Clinical question

Should air (reactive) full body support surfaces vs. pressure redistribution foam (reactive) full body support surfaces be used for people at risk of pressure injuries?

Context

Population:

Intervention:

Comparison:

Main Outcomes:

Setting:

Conflicts on Interest:

Individuals at risk of pressure injuries

pressure redistribution foam (reactive) full body support surfaces

standard mattress/non-pressure redistribution foam (reactive) surface

Any clinical setting

Pressure Injury occurrence

No Guideline Governance Group members of Core Review Group members had a conflict of interest

Evidence to Decision Framework

(Click on the individual judgements for more information)

Summary of Judgements

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

Yes

Small

Large

Low

No important uncertainty or variability

Probably favors the intervention

Varies

Very low

Probably favors the intervention

Varies

Probably yes

Yes

1. Problem:
Is the problem (pressure injuries) a priority?

JUDGEMENT

  • No

  • Probably No

  • Probably Yes

  • Yes

  • Varies

  • Don’t Know

RESEARCH EVIDENCE

The problem of preventing pressure injuries is a significant priority to healthcare in most clinical settings. In a stakeholder survey conducted by the Guideline Governance Group in 2021, the target audiences for the guideline, including individuals with or at risk of PIs, their informal carers and health professionals, all identified that receiving clinical guidance on selection of support surfaces is of the highest priority (median ranking 5/5).

In an earlier survey conducted by the International Pressure Injury Guideline, Guideline Governance Group (Haesler, Pittman et al. 2022), 68.6% (263/383) of individuals with or at risk of PIs and 61.5% (523/850) of informal carers rated receiving information on support surfaces to use as important or very important. The median priority ranking for receiving information on support surfaces was 4/5 for both individuals with or at risk of PIs of informal carers (Haesler, Pittman et al. 2022).

2. Desirable Effects:
How substantial are the desirable anticipated effects?

JUDGEMENT

  • Trivial

  • Small

  • Moderate

  • Large

  • Varies

  • Don’t Know

RESEARCH EVIDENCE

Outcome Pressure redistribution foam (reactive) full body support surfaces Standard mattresses/non-pressure redistribution foam (reactive) full body support surface Difference Relative effect
PI occurrence 102/1296 (7.9%) 138/831 (16.6%) 106 fewer PIs per 1,000
(from 135 fewer to 58 fewer)
RR 0.36
(0.19-0.65)
Comfort (Russell, Reynolds et al. 2003) - - No difference -

Outcome 1: Reduction in PI Occurrence

The meta-analysis included six RCTs (Gray and Campbell 1994, Hofman, Geelkerken et al. 1994, Santy, Butler et al. 1994, Collier 1996, Russell, Reynolds et al. 2003, Park and Park 2017) that compared pressure redistribution foam (reactive) surfaces to standard mattresses/non-pressure redistribution surfaces.**

A range of pressure redistribution foam mattresses (circa 1994 to 2003) were explored as the intervention of interest, and all were compared to a “standard polypropylene/vinyl hospital mattress”. Pressure-redistribution foam (reactive) surfaces were associated with a lower rate of PIs (RR = 0.36, 95% CI 0.19 to 0.65) It is uncertain if using a pressure redistribution foam (reactive) surface reduce the rate of new PIs compared to a standard foam mattress without pressure redistribution characteristic.

Comfort

In one of the studies (Russell, Reynolds et al. 2003), 706 individuals rated surface comfort on a 10-point scale, with no significant difference found between pressure redistribution foam (reactive) surfaces and non-pressure redistribution foam (reactive) surfaces.

** Support surfaces reported in the research were considered in this Guideline based on their categorization by the researchers (at the time the research was undertaken). Where available, the product name and characteristics were included in the data extraction tables. Product names/technology may have changed. Due to advances in technology, currently available support surfaces in the same category may have different performance characteristics.

3. Undesirable Effects:
How substantial are the undesirable anticipated effects?

JUDGEMENT

  • Trivial

  • Small

  • Moderate

  • Large

  • Varies

  • Don’t Know

RESEARCH EVIDENCE

In the GGGs expert opinion, the rate of adverse events from pressure redistribution foam (reactive) support surface is small.. This is supported

by the rate of adverse events reported with these support surfaces in studies making other comparisons (Sauvage, Touflet et al. 2017, Nixon, Brown et al. 2019).

4. Overall certainty of evidence: What is the overall certainty of the evidence of effects?

JUDGEMENT

  • Very low

  • Low

  • Moderate

  • High

  • No included studies

RESEARCH EVIDENCE

Outcome Relative Importance Certainty of Evidence
PI occurrence CRITICAL LOW

Outcome 1: PI occurrence

In a Delphi survey (Lechner, Coleman et al. 2022) that developed a core outcomes et for PI prevention trials, the outcome of PI occurrence was rated as being of critical importance (score of 7-9).

