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National Clinical Guideline Centre (UK). The Prevention and Management of Pressure Ulcers in Primary and Secondary Care. London: National Institute for Health and Care Excellence (NICE); 2014 Apr. (NICE Clinical Guidelines, No. 179.)
6.1. Introduction
Pressure relieving and redistributing devices are widely accepted methods of both preventing and treating pressure ulcers. A vast range of devices, including different types of mattresses, overlays, cushions and seating, are available which vary considerably in both cost and mechanism. Generally, these devices work by reducing pressure, friction or shearing forces and may be unpowered and considered ‘low-tech’ or ‘static’, or powered devices which are ‘high-tech’.
The selection of device by the healthcare professional is likely to depend upon the person's mobility, the result of skin assessment, the severity and site of the pressure ulcer, weight, staff availability and skill. The choice of a pressure redistributing device by a healthcare professional should also account for a person's wishes and tolerability of the device.
It is generally accepted that these devices should be used in conjunction with other treatment strategies such as repositioning and management of the pressure ulcer (for example, by use of an appropriate dressing).
The GDG were interested in what the most clinically and cost effective pressure redistributing devices are for the management of pressure ulcers.
Recommendations on the use of pressure redistributing devices for the prevention of pressure ulcers can be found in part 1 of the guideline.
6.2. Review question: What are the most clinically and cost effective pressure redistributing devices for the management of pressure ulcers?
For full details see review protocol in Appendix D.
6.2.1. Clinical evidence (adults)
A Cochrane Review looking at support surfaces for treating pressure ulcers was retrieved from the search and this was used as the basis for our review. It included 17 randomised trials6,29,44,51,55-57,59,73,89,123,126,136,145,161,162,180 Two additional randomised trials were found via systematic searches and were used to update the Cochrane review.39,108 Evidence from the RCTs are summarised in the clinical GRADE evidence profile below. See also the study selection flow chart in Appendix D, forest plots in Appendix I, study evidence tables in Appendix G and exclusion list in Appendix J.
Various types of devices were used to redistribute pressure, and for the purposes of the Cochrane review, these were categorised as ‘low-tech’ (non-powered), constant low pressure (CLP), high-tech and other devices.
The ‘low-tech’ CLP devices included:
- Standard foam mattresses
- Alternative foam mattresses or overlays
- Gel-filled mattresses or overlays
- Fibre-filled mattresses or overlays
- Air-filled mattresses or overlays
- Water-filled mattresses or overlays
- Bead-filled mattresses or overlays
- Sheepskins
The high-tech support surfaces included:
- Alternating-pressure mattresses or overlays
- Air-fluidised beds
- Low-air-loss beds
The other support surfaces included:
- Turning beds or frames
- Operating table overlays
- Wheelchair cushions
The Cochrane Review notes that this classification has since been updated by the National Pressure Ulcer Advisory Panel (EPUAP & NPUAP 2009) and will be considered in future updates of their review.
Summary of included studies
Study | Intervention/comparison | Population | Outcomes | Length of study |
---|---|---|---|---|
Allman 19876 | Air-fluidised therapy (CLINITRON) repositioned every 4 hours versus conventional treatment (including 2-hourly turns, heel and elbow protectors, alternating-pressure mattresses). | People undergoing surgery aged 18 or over with pressure ulcers of all stages. Graded using the Shea staging system. |
| Mean 13 days follow-up (range 4-77 days). |
Branom 200129 | PressureGuard CFT (constant force therapy) (non-powered mattress) versus LAL mattress. | People in hospital from long term and sub-acute care centre specialising in ventilator-dependent adults and those with extensive wound care needs. Bedridden adults with a pressure ulcer at grade 3 or 4 on trunk or pelvis (classification system not reported). |
| 8-week follow-up. |
Caley 199438 | LAL bed (Monarch, Mediscus) versus LAL overlay. | People in acute care with existing pressure ulcers. |
| Average 24-day follow-up. |
Cassino 201339 | Three-dimensional overlay (AIARTEX), made of 3-D macro-porous material vs dry viscoelastic polyurethane polymer overlay (AKTON) | Long-term care patients |
| 12 weeks |
Clark 199844 | ProActive 2 cushion (Pegasus) (cushion for day chairs and wheelchairs, seating automatically adjusts to an individual's weight) versus ROHO cushion (dry flotation system). All individuals had a Pegasus Airwave System in bed. | Elderly adults in 2 acute care hospitals and 2 nursing homes. Grade 2 pressure ulcers or above, classification system not reported. |
| Average 58.6 days (ProActive and 43.73 days (ROHO). |
Day 199351 | Air suspension bed (Therapulse, Kinetic concepts); foam mattress overlay (Geomatt, SpanAmerica). Wound care standardised for 2 groups. | Hospitalised adults with existing grade 2-4 pressure ulcers, graded using the NPUAP classification system. |
| 7-day follow-up. |
Devine 199555 | Alternating-pressure mattress (Nimbus I) (modular, with rows of figure-of-8 shaped cells; 2 sets of cells are inflated and deflated over 10 minute cycle) versus alternating-pressure mattress (Pegasus Airwave) (double layer mattress with a 3-cell alternating cycle lasting 7.5 minutes). All participants were subject to the standard hospital protocol for wound dressing; details of this were not provided. | Elderly adults in hospital with pressure ulcers of grade 2 or above. The classification system used was not specified. |
| 4-week follow-up. |
Evans 200056 | Alternating-pressure mattress replacement system (APMRS) (Nimbus 3) versus alternating-pressure mattress replacement system (APMRS) for adults in hospital (P.Biwave, P.Airwave.P.Cairwave or AlphaXCell) or alternating-pressure mattress overlay (AlphaXCell or Quattro) for people in a nursing home. Turning and wound care was standardised for 2 groups. | People in a hospital or nursing home, aged over 65 years with either grade 2 or 3 pressure ulcer (classification system not reported), or grade 2 pressure ulcer and difficulty to reposition in bed, unable to tolerate 30 degree tilt, unable to move in bed, in bed for over 20 hours or 24 hours, over 108kg and bed-bound or who have undergone spinal anaesthetic. |
| 2-week follow-up period. |
Ferrell 199359 | LAL bed (KINAIR) versus 10cm convoluted foam overlay on top of standard foam mattress .Both groups had similar co-interventions as per standard care that is mobilisation as much as possible; 2-hourly turning during waking hours; avoidance of head-of-bed elevation; avoidance of dragging people on sheets; nutritional support; infection control. | Older adults in an elderly nursing home with multiple medical problems, and with trunk or trochanter pressure ulcers. Grade 2 pressure ulcers or above (Shea grading system). |
| Median follow-up of 33 days (LAL group) and 40 days (foam mattress). |
Groen 199973 | Foam replacement mattress (3 layers of polyurethane foam designated as comfort, load-distributing and support layers) versus Secutex water mattress (placed on top of standard hospital mattress, 3 PVC sections holding 26 litres water each, with heating element).Standard turning protocol (every 2-3 hour) for both groups. | People in a nursing home, aged over 59 years with a pressure ulcer on trunk, grade 3 (superficial cutaneous or subcutaneous necrotic) or grade 4 (deep subcutaneous necrotic). The classification system used was not reported. |
| 4-week follow-up. |
Keogh 200189 | Profiling bed with a pressure reducing foam mattress or cushion versus flat-based bed with a pressure relieving or redistributing mattress or cushion. | People from 2 surgical and 2 medical wards; over 18 years old; Waterlow score of 15-25; tissue damage no greater than grade 1 (EPUAP grading system). |
| 5-10 days follow-up. |
