Clinical question

Should a medical grade sheepskin support surface vs. any other support surface be used to reduce pressure injury occurrence in people at risk?

Context

Population:

Intervention:

Comparison:

Main Outcomes:

Setting:

Background:

Conflicts on Interest:

Individuals at risk of pressure injuries

Medical grade sheepskin support surface

Any other support surfaces

Any clinical setting

Pressure Injury occurrence

No Guideline Governance Group members or Core Review Group members had a conflict of interest

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

Moderate

Very low

No important uncertainty or variability

Don’t know

Don’t know

No included studies

No included studies

Probably no impact

Probably yes

Varies

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 selection of support surfaces is of the highest priority (median ranking 5/5).

In an earlier survey conducted by the International Pressure Injury Guideline, Guideline Governance Group (Haesler, Pittman et al. 2022), 68.6% (263/383) of individuals with or at risk of PIs and 61.5% (523/850) of informal carers rated receiving information on support surfaces to use as important or very important. The median priority ranking for receiving information on support surfaces was 4/5 for both individuals with or at risk of PIs of informal carers (Haesler, Pittman et al. 2022).

2. Desirable Effects:
How substantial are the desirable anticipated effects?

JUDGEMENT

  • Trivial

  • Small

  • Moderate

  • Large

  • Varies

  • Don’t Know

RESEARCH EVIDENCE

Outcome Medical grade sheepskin support surfaces Any other support surfaces Difference Relative effect
PI occurrence 18/720 (2.5%) 33/704 (4.7%)0.59 19 fewer PIs per 1,000
(from 0 fewer to 2 more)
RR 0.59
(0.33-1.05)

Outcome 1: Reduction in PI Occurrence

The meta-analysis (McInnes, Jammali-Blasi et al. 2015) included three randomized controlled trials (RCTs) (McGowan, Montgomery et al. 2000, Jolley, Wright et al. 2004, Mistiaen, Achterberg et al. 2010) that compared medical grade sheepskins to pressure redistribution support surfaces, standard vinyl mattress and un-defined comparators. Medical grade sheepskin supports were associated a lower rate of PI occurrence effect size (RR = 0.59, 95% CI 0.33 to 1.05. It is uncertain if using medical grade sheepskin surfaces versus any other support surfaces would prevent a new Category/Stage 1 or greater PI (McInnes, Jammali-Blasi et al. 2015).

** Support surfaces reported in the research were considered in this Guideline based on their categorization by the researchers (at the time the research was undertaken). Where available, the product name and characteristics were included in the data extraction tables. Product names/technology may have changed. Due to advances in technology, currently available support surfaces in the same category may have different performance characteristics.

3. Undesirable Effects:
How substantial are the undesirable anticipated effects?

JUDGEMENT

  • Trivial

  • Small

  • Moderate

  • Large

  • Varies

  • Don’t Know

RESEARCH EVIDENCE

There was no evidence about serious adverse events. In consideration of the lack of published cases, and in the expert opinion of the Panel Group, serious adverse events are unlikely to be associated with a sheepskin support surface. In one study (Mistiaen, Achterberg et al. 2010) 33% of participants reported medical grade sheepskin was too warm and this contributed to some people requesting a change of surface. About 5% of 218 individuals in a second study (Jolley, Wright et al. 2004) reported the sheepskin was not acceptable due to being too hot, too uncomfortable of due to wool sensitivity.

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 was low. The evidence was downgraded once for risk of bias. all studies had high risk of performance bias, plus two studies with approximately 90% of weight in the analysis had another domain at high risk of bias (McInnes, Jammali-Blasi et al. 2015). Evidence was downgraded because the comparator surfaces were either reported to be surfaces that are no longer considered standard care (e.g. vinyl mattresses) or were not reported. Certainty was also downgraded for imprecision.

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 evidence on desirable and desirable effects is very low certainty.

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

There is no evidence on resources required.

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 no evidence on resources required.

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 was no evidence on cost-effectiveness of the options.

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 noted that medical grade sheepskins are already used in lower resources countries and communities. They are commonly used in some countries under heel (usually on top of a pressure redistribution surface).

11. Acceptability:
Is the intervention acceptable to key stakeholders?

JUDGEMENT

  • No

  • Probably no

  • Probably yes

  • yes

  • Varies

  • Don’t know

RESEARCH EVIDENCE

In one of the studies (Mistiaen, Achterberg et al. 2010), 52% of the 209 individuals stated they would recommend a sheepskin surface. In the Guideline Governance Group’s opinion, there is varied acceptability; it is not uncommon for people to experience a medical grade sheepskin support surface as too warm.

12. Feasibility:
Is the intervention feasible to implement?

JUDGEMENT

  • No

  • Probably no

  • Probably yes

  • Yes

  • Varies

  • Don’t know

RESEARCH EVIDENCE

Medical sheepskins require specialist laundering to achieve thermal disinfection. This may reduce their feasibility for use in some clinical settings and for some individuals (e.g., individuals who are incontinent or those with a heavily exuding wound) (Jolley, Wright et al. 2004).