with known allergy to the product being tested or dermatological diseases that prevent the use of topical products
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Italy9 sites
ASO Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo
Alessandria, 15121
Ausl Bologna Ospedale Maggiore
Bologna, 40133
Policlinico di S.Orsola Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
Ausl della Romagna
Cesena, 47521
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
Azienda USL- IRCCS di Reggio Emilia
Reggio Emilia, 42122
Policlinico Universitario Campus Bio-Medico di Roma
Roma, 00128
APSS Trento
Trento, 38123
Azienda Ospedaliera Universitaria Integrata di Verona
Verona, 37126
About this study
Official title: Effectiveness of the Use of a Polyurethane Foam Multilayer Dressing in the Sacral Area, in Addition to Standard Healthcare, to Prevent the Onset of Pressure Ulcer in Patients at Risk. Multicentric Randomized Controlled Trial
The aim of the present study was to assess whether the application of a multilayered dressing made of hydrocellular polyurethane foam conformed to the sacral area (MSP) in addition to standard preventive care reduces the rate of pressure ulcer (PU) and their severity in population at risk admitted in acute care Hospital.
- Conditions
- Pressure Ulcer Risk
- Being tested
- Hydrocellular polyurethane foam multilayer dressing, Standard preventive care
- Keywords
- Patients at risk, polyurethane foam, pressure ulcer
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrocellular polyurethane foam multilayer dressingDevice
Also called ALLEVYN LIFE
Application of a multilayer foam with 4 flaps that can be adapted to several areas of the body (including the sacrum) and consists of: an external polyurethane film, which is impermeable to liquids and bacteria using dynamic transpiration, which can form an impenetrable barrier to protect the skin; a protective layer that shields the skin against accidental knocks and helps to spread the pressure; a highly absorbent and leak-proof layer that traps the exudate inside; a layer of hydrocellular polyurethane foam; and, finally, in contact with the skin, a perforated evenly covered layer of silicone gel adhesive. in addition to Standard preventive care
Standard preventive careProcedure or surgery
Pressure Ulcer risk assessment using the Braden scale within 8 hours of admission. Place patient on pressure mattress (static or alternating pressure) if Braden score <17, daily inspection of the skin in the various pressure points and moving the patient at list every 4 hours. Management of possible incontinence, humidity control and prevention of skin damage and rubbing/friction during postural changes as per hospital procedure
| Study group | Role | What they receive |
|---|---|---|
| Hydrocellular polyurethane foam multilayer dressing | Experimental | Not described Receives: Device: Hydrocellular polyurethane foam multilayer dressing; Procedure: Standard preventive care |
| standard preventive care | Active comparator | Not described Receives: Procedure: Standard preventive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of any type of pressure ulcer in the sacral area.
The ulcer will be classified according to the National Pressure Ulcers Advisory Panel Classification. Pressure ulcer are classified and described through the use of staging systems. Staging systems describe the extent of tissue loss and the physical appearance of the injury caused by pressure and/or shear. From stage 1 (intact skin) to Stage 4 (Full-thickness skin and tissue loss).
Measured: On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day
Secondary outcomes (3)
Pressure Ulcer Rate in the Sacral Area of Category≥ II
The ulcer will be classified according to the National Pressure Ulcers Advisory Panel Classification. Pressure ulcer are classified and described through the use of staging systems. Staging systems describe the extent of tissue loss and the physical appearance of the injury caused by pressure and/or shear. From stage 1 (intact skin) to Stage 4 (Full-thickness skin and tissue loss).
Measured: On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day
Skin irritation/damage due to the adhesive dressing
Clinical evaluation. It refers to any sort of inflammation and/or discoloration that distorts the skin's normal appearance. The skin may become scaly, bumpy, itchy, or otherwise irritated.
Measured: On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day
Number of dressing used per patient.
Measured: On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start21 Oct 2019
- Primary completion12 Mar 2020
- Study completion19 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pressure Ulcer RiskStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe 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
- 711 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900455
- Sponsor's protocol ID
- Multischiume
- Acronym
- Multischiume
- Status last verified
- Feb 2021
- First submitted
- 1 Apr 2019
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Forni C, Gazineo D, Allegrini E, Bolgeo T, Brugnolli A, Canzan F, Chiari P, Evangelista A, Grugnetti AM, Grugnetti G, Guberti M, Matarese M, Mezzalira E, Pierboni L, Prosperi L, Sofritti B, Tovazzi C, Vincenzi S, Zambiasi P, Zoffoli C, Ambrosi E; Multischiume Group. Effectiveness of a multi-layer silicone-adhesive polyurethane foam dressing as prevention for sacral pressure ulcers in at-risk in-patients: Randomized controlled trial. Int J Nurs Stud. 2022 Mar;127:104172. doi: 10.1016/j.ijnurstu.2022.104172. Epub 2022 Jan 8.
