Clinical question
Should any preventive dressing versus a leave-on topical product be used to prevent PI occurrence in individuals at risk?
Context
Population:
Intervention:
Comparison:
Main Outcomes:
Setting:
Conflicts on Interest:
People at risk of pressure injuries
Any preventive dressing
Any leave-on topical product
Any clinical setting
Pressure injury (PI) occurrence
Yee Yee Chang declared that she is the lead researcher of the study considered in this meta-analysis. She was not involved in the critical appraisal of the research or the evaluation of the certainty of evidence.
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
Does not favor the intervention or the comparison
Moderate costs
Moderate
Probably favors the intervention
Probably increased
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 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 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 |
|---|---|---|---|---|
| PI occurrence | 4/86 (4.7%) | 6/101 (5.9%) | 13 fewer per 1,000 (from 46 fewer to 100 more) |
RR 0.78 (0.23-2.68) |
Outcome 1: PI Occurrence
The meta-analysis included 1 randomized controlled trial (RCT)(Chang, Tay et al. 2017) that compared using a preventive dressing (a multi-layer soft silicone foam dressing) to a leave-on topical product (a fatty acid) for preventing PIs. The study was conducted in an inpatient tertiary setting with participants who were assessed as being at high risk of PI and the regimens were implemented for 14 days. The meta-analysis showed that using a preventive dressing was associated with a statistically non-significant lower rate of PIs (RR 0.78, 95% CI 0.23 to 2.68, p = 0.70), translating to a difference of 13 fewer per 1,000 experiencing a PI when a preventive dressing is used. However, it is very uncertain if the result represents a true effect; the true effect lies between 46 fewer people and 100 more people experiencing a PI with a preventive dressing.
3. Undesirable Effects:
How substantial are the undesirable anticipated effects?
JUDGEMENT
Trivial
Small
Moderate
Large
Varies
Don’t Know
RESEARCH EVIDENCE
A Cochrane review (Patton, Moore et al. 2024) found insufficient data on adverse events to conduct a meta-analysis. Indicative undesirable effects associated with using a preventive dressing that are reported in the literature include:
undesirable effect rate of 3% (33/1087) (Beeckman, Fourie et al. 2021)
itching (1/300, 0.33%) and desquamation (1/300, 0.33%) (Oe, Sasaki et al. 2020)
burning pain and warm sensation under a sacral dressing (1/212, 0.47%) (Hahnel, El Genedy et al. 2020)
no adverse events (Santamaria, Gerdtz et al. 2015, Kalowes, Messina et al. 2016, Gazineo, Chiarabelli et al. 2020)
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
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).
The certainty of evidence is very low. The evidence was downgraded once due to high risk of attrition bias.(Patton, Moore et al. 2024) The evidence was also downgraded twice due to imprecision due to a wide confidence interval 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 GGG determined that the balance between desirable and undesirable effects did not favour either the intervention or the comparison.
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
Several studies have reported costs associated with using a multi-layered soft silicone foam preventive dressing. Some indicative costs reported in the literature include:
heel dressings and the nursing time to apply the dressings for a three-day unit admission to ICU €116/person ( Germany in 2020) (El Genedy, Hahnel et al. 2020)
sacral dressing cost of $11 per person for a 4 day trauma admission (US in 2018) (Serrano, Paiva et al. 2020)
cost of dressing of $20 per person for hospital admission (US in 2017) (Padula 2017)
cost of dressing of $36 per person for an admission to ICU (Australia in 2014)(Santamaria, Liu et al. 2014, Santamaria and Santamaria 2014)
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 GGG considered the evidence on cost effectiveness to be of moderate 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 cost-effectiveness analysis(El Genedy, Hahnel et al. 2020) reported incremental cost-effectiveness ratio (ICER) of using preventive 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 PI (dressing equipment, nursing time to assess, manage and document a PI). An ICER of €8144.72 per heel was reported.