Makhsous 2009108 | Wheelchair cushion equipped with an individualised cyclic pressure-relief protocol versus regular wheelchair cushions. Treatment was specific to the individual and a variety of wound care modalities applied when required (topical wound dressings eg wound gel, hydrocolloid, alginate, foam and moisture barrier) also silver antimicrobial dressings and negative pressure wound therapy. | Wheelchair users with spinal cord injury (paraplegia or tetraplegia) with existing stage 2 or 3 pressure ulcers (classification system not specified) in the sacral and/or ischial area. |
| 30 days follow-up. |
Mulder 1994123 | Air suspension bed (Therapulse, Kinetic concepts) (a pulsating air suspension therapy – cushions alternatively inflate and deflate but classed as LAL rather than AP) versus convoluted foam mattress overlay. Wound care and repositioning standardised for both groups. | People in a nursing home with grade 3-4 pressure ulcers (International Association of Enterostomal Therapists staging system). |
| Maximum 12-weeks' follow-up or until ulcers healed, whichever came first. |
Munro 1989126 | Air-fluidised bed (Clinitron) versus standard care. The bed/mattress in the standard care group was not described. Sheepskins or gel pads were placed beneath ulcer areas. Standard care involved positioning and massage. | Males with grade 2 or 3 pressure ulcers (classification system not specified), expected to remain in hospital for at least 15 days. |
| 15-day follow-up. |
Nixon 2006136 | Alternating-pressure overlay within 24 hours of admission versus alternating-pressure mattress within 24 hours of admission. | Adults over 55 years of age, from vascular, orthopaedic, medical or care of the elderly wards with an expected length of stay at least 7 days and Braden score of 1 or 2, or an existing grade 2 pressure ulcer (grading system not specified). |
| 30-day follow-up. |
Osterbrink 2005145 | Repose device versus small cell versus large cell. | Participants recruited from aged care facility, acute care hospitals and home care setting, over 18 years old, with at least 1 grade 2 pressure ulcer at any bony prominence (EPUAP classification). If recruited from hospital, must have been nursed on care of the elderly, neurological or surgical units. |
| Follow-up time as long as clinical circumstances allowed. Maximum duration 42 days. |
Russell 2000160 | Two types of alternating cell mattress systems with pressure-relieving cushions: Huntleigh Nimbus 3 with Aura cushion and 4-hourly turning versus Pegasus Cairwave Therapy System with Proactive 2 seating cushion and 8-hourly turning. | Individuals from care of the elderly units with pressure ulcers of grade 2 and above (Torrance classification system). Average age 83.9 and 84.6 years in the 2 groups. |
| 18-month follow-up. |
Russell 2003162 | Alternating-pressure, multicell mattress with 10 minute cycle time (Nimbus 3) versus fluid overlay mattress (RIK static). All adults had standard 4-hourly repositioning, but could have additional turning at the individual's request. | Adults with grade 1 or 2 pressure ulcers (EPUAP classification) admitted to hospital. Mean age 80 years. Baseline Waterlow scores 21.8 and 21.3 in groups 1 and 2 respectively and baseline Burton scores 14.6 and 14.2. |
| Length of follow-up unclear, but presumably until discharge from enrolment hospital. |
Strauss 1991180 | Home air-fluidised therapy (CLINITRON) when grade 3 or 4 prsesure ulcers present, plus the consultative and technical services of a visiting nurse specialist versus conventional or standard therapy, individual specific and prescribed (n=50), but included alternating –pressure pads, air-filled mattresses, water-filled mattresses, high density foam pads. | People: with at least 1 grade 3 or 4 pressure ulcer (Shea classification); who would probably require future hospitalisation for the pressure ulcer; with severely limited mobility; for who home air-fluidised therapy was a practical option, likely to comply, live at least 1 year; aged 16 years or over. |
| 36-week follow-up |
6.2.1. Economic evidence (adults)
Published literature
One study was included with a relevant comparison.61 This is summarised in the economic evidence profile below (Table 54). See also the study selection flow chart in Appendix D and study evidence tables in Appendix H.
One study that met the inclusion criteria was selectively excluded196 – this is summarised in Appendix H, with reasons for exclusion given.
One additional study was found which included devices for the management of pressure ulcers as part of a more complex management strategy.193 This study was not included as the cost-effectiveness of the strategy as a whole is evaluated, and does not provide information on the cost-effectiveness of the device alone.
Unit costs
Unit costs were presented to aid consideration of cost effectiveness (see Table 55).
Note - these prices have been obtained directly from manufacturers, and represent the list price for the NHS. It is acknowledged that prices vary locally; therefore these prices are illustrative only. The devices included in the table are those identified by GDG members as being commonly used, and should not be interpreted as recommended devices.
6.2.2. Clinical evidence (neonates, infants, children and young people)
No RCTs or cohort studies were identified. Recommendations were developed using a modified Delphi consensus technique. Further details can be found in Appendix N.
6.2.3. Economic evidence (neonates, infants, children and young people)
Published literature
No relevant economic evaluations were identified.
Economic considerations
In the absence of economic evidence, the GDG considered relevant UK NHS unit costs of various mattresses and overlays (see Table 56) These were considered alongside clinical evidence obtained from the Delphi consensus panel to inform qualitative judgement about cost-effectiveness.
Note: the costs above are included for illustrative purposes only and should not be interpreted as recommendations in favour of these particular devices. These are list prices only and local prices may vary.
6.2.4. Evidence statements
6.2.4.1. Clinical (adults)
6.2.4.1.1. Water mattress overlay versus low-tech mattress
- One study (n=120) showed there may be no clinical difference between a water mattress overlay and a low-tech mattress for the proportion of people with pressure ulcers completely healed within trial period, but the direction of the estimate of effect favoured the low-tech mattress (very low quality).
- One study (n=120) showed there may be a clinical benefit for a water mattress overlay compared to a low tech mattress for reducing reduction in pain. No estimate of precision could be derived (very low quality).
- No evidence was found for the following outcomes:
- Time to complete healing
- Rate of reduction in size of ulcers
- Reduction in size and/or volume of pressure ulcer
- Time in hospital or NHS care
- Patient acceptability
- Side effects
- Mortality (all cause)
- Health-related quality of life
6.2.4.1.2. 3-D macroporous overlay versus gel overlay
- One study (n=72) showed there may be no clinical difference between a 3-D macroporous overlay and a gel overlay for the proportion of people with pressure ulcers completely healed. The direction of the estimate of effect favoured the gel overlay (very low quality).
- One study (n=72) showed a 3-D macroporous overlay may be more clinically effective for reducing mortality (all-cause) when compared to a gel overlay (very low quality).
- One study (n=72) showed a 3-D macroporous overlay is potentially more clinically effective for reducing suspension due to worsening of pressure ulcers when compared to a gel overlay (very low quality).
- One study (n=72) showed a 3-D macroporous overlay may be more clinically effective for reducing suspension due to intolerance when compared to a gel overlay (very low quality).
- One study (n=72) showed a 3-D macroporous overlay is potentially more clinically effective for reducing unchanged/worsened pressure ulcers when compared to a gel overlay (very low quality).
- One study (n=72) showed a 3-D macroporous overlay is potentially more clinically effective for improving pressure ulcers when compared to a gel overlay (very low quality).
