Clinical question
Should any preventive dressing versus any other type preventive dressing be used for people at risk of heel pressure injuries?
Context
Population:
Intervention:
Comparison:
Main Outcomes:
Setting:
Conflicts on Interest:
People at risk of heel pressure injuries
Any preventive dressing (note: the intervention dressing in this analysis was silicone adhesive multilayer foam dressings)
Any other type preventive dressing (the comparator in the only eligible study is polyurethane dressing)
Any clinical setting
Pressure injury (PI) occurrence
None
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
Moderate
Small
Very low
No important uncertainty or variability
Probably favors the intervention
Varies
Low
Varies
Increased
Don’t know
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 local interventions to prevent heel PIs (e.g. skin care, strategies to reduce moisture or friction) as being the highest priority (median ranking 5/5, where 5 is the highest priority).
In an earlier survey conducted by the previous Guideline Governance Group in 2018 (Haesler, Pittman et al. 2022), 90.10% (304/337) of individuals with or at risk of PIs and 87.52% (603/689) of informal carers rated receiving information on skin care (in general, not specific to heels) as important or very important.
2. Desirable Effects:
How substantial are the desirable anticipated effects?
JUDGEMENT
Trivial
Small
Moderate
Large
Varies
Don’t Know
RESEARCH EVIDENCE
| Outcome | Preventive heel dressing (multilayered silicone foam) |
Another type or preventive dressing (polyurethane dressing) |
Difference | Relative effect |
|---|---|---|---|---|
| Reduction in heel PI occurrence | 75/227 (33.0%) | 44/227 (19.4%) | 135 fewer PIs per 1,000 (from 188 fewer to 66 fewer) |
RR 0.59 (0.43-0.80) |
Outcome 1: Reduction PI Occurrence
The meta-analysis included two RCTs(Alves, Rhea et al. 2020, Eberhardt, de Lima et al. 2021) that compared using any preventive dressing to another type of preventive dressing for preventing heel PIs. In both studies, the preventive dressing was a silicone adhesive multilayer foam dressing and the comparator was a polyurethane dressing.[*] The heel preventive dressings were used for 48 hours for people at PI risk undergoing elective surgery in one study,(Eberhardt, de Lima et al. 2021) and for unclear duration in ICU in the second study.(Alves, Rhea et al. 2020) In one study, over 90% of the PIs that occurred in both groups were Category/Stage 1.(Eberhardt, de Lima et al. 2021) The meta-analysis showed that using a multilayered silicone foam preventive dressing was associated with a statistically significant lower rate of heel PIs (RR 0.59, 95% CI 0.43 to 0.80, p = 0.0008,), translating to a difference of 135 fewer per 1,000 experiencing a heel PI when a multilayered silicone foam preventive dressing was used rather than a polyurethane dressing. However, the evidence was of very low quality. It is very uncertain if the result represents a true effect; the true effect lies between 188 fewer people and 66 fewer people experiencing a PI with a multilayered silicone foam preventive dressing.
[*] Specific products are reported in the data extraction tables
3. Undesirable Effects:
How substantial are the undesirable anticipated effects?
JUDGEMENT
Trivial
Small
Moderate
Large
Varies
Don’t Know
RESEARCH EVIDENCE
One study that explored the multilayered silicone foam dressing reported an undesirable effect rate of 3% (33/1087) in a cohort treated with the dressing; however, the study did not report adverse events in the comparator group receiving standard care (no dressing).(Beeckman, Fourie 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 |
|---|---|---|
| PI occurrence | CRITICAL | VERY LOW |
Outcome 1: PI occurrence
The certainty of evidence is very low. The evidence was downgraded twice for risk of bias due to performance and detection bias.(Patton, Moore et al. 2024) The evidence was also downgraded once for imprecision base don a small sample size.
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 were moderate desirable effects and small undesirable effects. The balance of effects probably favors a silicone adhesive multilayer foam dressing versus a polyurethane dressing.
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
One cost analysis(El Genedy, Hahnel et al. 2020) calculated the resources required for implementing preventive dressings for the heels for people at high risk of PIs in ICU settings. Considering the cost of dressings and the nursing time to apply the dressings for a three-day unit admission, the study reported the cost of protecting the heels of 212 participants was €24,688 (i.e., € 116/person; data based on an ICU Germany in 2020).
