Clinical question
Should water filled (reactive) 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 who have a pressure injury
Water filled (reactive) full body support surfaces
Pressure-redistributing foam (reactive) full body support surfaces
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
Small
Trivial
Very low
No important uncertainty or variability
Does not favor either the intervention or the comparison
Don’t know
No included studies
No included studies
Probably no impact
Don’t know
Don’t know
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 | water filled (reactive) full body support surfaces | Pressure redistributing foam (reactive) support surfaces | Difference | Relative effect |
|---|---|---|---|---|
| PI completely healed (%) | 25/52 (48.07%) | 22/49 (44.9%) | 31 more healed PIs per 1,000 (from 135 fewer to 283 more) |
RR 0.63 (0.34-1.17) |
Outcome 1: Percent reaching complete PI healing
A forest plot (Shi, Dumville et al. 2021) representing the data from one RCT (Groen, Groenier et al. 1999) showed the effectiveness of water filled (reactive) support surfaces for supporting PIs to completely heal compared with pressure redistribution foam (reactive) support surface.** The study were conducted in individuals in nursing homes with Category/Stage 2-4 PIs. The support surfaces were used in conjunction with 2-3 hourly repositioning and follow-up time was four weeks (Groen, Groenier et al. 1999). The analysis (Shi, Dumville et al. 2021) showed there was no significant difference between the two different support surfaces for achieving complete healing of PIs (48.07% versus 44.9%, risk ratio [RR] 1.07, 95% confidence interval [CI] 0.70 to 1.63, p = 0.75). This translated to 31 more PIs per 1,000 healing with a water filled (reactive) support surface. However, there is very little confidence in this effect estimate and the true effect may be substantially different (from 135 fewer to 283 more PIs healing). The evidence was downgraded twice for risk of bias and downgraded twice for imprecision (Shi, Dumville et al. 2021).
3. Undesirable Effects:
How substantial are the undesirable anticipated effects?
JUDGEMENT
Trivial
Small
Moderate
Large
Varies
Don’t Know
RESEARCH EVIDENCE
The RCT (Groen, Groenier et al. 1999) reported undesirable effects as complicating factors, defined as eczema, maceration and pain.
No data was available for eczema. At four weeks the incidence of maceration and the incidence of pain were both 4.1% for the pressure redistribution foam surface and 3.8% for the water filled surface (Shi, Dumville et al. 2021).
In a meta-analysis (Shi, Dumville et al. 2021), data on adverse events were unable to be pooled due to the difference in definitions of adverse event used across the studies (Rosenthal, Felton et al. 2003, Sauvage, Touflet et al. 2017, Nixon, Brown et al. 2019). The evidence was considered very low certainty and it is uncertain if there is any difference.
Serious adverse events
Studies reported that no related and unexpected serious adverse events occurred in either study group (Nixon, Brown et al. 2019). Rates of expected/serious adverse events (including death, re-admission and falls) were not different between alternating pressure (active) air surface and a pressure redistributing foam (reactive) surface(Sauvage, Touflet et al. 2017, Nixon, Brown et al. 2019). Falls-related events were slightly higher with alternating pressure air support surfaces.(Nixon, Brown et al. 2019)
Discomfort
Based on very low certainty of evidence from one RCT (Sauvage, Touflet et al. 2017), it is uncertain if there is any difference in comfort between alternating pressure (active) air surfaces and pressure redistributing foam (reactive) surfaces. In this study less than 10% of respondents reported sleep disruption or disruptive noise associated with the support surface.
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 complete healinge | 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).
Outcomes of interest:
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. In the meta-analysis (Shi, Dumville et al. 2021), the certainty was downgraded twice for risk of bias due to high risk of bias from high risk of detection bias and was also downgraded twice for imprecision, due to the wide confidence interval and unmet optimal information size criteria (Shi, Dumville et al. 2021).
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 trivial desirable effects and small undesirable effects do not favor either water-filled (reactive) support surface or a pressure redistribution foam (reactive) support surface.
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
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
No evidence was available
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
No evidence was available
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 water filled (reactive) surfaces is highly variable depending upon geographic and clinical context.
11. Acceptability:
Is the intervention acceptable to key stakeholders?
JUDGEMENT
No
Probably no
Probably yes
yes
Varies
Don’t know
RESEARCH EVIDENCE
No evidence was available.
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. The GGG noted that water-filled support surfaces are not available in all geographic regions and are no longer used in tertiary and rehabilitative care settings in many countries, but might be in use in some geographic regions or in community settings.
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.
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.
Groen, H. W., K. H. Groenier and J. Schuling (1999). "Comparative study of a foam mattress and a water mattress." J Wound Care 8(7): 333-335.
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 Care37(9): 490-498.