- One study (n=72) showed a 3-D macroporous overlay may be more clinically effective for increased comfort when compared to a gel overlay (very low quality).
- One study (n=72) showed a 3-D macroporous overlay is potentially more clinically effective for reducing discomfort when compared to a gel overlay (very low quality).
- No evidence was found for the following outcomes:
- Time to complete healing (time to event data)
- Rate of healing (continuous data)
- Rate of change in size of ulcer (absolute and relative) (continuous data)
- Reduction in size of ulcer and volume of ulcer
- Pain (pressure ulcer related)
- Time in hospital or NHS care (continuous data)
- Side effects
- Health-related quality of life (continuous data)
6.2.4.1.3. Low-air loss-bed versus low-tech foam mattress overlay
- One study (n=84) showed a low-air-loss bed is potentially more clinically effective for the proportion of people with pressure ulcers completely healed within the trial period when compared to a low-tech foam mattress overlay (very low quality).
- One study (n=49) showed there may be no clinical harm between a low-air-loss bed and a low tech foam mattress overlay for the proportion of people with pressure ulcers completely healed within the trial period, but the direction of the estimate of effect could favour the low-tech foam mattress overlay (very low quality).
- Two studies (n=133) showed a low-air-loss bed is potentially more clinically effective for the proportion of people with pressure ulcers completely healed within the trial period at when compared to a low-tech foam mattress overlay (very low quality).
- One study (n=49) showed there may be no clinical difference between a low-air-loss bed and a low-tech foam mattress overlay for pressure ulcers reduced by 1 grade or more, including completely healed (very low quality).
- One study (n=84) reported there is potentially a clinical benefit for a low-air-loss bed compared to a low-tech foam mattress overlay for rate of ulcer healing. No estimate of precision could be derived (very low quality).
- One study (n=48) reported a mean difference for change in pressure ulcer size for stage 2 pressure ulcers was 2 higher (0.73 to 3.27) in a low-air-loss bed compared with a low-tech foam mattress overlay. The clinical importance is unknown (very low quality).
- One study (n=29) reported a mean difference for change in pressure ulcer size for stage 3 and stage 4 pressure ulcers was 24.7 higher (20.37 to 29.03)in a low-air-loss bed compared with a low-tech foam mattress overlay. The clinical importance is unknown (very low quality).
- One study (n=39) showed there is no clinical benefit of a low-air-loss bed for patient acceptability (mean comfort score) when compared with a low-tech foam mattress overlay (low quality).
- One study (n=84) showed there may be a clinical harm for a low-air-loss bed compared to a low-tech foam mattress overlay for all-cause mortality (very low quality).
- No evidence was found for the following outcomes:
- Time to complete healing
- Pain (prssure ulcer related)
- Time in hospital or NHS care
- Side effects
- Health-related quality of life
6.2.4.1.4. Low-air-loss bed versus low-air-loss overlay
- One study (n=93) showed there may be a clinical benefit for a low-air-loss bed compared to a low-air-loss overlay for reduction in size of pressure ulcer (median change in pressure ulcer area). No estimate of precision could be derived (very low quality).
- One study (n=93) showed there may be a clinical benefit for a low-air-loss bed compared to a low-air-loss overlay for reduction in size of pressure ulcer (mean change in pressure ulcer surface area). No estimate of precision could be derived (very low quality).
- No evidence was found for the following outcomes:
- Time to complete healing
- Rate of reduction in size of ulcers
- Proportion of completely healed within trial period
- Pain (pressure ulcer-related)
- Time in hospital or NHS care
- Patient acceptability
- Side effects
- Mortality (all cause)
- Health-related quality of life
6.2.4.1.5. Air-fluidised therapy (AFT) versus standard/conventional therapies
- One study (n=65) showed there may be no clinical difference between an air-fluidised therapy and a standard/conventional therapy for proportion of people with 50% reduction in total surface area (very low quality).
- One study (n=35) showed air-fluidised therapy is potentially more clinically effective for proportion with improvement in pressure ulcers when compared to standard/conventional therapy (very low quality).
- One study (n=65) showed air-fluidised therapy is potentially more clinically effective for proportion with improvement in pressure ulcers when compared to standard/conventional therapy (low quality).
- Two studies (n=100) showed air-fluidised therapy is potentially more clinically effective for proportion with improvement in pressure ulcers when compared to standard/conventional therapy (low quality).
- One study (n=40) showed there may be a clinical benefit for air-fluidised therapy compared to standard/conventional therapy for change in mean ulcer area (stage 2 or 3 ulcers). No estimate of precision could be derived (very low quality).
- One study (n=65) showed there may be a clinical benefit for air-fluidised therapy compared to standard/conventional therapy for change in total pressure ulcer surface area (very low quality).
- One study (n=18) showed air-fluidised therapy is more clinically effective for patient acceptability (patient satisfaction) when compared to standard/conventional therapy (low quality).
- One study (n=27) showed air-fluidised therapy is potentially more clinically effective for patient acceptability (more people experiencing an increase in comfort) when compared to standard/conventional therapy (very low quality).
- One study (n=27) showed there may be a clinical benefit for air-fluidised therapy compared to standard/conventional therapy for patient acceptability (fewer people experiencing a reduction in comfort) (very low quality).
- One study (n=97) showed there may be a clinical benefit for air-fluidised therapy compared to standard/conventional therapy for time in hospital (very low quality).
- One study (n=27) reported there may be no clinical difference between air-fluidised therapy and standard/conventional therapy length of stay in hospital after randomisation, but the direction of the estimate of effect could favour standard care. No estimate of precision could be derived (very low quality).
- One study (n=27) showed air-fluidised therapy is potentially more clinically effective for pain (more people experiencing a reduction in pain) when compared to standard or conventional therapy (very low quality).
- One study (n=27) showed there may be a clinical benefit for air-fluidised therapy compared to standard/conventional therapy for pain (fewer people experiencing an increase in pain) (very low quality).
- One study (n=112) showed air-fluidised therapy is potentially more clinically effective at reducing all-cause mortality when compared to standard/conventional therapy (very low quality).
- Two studies (n=177) showed there may be no clinical difference between an air-fluidised therapy and standard/conventional therapy at reducing all-cause mortality, the direction of the estimate of effect favoured air-fluidised therapy (very low quality).
- No evidence was found for the following outcomes:
- Time to complete healing
- Rate of reduction in size of pressure ulcers
- Proportion of completely healed within trial period
- Side effects
- Health-related quality of life
6.2.4.1.6. Alternating-pressure mattress (Nimbus 1) versus. alternating-pressure mattress (Pegasus Airwave)
- One study (n=30) showed an alternating-pressure mattress (Nimbus 1) is potentially more clinically effective for proportion of people with pressure ulcers completely healed (grade 2 and above) when compared to an alternating-pressure mattress (Pegasus Airwave) (very low quality).
- One study (n=30) showed there may be a clinical harm for a alternating-pressure mattress (Nimbus 1) compared to an alternating-pressure mattress (Pegasus Airwave) for proportion of people with decrease in pressure ulcer size (grade 2 and above) (very low quality).
- One study (n=30) showed an alternating-pressure mattress (Nimbus 1) may be more clinically effective than an alternating-pressure mattress (Pegasus Airwave) for proportion of people with increase in pressure ulcer size (grade 2 and above) (very low quality).
