Clinical question
Should low air loss full body support surfaces versus any other full body support surfaces with pressure management properties be used to promote healing in individuals with pressure injuries?
Context
Population:
Intervention:
Comparison:
Main Outcomes:
Setting:
Conflicts of Interest:
Individuals who have a pressure injury
Low air loss full body support surfaces
Any full body support surface with pressure management properties
Any clinical setting
Hierarchy of outcome measures:
Outcome 1: Time to healing
Outcome 2: Complete healing (total/percent healed)
Outcome 3: Change in wound size (% change)
Outcome 4: Pain
Outcome 5: If infected at baseline, changes in signs and symptoms of infection
No Guideline Governance Group members or 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
Don’t know
Moderate
Very low
No important uncertainty or variability
Don’t know
Moderate costs
No included studies
No included studies
Probably increased
Probably yes
Probably 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 | Low air loss support surfaces | Any support surface with pressure management properties | Difference | Relative effect |
|---|---|---|---|---|
| Complete PI healing | 19/41 (46.30%) | 26/43 (60.5%) | 139 more PIs healed per 1,000 (from 60 fewer to 445 more) |
RR 1.30 (0.87 to 1.96) |
Outcome 1: Complete PI healing
The forest plot conducted by the GGG representing the data from one RCT (Ferrell, Osterweil et al. 1993)showed the effectiveness of low air loss support surfaces for supporting PIs to completely heal compared with any other type of support surface with pressure management properties.** The comparator surface in the included study was a 3.9 inch (10 cm) convoluted foam mattress overlying a regular hospital mattress. The study was conducted in individuals in nursing homes with Category/Stage 2-4 PIs who were repositioned two hourly (Ferrell, Osterweil et al. 1993). The analysis showed there was no statistically significant difference between the two different support surfaces for achieving complete healing of PIs (46.30% versus 60.50%, risk ratio [RR] 1.30, 95% confidence interval [CI] 0.87 to 1.96, p = 0.20). This translated to 139 more PIs per 1,000 healing with a low air loss support surface. However, there is very little confidence in this estimate; the true effect may be substantially different (from 60 fewer to 445 more PIs healing). The evidence was downgraded twice for risk of bias and downgraded once for imprecision.
** Support surfaces are described in data extraction tables. Product names may have changed, study conducted <20 years ago.
3. Undesirable Effects:
How substantial are the undesirable anticipated effects?
JUDGEMENT
Trivial
Small
Moderate
Large
Varies
Don’t Know
RESEARCH EVIDENCE
Undesirable effects related to support surface use were not reported in the RCT.
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 |
|---|---|---|
| Complete PI healing | CRITICAL | VERY LOW |
There is no core outcome set specific to pressure injury healing. To determine the relative importance of outcome measures, the GGG reviewed literature(Gottrup, Apelqvist et al. 2010, Augustin, Schmitt et al. 2014, Driver, Gould et al. 2017, Driver, Gould et al. 2019, Miranda, Deonizio et al. 2021, Raepsaet, Alves et al. 2023, Gupta, Goldstone et al. 2024, Zhang, Zhang et al. 2024) on PI and wound healing outcome measures and, in 2021, undertook a survey of stakeholders regarding their perspective on the importance of commonly reported wound healing outcomes. Based on the review and survey, the GGG prioritized consideration of the following five outcome measures of interest when evaluating evidence for interventions to support PI healing (see below). These clinical outcomes were supported by all surveyed stakeholder groups as critically important to making decisions about the evidence, and are wound agnostic(Gupta, Goldstone et al. 2024), frequently reported in PI research,(Miranda, Deonizio et al. 2021) and relevant to both clinical practice and quality of life for individuals with a PI.(Driver, Gould et al. 2017, Driver, Gould et al. 2019)Selected outcome measures:
Outcome 1: Time to healing
Outcome 2: Complete healing (total/percent healed)
Outcome 3: Change in wound size (% change)
Outcome 4: Pain
Outcome 5: If infected at baseline, changes in signs and symptoms of infection
Certainty of evidence for outcome measures
Certainty of evidence for complete PI healing was very low. The certainty was downgraded twice for risk of bias due to high risk of performance and detection bias and unclear risk of selection bias. The certainty was also downgraded for imprecision, due to the confidence interval crossing the line of no effect.
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
There was no evidence available on potential adverse events.
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
No evidence was available. The GGG determined that low air loss beds fall within a moderate cost range.
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
There was no evidence on the costs of required resources.
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
Don’t know
RESEARCH EVIDENCE
One study (Ferrell, Keeler et al. 1995) reported an estimate of cost effectiveness from the findings of an investigation with 87 participants conducted in nursing homes in the US in the early 1990s. The study found that using a low air loss support surface cost an extra $26 (USD in 1993) for every PI-free day in the first year of treatment compared with standard treatment (a combined air/foam mattress). This evidence was rated as low certainty (Shi, Dumville et al. 2021). The GGG determined this data was outdated.
