Prehospital Recognition and Antibiotics for 999 patients with Severe sepsis (PHRASe): a feasibility study

Pressure ulcers (PU) remain a serious problem in acute care. Evidence of prevalence is variable, with ranges from less than 1% to 41%. Variation may be due to heterogeneity in study populations (including acute and community settings) and advances in preventative strategies. These include SKIN bundles, a holistic approach that includes documented nursing intervention at least every two hours for: (S) Surface, (K) Keep moving, (I) Incontinence and (N) Nutrition. SKIN bundles also include audit of staff compliance.

The term ?pressure ulcer? describes a widely understood clinical presentation but does not fully reflect all mechanisms of skin damage leading to ulceration. In addition to pressure, friction and shear are also known to lead to skin breakdown.

Assessment tools (e.g. Waterlow) can identify patients at high risk of PUs, but do not discriminate risk of pressure from risk of friction and shear. This discrimination requires clinical experience and judgment on an individual patient basis.

Bedbound, restless patients (including those with neurological conditions leading to repetitive limb movements) are reported by tissue viability clinicians to be a distinct group at high risk of damage due to friction and shear.

Approximately 20% of PUs occur on the heel. Parafricta bootees are designed to eliminate friction and shear forces and protect the heel from associated skin damage. They are intended as a prophylactic adjunct to standard care (which is predominantly a pressure relieving mattress) but could replace the use of heel elevation bootees, used in response to early signs of heel skin damage. Walking is contraindicated in Parafricta bootees but transfer to a chair is within their intended use.

The National Institute for Health and Care Excellence (NICE) reviewed evidence on Parafricta and recommended further research to demonstrate effectiveness of the product [MTG20].

Aims:

We propose a randomised study comparing Parafricta bootees (n=225) as an adjunct to standard care versus standard care alone (n=225). The study will determine whether use of Parafricta reduces the incidence of heel PU. Question to be addressed Population: hospital inpatients, aged 18 or over, who are bedbound, Waterlow Score of 20 or more and without heel PU. Intervention: Parafricta bootees as an adjunct to standard care. Comparator: Standard care alone. Outcomes i) Incidence of heel PU at 3 days and at 14 days. ii) Length of hospital stay.iii) Grade (severity) of PU (range 1-4).iv) Patient acceptability. v) Cost effectiveness of Parafricta bootees.

Study design: Randomised controlled trial.

Plan: We will recruit 450 participants at three participating acute care centres over 12 months. Participants will be assessed on days 0, 3 and 14. PU digital images will undergo blinded independent assessment, by a WWIC research nurse, not involved in other patient assessments. Summary of the potential benefits Smith and Ingram (2010) found introducting Parafricta bootees reduced the incidence of heel PU in patients in acute care with Waterlow Score of 15 or more, from 41% to 25%. The study estimated the financial saving to the NHS as over ś63,000 per 100 at risk patients. Our study will be the first randomised study of Parafricta to quantify the benefits to patients and the NHS.