- One study (n=41) reported medians an alternating-pressure mattress (Nimbus 1) and an alternating-pressure mattress (Pegasus Airwave) for patient acceptability (comfort). The median for both interventions was 8/10. No estimate of effect or precision could be derived (very low quality).
- One study (n=41) showed there may be no clinical difference between an alternating-pressure mattress (Nimbus 1)and an alternating-pressure mattress (Pegasus Airwave) for mortality, but the direction of the estimate of effect could favour either intervention (very low quality).
- One study (n=41) reported there may be no clinical difference between an alternating-pressure mattress (Nimbus 1) and an alternating-pressure mattress (Pegasus Airwave) for rate of reduction in pressure ulcer surface area (grade 2 and above), but the direction of the estimate of effect could favour either intervention (very low quality).
- No evidence was found for the following outcomes:
- Time to complete healing
- Pain (pressure ulcer related)
- Time in hospital or NHS care
- Side effects
- Health-related quality of life
6.2.4.1.7. Alternating-pressure mattress (Nimbus 3) with cushion (Aura) and 4-hourly turning versus an alternating-pressure mattress (Pegasus Cairwave Therapy System) with seating cushion (Proactive 2) and 8-hourly turning
- One study (n=141) showed no clinical difference between an alternating-pressure mattress (Nimbus 3) with cushion (Aura) and 4-hourly turning for proportion of people with pressure ulcers completely healed (grade 2 and above) when compared with an alternating-pressure mattress (Pegasus Cairwave Therapy System) with seating cushion (Proactive 2) and 8-hourly turning, the direction of the estimate of effect favours the 4-hourly turning (moderate quality).
- One study (n=112) reported the mean difference for time in hospital for an alternating-pressure mattress (Nimbus 3) with cushion (Aura) and 4-hourly turning, and an alternating-pressure mattress (Pegasus Cairwave Therapy System) with seating cushion (Proactive 2) and 8-hourly turning. The mean for the alternating-pressure mattress (Nimbus 3) was 21.6 days and 21.7 days for the alternating-pressure mattress (Pegasus Cairwave Therapy System). No estimate of effect or precision could be derived (very low quality).
- One study (n=141) showed an alternating-pressure mattress (Nimbus 3) with cushion (Aura) and 4-hourly turning is potentially more clinically harmful for mortality when compared to an alternating-pressure mattress (Pegasus Cairwave Therapy System) with seating (Proactive 2)cushion and 8-hourly turning (low quality).
- No evidence was found for the following outcomes:
- Time to complete healing
- Rate of reduction in size of ulcers
- Reduction in size and/or volume of ulcer
- Pain (pressure ulcer related)
- Patient acceptability
- Side effects
- Health-related quality of life
6.2.4.1.8. Alternating-pressure mattress (Nimbus 3) versus alternating-pressure mattress (Pegasus Biwave, Pegasus Airwave, Pegasus Cairwave or AlphaXCell) or alternating-pressure mattress overlay (AlphaXCell or Quattro)
- One study (n=32) reported medians for patient acceptability (comfort) for people in hospital for an alternating-pressure mattress (Nimbus 3) and a different alternating-pressure mattress (Pegasus Biwave, Pegasus Airwave, Pegasus Cairwave or AlphaXCell) or alternating-pressure mattress overlay (AlphaXCell or Quattro). The median for the alternating-pressure mattress (Nimbus 3) was 5 (very comfortable) and 4 (comfortable) for alternating-pressure mattress (Pegasus Biwave, Pegasus Airwave, Pegasus Cairwave or AlphaXCell) or alternating-pressure mattress overlay (AlphaXCell or Quattro). No estimate of effect or precision could be derived (very low quality).
- One study (n=32) reported medians for patient acceptability (comfort)for elderly people in a hospital or nursing home for an alternating-pressure mattress (Nimbus 3) and a different alternating-pressure mattress (Pegasus Biwave, Pegasus Airwave, Pegasus Cairwave or AlphaXCell) or alternating-pressure mattress overlay (AlphaXCell or Quattro). The median for the alternating-pressure mattress (Nimbus 3) was 5 (very comfortable) and 4 (comfortable) for alternating-pressure mattress (Pegasus Biwave, Pegasus Airwave, Pegasus Cairwave or AlphaXCell) or alternating-pressure mattress overlay (AlphaXCell or Quattro). No estimate of effect or precision could be derived (very low quality).
- One study (n=32) showed there may be a clinical harm for an alternating-pressure mattress (Nimbus 3) compared to a different alternating-pressure mattress (Pegasus Biwave, Pegasus Airwave, Pegasus Cairwave or AlphaXCell) or alternating-pressure mattress overlay (AlphaXCell or Quattro) for mortality (very low quality).
- One study (n=32) reported medians for absolute reduction in wound surface area per day (grade 2 and above) for people in hospital for an alternating-pressure mattress (Nimbus 3) and a different alternating-pressure mattress (Pegasus Biwave, Pegasus Airwave, Pegasus Cairwave or AlphaXCell) or alternating-pressure mattress overlay (AlphaXCell or Quattro). The median for the Nimbus 3 alternating-pressure mattress was 0.12cm2 (range 0 to 0.21cm2) and 0.08cm2(range 0.04 to 0.33cm2) for alternating-pressure mattress (Pegasus Biwave, Pegasus Airwave, Pegasus Cairwave or AlphaXCell) or alternating-pressure mattress overlay (AlphaXCell or Quattro). No estimate of precision could be derived (very low quality).
- One study (n=32) reported medians for relative reduction in wound surface area (grade 2 and above) for people in hospital for an alternating-pressure mattress (Nimbus 3) and a different alternating-pressure mattress (Pegasus Biwave, Pegasus Airwave, Pegasus Cairwave or AlphaXCell) or alternating-pressure mattress overlay (AlphaXCell or Quattro),. The median for the Nimbus 3 alternating-pressure mattress was 2.44% (range 0 to 7.14%) and 1.34% (range 1.11 to 2.88%) for alternating-pressure mattress (Pegasus Biwave, Pegasus Airwave, Pegasus Cairwave or AlphaXCell) or alternating-pressure mattress overlay (AlphaXCell or Quattro). No estimate of precision could be derived (very low quality).
- One study (n=32) reported medians for absolute reduction in wound surface area per day (grade 2 and above) for elderly people in hospital or a nursing home for an alternating-pressure mattress (Nimbus 3) and a different alternating-pressure mattress (Pegasus Biwave, Pegasus Airwave, Pegasus Cairwave or AlphaXCell) or alternating-pressure mattress overlay (AlphaXCell or Quattro). The median for the Nimbus 3 alternating-pressure mattress was 0.11cm2 (range 0.04 to 0.41cm2) and 0.05cm2(range 0 to 0.48cm2) for alternating-pressure mattress (Pegasus Biwave, Pegasus Airwave, Pegasus Cairwave or AlphaXCell) or alternating-pressure mattress overlay (AlphaXCell or Quattro). No estimate of precision could be derived (very low quality).
- One study (n=32) reported medians for relative reduction in wound surface area (grade 2 and above)for elderly people in hospital or a nursing home for an alternating-pressure mattress (Nimbus 3) and a different alternating-pressure mattress (Pegasus Biwave, Pegasus Airwave, Pegasus Cairwave or AlphaXCell) or alternating-pressure mattress overlay (AlphaXCell or Quattro). The median for the alternating-pressure mattress (Nimbus 3) was 1.57% (range 0.45 to 5%) and 0.99% (range 0 to 2.54%) for alternating-pressure mattress (Pegasus Biwave, Pegasus Airwave, Pegasus Cairwave or AlphaXCell) or alternating-pressure mattress overlay (AlphaXCell or Quattro). No estimate of precision could be derived (very low quality).
