- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03894267
An Evaluation of the Impact of a Wound Dressing on Pressure Ulcer Incidence.
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Dublin, Irland
- Rekruttering
- Cherry Orchard Hospital
-
Kontakt:
- Dr O'Dea, Doctor
- Telefonnummer: +353 1 620 6400
-
Kontakt:
- Urmilla Victor, Tissue Viability Nurse
- Telefonnummer: +353 1 620 6400
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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:
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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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 |
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.
|
|
Ingen indgriben: Control Arm
Daily SEM reading, visual skin assessment. Early Sense placed under study subject's mattress. Follow up for 20 days. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pressure Ulcer incidence
Tidsramme: 12 months
|
The primary objective is to examine the pressure ulcer occurrence in the two participant groups.
|
12 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
PU incidence related to movement.
Tidsramme: 12 months
|
The rate of PU incidence among those assessed as high movers compared to those assessed as low movers
|
12 months
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Zena Moore, PhD, RCSI
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NM/1002/2018
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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