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
In the Panel Group’s expert opinion, accessibility of low air loss surfaces is highly variable depending upon geographic and clinical context. The Panel Group noted that people from low economic backgrounds in all geographic regions, including people who are homeless, have reduced access to support surfaces.
11. Acceptability:
Is the intervention acceptable to key stakeholders?
JUDGEMENT
No
Probably no
Probably yes
yes
Varies
Don’t know
RESEARCH EVIDENCE
In the RCT, individuals using a low air loss was equally likely as those on the comparator support surface to request that the support surface be discontinued (5% in both groups).
12. Feasibility:
Is the intervention feasible to implement?
JUDGEMENT
No
Probably no
Probably yes
Yes
Varies
Don’t know
RESEARCH EVIDENCE
No evidence was available
References
Augustin, M., J. Schmitt, K. Herberger, L. Goepel, K. Heyer, J. Dissemond, A. Mayer, R. Aschoff, F. Beikert, M. Bischoff, C. Blome, J. Bunse, H. Diener, T. Eberlein, S. Eming, H. Fansa, F. Flesch, F. Gaiser, S. Gartner, S. Gass, V. Gerber, S. Glau, T. Goerge, V. Großkopf, C. Hampel-Kalthoff, B. Hartmann, J. Helfrich, T. Hirsch, D. Hochlenert, T. Horn, U. Imkamp, C. Janetzko, J. O. Jost, M. Jünger, R. Kaufmann, F. Kamperhoff, B. Lange-Asschenfeldt, S. Langer, M. May, K. C. Münter, R. Nagel, A. Nast, T. R. Neubert, A. D. Niederbichler, R. U. Peter, T. Petzold, K. Protz, A. Risse, E. Schäfer, K. Scharffetter-Kochanek, M. Schindzielorz, M. Schmidt, H. Schuster, A. Sindrilaru, M. Storck, W. Tigges, C. Tonn, E. Valesky, C. van Montfrans, W. Vanscheidt, A. von Lienen, K. Waldvogel-Röcker, T. Wild, C. C. Zouboulis and E. S. Debus (2014). "The German national consensus on wound documentation and outcomes: Rationale, working programme and current status." Wound Medicine 7: 8-13.
Driver, V. R., L. J. Gould, P. Dotson, L. L. Allen, M. J. Carter and L. L. Bolton (2019). "Evidence supporting wound care end points relevant to clinical practice and patients' lives. Part 2. Literature survey." Wound Repair Regen 27(1): 80-89.
Driver, V. R., L. J. Gould, P. Dotson, G. W. Gibbons, W. W. Li, W. J. Ennis, R. S. Kirsner, W. H. Eaglstein, L. L. Bolton and M. J. Carter (2017). "Identification and content validation of wound therapy clinical endpoints relevant to clinical practice and patient values for FDA approval. Part 1. Survey of the wound care community." Wound Repair Regen 25(3): 454-465.
Ferrell, B. A., E. Keeler, A. L. Siu, S. H. Ahn and D. Osterweil (1995). "Cost-effectiveness of low-air-loss beds for treatment of pressure ulcers." J Gerontol A Biol Sci Med Sci 50(3): M141-146.
Ferrell, B. A., D. Osterweil and P. Christenson (1993). "A randomized trial of low-air-loss beds for treatment of pressure ulcers." J Am Med Assoc 269(4): 494-497.
Gottrup, F., J. Apelqvist and P. Price (2010). "Outcomes in controlled and comparative studies on non-healing wounds: recommendations to improve the quality of evidence in wound management." J Wound Care 19(6): 237-268.
Gupta, R., L. Goldstone, S. Eisen, D. Ramachandram, A. Cassata, R. D. J. Fraser, J. L. Ramirez-GarciaLuna, R. Bartlett and J. Allport (2024). "Towards an AI-based objective prognostic model for quantifying wound healing." IEEE J Biomed Health Inform 28(2): 666-677.
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.
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.
Miranda, J. S., A. P. Deonizio, J. F. Abbade, H. A. Miot, L. Mbuagbaw, L. Thabane and L. P. F. Abbade (2021). "Quality of reporting of outcomes in trials of therapeutic interventions for pressure injuries in adults: a systematic methodological survey." Int Wound J 18(2): 147-157.
Raepsaet, C., P. Alves, B. Cullen, A. Gefen, J. L. Lázaro-Martínez, H. Lev-Tov, B. Najafi, N. Santamaria, A. Sharpe, T. Swanson, K. Woo and D. Beeckman (2023). "The development of a core outcome set for clinical effectiveness studies of bordered foam dressings in the treatment of complex wounds." J Tissue Viability 32(3): 430-436.
Shi, C., J. C. Dumville, N. Cullum, S. Rhodes, A. Jammali-Blasi, V. Ramsden and E. McInnes (2021). "Beds, overlays and mattresses for treating pressure ulcers." Cochrane Database Syst Rev 5: CD013624.
Zhang, J., M. Zhang, C. Xu, J. Tian, D. Yang and B. Wang (2024). "Heterogeneous outcome selection and incomplete prespecification of outcomes in systematic reviews: A case study on pressure injury." Advin Skin Wound Care 37(9): 490-498.