The evidence was of low certainty. The evidence was downgraded twice for risk of bias based on critical appraisal in an existing review (McInnes, Jammali-Blasi et al. 2015). Five of the studies in the analysis had high or unclear risk of performance and detection bias. Certainty was also downgraded for inconsistency.

5. Values:
Is there important uncertainty about or variability in how much people value the main outcomes?

JUDGEMENT

  • Important uncertainty or variability

  • Possibly important uncertainty or variability

  • Probably no important uncertainty or variability

  • No important uncertainty or variability

RESEARCH EVIDENCE

In a Delphi survey (Lechner, Coleman et al. 2022) that developed a core outcomes et for PI prevention trials, the outcome of PI occurrence was rated as being of critical important (score of 7-9) by all types of stakeholders (health professionals, people with or at risk of a PI and their informal carers, industry representatives and researchers). Greater than 90% of the 158 participants rated this outcome measure as critically important (Lechner, Coleman et al. 2022).

6. Balance of Effects:
Does the balance between desirable and undesirable effects favour the intervention or the comparison?

JUDGEMENT

  • Favors the comparison

  • Probably favors the comparison

  • Does not favor either the intervention or the comparison

  • Probably favors the intervention

  • Favors the intervention

  • Varies

  • Don’t know

RESEARCH EVIDENCE

The desirable effects for using a pressure redistribution foam mattress were large and this was balanced with a small rate of undesirable effects, which favors the intervention.

7. Resources Required:
How large are resource requirements (costs) of the intervention?

JUDGEMENT

  • Large costs

  • Moderate costs

  • Negligible costs and savings

  • Moderate savings

  • Large savings

  • Varies

  • Don’t know

RESEARCH EVIDENCE

A cost analysis (Pham, Teague et al. 2011) that investigated exchanging a non-pressure redistribution foam surface for a pressure redistribution foam (reactive) surface identified the cost difference between surfaces as between $38 and $2,238 per bed/stretcher in an emergency department (Canadian dollars in 2009), which equated to an average of $0.30 per patient (Pham, Teague et al. 2011). Non-pressure redistribution foam surfaces are primarily used in low resources settings as they have been superseded in most settings. The cost of accessible a pressure redistribution foam (reactive) support surfaces in the areas where they are currently not the standard is variable.

8. Certainty of evidence of required resources:
What is the certainty of evidence of resource requirements (costs) of the intervention?

JUDGEMENT

  • Very low

  • Low

  • Moderate

  • High

  • No included studies

RESEARCH EVIDENCE

Unknown

9. Cost Effectiveness: Does the cost-effectiveness of the intervention favour the intervention or the comparison?

JUDGEMENT

  • Favors the comparison

  • Probably favors the comparison

  • Does not favor either the intervention or the comparison

  • Probably favors the intervention

  • Varies

  • No included studies

RESEARCH EVIDENCE

A cost-effectiveness model (Pham, Stern et al. 2011) based solely on costs of replacing a non-pressure-relieving foam (reactive) surface with a pressure-relieving foam (reactive) surface in long term aged care settings showed an increased life expectancy by 1.61 QALYs and an increased the mean lifetime cost by $389 (Canadian dollars in 2009) corresponding to a cost per quality adjusted life year (QALY) gained of approximately $88,000. At a threshold of $50,000 for one QALY gained, the probability that improving PI prevention only by changing from anon-pressure relieving foam to a pressure-relieving foam (reactive) surface is cost-effective. Costs were based on input from 34 facilities and included surface costs over the lifetime of the product and care costs (Pham, Stern et al. 2011). A similar analysis (Pham, Teague et al. 2011) conducted in Canadian emergency departments found a mean cost saving of $32 per individual aged over 65 years by changing from a non-pressure relieving foam (reactive) surface to a pressure-relieving foam (reactive) surface, with an 81% likelihood of cost-effectiveness.

10. Inequity:
What would be the impact of recommending the intervention on health inequity?

JUDGEMENT

  • Reduced

  • Probably reduced

  • Probably no impact

  • Probably increased

  • Increased

  • Varies

  • Don’t know

RESEARCH EVIDENCE

Non-pressure redistribution foam surfaces are primarily used in low resources settings as they have been superseded in most settings. The impact on health equity of recommending a pressure redistribution foam (reactive) support surfaces in the areas where they are currently not the standard is variable.

11. Acceptability:
Is the intervention acceptable to key stakeholders?

JUDGEMENT

  • No

  • Probably no

  • Probably yes

  • yes

  • Varies

  • Don’t know

RESEARCH EVIDENCE

In an observational study, healthy people rated pressure redistribution foam (reactive) surfaces for an operating room table to be comfortable, with comfort ratings for different surfaces associated with interface pressure values at the sacrum and heels (Han and Ko 2021).

