None listed
Conditions
Brief summary
A pressure injury, or pressure ulcer, is localised damage to the skin and/or underlying tissue caused by unrelieved pressure, shear or friction. Some hospital patients develop pressure injuries- with those in intensive care units at increased risk because they are critically ill and immobile. Intensive care unit (ICU) patients are among the most vulnerable patients in hospital, placing them at very high risk of developing sacral (tailbone) pressure injuries (PI) or bed sores. PI prolongs hospitalisation for patients and increases healthcare costs. Patients report PI are painful and compromise their quality of life. Several specialised dressings prevent sacral PI however limited effectiveness evidence results in clinicians asking, ‘which dressing is better’? This ICU pilot study will determine the feasibility of launching a larger randomised controlled trial testing two prophylactic sacral dressing and provide clinicians with a definitive answer to inform their practice. The study hypothesis is to evaluate the feasibility of achieving participant recruitment (50% eligible and 70% recruited, with 90% retention), protocol fidelity (95% participants will receive the correct intervention) and less than 10% missing data.
Interventions
Intervention: Allevyn Life Sacrum (Smith+Nephew) and usual pressure injury prevention (PIP) care.
The Research Nurse applying the Allevyn Life Sacrum (Smith + Nephew) dressing to the patient's sacrum on study recruitment and changed as per the manufacturer's recommendations. The Research Nurse will check the dressing each day and monitor its adherence. This will be documented in the study data collection tool. An inbuilt ‘dressing change indicator’ signals when the dressing should be replaced.
Intervention: Allevyn Life Sacrum (Smith+Nephew) and usual pressure injury prevention (PIP) care. The Research Nurse applying the Allevyn Life Sacrum (Smith + Nephew) dressing to the patient's sacrum on study recruitment and changed as per the manufacturer's recommendations. The Research Nurse will check the dressing each day and monitor its adherence. This will be documented in the study data collection tool. An inbuilt ‘dressing change indicator’ signals when the dressing should be replaced. Dressings will also be changed if saturation and soiling of the dressing occurs, if the adhesive edges ‘roll’, staff accidentally remove the dressing or if the dressing becomes dislodged. The dressing will be removed when the patient reaches any of the trial end points. Trial end points: participants will remain in the trail for a maximum of 14-days or until a study endpoint is reached: (i) develop a sacral hospital-acquired pressure injury (HAPI) (any stage); (ii) requires more than 6-hours continuous prone positioning; (iii) ICU discharge; (iv) death; (v) urinary/faecal incontinence; (vi) consent withdrawal; whichever comes first. Usual PIP care includes regular skin inspection and assessment, second hourly repositioning, elevating heels off the bed, pressure relieving heel boots, and use of pressure redistributing mattresses.
Sponsors
Griffith University
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria (all criteria met): (i) 18 years and older; (ii) recruited within 24-hours of ICU admission; (iii) assessed as high pressure injury (PI) risk; (iv) ICU length of stay greater than 24-hours; (v) consent [patient/representative].
Exclusion criteria
Exclusion criteria (one criterion excludes): (i) requires greater than 6-hours continuous prone; (ii) receiving end-of-life care; (iii) conditions preventing repositioning; (iv) previous or current sacral PI; (v) sacral skin injury/condition/allergy; (vi) urinary/faecal incontinence at recruitment; (vii) regular sacral topical creams (e.g. hydrocortisone); (viii) prior to screening, ICU team applied a prophylactic sacral dressing as part of their PIP care.
Outcome results
None listed