Review question
We reviewed the evidence about whether dressings and topical agents, like creams, can prevent pressure ulcers.
Background
Pressure ulcers, also known as bed sores or pressure sores, are injuries to the skin or tissue underneath, or both. They develop as a result of sustained pressure on bony parts of the body. They are common among elderly people and those with mobility problems. They are often difficult to heal, expensive to treat and have a negative impact on people's quality of life, so it is important to prevent them. Special mattresses, cushions, and regular changes of position are used for prevention. Dressings and creams are also widely used. We wanted to compare different dressings and topical agents and find out which were best at preventing pressure ulcers in people at risk of developing them. We also wanted to consider other outcomes, like pain, quality of life, and the cost to healthcare systems of the different treatments.
Trial characteristics
In order to ensure that the information contained within this review is up to date, in March 2017 we searched for any new randomised controlled trials (RCTs) that compared dressings and/or topical agents with other methods for preventing pressure ulcers. RCTs are medical studies where patients are chosen at random to receive different treatments. This type of trial provides the most reliable evidence. This is the first time we have updated this review. We found nine RCTs, giving us a total of 18 relevant trials. These trials included 3629 adults, mainly elderly people, though some included younger adults with mobility-limiting injuries. Products tested included fatty acid (fatty acids come from animal and vegetable fats and oils and are used to moisten the skin), creams and dressings made with silicone or foam.
Key results
The results of six trials suggest that silicone dressings may reduce the likelihood of people developing pressure ulcers . However, we were uncertain about the evidence from five of these trials because they used poor methods, so we cannot be confident about these results. We also found that use of fatty acid versus a control compound (a cream that does not include fatty acid) may reduce the incidence of pressure ulcers, but results from this trial were uncertain. None of the other comparisons involving topical agents provided conclusive evidence that they make it less likely that people will develop a pressure ulcer.
Quality of the evidence
The certainty of the evidence in the trials was low to very low. Additional trials at low risk of bias are needed to clarify the effect of dressings and topical agents in preventing pressure ulcers.
We searched for trials that had been published up to March 2017.
Most of the trials exploring the impact of topical applications on pressure ulcer incidence showed no clear benefit or harm. Use of fatty acid versus a control compound (a cream that does not include fatty acid) may reduce the incidence of pressure ulcers. Silicone dressings may reduce pressure ulcer incidence (any stage). However the low level of evidence certainty means that additional research is required to confirm these results.
Pressure ulcers, localised injuries to the skin or underlying tissue, or both, occur when people cannot reposition themselves to relieve pressure on bony prominences. These wounds are difficult to heal, painful, expensive to manage and have a negative impact on quality of life. Prevention strategies include nutritional support and pressure redistribution. Dressing and topical agents aimed at prevention are also widely used, however, it remains unclear which, if any, are most effective. This is the first update of this review, which was originally published in 2013.
To evaluate the effects of dressings and topical agents on pressure ulcer prevention, in people of any age, without existing pressure ulcers, but considered to be at risk of developing one, in any healthcare setting.
In March 2017 we searched the Cochrane Wounds Group Specialised Register, CENTRAL, MEDLINE, MEDLINE (In-Process & Other Non-Indexed Citations), Embase, and EBSCO CINAHL Plus. We searched clinical trials registries for ongoing trials, and bibliographies of relevant publications to identify further eligible trials. There was no restriction on language, date of trial or setting. In May 2018 we updated this search; as a result several trials are awaiting classification.
We included randomised controlled trials that enrolled people at risk of pressure ulcers.
Two review authors independently selected trials, assessed risk of bias and extracted data.
The original search identified nine trials; the updated searches identified a further nine trials meeting our inclusion criteria. Of the 18 trials (3629 participants), nine involved dressings; eight involved topical agents; and one included dressings and topical agents. All trials reported the primary outcome of pressure ulcer incidence.
Topical agents
There were five trials comparing fatty acid interventions to different treatments. Two trials compared fatty acid to olive oil. Pooled evidence shows that there is no clear difference in pressure ulcer incidence between groups, fatty acid versus olive oil (2 trials, n=1060; RR 1.28, 95% CI 0.76 to 2.17; low-certainty evidence, downgraded for very serious imprecision; or fatty acid versus standard care (2 trials, n=187; RR 0.70, 95% CI 0.41 to 1.18; low-certainty evidence, downgraded for serious risk of bias and serious imprecision). Trials reported that pressure ulcer incidence was lower with fatty acid-containing-treatment compared with a control compound of trisostearin and perfume (1 trial, n=331; RR 0.42, 95% CI 0.22 to 0.80; low-certainty evidence, downgraded for serious risk of bias and serious imprecision). Pooled evidence shows that there is no clear difference in incidence of adverse events between fatty acids and olive oil (1 trial, n=831; RR 2.22 95% CI 0.20 to 24.37; low-certainty evidence, downgraded for very serious imprecision).
Four trials compared further different topical agents with placebo. Dimethyl sulfoxide (DMSO) cream may increase the risk of pressure ulcer incidence compared with placebo (1 trial, n=61; RR 1.99, 95% CI 1.10 to 3.57; low-certainty evidence; downgraded for serious risk of bias and serious imprecision). The other three trials reported no clear difference in pressure ulcer incidence between active topical agents and control/placebo; active lotion (1 trial, n=167; RR 0.73, 95% CI 0.45 to 1.19), Conotrane (1 trial, n=258; RR 0.74, 95% CI 0.52 to 1.07), Prevasore (1 trial, n=120; RR 0.33, 95% CI 0.04 to 3.11) (very low-certainty evidence, downgraded for very serious risk of bias and very serious imprecision). There was limited evidence from one trial to determine whether the application of a topical agent may delay or prevent the development of a pressure ulcer (DermalexTM 9.8 days vs placebo 8.7 days). Further, two out of 76 reactions occurred in the DermalexTM group compared with none out of 91 in the placebo group (RR 6.14, 95% CI 0.29 to 129.89; very low-certainty evidence; downgraded for very serious risk of bias and very serious imprecision).
Dressings
Six trials (n = 1247) compared a silicone dressing with no dressing. Silicone dressings may reduce pressure ulcer incidence (any stage) (RR 0.25, 95% CI 0.16 to 0.41; low-certainty evidence; downgraded for very serious risk of bias). In the one trial (n=77) we rated as being at low risk of bias, there was no clear difference in pressure ulcer incidence between silicone dressing and placebo-treated groups (RR 1.95, 95% CI 0.18 to 20.61; low-certainty evidence, downgraded for very serious imprecision).
One trial (n=74) reported no clear difference in pressure ulcer incidence when a thin polyurethane dressing was compared with no dressing (RR 1.31, 95% CI 0.83 to 2.07). In the same trial pressure ulcer incidence was reported to be higher in an adhesive foam dressing compared with no dressing (RR 1.65, 95% CI 1.10 to 2.48). We rated evidence from this trial as very low certainty (downgraded for very serious risk of bias and serious imprecision).
Four trials compared other dressings with different controls. Trials reported that there was no clear difference in pressure ulcer incidence between the following comparisons: polyurethane film and hydrocolloid dressing (n=160, RR 0.58, 95% CI 0.24 to 1.41); Kang’ huier versus routine care n=100; RR 0.42, 95% CI 0.08 to 2.05); 'pressure ulcer preventive dressing' (PPD) versus no dressing (n=74; RR 0.18, 95% CI 0.04 to 0.76) We rated the evidence as very low certainty (downgraded for very serious risk of bias and serious or very serious imprecision).