Clinical question

Should alternating pressure (active) air full body support surfaces versus pressure redistribution foam (reactive) full body support surfaces be used to promote healing in individuals with pressure injuries?

Context

Population:

Intervention:

Comparison:

Main Outcomes:

Setting:

Conflicts of Interest:

Individuals with a pressure injury

An alternating pressure (active) air full body support surface

Pressure redistribution foam (reactive) full body support surface

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

Trivial

Small

Very low

No important uncertainty or variability

Does not favor either the intervention or the comparison

Varies

No included studies

No included studies

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 treating pressure injuries is a significant priority to healthcare. Treating pressure injuries to achieve healing is a priority to most individuals who experience a PI. In 2021, the Guideline Governance Group undertook a stakeholder survey on priority issues to address in the guideline. Receiving clinical guidance support surfaces for supporting the healing of pressure injuries (PIs) was rated as a high priority by clinicians (median ranking 5/5), people with or at risk of PIs and their informal carers (median ranking 5/5) and by industry representatives (median ranking 5/5).  

In an earlier survey conducted by the 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

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Outcome Alternating presure (active) air support surfaces Pressure redistribution foam (reactive) foam support surface Difference Relative effect
Time to complete healing Mean time to PI healing 16.54 days Mean time to PI healing 29.2 days Mean difference was 12.66 days shorter
(54.29 shorter to 28.97 longer)
MD -12.66
(-54.9 to 28.97)
Complete PI healing 8/37 (21.6%) 6/24 (25%) 8 fewer PIs per 1,000
(from 183 fewer to 633 more)
RR 0.97
(0.27-3.53)

Outcome 1: Time to complete healing

One RCT (Rae, Barker et al. 2024) provided evidence on the effectiveness of alternating pressure (active) air support surfaces for reducing the time to completely heal PIs compared with pressure redistribution foam (reactive) support surface.**  The study was conducted in community settings in participants with Category/Stage 2 PIs.(Rae, Barker et al. 2024) and in the pragmatic study design, a range of different support surfaces in each category were used (i.e., multiple active and reactive support surfaces were used). The mean difference in time to complete PI healing was 12.66 days shorter with an alternating pressure (active) air mattress. However, the result was very uncertain, and the true value ranges between 54.29 days shorter to 28.97 days longer.

Outcome 2: Complete PI healing

The meta-analysis we conducted of two RCTs (Mulder, Taro et al. 1994, Rae, Barker et al. 2024) showed the effectiveness of alternating pressure (active) air support surfaces compared with pressure redistribution foam (reactive) support surface** for supporting PIs to completely heal. One study was conducted with individuals in a nursing home with Category/Stage 3-4 PIs who used a bed with both alternating pressure and low-air-loss features. bed with pulsating air suspension and alternating deflation and inflation of air cushions (Mulder, Taro et al. 1994). The second study included individuals in community setting with Category/Stage 2 PIs using a range of different full body alternating pressure support surfaces.(Rae, Barker et al. 2024) In one of the studies participants with malnutrition, diabetes mellitus, wound infection or immune disorders were excluded (Mulder, Taro et al. 1994). However, the second study included many participants had malnutrition, incontinence, neurological conditions and/or diabetes melllitus (Rae, Barker et al. 2024). In the nursing home setting, the support surfaces were used in conjunction with two-hourly repositioning for 12 weeks (Mulder, Taro et al. 1994). The community-based study noted that participants used an air flotation cushion when seated (Rae, Barker et al. 2024).  

The meta-analysis showed there was no statistically significant difference between the two different support surfaces for achieving complete healing of PIs (21.6% versus 25%, risk ratio [RR] 0.97, 95% confidence interval [CI] 0.27 to 3.53, p = 0.97). This translated to 8 fewer PIs per 1,000 healing with an alternating pressure (active) support surface. However, there is very little confidence in this effect estimate, and the true effect may be substantially different (ranging from 183 fewer to 633 more PIs healing). The evidence was downgraded for high risk of performance and attrition bias and downgraded twice for imprecision due to a small sample size and a wide confidence interval that includes the null effect. A third RCT (Day and Leonards 1993) conducted in in an acute care setting for at least seven days had results that concurred with this analysis; however, the data was not appropriate for pooling.

