Hip FractureNCT02692482
Polyurethane Foam on the Sacrum for Prevention
A study testing hydrocellular polyurethane foam multilayer dressing in people with Hip Fracture and Pressure Ulcer, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
The aim of the present study is to assess whether the application of a new hydrocellular polyurethane foam multilayer dressing shaped for the sacral area (MSP) in addition to standard care reduces the rate of pressure sores (PU) and their severity especially in the elderly population admitted for fragility Hip… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fracture, Pressure Ulcer
- What is being tested?
- hydrocellular polyurethane foam multilayer dressing
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 359 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2016to Dec 2016
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients aged ≥ 65 years with Hip fragility fracture without National Pressure Ulcers Advisory Panel scale (NPUAP) scale grade ≥ II PU
- 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
- Patients with peri-prosthetic or pathological fractures
- Patients with diaphyseal or distal femoral fractures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of the Use of a New Polyurethane Foam Multilayer Dressing in the Sacral Area to Prevent the Onset of Pressure Sores in the Elderly With Hip Fractures. Randomized Controlled Trial.
The aim of the present study is to assess whether the application of a new hydrocellular polyurethane foam multilayer dressing shaped for the sacral area (MSP) in addition to standard care reduces the rate of pressure sores (PU) and their severity especially in the elderly population admitted for fragility Hip Fractures.
- Conditions
- Hip Fracture, Pressure Ulcer
- Being tested
- hydrocellular polyurethane foam multilayer dressing, standard care
- Medical subject headings
- Hip Fractures, 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 hydrocellular polyurethane foam in the sacral region within 24 hours of admission and replaced when detaches or gets wet or dirty in addition to standard care
standard careProcedure or surgery
Standard care: PU risk assessment using the Braden scale within 24 hours of admission. Place patient on pressure mattress (static or alternating pressure) if Braden score <18, daily inspection of the skin in the various pressure points and moving the patient every 4 hours after surgery. 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 |
|---|---|---|
| polyurethane foam | Experimental | Hydrocellular polyurethane foam multilayer dressing shaped for the sacral area Receives: Device: hydrocellular polyurethane foam multilayer dressing; Procedure: standard care |
| standard care | Active comparator | Not described Receives: Procedure: standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Pressure Sores
Measured: On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.
Secondary outcomes (3)
Number of Participants With Pressure Ulcers in Other Areas (Heel, Back and Calf)
Measured: On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.
Pressure Ulcer Rate in the Sacral Area of Grade ≥ II 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 eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.
Number of Participants With 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 eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2016
- Study completionDec 2016
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 Hip FractureStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 359 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
- NCT02692482
- Sponsor's protocol ID
- 22022016
- Status last verified
- Mar 2019
- First submitted
- 23 Feb 2016
- Last updated
- 19 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Use of a New Polyurethane Foam Multilayer Dressing in the Sacral Area to Prevent the Onset of Pressure Sores in the Elderly With Hip Fractures. Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02692482
- Acronym / sponsor ID
- 22022016
- Conditions
- Hip Fracture, Pressure Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 359 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 26 Feb 2016 (estimated)
- Results
- Posted 19 Jun 2019
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 is to assess whether the application of a new hydrocellular polyurethane foam multilayer dressing shaped for the sacral area (MSP) in addition to standard care reduces the rate of pressure sores (PU) and their severity especially in the elderly population admitted for fragility Hip Fractures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| polyurethane foam | Experimental | Device: hydrocellular polyurethane foam multilayer dressing, Procedure: standard careHydrocellular polyurethane foam multilayer dressing shaped for the sacral area |
| standard care | Active comparator | Procedure: standard care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patients aged ≥ 65 years with Hip fragility fracture without National Pressure Ulcers Advisory Panel scale (NPUAP) scale grade ≥ II PU
- Patients or legal guardians who give their consent to take part in the study
Key exclusion criteria (3 listed)
- Patients with known allergy to the product being tested or dermatological diseases that prevent the use of topical products
- Patients with peri-prosthetic or pathological fractures
- Patients with diaphyseal or distal femoral fractures
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 hydrocellular polyurethane foam in the sacral region within 24 hours of admission and replaced when detaches or gets wet or dirty in addition to standard care | Device | polyurethane foam |
| standard careStandard care: PU risk assessment using the Braden scale within 24 hours of admission. Place patient on pressure mattress (static or alternating pressure) if Braden score <18, daily inspection of the skin in the various pressure points and moving the patient every 4 hours after surgery. Management of possible incontinence, humidity control and prevention of skin damage and rubbing/friction during postural changes as per hospital procedure. | Procedure or surgery | polyurethane foam, standard care |
Primary outcome
Number of Participants With Pressure Sores
Time frame: On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.
3 secondary outcomes
Number of Participants With Pressure Ulcers in Other Areas (Heel, Back and Calf)
Time frame: On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.
Pressure Ulcer Rate in the Sacral Area of Grade ≥ II According to the National Pressure Ulcers Advisory Panel Classification
Time frame: On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.
Number of Participants With Skin Irritation/Damage Due to the Adhesive Dressing
Time frame: On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 in people with Hip Fracture and Pressure Ulcer, run by Istituto Ortopedico Rizzoli at 1 site 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 2 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 19 Jun 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 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?
Yes. Results are posted in the registry (first posted 19 Jun 2019). 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 Participants With Pressure Sores (time frame: On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.). 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 19 Jun 2019.