- No evidence was found for the following outcomes:
- Time to complete healing
- Proportion of completely healed within trial period
- Pain (pressure ulcer related)
- Time in hospital or NHS care
- Side effects
- Health-related quality of life
6.2.4.1.9. Alternating-pressure mattress overlay versus alternating-pressure mattress
- One study (n=113) showed there may be no clinical difference between an alternating-pressure mattress overlay and an alternating-pressure mattress for proportion of people with pressure ulcers completely healed (grade 2 and above), but the direction of the estimate of effect could favour the alternating-pressure mattress (very low quality).
- One study (n=158) showed there is no clinical benefit of an alternating-pressure mattress overlay for pressure ulcer improvement (grade 1 or 2) when compared with an alternating-pressure mattress (low quality).
- One study (n=158) showed there may be no clinical difference between an alternating-pressure mattress overlay and an alternating-pressure mattress for worsening of pressure ulcers (grade 1 or 2), but the direction of the estimate of effect could favour either intervention (very low quality).
- One study (n=1971) showed there is potentially no clinical difference between an alternating-pressure mattress overlay and an alternating-pressure mattress for patient acceptability (number requesting changes for comfort or other device-related reason) (low quality).
- One study (n=158) reported the mean for time in hospital for an alternating-pressure mattress overlay and an alternating-pressure mattress. The mean for an alternating-pressure mattress was 22.17 days and 20.02 days for an alternating-pressure mattress. No estimate of precision could be derived (very low quality).
- One study (n=113) showed an alternating-pressure mattress overlay is potentially more clinically harmful for mortality when compared to an alternating-pressure mattress (very low quality).
- One study (n=113) reported medians for an alternating-pressure mattress and an alternating-pressure mattress overlay for time to ulcer heading. The median for both interventions was 20 days. No estimate of precision could be derived (very low quality).
- One study (n=69) showed there is potentially no clinical difference between an alternating-pressure mattress and an alternating-pressure mattress overlay for absolute change in pressure ulcer surface area (very low quality).
- One study (n=1820) showed there is potentially no clinical difference between an alternating-pressure mattress overlay and an alternating-pressure mattress for patient acceptability (proportion of people with negative comments on mattress motion). The direction of the estimate of effect favoured the air-filled devices (very low quality).
- One study (n=1820) showed there is no clinical difference between an alternating-pressure mattress overlay for patient acceptability (proportion of people with positive comments on mattress motion) when compared with an alternating-pressure mattress the direction of the estimate of effect favoured the alternating-pressure mattress (low quality).
- One study (n=1820) showed there is potentially no clinical difference between an alternating-pressure mattress overlay and an alternating-pressure mattress for patient acceptability (proportion of people with negative comments on getting into/out of bed). The direction of the estimate of effect favoured the alternating-pressure mattress (low quality).
- One study (n=1820) showed there is no clinical difference between an alternating-pressure mattress overlay for patient acceptability (proportion of people with negative comments on movement in bed) when compared with an alternating-pressure mattress. The direction of the estimate of effect favoured the alternating-pressure mattress (low quality).
- One study (n=1820) showed there may be no clinical difference between an alternating-pressure mattress overlay and an alternating-pressure mattress for patient acceptability (proportion of people with positive comments on movement in bed). The direction of the estimate of effect favoured the alternating-pressure mattress (very low quality).
- One study (n=1820) showed there is potentially no clinical difference between an alternating-pressure mattress overlay and an alternating-pressure mattress for patient acceptability (proportion of people commenting on temperature as hot orwarm). The direction of the estimate of effect favoured the alternating-pressure mattress (very low quality).
- One study (n=1820) showed there is potentially no clinical difference between an alternating-pressure mattress overlay and an alternating-pressure mattress for patient acceptability (proportion of people commenting on temperature as sweaty or sticky). The direction of the estimate of effect favoured the alternating-pressure mattress overlay (very low quality).
- One study (n=1820) showed there may be no clinical difference between an alternating-pressure mattress overlay and an alternating-pressure mattress for patient acceptability (proportion of people commenting on temperature as cold/cool), but the direction of the estimate of effect favoured either intervention (very low quality).
- One study (n=1820) showed there may be no clinical difference between an alternating-pressure mattress overlay and an alternating-pressure mattress for patient acceptability (proportion of people reporting the mattress not working or not working properly). The direction of the estimate of effect favoured the alternating-pressure mattress overlay (very low quality).
- One study (n=1820) showed there is potentially no clinical difference between an alternating-pressure mattress overlay and an alternating-pressure mattress for patient acceptability (proportion of people commenting that it was hard to tuck the sheet under, sheets come off or gather or the mattress cover slips). The direction of the estimate of effect favoured the alternating-pressure mattress overlay (very low quality).
- One study (n=1820) showed there is potentially no clinical difference between an alternating-pressure mattress overlay and an alternating-pressure mattress for patient acceptability (proportion of people commenting the mattress/bed was too high). The direction of the estimate of effect favoured the alternating-pressure mattress overlay (very low quality).
- One study (n=1820) showed there may be no clinical difference between an alternating-pressure mattress overlay and an alternating-pressure mattress for patient acceptability (proportion of people reporting the mattress as slippery). The direction of the estimate of effect favoured the alternating-pressure mattress overlay (very low quality).
- One study (n=1820) showed there is potentially no clinical difference between an alternating-pressure mattress overlay and an alternating-pressure mattress for patient acceptability (proportion of people reporting the mattress as too softor edges soft or sloping). The direction of the estimate of effect favoured the alternating-pressure mattress overlay (very low quality).
- One study (n=1820) showed there may be no clinical difference between an alternating-pressure mattress overlay and an alternating-pressure mattress for patient acceptability (proportion of people reporting they were not able to use backrest). The direction of the estimate of effect favoured the alternating-pressure mattress overlay (very low quality).
- One study (n=1820) showed there is potentially no clinical difference between an alternating-pressure mattress overlay and an alternating-pressure mattress for side effects (mattress related fall). The direction of the estimate of effect favoured the alternating-pressure mattress overlay (very low quality).
- One study (n=1820) showed there may be no clinical difference between an alternating-pressure mattress overlay and an alternating-pressure mattress for side effects (mattress-related suspected contact dermatitis). The direction of the estimate of effect favoured the alternating-pressure mattress overlay (very low quality).
- One study (n=1820) showed there may be no clinical difference between an alternating-pressure mattress overlay and an alternating-pressure mattress for side effects (mattress-related climbed over/fell through cot sides). The direction of the estimate of effect favoured the alternating-pressure mattress overlay (very low quality).
- One study (n=1820) showed there may be no clinical difference between an alternating-pressure mattress overlay and an alternating-pressure mattress for side effects (mattress deflation during transfer). The direction of the estimate of effect favoured the alternating-pressure mattress overlay (very low quality).
- No evidence was found for the following outcomes:
- Rate of reduction in size of pressure ulcers
- Pain (pressure ulcer related)
- Side effects
- Health-related quality of life
6.2.4.1.10. Air-filled devices versus alternating-pressure mattress
- One study (n=60) showed there may be a clinical benefit for an air filled device compared to an alternating-pressure mattress for the proportion of people with pressure ulcers completely healed (grade 2 and above) (very low quality).