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
The Guideline Governance Group considered the evidence on required resources was of low certainty.
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 recent cost-effectiveness analysis(El Genedy, Hahnel et al. 2020) reported incremental cost-effectiveness ratio (ICER) of using a silicone adhesive multilayered foam preventive dressing based on data from an RCT conducted in an ICU setting. The analysis considered intervention costs (preventive dressings and nursing time to manage dressings) and the cost of treating a heel PI (dressing equipment, nursing time to assess, manage and document a heel PI). An ICER of €8144.72 per heel was reported.
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 reported that there might be inequity if a preventive dressing is recommended for preventing heel PIs. The Panel Group reported that preventive dressings are difficult to access outside of a tertiary care setting in most geographic locations.
11. Acceptability:
Is the intervention acceptable to key stakeholders?
JUDGEMENT
No
Probably no
Probably yes
yes
Varies
Don’t know
RESEARCH EVIDENCE
There was no information on acceptability.
12. Feasibility:
Is the intervention feasible to implement?
JUDGEMENT
No
Probably no
Probably yes
yes
Varies
Don’t know
RESEARCH EVIDENCE
One study that used multilayer silicone foam dressings for protecting the heels(Santamaria, Gerdtz et al. 2015) reported minor difficulties maintaining the dressing in place when used with agitated people in ICU settings. This was overcome by using a tubular bandage to maintain the product in position. Another study that used multilayer silicone foam dressings for protecting the heels(Beeckman, Fourie et al. 2021) reported 246 device deficiencies occurred in 97 patients when used in ICU setting.
These deficiencies included issues with adhesion failure (n = 127), rolled edges on the prophylactic dressing (n = 44) and the dressing being too slippery on the floor (n = 26), particularly in ambient temperatures above 30°C. The researchers reported that the participants were instructed to wear shoes of non-slip socks to prevent falls from slipping.
The Panel Group reported that preventive dressings are difficult to access outside of a tertiary care setting in most geographic locations.
References
Alves, P., S. Rhea, L. Suzinara, S. Lidiana, E. Thais and M. Camila (2020). "Efficacy of multi-layered soſt silicone foam dressing compared to transparent polyurethane film in heels pressure ulcer prevention." J Wound Care 29(Suppl 7B): 248.
Beeckman, D., A. Fourie, C. Raepsaet, N. Van Damme, B. Manderlier, D. De Meyer, H. Beele, S. Smet, L. Demarré, R. Vossaert and et al. (2021). "Silicone adhesive multilayer foam dressings as adjuvant prophylactic therapy to prevent hospital-acquired pressure ulcers: a pragmatic noncommercial multicentre randomized open-label parallel-group medical device trial." Br J Dermatol 185(1): 52‐61.
Eberhardt, T. D., S. B. S. de Lima, R. S. de Avila Soares, L. B. T. D. Silveira, B. Rossarola Pozzebon, C. R. Reis, K. P. P. dos Santos and P. J. P. Alves (2021). "Prevention of pressure injury in the operating room: Heels operating room pressure injury trial." International Wound Journal 18(3): 359-366.
El Genedy, M., E. Hahnel, T. Tomova-Simitchieva, W. V. Padula, A. Hauß, N. Löber, U. Blume-Peytavi and J. Kottner (2020). "Cost-effectiveness of multi-layered silicone foam dressings for prevention of sacral and heel pressure ulcers in high-risk intensive care unit patients: An economic analysis of a randomised controlled trial." International Wound Journal 17(5): 1291-1299.
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.
Patton, D., Z. E. H. Moore, F. Boland, W. P. Chaboyer, S. L. Latimer, R. M. Walker and P. Avsar (2024). "Dressings and topical agents for preventing pressure ulcers." Cochrane Database of Systematic Reviews 12: Art. No. CD009362.
Santamaria, N., M. Gerdtz, S. Sage, J. McCann, A. Freeman, T. Vassiliou, S. De Vincentis, A. W. Ng, E. Manias, W. Liu and J. Knott (2015). "A randomised controlled trial of the effectiveness of soft silicone multi-layered foam dressings in the prevention of sacral and heel pressure ulcers in trauma and critically ill patients: The Border trial." Int Wound J 12(3): 302-308.