A cost analysis concluded that, after considering cost of nursing time associated with applying dressings, number of dressings per person, and cost of materials and comparing this to the incidence of PI and cost to treat a PI, the expected incremental cost of using a preventive dressing was zero at a PI treatment cost threshold of €157 (Italy, 2020) and $311 (US, 2020). For PIs that cost more than these amount to treat, there would be a cost saving from having used a preventive dressing.(Forni and Searle 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
Panel Groups reported that there might be inequity if a preventive dressing is recommended for preventing PIs. Panel Groups 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
In one study, people using a preventive dressing rated comfort as high, but comfort declined over time.(Lovegrove, Fulbrook et al. 2022)
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 preventive dressings on heels, 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) and rolled edges on the prophylactic dressing (n = 44). Another study reported similar issues with poor adhesion, rolling dressing edges and frequent change requirements due to soiling.(Lovegrove, Fulbrook et al. 2022)
Panel Groups 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.
Chang, Y. Y., A. C. Tay, M. L. Lim, S. B. Lian and F. A. B. Aloweni (2017). "Preliminary findings of a randomized controlled trial to evaluate the effectiveness of prophylactic dressing and fatty acids oil in the prevention of pressure injuries." J Wound Care 26(SUPPL): 424.
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.
Forni, C. and R. Searle (2020). "A multilayer polyurethane foam dressing for pressure ulcer prevention in older hip fracture patients: an economic evaluation." Journal of wound care 29(2): 120-127.
Gazineo, D., M. Chiarabelli, R. Cirone, P. Chiari and E. Ambrosi (2020). "Effectiveness of Multilayered Polyurethane Foam Dressings to Prevent Hospital-Acquired Sacral Pressure Injuries in Patients With Hip Fracture: A Randomized Controlled Trial." Journal of wound, ostomy, and continence nursing : official publication of The Wound, Ostomy and Continence Nurses Society 47(6): 582-587.
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.
Kalowes, P., V. Messina and M. Li (2016). "Five-layered soft silicone foam dressing to prevent pressure ulcers in the intensive care unit." American Journal of Critical Care 25(6): e108-e119.
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.
Lovegrove, J., P. Fulbrook and S. J. Miles (2022). "Use of a Sacral Foam Dressing to Prevent Pressure Injury in At-Risk Subacute Hospitalized Older Adults: A Pilot Randomized Controlled Trial." Journal of wound, ostomy, and continence nursing : official publication of The Wound, Ostomy and Continence Nurses Society 49(4): 322-330.
Oe, M., S. Sasaki, T. Shimura, Y. Takaki and H. Sanada (2020). "Effects of multilayer silicone foam dressings for the prevention of pressure ulcers in high-risk patients: a randomized clinical trial." Adv Wound Care 9(12): 649-656.
Padula, W. V. (2017). "Effectiveness and value of prophylactic 5-layer foam sacral dressings to prevent hospital-acquired pressure injuries in acute care hospitals: An observational cohort study." Journal of Wound, Ostomy, and Continence Nursing 44(5): 413-419.
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.
Santamaria, N., W. Liu, M. Gerdtz, S. Sage, J. McCann, A. Freeman, T. Vassiliou, S. Devincentis, A. W. Ng, E. Manias, J. Knott and D. Liew (2014). "The cost-benefit of using soft silicone multilayered foam dressings to prevent sacral and heel pressure ulcers in trauma and critically ill patients: A within-trial analysis of the Border trial." International Wound Journal epub.
Santamaria, N. and H. Santamaria (2014). "An estimate of the potential budget impact of using prophylactic dressings to prevent hospital-acquired PUs in Australia." Journal of Wound Care 23(11): 583-589.
Serrano, J., C. F. Paiva, F. Dong, D. Wong and M. Neeki (2020). "Sacral Pressure Injury Prevention in Trauma Patients: Silicone-Bordered Multilayered Foam Dressing." Journal of trauma nursing : the official journal of the Society of Trauma Nurses 27(4): 246-249.
