Clinical question
Should any preventive dressing versus no 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: all the dressings in this analysis were silicone adhesive multilayer foam dressings)
No preventive dressing
Any clinical setting
Pressure injury (PI) occurrence
Dr Kottner declared a conflict of interest and did not participate in the evaluation of the evidence or contribute to discussions on the use of preventive dressings
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
Large
Small
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 | Any preventive dressing |
No preventive dressing |
Difference | Relative effect |
|---|---|---|---|---|
| Reduction in heel PI occurrence | 23/1574 (1.5%) | 39/1050 (3.7%) | 21 fewer PIs per 1,000 (from 39 fewer to 2 more) |
RR 0.44 (0.21-0.95) |
Outcome 1: Reduction PI Occurrence
The meta-analysis(Patton, Moore et al. 2024) included four randomized controlled trials (RCTs)(Santamaria, Gerdtz et al. 2015, Santamaria, Gerdtz et al. 2018, Hahnel, El Genedy et al. 2020, Beeckman, Fourie et al. 2021) that compared using any preventive dressing to no preventive dressing for preventing heel PIs. In all the studies, the preventive dressing was a silicone adhesive multilayer foam dressing. In the included studies, heel preventive dressings were used for between 12 days and 4 weeks for people at PI risk in critical care, aged care and general tertiary hospital settings. The meta-analysis showed that using a preventive dressing was associated with a lower rate of heel PIs (RR 0.44, 95% CI 0.21 to 0.95, p = 0.04), translating to a difference of 21 fewer per 1,000 experiencing a heel PI when a preventive dressing is used. However, the evidence was of low quality. It is very uncertain if the result represents a true effect; the true effect lies between 39 fewer people and 2 more people experiencing a PI with a preventive dressing.(Patton, Moore et al. 2024)
3. Undesirable Effects:
How substantial are the undesirable anticipated effects?
JUDGEMENT
Trivial
Small
Moderate
Large
Varies
Don’t Know
RESEARCH EVIDENCE
One study reported an undesirable effect rate of 3% (33/1087) in a cohort treated with a preventive heel dressing group but the adverse events occurring in the standard care comparator group were not reported so it is unknown if there is a difference.(Beeckman, Fourie et al. 2021) A second study reported that no adverse events occurred in either the group receiving a preventive heel dressing or the standard care comparator group.(Santamaria, Gerdtz et al. 2015)
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
The certainty of evidence is low. The evidence was downgraded twice for risk of bias due to performance and detection bias.(Patton, Moore et al. 2024)
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 large desirable effects and small undesirable effects. The balance of effects probably favors preventive dressings.
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). The GGG considered that the resources required would vary based on the clinical and geographic context, and the duration of time over which the intervention was used.
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 only one study on the resources,(El Genedy, Hahnel et al. 2020) and the study provided evidence for only one clinical setting.
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 preventive heel dressings 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.
The GGG considered that cost effectiveness varies, and the duration of time over which the intervention was used would likely impact cost effective analyses.
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 of the studies(Santamaria, Gerdtz et al. 2015) reported minor issues with using heel prophylactic dressings, including minor difficulties maintaining the dressing in place when used with agitated people. This was overcome by using a tubular bandage to maintain the product in position.
One of the studies(Beeckman, Fourie et al. 2021) reported 246 device deficiencies occurred in 97 patients over the course of the study. 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
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.
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.
Hahnel, E., M. El Genedy, T. Tomova-Simitchieva, A. Hauß, A. Stroux, A. Lechner, C. Richter, M. Akdeniz, U. Blume-Peytavi, N. Löber and J. Kottner (2020). "The effectiveness of two silicone dressings for sacral and heel pressure ulcer prevention compared with no dressings in high-risk intensive care unit patients: a randomized controlled parallel-group trial." Br J Dermatol 183(2): 256-264.
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. Kapp, L. Wilson and A. Gefen (2018). "A randomised controlled trial of the clinical effectiveness of multilayer silicone foam dressings for the prevention of pressure injuries in high-risk aged care residents: the Border III Trial." Int Wound J 15(3): 482-490.
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.