12. Feasibility:
Is the intervention feasible to implement?

JUDGEMENT

  • No

  • Probably no

  • Probably yes

  • Yes

  • Varies

  • Don’t know

RESEARCH EVIDENCE

The Panel Group noted that use of a pressure redistribution foam (reactive) surface is generally universal in formal health services so feasibility is high.

References

Collier, M. E. (1996). "Pressure-reducing mattresses." J Wound Care 5(5): 207–211.

Gray, D. and M. Campbell (1994). "A randomised clinical trial of two types of foam mattresses." Journal of Tissue Viability 4(4): 128-132.

Haesler, E., J. Pittman, J. Cuddigan, S. Law, Y. Y. Chang, K. Balzer, D. Berlowitz, K. Carville, J. Kottner, M. Litchford, Z. Moore, P. Mitchell and D. Sigaudo-Roussel (2022). "An exploration of the perspectives of individuals and their caregivers on pressure ulcer/injury prevention and management to inform the development of a clinical guideline." J Tissue Viability 31(1): 1-10.

Han, M. J. and S. Ko (2021). "Comparison of Interface Pressures and Subjective Comfort of Pressure-Relieving Overlays on the Operating Table for Healthy Volunteers." International Journal of Environmental Research & Public Health 18(5): 05.

Hofman, A., R. H. Geelkerken, J. Wille, J. J. Hamming, J. Hermans and P. J. Breslau (1994). "Pressure sores and pressure-decreasing mattresses: Controlled clinical trial." Lancet 343(8897): 568–571.

Lechner, A., S. Coleman, K. Balzer, J. J. Kirkham, D. Muir, J. Nixon and J. Kottner (2022). "Core outcomes for pressure ulcer prevention trials: results of an international consensus study." Br J Dermatol 187(5): 743-752.

McInnes, E., A. Jammali-Blasi, S. E. M. Bell-Syer, J. C. Dumville, V. Middleton and N. Cullum (2015). "Support surfaces for pressure ulcer prevention." Cochrane Database of Systematic Reviews 9(CD001735).

Nixon, J., S. Brown, I. L. Smith, E. McGinnis, A. Vargas-Palacios, E. Andrea Nelson, J. Brown, S. Coleman, H. Collier, C. Fernandez, R. Gilberts, V. Henderson, C. McCabe, D. Muir, C. Rutherford, N. Stubbs, B. Thorpe, K. Wallner, K. Walker, L. Wilson and C. Hulme (2019). "Comparing alternating pressure mattresses and high-specification foam mattresses to prevent pressure ulcers in high-risk patients: The PRESSURE 2 RCT." Health Technology Assessment 23(52): vii-175.

Park, K. H. and J. Park (2017). "The efficacy of a viscoelastic foam overlay on prevention of pressure injury in acutely ill patients: A prospective randomized controlled trial." Journal of Wound, Ostomy, and Continence Nursing 44(5): 440-444.

Pham, B., A. Stern, W. Chen, B. Sander, A. John-Baptiste, H. H. Thein, T. Gomes, W. P. Wodchis, A. Bayoumi, M. Machado, S. Carcone and M. Krahn (2011). "Preventing pressure ulcers in long-term care: a cost-effectiveness analysis." Arch Intern Med 171(20): 1839-1847.

Pham, B., L. Teague, J. Mahoney, L. Goodman, M. Paulden, J. Poss, J. Li, L. Ieraci, S. Carcone and M. Krahn (2011). "Early Prevention of Pressure Ulcers Among Elderly Patients Admitted Through Emergency Departments: A Cost-effectiveness Analysis." Annals of Emergency Medicine 58(5): 468-478.e463.

Russell, L. J., T. M. Reynolds, C. Park, S. Rithalia, M. Gonsalkorale, J. Birch, D. Torgerson, C. Iglesias and P.-S. Group. (2003). "Randomized clinical trial comparing 2 support surfaces: Results of the Prevention of Pressure Ulcers Study." Adv Skin Wound Care 16(6): 317-327.

Santy, J., M. Butler and J. Whyman (1994). "A comparison study of 6 types of hospital mattress to determine which most effectively reduces the incidence of pressure sores in elderly patients with hip fractures in a District General Hospital. Report to Northern and Yorkshire Regional Health Authority." reported in: McInnes E, Jammali-Blasi A, Bell-Syer SEM, Dumville JC, Middleton V, Cullum N. Support surfaces for pressure ulcer prevention. Cochrane Database Syst Rev, 2015; 9 (CD001735).

Sauvage, P., M. Touflet, C. Pradere, F. Portalier, J.-M. JMichel, P. Charru, Y. Passadori, R. Fevrier, A.-M. Hallet-Lezy, F. Beauchêne and B. Scherrer (2017). "Pressure ulcers prevention efficacy of an alternating pressure air mattress in elderly patients: E²MAO a randomised study." J Wound Care 26(6): 304-312.