Pressure ulcer healing with an intensive nutrition intervention in an acute setting: a pilot randomised controlled trial
To investigate the feasibility of recruitment, retention, intervention delivery and outcome measurement in a nutritional intervention to promote pressure ulcer (PU) healing in an acute setting.
Some 50 tertiary hospital patients with stage II or greater PUs were randomised to receive either individualised nutritional care by a dietitian, including prescription of wound healing supplements; or standard nutritional care. Relevant nutritional and PU parameters were collected at days five, 10, 15, 22 and then weekly or until discharge.
The median length of hospital stay was 14 days (1–70) with 29 patients discharged by day 15. There were 24 patients discharged before their PU fully healed. Per cent change in valid PU area and score measures from baseline to day 15 were chosen for outcome data analysis to account for varying initial size and severity of the wound and length of stay. There was a larger percentage reduction in PU measures in the intervention group, but this was not statistically significant. Little difference was found in nutritional intake between the control and intervention groups indicating a requirement to focus on effective delivery of the intervention in future studies. Future studies in the acute setting need to account for length of stay and ideally follow patients until full healing.
Results indicate a positive association with nutrition intervention and PU healing and that a rigorously designed and adequately powered study is feasible.
Malnutrition has been found to be associated with a significantly higher risk of developing a pressure ulcer (PU).1,2,3 Targeted nutritional interventions, such as provision of nutritional supplementation, have been found to reduce the incidence of PU in at-risk patients,4 and this was shown to be a cost-effective approach to the prevention of PU.5
Few high-quality studies have investigated nutritional interventions in the treatment of established PU. Systematic reviews of nutrition support in the treatment of PU describe a non-significant trend towards enhanced healing, especially with a high protein formula or formulae marketed as ‘wound healing’ (enriched with arginine, vitamin C and zinc).4,6 However, sample sizes of the studies were small and lacked statistical power, or were of poor methodological quality. The most recent Cochrane systemic review6 concluded that there is no clear evidence of a benefit with nutrition interventions in the treatment of PUs, and that further trials of high methodological quality are necessary. Recently a multicentre, randomised, controlled, blinded trial was conducted in 200 malnourished patients from long-term care and home care services. This found supplementation with ‘wound healing formula’ resulted in a greater reduction in PU area compared with control formula at eight weeks.7 Observational studies of nutritional requirements and intake of patients with PU and chronic wounds indicate that protein, energy and micronutrient intake often do not meet requirements and many patients are malnourished as a consequence.8,9,10 It therefore remains unclear whether nutritional intervention in the acute hospital setting is effective in enhancing the healing of PU. Furthermore, it is still unknown if patients' nutritional needs remain unmet due to poor intake, and/or do patients with PU have increased nutritional requirements, if so, what type of intervention is most likely to be effective and/or do pharmacological intakes of particular nutrients enhance healing? Answers to these clinical questions are urgently needed, so that effective dietary approaches to PU treatment become an established part of routine care. However, there are significant challenges to designing trials of nutrition intervention to promote PU healing. PU are most prevalent in vulnerable older patients who may be difficult to recruit to clinical trials and comorbidity may introduce important confounders. In an acute environment, patients may be discharged before PU healing, making measuring outcomes difficult. Efficacy of nutrition intervention will depend on the effective delivery of the intervention as part of complex care regimens.
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