Clinical question
Should a leave on topical product versus no leave on product (usual care) for people at risk of heel pressure injuries?
Context
Population:
Intervention:
Comparison:
Main Outcomes:
Setting:
Conflicts on Interest:
Background:
People at risk of heel pressure injuries
Leave on topical product applied to heels
Usual care with no leave on product
Any clinical setting
Pressure injury (PI) occurrence
None
Topical leave-on products are commonly applied to the heels in some clinical contexts. Descriptions of leave-on topical products used to prevent PIs are varied and may not accurately characterize the product. There are a range of products available and they are sometimes categorized based on their action on the skin; for example, as moisturizers, emollients or barrier products.(Ryan, Mitchell et al. 2023) However, many products purport to have multiple potential mechanisms of action, and it is difficult to make distinctions. In one systematic review,(Ryan, Mitchell et al. 2023) products were classified as based on whether products were active or inert; however, there is insufficient information on the combined ingredients in many products. In a Cochrane review,(Patton, Moore et al. 2024) products were classified as creams or fatty-acid based oils; however, it is difficult to make clear distinctions; for example, many creams contain fat emulsions. Most products have a range of ingredients, and the active ingredient may be unclear. For example, products described as hyper-oxygenated, fatty oil acid-based preparations consist of esters from glycerol and fatty acids. Although present, the fatty acid is not a defining product characteristic. As a pragmatic approach, the Guideline Governance Group be considered the use of any topical leave-on product compared to usual care without a leave-on product.
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
Don’t know
Very low
No important uncertainty or variability
Don’t know
Negligible costs and savings
Low
No included studies
Probably no impact
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 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 | Leave on topical product |
No leave on topical product (usual care) |
Difference | Relative effect |
|---|---|---|---|---|
| Heel PI occurrence | 0/36 (0.0%) | 2/36 (5.6%) | 45 fewer PIs per 1,000 (from 55 fewer to 171 more) |
RR 0.19 (0.01-4.08) |
Outcome 1: Heel PI Occurrence
The meta-analysis(Patton, Moore et al. 2024) included one randomized trial (RCT)(Borzou, Amiri et al. 2020) that compared using a leave on topical product to no leave on topical product (usual care) for preventing heel PIs. The topical leave on product in this trial was a sweet almond oil that was applied by hand (without massage or pressure) once daily to the heels, for a total of seven days. The control group received usual care that did not include any topical product applied to the heels. The participants were people assessed as being at high risk of PIs (based on the Braden Scale score). Both groups were confined to bed for the duration of the study. The meta-analysis showed that using topical leave on product on the heels was associated with a non-significant lower rate of heel PIs (0% versus 5.6%, RR 0.19, 95% CI 0.01 to 4.08, p = 0.29), translating to a difference of 45 fewer per 1,000 experiencing a heel PI when a topical leave on product is used. However, it is very uncertain if the result represents a true effect; the true effect lies between 55 fewer people and 171 more people experiencing a PI with a topical leave on product.
3. Undesirable Effects:
How substantial are the undesirable anticipated effects?
JUDGEMENT
Trivial
Small
Moderate
Large
Varies
Don’t Know
RESEARCH EVIDENCE
In the study, no people who were treated with sweet almond oil experienced any adverse events.(Borzou, Amiri et al. 2020)
There is large body of evidence that is not specific to PI prevention suggesting that vegetable and seed oils should not be used in people with skin barrier impairments, because of disruption to the stratum corneum (e.g. from free fatty acids) can lead to skin irritation and other adverse events.(Moore, Wagner et al. 2020)
Evidence is also unclear about the role of leave-on topical products for protecting the skin of neonates and infants.(Cooke 2018, 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 | VERY 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 once for risk of bias due to performance bias. The evidence was also downgraded twice times for imprecision for an extremely wide 95% confidence interval, 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
There was a paucity of studies, the results for desirable effects had a wide confidence interval, and there is unknown potential undesirable effects.
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 topical leave on product (sweet almond oil) was easily accessible in the context of the study (an ICU ward in Iran) at a cost of $6 per patient (currency not clear). The nursing hours to apply the product were low because application too less than one minutes/day.(Borzou, Amiri et al. 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
It is unclear whether all potential costs were considered. The study(Borzou, Amiri et al. 2020) that reported on resourcses was only conducted over a 7-day duration.
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 is no available evidence.
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
Studies exploring leave-on skin products are conducted in low resource geographic areas.
11. Acceptability:
Is the intervention acceptable to key stakeholders?
JUDGEMENT
No
Probably no
Probably yes
yes
Varies
Don’t know
RESEARCH EVIDENCE
There is no evidence, but a leave on product with no adverse effects is likely to be acceptable to most people.
12. Feasibility:
Is the intervention feasible to implement?
JUDGEMENT
No
Probably no
Probably yes
yes
Varies
Don’t know
RESEARCH EVIDENCE
There were no threats to feasibility observed in this study, the application of the product took less than one minute/day.
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.
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.
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.
Moore, E. M., C. Wagner and S. Komarnytsky (2020). "The enigma of bioactivity and toxicity of botanical oils for skin care." Frontiers in Pharmacology(11): 785.
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.
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.
Ryan, H. M., B. Mitchell, O. Gumuskaya, A. Hutton and P. E. Tehan (2023). "Moisturisers, emollients, or barrier preparations for the prevention of pressure injury: a systematic review and meta-analysis." Advances Wound Care 03.
