Clinical question
Should multilayered soft silicone foam dressing versus no preventive dressing 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 (note: all the dressings in this analysis were silicone adhesive multilayer foam dressings)
No preventive 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
Large
Small
Very low
No important uncertainty or variability
Probably favors the intervention
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 |
No preventive dressing |
Difference | Relative effect |
|---|---|---|---|---|
| PI occurrence | 136/3204 (4.2%) | 274/2808 (9.8%) | 53 fewer per 1,000 (from 66 fewer to 34 fewer) |
RR 0.46 (0.32-0.65) |
Outcome 1: PI Occurrence
The meta-analysis included 18 randomized controlled trials (RCTs)(Qiuli and Qiongyu 2010, Saab, Solomon et al. 2015, Santamaria, Gerdtz et al. 2015, Walker, Aitken et al. 2015, Kalowes, Messina et al. 2016, Aloweni, Lim et al. 2017, Chang, Tay et al. 2017, Guerra 2017, Forni, D'Alessandro et al. 2018, Santamaria, Gerdtz et al. 2018, De Wert, Essers et al. 2019, Lee, Kim et al. 2019, Gazineo, Chiarabelli et al. 2020, Hahnel, El Genedy et al. 2020, Oe, Sasaki et al. 2020, Beeckman, Fourie et al. 2021, Forni, Gazineo et al. 2022, Lovegrove, Fulbrook et al. 2022) that compared using a multi-layer soft silicone foam dressing to no preventive dressing for preventing PIs. The studies were conducted in intensive care units, medical and surgical wards, emergency departments and aged/long term care and were used for between 4 days and 6 weeks for people at PI risk. About half of the studies used the preventive dressing 2 weeks or shorter durations. The meta-analysis showed that using a preventive dressing was associated with a lower rate of PIs (RR 0.46, 95% CI 0.32 to 0.65, p < 0.0001), translating to a difference of 53 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 66 fewer people and 34 fewer 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 twice due to high or unclear risk of bias.(Patton, Moore et al. 2024) The evidence was also downgraded due to inconsistency because tests of heterogeneity indicated variation in point estimates among studies.
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 considered that the balance of effects probably favors the intervention, based on the large effect size and undesirable effects that occurred at low rates and were not serious in nature.
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; (ICU in 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 rated the certainty of the available research evidence on resources as being moderate.
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). ICERs of €8144.72 per heel and €701.54 per sacrum were 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)
The GGG noted that cost-benefit may be influenced by the clinical setting and length of hospital admission. The individual’s risk of PIs should be considered.
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.
The GGG was of the opinion that inequity would likely increase if preventive dressings were recommended.
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
Aloweni, F., M. L. Lim, T. L. Chua, S. B. Tan, S. B. Lian and S. Y. Ang (2017). "A randomised controlled trial to evaluate the incremental effectiveness of a prophylactic dressing and fatty acids oil in the prevention of pressure injuries." Wound Practice & Research 25(1): 24-34.
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.
De Wert, L. A., B. A. Essers, A. A. Kessels, R. R. Vogels, M. Poeze, L. Schoonhoven and e. al. (2019). "The prevention of sacral pressure ulcers in high-risk patients with the use of a sacral wound dressing: a randomized clinical trial." Maastricht University. https:// doi.org/10.26481/dis.20190222lw
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., F. D'Alessandro, P. Gallerani, R. Genco, A. Bolzon, C. Bombino, S. Mini, L. Rocchegiani, T. Notarnicola, A. Vitulli, A. Amodeo, G. Celli and P. Taddia (2018). "Effectiveness of using a new polyurethane foam multi-layer dressing in the sacral area to prevent the onset of pressure ulcer in the elderly with hip fractures: A pragmatic randomised controlled trial." International Wound Journal 15(3): 383-390.
Forni, C., D. Gazineo, E. Allegrini, T. Bolgeo, A. Brugnolli, F. Canzan, P. Chiari, A. Evangelista, A. M. Grugnetti, G. Grugnetti and et al. (2022). "Effectiveness of a multi-layer silicone-adhesive polyurethane foam dressing as prevention for sacral pressure ulcers in at-risk in-patients: randomized controlled trial." International journal of nursing studies 127: 104172.
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.
Guerra, S. (2017). "Polyurethane foam on the heel for prevention in children (SCHIUMABIMB) [Effectiveness of polyurethane foam in preventing the onset of pressure sores in a pediatric orthopedic population: randomized controlled trial]. NCT03039179. https:// classic.clinicaltrials.gov/ct2/show/NCT03039179 (first received 1 February 2017)."
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