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WoundsNCT03894267

An Evaluation of the Impact of a Wound Dressing on Pressure Ulcer Incidence.

A study testing Cutimed Siltec Heel and Sacrum dressing in people with Wounds, run by Royal College of Surgeons, Ireland at 1 site in Ireland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A pressure ulcer (PU) is localized injury to the skin and/or underlying tissue usually over a bony prominence, as a result of pressure, or pressure in combination with shear. PUs are common, affecting up to 40% of participants receiving health care. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Wounds
What is being tested?
Cutimed Siltec Heel and Sacrum dressing
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteIreland
Study dates
12 Mar 2019to Sep 2019
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

  • Participants will be considered eligible if they fulfil the following criteria:
  • male or female subject aged at least 18 years
  • willing and able to give written informed consent and to comply with the requirements
  • being at risk of PU development as measured by the activity and mobility components of a mobility assessment tool

Who cannot join

  • Participants will be ineligible for enrolment if they meet any of the following criteria:
  • unable to provide written informed consent
  • known hypersensitivity to any of the ingredients
  • participant in any clinical trial of an investigational medicinal product (CTIMP or clinical investigation within 30 days prior to screening)

Trial locations and contacts

1 site in 1 country.

Declan Patton, PhD contact

35314022184

declanpatton@rcsi.com

Ireland1 site, 1 recruiting
  • Cherry Orchard Hospital

    Dublin

    Dr O'Dea, Doctor, +353 1 620 6400

    Urmilla Victor, Tissue Viability Nurse, +353 1 620 6400

    Recruiting

Other trials in Ireland

About this study

Official title: An Evaluation of the Impact of a Wound Dressing on Pressure Ulcer Incidence, Among at Risk Individuals, Residing in a Long Stay Health Care Setting (A Pilot RCT Feasibility Study)

A pressure ulcer (PU) is localized injury to the skin and/or underlying tissue usually over a bony prominence, as a result of pressure, or pressure in combination with shear. PUs are common, affecting up to 40% of participants receiving health care. Furthermore, PUs impact negatively on an individual's health related quality of life, with pain being the most frequently cited complaint. PUs commonly occur in those who cannot reposition themselves to relieve pressure/shear over bony prominences. The ability to reposition is often diminished in the very old, the malnourished and those with acute illness. Pressure ulcers are common devastating wounds, extending from deep in the bone and muscle layers through to the skin, occurring most often in older persons with limited mobility. They contribute to significant morbidity and mortality as they are smelly, highly painful and very prone to infection.

Existing research carried out by the RCSI School of Nursing and Midwifery shows that both high and low movers are at risk of pressure ulcer development.

Read the detailed description

A pressure ulcer (PU) is localized injury to the skin and/or underlying tissue usually over a bony prominence, as a result of pressure, or pressure in combination with shear. PUs are common, affecting up to 40% of participants receiving health care. Furthermore, PUs impact negatively on an individual's health related quality of life, with pain being the most frequently cited complaint. PUs commonly occur in those who cannot reposition themselves to relieve pressure/shear over bony prominences. The ability to reposition is often diminished in the very old, the malnourished and those with acute illness. Pressure ulcers are common devastating wounds, extending from deep in the bone and muscle layers through to the skin, occurring most often in older persons with limited mobility. They contribute to significant morbidity and mortality as they are smelly, highly painful and very prone to infection.

Existing research carried out by the RCSI School of Nursing and Midwifery shows that both high and low movers are at risk of pressure ulcer development.

The wound dressing used in this study has been developed to facilitate exudate management in the treatment of wounds. Newly formed tissue enjoys optimal protection under a moist environment. The foam core with super-absorbers ensures reliable absorption in slightly to heavily exuding wounds. This core has an excellent retention capacity, even under compression. Hydrogen bridges bind the water so securely that, even when subject to pressure, the water is not released. Vertical absorption through the polyurethane foam and the hydro- phobic wound contact layer minimizes the risk of macerations in the peri-ulcer skin.

This study is interested in pressure ulcer incidence among low and high movers, residing in a long stay health care facility. The dressing will be applied to intact skin over participant's sacrum and heels as these areas are shown to be at highest risk of pressure ulcer development, in the study population. Participants will be followed up for 20 days, during which time the participant's sacrum and heels will be assessed daily with a non invasive SEM scanner, the EPUAP grading tool, and the usual additional pressure ulcer prevention care. To measure if the participant is a low or high mover an EasySense mobility sensor will be placed under the participant's mattress.

The overall aim of the study is to the impact of the dressing on pressure ulcer incidence in the study population. From a health economics perspective, the management of PUs is suggested to consume 4% of health budgets across Europe, annually. In Ireland PUs of stage 3 and 4 are considered to be serious reportable adverse healthcare events and as such impact negatively on participant safety goals. Furthermore, a recent report from the OECD suggests that PUs are among the most burdensome adverse event type in healthcare, secondary to venous thromboembolism. As such, PUs are a significant threat to participant safety, with prevention being substantially cheaper than treatment5. Indeed, in Europe the cost of PU treatment across all levels of care is estimated at 121.44 million to 2.59 billion EUR, whereas prevention is estimated at 195.27 to 291.33 million EUR5.

Conditions
Wounds
Being tested
Cutimed Siltec Heel and Sacrum dressing
Medical subject headings
Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cutimed Siltec Heel and Sacrum dressingDevice

    The dressing has been developed to facilitate exudate management in the treatment of wounds. Newly formed tissue enjoys optimal protection under a moist environment. The foam core with super-absorbers ensures reliable absorption in slightly to heavily exuding wounds. This core has an excellent retention capacity, even under compression. Hydrogen bridges bind the water so securely that, even when subject to pressure, the water is not released. Vertical absorption through the polyurethane foam and the hydro- phobic wound contact layer minimizes the risk of macerations in the peri-ulcer skin.

Study groups in NCT03894267
Study groupRoleWhat they receive
Experimental ArmExperimentalSelf-adhesive silicone bordered foam dressing will be secured to the heels and sacrum. Daily SEM reading, visual skin assessment. Early Sense placed under study subject's mattress. Follow up 20 days
Receives: Device: Cutimed Siltec Heel and Sacrum dressing
Control ArmNo interventionDaily SEM reading, visual skin assessment. Early Sense placed under study subject's mattress. Follow up for 20 days.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pressure Ulcer incidence

    The primary objective is to examine the pressure ulcer occurrence in the two participant groups.

    Measured: 12 months

Secondary outcomes (1)
  1. PU incidence related to movement.

    The rate of PU incidence among those assessed as high movers compared to those assessed as low movers

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2019
  2. Study start12 Mar 2019
  3. Primary completionSep 2019 (estimated)
  4. Study completionSep 2019 (estimated)

Resources

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
Single group
Model description
This study is a prospective, randomized control design.
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03894267
Sponsor's protocol ID
NM/1002/2018
Status last verified
Jun 2018
First submitted
20 Jun 2018
Last updated
28 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data will be available to other researchers when it is published.

Questions about this trial

What is this clinical trial studying?

A study testing Cutimed Siltec Heel and Sacrum dressing in people with Wounds, run by Royal College of Surgeons, Ireland at 1 site in Ireland.

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 4 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: status not confirmed, as of the sponsor's last update on 28 Mar 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 Ireland. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Declan Patton, PhD (35314022184, declanpatton@rcsi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pressure Ulcer incidence (time frame: 12 months). 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 28 Mar 2019.

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