Parafricta Bootees and Undergarments to reduce skin breakdown in people with or at risk of pressure ulcers

Parafricta Bootees and Undergarments (APA Parafricta) are intended to reduce the potential for both the development and the progression of skin damage caused by friction and shear in people who have, or are at risk of developing, pressure ulcers, and in people with frail skin or those who have medical conditions in which skin frailty is a primary factor. Bootees provide protection for the heel and ankle, and Undergarments provide protection for the sacrum, buttocks and hips. The items are made from proprietary Parafricta fabric which is designed to reduce the shear stress and friction associated with movement. It has a friction coefficient value of 0.2, whereas most textiles typically range from 0.3 to 0.7. Parafricta fabric has no stiction, which is the additional force needed to overcome skin sticking to a surface before sliding. Because of this, it reduces the 'jerk' effect on skin when movement occurs. The lower the friction and stiction, the less likely it is that shear forces will develop and break the skin down, thereby reducing the risk of pressure ulcers. This mechanism of action is different from current methods of pressure ulcer management or prevention, which aim to manage or prevent pressure ulcers by reducing or redistributing pressure.

Parafricta fabric is used to protect the skin in areas most at risk. Both Parafricta Bootees and Undergarments have non‑slip areas to help patient positioning, and Velcro fastenings for easy application and removal. The positioning of the Velcro fasteners and the garments' flat seams are designed to minimise skin creasing or damage. The Bootee is supplied singly and is available in a range of adult sizes (starting from an adult size 2). They come in 2 types – with slip‑on or Velcro fasteners – and have non‑slip soles. The Undergarment is available in several sizes as a slip‑on garment or with Velcro fasteners, and as briefs or boxer shorts. Parafricta fabric is described as breathable but durable. The products are reusable after washing in accordance with garments for NHS use.

The cost of each Parafricta Bootee stated in the sponsor's submission is £35.14 (excluding VAT). The cost of the Parafricta Undergarment stated in the sponsor's submission is also £35.14 (excluding VAT). Parafricta garments are prescribable on a standard FP10 prescription.

The sponsor's claimed patient and healthcare benefits for Parafricta Bootees and Undergarments are as follows:

• A reduction in pressure ulcer incidence and severity in people who are at high risk of pressure ulcers following assessment, thereby reducing or avoiding adverse impact on quality of life, pain, discomfort, hospital length of stay, morbidity and mortality.

• Protection of susceptible skin in people in whom a repetitive, rubbing motion – due to an underlying neurological or other medical condition – can break down the skin.

• Ease of use for patients and carers, combined with a familiarity with the type of products in older people or those with cognitive impairment, may lead to greater compliance with pressure ulcer preventative measures.

• The products can be used in the home or in community care or hospitals, enabling the patient to easily transition between these settings.

• The ease of use and practicality of Parafricta garments imply that the technology may be implemented easily in the community, and could be used as a long‑term care strategy to improve people's quality of life.

• Prevention of pressure ulcer formation and reduced pressure ulcer incidence would shorten stays in hospital and may allow people to be transferred to lower cost community care. Hospital‑acquired pressure ulcers result in lengthened hospital stays and increased complications.

• Reduction in NHS costs including but not limited to:

  • quicker return of people to the community or community long‑term care

  • reduced pressure ulcer incidence resulting in lower costs of nursing care, dressings and rehabilitation

  • the reusable nature of the garments.

Current options to reduce breakdown of frail skin and to prevent and manage pressure ulcers focus on the reduction or redistribution of pressure. They include: dynamic or static high‑specification pressure‑relieving or pressure‑redistributing beds, mattresses, overlays and cushions; and sheepskin or pressure‑relieving bootees or silicone gel pads (numerous products, shapes and sizes are available).

NICE's guideline on pressure ulcers states that there is overlap between ulcers caused mainly by moisture and those caused by shear stresses or friction rather than pressure alone. This can cause some confusion in classification. In reality, however, pressure, shear, friction and moisture may all contribute in varying degrees to the development of an ulcer. The guideline recommends that when a person presents with or is at increased risk of developing a pressure ulcer, risk should be assessed and documented and then reassessed regularly.

NICE's guideline on pressure ulcers recommends that risk assessment should be followed by consideration of mobilising, positioning and repositioning interventions to prevent or minimise skin damage. When indicated, the recommended minimum provision is a high‑specification foam pressure‑relieving mattress or high‑specification foam mattress with an alternating pressure overlay, or a sophisticated continuous low pressure system. Any ulcer should be closely observed for deterioration.