- No evidence was found for the following outcomes:
- Time to complete healing
- Rate of reduction in size of pressure ulcers
- Reduction in size and/or volume of ulcer
- Pain (pressure ulcer related)
- Time in hospital or NHS care
- Patient acceptability
- Side effects
- Mortality (all cause)
- Health-related quality of life
6.2.4.1.11. Alternating-pressure cushion versus dry flotation cushion
- One study (n=25) showed there may be a clinical benefit for a dry flotation cushion for proportion of people with pressure ulcers completely healed (grade 2 and above) compared to an alternating-pressure cushion (very low quality).
- One study (n=25) showed there may be a clinical benefit for a dry flotation cushion for mortality when compared to an alternating-pressure cushion (very low quality).
- One study (n=25) showed there may be a clinical benefit for a dry flotation cushion for rate of ulcer healing (area of ulcer) when compared to an alternating-pressure cushion (very low quality).
- One study (n=25) showed there may be a clinical benefit for an alternating-pressure cushion compared to a dry flotation cushion for rate of ulcer healing (volume of ulcer) (very low quality).
- One study (n=25) showed an alternating-pressure cushion is potentially more clinically effective for percentage change in pressure ulcer area per day when compared to a dry flotation cushion (very low quality).
- One study (n=25) showed there may be a clinical benefit for an alternating-pressure cushion compared to a dry flotation cushion for percentage change in volume of pressure ulcer per day (very low quality).
- No evidence was found for the following outcomes:
- Time to complete healing
- Reduction in size and/or volume of pressure ulcer
- Pain (pressure ulcer related)
- Time in hospital or NHS care
- Patient acceptability
- Side effects
- Health-related quality of life
6.2.4.1.12. Profiling bed versus foam mattress
- One study (n=14) showed there is potentially a clinical benefit for a profiling bed compared to a foam mattress for the proportion of people with completely healed pressure ulcers (very low quality).
- No evidence was found for the following outcomes:
- Time to complete healing
- Rate of reduction in size of pressure ulcers
- Reduction in size and/or volume of pressure ulcer
- Pain (pressure ulcer related)
- Time in hospital or NHS care
- Patient acceptability
- Side effects
- Mortality (all cause)
- Health-related quality of life
6.2.4.1.13. Constant force mattress versus low-air-loss mattress
- One study (n=18) showed a constant force mattress is potentially more clinically effective for the percentage rate of pressure ulcer closure per week when compared to a low-air-loss mattress (very low quality).
- No evidence was found for the following outcomes:
- Time to complete healing
- Reduction in size and/or volume of pressure ulcer
- Proportion of completely healed within trial period
- Pain (pressure ulcer related)
- Time in hospital or NHS care
- Patient acceptability
- Side effects
- Mortality (all cause)
- Health-related quality of life
6.2.4.1.14. Wheelchair cushion with equipped with individualised cyclic pressure-relief protocol versus standard wheelchair cushion
- One study (n=44) showed a wheelchair cushion equipped with individualised cyclic pressure-relief protocol is more clinically effective for pressure ulcer closure rate (area) when compared to a standard wheelchair cushion (low quality).
- One study (n=44) showed a wheelchair cushion equipped with individualised cyclic pressure-relief protocol is more clinically effective for PUSH score improvement when compared to a standard wheelchair cushion (low quality).
- One study (n=44) showed a wheelchair cushion equipped with individualised cyclic pressure-relief protocol is more clinically effective for percentage surface area reduction improvement when compared to a standard wheelchair cushion (low quality).
- One study (n=44) showed a wheelchair cushion equipped with individualised cyclic pressure-relief protocol is more clinically effective for PUSH score improvement when compared to a standard wheelchair cushion (low quality).
- One study (n=44) showed a wheelchair cushion equipped with individualised cyclic pressure-relief protocol is more clinically effective for percentage PUSH score improvement when compared to a standard wheelchair cushion (low quality).
- No evidence was found for the following outcomes:
- Time to complete healing
- Proportion of completely healed within trial period
- Pain (pressure ulcer related)
- Time in hospital or NHS care
- Patient acceptability
- Side effects
- Mortality (all cause)
- Health-related quality of life
6.2.4.2. Economic (adults)
- One cost-utility analysis found that alternating pressure mattress replacements dominate alternating pressure overlays and standard care (high specification foam mattresses) in the treatment of pressure ulcers. This study was assessed to be directly applicable with potentially serious limitations.
6.2.4.3. Clinical (neonates, infants, children and young people)
No evidence was identified.
6.2.4.4. Economic (neonates, infants, children and young people)
No evidence was identified.
6.3. Recommendations and link to evidence
6.3.1. Adults
Recommendations |
|
---|---|
Relative values of different outcomes | The GDG identified that the proportion of people with pressure ulcers completely healed, time to complete healing, reduction in size and volume and rate of reduction in size and volume of pressure ulcers were the most critical outcomes to inform decision making. |
Trade off between clinical benefits and harms | One study showed that a low-air-loss bed was more clinically beneficial than a foam mattress overlay for complete healing. Another study showed no difference between a foam mattress overlay and a low-air-loss bed for grade 3 and 4 pressure ulcers. There was higher mortality in the low-air-loss bed group and there was a clinical benefit of low-air-loss bed for rate of ulcer healing, but no clinical difference for patient acceptability or reduction by 1 grade of pressure ulcer. Air-fluidised therapy beds showed some clinical benefit compared to standard or conventional therapies (these varied and included repositioning and massage, use of a sheepskin, gel pad, heel and elbow protector, alternating pressure mattress, alternating pressure pads, air-filled mattresses, water filled mattresses and pads or high density foam pads) for improvement in pressure ulcers. This study also showed a clinical benefit for the reduction in pain, time in hospital, patient satisfaction, and an increase in comfort. There was no clinical benefit for length of stay in hospital or reduction in mortality. There was no clinical difference between a water mattress overlay and a low-tech mattress for pressure ulcers completely healed but there were less people on the water mattress overlay with pain. There were no clinically beneficial results for alternating-pressure mattress overlays compared to alternating-pressure mattresses except for percentage change in surface area. In this study there were more deaths in the mattress group compared to the mattress overlay group. There was a clinical benefit for air-filled devices compared to alternating pressure mattress for proportion of people with pressure ulcers completely healed. There were varying results for 1 alternating-pressure mattress compared to another alternating-pressure mattress. This however was dependant on the exact device in use. There were no clear outcomes for low-air-loss beds compared to low-air-loss overlays. There was an uncertain clinical benefit for a constant force mattress when compared to a low-air-loss mattress. There was a large clinical benefit for a profiling bed when compared to a foam mattress for complete healing of pressure ulcers. An alternating-pressure cushion was more clinically beneficial than a dry flotation cushion for completely healing grade 2 or above pressure ulcers. There was less mortality in the dry flotation cushion group. A 3-D macroporous overlay compared to a gel overlay showed no clinical difference for pressure ulcers completely healed but a benefit of the 3-D macroporous overlay for reducing mortality, discomfort and suspension due to worsening of pressure ulcers or intolerance, and increasing improvement. A wheelchair cushion equipped with an individualised pressure-relief protocol was more clinically beneficial for the reduction in the size of pressure ulcers. Overall, there is no high quality evidence to suggest a benefit in healing for any particular type of device. However people with pressure ulcers are at risk of developing further pressure ulcers, thus the GDG felt it appropriate to recommend the use of high specification mattresses (which are widely used in current clinical practice) for all people as standard. This recommendation is reflective of preventation strategies for pressure ulcers. The GDG highlighted that standard foam mattresses should not be provided to people who have developed pressure ulcers and developed a recommendation to emphasise this. Wheelchair cushions Evidence from one study showed that a wheelchair cushion equipped with individualised cyclic pressure-relief protocol had more benefit when compared to a standard wheelchair cushion in spinal cord injured patients, however the GDG felt that the intervention was very complicated and combined a number of other interventions and may not be representative of clinical practice. This was a very small study of low quality and the GDG thought that the study may not have been long enough for patients to reach complete healing of ulcers and the loss to follow up may potentially be large. The GDG therefore chose to develop a recommendation similar to that included in the ‘prevention guideline’ to highlight that people who use a wheelchair who have pressure ulcers should be provided with a high specification foam cushion as a minimum. The GDG also felt that people who were likely to be seated for a long period, who have a pressure ulcer, should be provided with a high specification foam cushion and should have their seating requirements carefully considered. |