** Support surfaces are described in the data extraction tables. Product names may have changed.

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

JUDGEMENT

  • Trivial

  • Small

  • Moderate

  • Large

  • Varies

  • Don’t Know

RESEARCH EVIDENCE

Adverse events

One RCT reported that there were no adverse events attributable to either alternating pressure (active) support surfaces or pressure redistribution foam (reactive) support surfaces within its 12-week follow up. (Mulder, Taro et al. 1994) However, there is very low certainty in this result because the study was at high risk of bias and had a small sample size (Shi, Dumville et al. 2021).

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
Time to complete healing CRITICAL VERY LOW
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)

Certainty of evidence for outcome measures

Certainty of evidence for time to complete PI healing was very low. The certainty was downgraded once for high risk of bias due to high risk of bias of performance and attrition bias. The certainty was downgraded twice for imprecision due to very sample size and very wide confidence interval that included the value indicating null effect.

Certainty of evidence for complete PI healing was very low. The certainty was downgraded twice for a high overall risk of bias and twice for imprecision due to a small sample size and a confidence interval that included the null 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

The GGG voted that the balance between the small desirable effects and trivial undesirable effects do not favor either an alternating pressure (active) support surface or a pressure redistribution foam (reactive) support sorface.

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

The GGG considered the wide variation in clinical and geographic context and determined that resource requirements vary.

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

  • No included studies

RESEARCH EVIDENCE

There was no evidence on cost-effectiveness of the options.

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

The Panel Group noted that there is significant inequity in access to the resources across different health settings and geographic regions. Many people at risk of PIs have no affordable access to alternating pressure (active) air support surfaces. Access can be influenced by health insurance schemes and other funding mechanisms, availability in the region and the way support surfaces are prioritized for use.

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. The Panel Group noted that the rising costs of power could increase the costs of using powered support surfaces and reduce access.

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

JUDGEMENT

  • No

  • Probably no

  • Probably yes

  • yes

  • Varies

  • Don’t know

RESEARCH EVIDENCE

Randomized controlled trials (Sauvage, Touflet et al. 2017, Nixon, Brown et al. 2019, Rae, Barker et al. 2024, Day and Leonards 1993) and observational studies (Meaume and Marty 2015, Gleeson 2016, Meaume and Marty 2018, Marutani, Okuwa et al. 2019, Meaume, Rousseaux et al. 2021) have reported the experience of patients using alternating pressure (active) air surfaces in a range of clinical settings, including community-based care, stroke care, palliative care and aged care. The studies explore overall satisfaction, ease of movement and reduction in pain. Individuals participating in these studies reported a high rate of positive experiences using an alternating pressure air (active) surface.

Specifically in populations with an existing PI, a forest plot (Shi, Dumville et al. 2021) of one RCT (Day and Leonards 1993) showed no significant difference between an alternating pressure (active) air surface and a pressure redistributing foam support surface with respect to comfort (mean difference 0.40, 95% CI -0.42 to 1.22). There is very low certainty in this result because the study was at high risk of bias (Shi, Dumville et al. 2021). Several participants who used an alternating pressure (active) air support surface in a community setting reported that the noise from the pump was an issue (Rae, Barker et al. 2024).

12. Feasibility:
Is the intervention feasible to implement?

JUDGEMENT

  • No

  • Probably no

  • Probably yes

  • Yes

  • Varies

  • Don’t know

RESEARCH EVIDENCE

In a survey of 83 nurses (Meaume and Marty 2018), overall high satisfaction of health professionals with aspects of feasibility when using an alternating pressure (active) air mattress.  Alternating pressure (active) air surfaces were rated highly for ease of cleaning (95.5%), implementation (93.2%), ease of turning (85.2%), and ease of assisting the person from a lying to a seated position (75.9%). Similar results were reported for an alternating air pressure (active) overlay (Meaume, Rousseaux et al. 2021).

References

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