Clinical question
Should any preventive dressing versus a leave on topical product 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
Leave on skin product
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
Small
Small
Very low
No important uncertainty or variability
Probably favors the intervention
Varies
Low
Probably favors the comparison
Probably 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 |
Leave on skin product |
Difference | Relative effect |
|---|---|---|---|---|
| Reduction in heel PI occurrence | 4/154 (2.6%) | 23/342 (6.7%) | 7 fewer PIs per 1,000 (from 66 fewer to 1000 more) |
RR 0.89 (0.02-49.24) |
Outcome 1: Reduction PI Occurrence
The meta-analysis included two non-randomized comparative studies(Cortes, Salazar-Beltran et al. 2018, Teo, Ang et al. 2018) comparing a heel preventive dressing* to a leave-on skin product. The studies included people at high risk of heel PIs who were in tertiary hospital settings or critical care. There was non-significantly fewer heel PIs in the group receiving a heel preventive dressing versus a leave-on skin product (2.6% versus 6.7%, p = 0.95, RR 0.89, 95% CI 0.02 to 49.24). This translated to a difference of 7 fewer people per 1,000 who might have a PI if a heel preventive dressing is used. However, there is a high level of uncertainty and the true effect lies between 66 fewer and 1,000 more.
* The studies used different preventive dressings, as detailed 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 reported an undesirable effect rate of 3% (33/1087) in a cohort treated with a preventive heel dressing group.(Beeckman, Fourie et al. 2021) A second study reported that no adverse events occurred for group receiving a preventive heel dressing.(Santamaria, Gerdtz et al. 2015)
There is a body of evidence suggesting some topical products may not be appropriate for individuals with skin barrier impairments, because of disruption to the stratum corneum that could lead to skin irritation and other adverse events. Evidence is also unclear about the role of leave-on topical products for protecting the skin of neonates and infants.(Cooke 2018, Aksucu, Azak et al. 2022, Noveir, Biba et al. 2024)
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 |
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 importance (score of 7-9).
Outcome 1: PI occurrence
The certainty of evidence is very low. The evidence was downgraded twice due to a high risk of selection, confounding and outcome measurement bias in all studies and high overall risk of bias. The evidence was downgraded for inconsistency due to very high variation point estimates and was also downgraded for imprecision because the confidence interval included the clinical decision threshold between recommending and not recommending treatment, in addition to the being a small sample size and small number of events.
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 desirable effect might favor the intervention, but this is very uncertain. However, a mechanism for preventing PIs for leave-on products is unclear. There are small known undesirable effects for preventive dressings. The undesirable effects associated with a leave-on product are unknown.
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
There is limited evidence from only one setting. Costs were only explored for 3 days in the available evidence.(El Genedy, Hahnel et al. 2020)
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
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).
One study reported the costs for a leave-on topical product (sweet almond oil) applied daily to heels was $6.00 per person (based on an ICU in Iran in 2020, currency not clear), with nursing hours of approximately one minute per day to apply.(Borzou, Amiri et al. 2020)
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 RCT that explored preventive heel dressings(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.
Another RCT that explored preventive heel dressings(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
Aksucu, G., M. Azak and S. Çağlar (2022). "Effects of Topical Oils on Neonatal Skin: A Systematic Review." Adv Skin Wound Care 35(12): 1-9.
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.
Borzou, S. R., S. Amiri, A. Azizi, L. Tapak, F. Rahimi Bashar and S. Moradkhani (2020). "Topical almond oil for prevention of pressure injuries: A single-blinded comparison study." J Wound Ostomy Cont Nurs 47(4): 336-342.
Cooke, A. (2018). "Effects of topical oils on neonatal skin: A systematic review." British Journal of Midwifery 26(3): 150-156.
Cortes, O. L., L. D. Salazar-Beltran, Y. A. Rojas-Castaneda, A. Alvarado-Muriel, A. Serna-Restrepo and D. Grinspun (2018). "Use of Hydrocolloid Dressings in Preventing Pressure Ulcers in High-risk Patients: a Retrospective Cohort." Investigacion y educacion en enfermeria 36(1): e11.
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.
Noveir, S. D., U. Biba, J. Galamgam and C. E. Cheng (2024). "A review of topical oils on the skin." JAAD Reviews 2: 36-40.
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.
Teo, K. Y., S. Y. Ang, L. Bian, E. S. Cheah, M. A. Somera and N. H. Ahmad (2018). "Evaluating the effectiveness of silicone multilayer foam dressing in preventing heel pressure injury among critically ill patients in Singapore." Wound Practice & Research.