Economic considerations | High specification foam mattresses are considered to be cost-effective for the prevention of pressure ulcers, compared to standard mattresses. It can therefore be inferred that it is cost-effective for people to remain on these mattresses once a pressure ulcer develops. The mattress will assist with on-going prevention, and will also aid pressure ulcer treatment. High specification foam mattresses are therefore considered to be cost-effective for the treatment of pressure ulcers, compared to standard mattresses. The GDG considered 1 cost-utility analysis which compared alternating pressure mattresses and alternating pressure overlays to high specification foam mattresses for the treatment of pressure ulcers. The study found that alternating pressure mattresses dominate alternating pressure overlays and high specification mattresses, with reduced costs and increased QALYs. However this study had potentially serious limitations and was considered to be only partially applicable. The GDG also considered the unit costs of various devices, and acknowledged that dynamic support surfaces are more costly than high specification foam mattresses. The GDG discussed that, although there was no clear clinical evidence, the crucial factor when healing pressure ulcers is pressure redistribution, and that the dynamic support surfaces do reduce pressure better than high specification foam. Efficient pressure redistributionwill improve quality of life and up front unit costs will be offset, or at least mitigated, by the reduction in further treatment costs. Based on the existing economic evidence, discussion of unit costs and potential benefits of dynamic surfaces, the GDG agreed that where high specification foam was not sufficient for the healing of a pressure ulcer, the use of dynamic support surfaces was likely to be cost effective. |
Quality of evidence | The evidence reviewed was of varying populations, interventions, comparisons, and outcomes which made a conclusion of which type of device was preferential very difficult. The evidence was of low to very low quality due to study limitations and most outcomes had serious to very serious imprecision. The GDG discussed the evidence limitations. They further agreed that that none of the studies followed up people for a sufficient amount of time, which is likely to have limited the apparent effectiveness of the mattresses. |
Other considerations | The GDG agreed that high specification foam mattresses are commonly used in the NHS for the prevention of pressure ulcers, thus the group considered that it would be unethical to discontinue the use of this device, if it had been started prior to the development of the pressure ulcer. |
6.3.2. Neonates, infants, children and young people
Recommendations |
|
---|---|
Relative values of different outcomes | The GDG identified that the proportion of people with pressure ulcers completely healed, time to complete healing, reduction in size and volume and rate of reduction in size and volume of pressure ulcers were the most critical outcomes to inform decision making. |
Trade-off between clinical benefits and harms | The GDG used 2 statements from the Delphi consensus panel to develop the recommendation, ‘Healthcare professionals should use a high specification cot or bed mattress for all neonates, infants and children who have developed pressure ulcers’ and ‘Healthcare professionals should use a high specification cot or bed overlay for all neonates, infants and children who have developed pressure ulcers’. The former was accepted during Round 1 of the Delphi consensus survey, the latter was not accepted. During Round 1, qualitative comments received on the use of high specification bed mattresses highlighted that the provision of a pressure redistributing device should be tailored to the child and that selection should consider the physical, clinical and environmental situation. Other comments emphasised that the use of any pressure redistributing device should only be used in combination will a repositioning regimen. The GDG subsequently discussed the latter statement on the use of overlays as well as the comments received during Round 1, which focused on the benefits of using an overlay where a mattress is unavailable. In particular, comments noted that the use of an overlay would be preferable to delaying pressure redistribution. However, comments also highlighted that there were potential safety issues in the use of certain overlays, particularly where this raises the height of the child above the bed rails. The statement was therefore amended to highlight that an overlay may be considered where a mattress is unavailable but safety should be considered where this is used. The GDG therefore amended the statement to ‘Healthcare professionals should consider the use of a high specification cot or bed overlay for neonates, infants and children who have developed pressure ulcers, where a high specification mattress is not available, taking into account safety’ for inclusion in Round 2 of the Delphi consensus survey. The amended statement was included in Round 2 of the survey and was agreed by the panel. Qualitative responses gathered in Round 2 emphasised that any overlay used should be high specification and noted that repositioning should still be considered a mainstay of care, regardless of the use of a pressure redistributing device. The GDG discussed both of the agreed statements. The GDG felt that high specification mattresses should be provided as standard to all neonates, infants, children and young people who have developed a pressure ulcer, as the potential benefits in reducing pressure were likely to outweigh any harms. The GDG discussed further the use of high specification overlays. The GDG noted that it was likely that high specification mattresses would be provided to people admitted to secondary care, as these would be given as standard preventative treatment. The GDG therefore felt that the recommendation should provide the option of providing people with pressure ulcers a high specification bed mattress or overlay. The GDG felt, although the Delphi consensus panel had agreed a statement that overlays used only be used in the absence of a mattress, that recommending the provision of either device would help to ensure that pressure was reduced across different settings in which care was provided (for example, in the operating theatre, where care is provided in the home, or in long term residential settings). The GDG felt that the option to provide an overlay to those who had developed a pressure ulcer should remain as pressure reduction was the most urgent consideration in this situation and, if the use of an overlay was to facilitate the reduction of pressure, this would be important where there is a delay in providing a high specification foam mattress. Furthermore, the GDG noted that some populations (for example, neonates in neonatal intensive care units) were often provided with high specification cot or bed overlays as standard. |
Economic considerations | There are costs associated with high specification foam cots and mattresses and overlays. The estimated purchase costs are £50-£199 (typical products identified by GDG members), and the devices can be used over a number of years, therefore the expected cost per patient is low. The GDG considered these costs likely to be offset by the benefits of the intervention in terms of improvement in the person's quality of life, and reduction in future treatment costs through improved healing. |
Quality of evidence | No RCTs or cohort studies were identified for neonates, infants, children or young people. Formal consensus using a modified Delphi was therefore used to develop the recommendation. To inform the recommendation, the GDG used 2 statements which were included in Round 1 of the Delphi consensus survey and reached 83% and 64% consensus agreement. The latter statement was therefore included in Round 2 of the survey, where it reached 86% consensus agreement. Further details can be found in Appendix N. |
Other considerations | The GDG highlighted that healthcare professionals should be aware of potential safety considerations in the use of overlays for neonates, infants, children and young people, where the use of an overlay causes the child to be above the height of the bed rails. |
Recommendations |
|
---|---|
Relative values of different outcomes | The GDG identified that the proportion of people with pressure ulcers completely healed, time to complete healing, reduction in size and volume and rate of reduction in size and volume of pressure ulcers were the most critical outcomes to inform decision making. |