PubMed 35124474
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Use of a Polyurethane Foam Multilayer Dressing in the Sacral Area, in Addition to Standard Healthcare, to Prevent the Onset of Pressure Ulcer in Patients at Risk. Multicentric Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03900455
- Acronym / sponsor ID
- Multischiume / Multischiume
- Conditions
- Pressure Ulcer Risk
- Keywords
- Patients at risk, polyurethane foam, pressure ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 711 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 19 Mar 2020 (actual)
- First posted
- 3 Apr 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 aim of the present study was to assess whether the application of a multilayered dressing made of hydrocellular polyurethane foam conformed to the sacral area (MSP) in addition to standard preventive care reduces the rate of pressure ulcer (PU) and their severity in population at risk admitted in acute care Hospital.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrocellular polyurethane foam multilayer dressing | Experimental | Device: Hydrocellular polyurethane foam multilayer dressing, Procedure: Standard preventive care |
| standard preventive care | Active comparator | Procedure: Standard preventive care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients at risk to develop Pressure Ulcer (Braden scale <17)
- without sacrum Pressure Ulcer
- Patients or legal guardians who give their consent to take part in the study
Key exclusion criteria (1 listed)
- Patients with known allergy to the product being tested or dermatological diseases that prevent the use of topical products
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 |
|---|---|---|
| Hydrocellular polyurethane foam multilayer dressingAlso: ALLEVYN LIFEApplication of a multilayer foam with 4 flaps that can be adapted to several areas of the body (including the sacrum) and consists of: an external polyurethane film, which is impermeable to liquids and bacteria using dynamic transpiration, which can form an impenetrable barrier to protect the skin; a protective layer that shields the skin against accidental knocks and helps to spread the pressure; a highly absorbent and leak-proof layer that traps the exudate inside; a layer of hydrocellular polyurethane foam; and, finally, in contact with the skin, a perforated evenly covered layer of silicone gel adhesive. in addition to Standard preventive care | Device | Hydrocellular polyurethane foam multilayer dressing |
| Standard preventive carePressure Ulcer risk assessment using the Braden scale within 8 hours of admission. Place patient on pressure mattress (static or alternating pressure) if Braden score <17, daily inspection of the skin in the various pressure points and moving the patient at list every 4 hours. Management of possible incontinence, humidity control and prevention of skin damage and rubbing/friction during postural changes as per hospital procedure | Procedure or surgery | Hydrocellular polyurethane foam multilayer dressing, standard preventive care |
Primary outcome
Rate of any type of pressure ulcer in the sacral area.
Time frame: On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day
The ulcer will be classified according to the National Pressure Ulcers Advisory Panel Classification. Pressure ulcer are classified and described through the use of staging systems. Staging systems describe the extent of tissue loss and the physical appearance of the injury caused by pressure and/or shear. From stage 1 (intact skin) to Stage 4 (Full-thickness skin and tissue loss).
3 secondary outcomes
Pressure Ulcer Rate in the Sacral Area of Category≥ II
Time frame: On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day
Skin irritation/damage due to the adhesive dressing
Time frame: On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day
Number of dressing used per patient.
Time frame: On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day
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 17 Feb 2021.
- Derived from this study: PubMed 35124474Forni C, Gazineo D, Allegrini E, Bolgeo T, Brugnolli A, Canzan F, Chiari P, Evangelista A, Grugnetti AM, Grugnetti G, Guberti M, Matarese M, Mezzalira E, Pierboni L, Prosperi L, Sofritti B, Tovazzi C, Vincenzi S, Zambiasi P, Zoffoli C, Ambrosi E; Multischiume Group. Effectiveness of a multi-layer silicone-adhesive polyurethane foam dressing as prevention for sacral pressure ulcers in at-risk in-patients: Randomized controlled trial. Int J Nurs Stud. 2022 Mar;127:104172. doi: 10.1016/j.ijnurstu.2022.104172. Epub 2022 Jan 8.
Related trials for Pressure Ulcer Risk
Not yet recruiting
Sacrum Pressure Injury Prevention Study Using ALLEVYN◊ Complete Care in Adults at Risk of Developing Hospital-acquired Pressure Injuries in Critical Care Units
Pressure Ulcers (Hospital-acquired Pressure Injuries)
Not yet recruiting
Effect of a Risk-Based Perioperative Pressure Injury Prevention Bundle in Elective Surgery Patients
Pressure Ulcer (PU), Pressure Injury Prevention
Enrolling by invitationObservational study
Arterial Blood Gas Levels, Oxygen Saturation, and Pressure Injury Risk in ICU Patients
Pressure Injury, Intensive Care Unit (ICU)
Not yet recruiting
Effect of Lateral Decubitus Position After Spinal Anesthesia on Hemodynamic Stability in High-Risk Geriatric Patients
Hypotension Drug-Induced, Spinal Aneshtesia
Not yet recruiting
Predictive Validity and Clinical Utility of an Ultrasound-based Quantitative Risk Score for Pressure Injury in Critically Ill Patients
Pressure Injury
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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrocellular polyurethane foam multilayer dressing and Standard preventive care in people with Pressure Ulcer Risk, run by Istituto Ortopedico Rizzoli at 9 sites in Italy.
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 3 inclusion and 1 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 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Italy. 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?
Rate of any type of pressure ulcer in the sacral area. (time frame: On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03900455, which also lists 1 linked publication.
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 17 Feb 2021.