CClinicalTrials.gg
Status unknownNCT03894267Updated Mar 28, 2019

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

An interventional study of Cutimed Siltec Heel and Sacrum dressing in Wounds, sponsored by Royal College of Surgeons, Ireland. Status unknown at 1 site in Ireland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-28.

Sponsored by Royal College of Surgeons, Ireland · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jun 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

03

In context

Pressure Ulcer

518 studies on the registry are indexed under Pressure Ulcer; 117 are open to participants now.

This study's planned enrollment of 50 is below the median of 70 across 395 interventional studies indexed under Pressure Ulcer.

Browse Pressure Ulcer studies →

Lead sponsor

Royal College of Surgeons, Ireland is the lead sponsor of 93 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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)
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Experimental Arm

    Self-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

    Device: Cutimed Siltec Heel and Sacrum dressing

  • No intervention
    Control Arm

    Daily SEM reading, visual skin assessment. Early Sense placed under study subject's mattress. Follow up for 20 days.

Interventions

  • DeviceCutimed Siltec Heel and Sacrum dressing

    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.

06

What researchers measure

Primary outcomes

  1. Pressure Ulcer incidence

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

    Time frame: 12 months

Secondary outcomes

  1. PU incidence related to movement.

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

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Cherry Orchard Hospital
    Dublin, Ireland
    • Dr O'Dea, Doctor · Contact · +353 1 620 6400
    • Urmilla Victor, Tissue Viability Nurse · Contact · +353 1 620 6400
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — Data will be available to other researchers when it is published.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03894267
Lead sponsor
Royal College of Surgeons, Ireland
Responsible party
Sponsor
First posted
Mar 28, 2019
Start date
Mar 12, 2019
Primary completion
Sep 2019 (estimated)
Completion
Sep 2019 (estimated)
Last update
Mar 28, 2019

Study contacts

Declan Patton, PhD
Contact
declanpatton@rcsi.com
35314022184
Zena Moore, PhD
principal investigator · RCSI

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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