Trade-off between clinical benefits and harms | The GDG used 1 statement from the Delphi consensus panel to develop the recommendation ‘Healthcare professionals should not use dynamic support surface for the treatment of pressure ulcers in neonates, infants and children’. The statement was not accepted during Round 1 of the Delphi consensus survey and was therefore amended for inclusion in Round 2 of the survey. The GDG discussed the use of dynamic support surfaces and the comments received during Round 1, which focused upon considering the appropriateness of a dynamic support surface, taking into account a child's weight, clinical condition and tolerability. The statement was therefore amended to highlight that a dynamic support surface may be considered however, any decision should account for these factors. Additionally, the GDG identified that dynamic support surfaces may be appropriate for both children and young people, depending upon individual factors. Therefore the statement was also amended to include children. The GDG therefore developed the statement ‘Healthcare professionals should consider the use of a dynamic support surface for children and young people who have developed pressure ulcers, where this can be tolerated, if pressure on the affected area cannot be relieved by other means (such as repositioning). The support surface should be appropriate for the size and weight of the child’ which was included in Round 2 of the survey, where it was accepted. The GDG discussed the agreed statement and agreed that a recommendation should be made. Qualitative comments received during round 2 of the survey noted that there were some dynamic support surfaces which would be appropriate for use in infants and children. Comments received from panel members generally felt the use of a dynamic support surface may be appropriate where pressure could not be relieved by any other means, for example repositioning. Comments also highlighted that individual patient factors should be taken into account when assessing the potential benefits that use of a dynamic support surface might bring. The GDG therefore felt that on balance, there were potential benefits of using a dynamic support surface for children and young people who have developed pressure ulcers, where pressure cannot be relieved by other means (for example, where a child cannot be repositioning). Any consideration of using a dynamic support surface should account for the individual patient factors and to minimise any potential harms, the size and weight of the child or young person should be carefully considered and an appropriate dynamic support surface selected. |
Economic considerations | Dynamic support surfaces are more costly than high specification devices, for example the Nimbus paediatric mattress which can be rented for £13.56 per day. Pressure redistribution is crucial for the treatment of pressure ulcers, and is greatly facilitated by such dynamic devices. Therefore the GDG agreed that the cost of these devices will likely be offset by improvements in quality of life and reduction in further treatment costs. Note that people with pressure ulcers are considered to be at high risk of developing further pressure ulcers, therefore these devices may also help to prevent further pressure ulcers. |
Quality of evidence | No RCTs or cohort studies were identified for neonates, infants, children or young people. Formal consensus using a modified Delphi was therefore used to develop the recommendation. To inform the recommendation, the GDG used 1 statement which was included in Round 1 of the Delphi consensus survey, where it reached 12% consensus. The statement was therefore amended for Round 2, where it was accepted at 95% consensus agreement. Further details can be found in Appendix N. |
Other considerations | The GDG emphasised that any dynamic support surface used for a child or young person should be appropriate to the size and weight of the child, to prevent safety issues and ensure optimum effectiveness. |
Recommendations |
|
---|---|
Relative values of different outcomes | The GDG identified that the proportion of people with pressure ulcers completely healed, time to complete healing, reduction in size and volume and rate of reduction in size and volume of pressure ulcers were the most critical outcomes to inform decision making. |
Trade-off between clinical benefits and harms | The GDG used 1 statement from the Delphi consensus panel to develop the recommendation ‘Healthcare professionals should not use a standard foam cot/bed mattress for neonates, children, infants or young people who have previously developed pressure ulcers and should use specialist patient support surfaces as clinically indicated.’ The statement was not accepted during Round 1 of the Delphi consensus survey and was therefore amended for inclusion in Round 2 of the survey. The GDG discussed comments received during Round 1 which highlighted that this would depend upon the reason for initial pressure ulcer development. The GDG agreed that, given pressure ulcers caused by devices were not included in the current guideline, standard foam mattresses should not be used for those who have developed a pressure ulcer previously, given this would mean that they were at risk of subsequent pressure ulcer development. The GDG therefore amended the statement to reflect that these should not be used routinely, however current risk level should be considered when choosing a specialist support surface for this population. The GDG therefore amended the statement for inclusion in Round 2 of the Delphi consensus to ‘Healthcare professionals should not routinely use a standard foam cot/bed mattress for neonates, children, infants or young people who have previously developed pressure ulcers and should consider using specialist support surfaces, taking into account current risk level and mobility.’ The statement was accepted. The GDG discussed the agreed statement and agreed that a recommendation should be made. Qualitative comments received during round 2 of the survey generally felt that high specification foam mattresses may be appropriate for this population however, standard foam would not be appropriate for infants, children and young people who had previously had a pressure ulcer. Some panel members noted that some people who had a pressure ulcer were likely to be a lesser risk as their risk was related to an acute situation. The GDG acknowledged this but did not feel that standard foam mattresses should be used for anyone who had previously developed a pressure ulcer, due to the increased risk of developing another pressure ulcer. The GDG also noted that many people in secondary care would be provided with a high specification foam mattress as standard care. The GDG felt that the benefits of providing an alternative foam mattress over a standard foam mattress outweighed any potential harms. A recommendation was therefore developed to reflect this and to highlight that specialist support surfaces, for example, dynamic support surfaces, would be more appropriate for this population. The GDG highlighted that provision of any support surface should take into account current risk level and mobility, as highlighted by comments from the Delphi consensus panel, who noted that a child's level of pressure ulcer risk may vary, depending on the risk factors. Comments from the Delphi consensus panel also highlighted the importance of ensuring that the support surface chosen was appropriate to the location and cause of the pressure ulcer. For example, the GDG noted that some pressure redistributing devices may increase pressure in at a risk site, whilst decreasing the pressure elsewhere. The GDG therefore felt that it was important to highlight that the choice of pressure redistributing surface should be tailored to the location and cause of the pressure ulcer. It was noted that this was particularly important given the specific sites considered to be at risk in neonates, infants, children and young people, for example, the head and scalp. The GDG therefore chose to develop a recommendation to reflect this. |
Economic considerations | Use of high specification and dynamic support surfaces is considered to be cost-effective for individuals with pressure ulcers and for those at significant risk of developing them; therefore standard foam mattresses are not considered to be an efficient use of resources. Furthermore, high specification foam and dynamic surfaces are current best practice and therefore this is not thought to require a substantial increase in resource. Current risk level, mobility, location, and cause of pressure ulcer should be taken into account when selecting the device in order to ensure that an effective device is implemented and clinical and economic benefits are realised as soon as possible. |
Quality of evidence | No RCTs or cohort studies were identified for neonates, infants, children or young people. Formal consensus using a modified Delphi was therefore used to develop the recommendation. To inform the recommendation, the GDG used 1 statement which was included in Round 1 of the Delphi consensus survey, where it reached 72% consensus. The statement was therefore amended for Round 2, where it was accepted at 89% consensus agreement. Further details can be found in Appendix N. |
Other considerations | There were no other considerations. |
- Pressure redistributing devices - The Prevention and Management of Pressure Ulce...Pressure redistributing devices - The Prevention and Management of Pressure Ulcers in Primary and Secondary Care
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