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National Clinical Guideline Centre (UK). The Prevention and Management of Pressure Ulcers in Primary and Secondary Care. London: National Institute for Health and Care Excellence (NICE); 2014 Apr. (NICE Clinical Guidelines, No. 179.)
5.1. Introduction
Nutritional factors are important in the healing process of pressure ulcers, in conjunction with other management strategies, as various nutrients have been associated with promoting pressure ulcer repair through their role in collagen formation and development of connective tissue. For example, nutrients such as protein, vitamin C and zinc have historically been considered important, due to their role in collagen formation. Other nutritional supplements considered to be potentially important are arginine, an amino acid that stimulates insulin secretion and protein formation, collagen protein and hydrolysate, which provide protein in a hydrolysed form. Adjusting intake of these components can be achieved by varying amounts in the diet but also by the use of specific supplements. Supplementation can be achieved by the use of single tablets or in combination, often as a drink. Due to the numerous compositions of nutrient drinks, they are notoriously difficult to compare with each other. One of the major factors frequently considered to impact on pressure ulcer healing is baseline nutritional status, as a poor nutritional state is generally considered to inhibit pressure ulcer healing. It is therefore important to identify those at risk of malnutrition and start treatment to improve nutritional state as well as contemplating any further needs associated with pressure ulcer repair. NICE clinical guideline 32 ‘Nutrition support in adults’130 provides recommendations on screening the nutritional status of people in hospital and in the community. The GDG were therefore interested in whether recommendations for nutritional interventions would be different depending on the presence or absence of malnutrition.
The GDG were also interested in whether there was any guidance on hydration interventions that would aid the treatment of pressure ulcers.
5.2. Review question: What are the most clinically and cost-effective nutritional interventions for the treatment of pressure ulcers?
For full details see review protocol in Appendix C.
5.2.1. Clinical evidence (adults)
No randomised trials of interventions for hydration to treat pressure ulcers were found. For nutritional interventions to treat pressure ulcers, 1 Cochrane review was identified102 which included 4 randomised trials (Taylor, 1974183, Ter Riet, 1995184, Chernoff, 199042, and Norris, 1971140). These randomised trials have been included in the evidence review and the Cochrane Review was updated. Ten further randomised trials were found(Desneves, 200554, Lee, 2006104, Cereda, 200940, Van Anholt, 2010198, Brewer, 196730, Benati, 200125 and Ohura, 2011142, Meaume, 2009114, Leigh, 2012105 and Theilla, 2012186,187). One study (Meaume, 2009)114 only included people with heel pressure ulcers. Benati (2001)25 met the inclusion criteria for the review but it had incomplete outcome reporting and so it was not possible to extract any results from this paper.
The evidence from these studies is summarised in the clinical GRADE evidence profile below (Table 4). See also the study selection flow chart in Appendix D, forest plots in Appendix I, study evidence tables in Appendix G and exclusion list in Appendix J.
Most of the studies identified looked at different forms of nutritional supplementation, in addition to the standard hospital diet, versus the standard hospital diet alone. The supplements differed in their composition therefore it was not possible to meta-analyse them. Two studies were identified which compared ascorbic acid against placebo. Although the populations differed (people in a nursing home and people who had undergone surgery) they were meta-analysed.
Studies which included pressure ulcers of all stages were analysed separately from those which included people with pressure ulcers of stages 2 and above (the classification system used is reported, where provided by the authors). Studies including participants who had an adequate nutritional status were separated from those who had a nutritional deficiency.
Summary of included studies
| Study | Intervention/comparator | Population | Outcomes | Study length |
|---|---|---|---|---|
| Benati 200125 | Normal hospital diet plus an oral supplementation with an iso-calorie and iso-protein solution enriched with arginine, vitamins and trace elements with antioxidant effect versus normal hospital diet plus oral supplementation with high protein calorie solution versus normal hospital diet. | People with severe cognitive impairment and pressure ulcers. Reduced oral food intake. |
| 2 weeks |
| Brewer 196730 | Oral zinc sulphate 220mgs (50mg zinc) 3 times per day versus inert substance (lactose). | People with spinal cord injuries and poorly healing pressure ulcers of various sizes, types, locations and duration (5 months to 2 years). |
| 2-3 months |
| Cereda 200940 | Disease-specific nutritional treatment -standard hospital diet plus 400ml oral supplement (500kcal, 34g protein, 6g arginine, 500mg vitamin C, 18mg zinc) or tube fed 100ml high protein formula (20% energy from protein, enriched with arginine, zinc and vitamin C) versus standard protocol - hospital diet (16% energy from protein) without any additional supplement or tube fed standard formula energy and the infusion of appropriate volumes of a standard formula satisfied protein requirements. | Elderly residents in long-term facilities with stage 2, 3 or 4 pressure ulcers (NPUAP 2007) who were orally or tube fed. |
| 12 weeks |
| Chernoff 199042 | Very high protein (25% of calories) formula versus high protein (16% of calories) formula. | Long-term tube fed institutionalised people with pressure ulcers. |
| 8 weeks |
| Desneves 200554 | Standard hospital diet plus 2 tetrapaks of a defined arginine-containing supplement (500kcal, 21g protein, 0g fat, 500mg vitamin C, 30mg zinc and 9g arginine) versus standard hospital diet plus 2 tetrapaks of high protein, high energy supplement (providing additional 500kcal, 18g protein, 0g fat, 72mg vitamin C and 7.5mg zinc) versus standard hospital diet. | Inpatients with stage 2,3 or 4 pressure ulcer. Diagnosis: dementia (n=1), cerebrovasulcar accident (n=6), spinal cord injury (n=2), parkinson's disease (n=1), chronic cardiac failure (n=2), fractured bones (n=3), pressure ulcers (alone) (n=1). |
| 3 weeks |
| Lee 2006104 | Standard diet plus concentrated, fortified, collagen protein hydrolysate supplement versus standard diet plus placebo. | Residents of long-term care facilities with pressure ulcers stage 2, 3 or 4. |
| 8 weeks |
| Leigh 2012105 | Hospital diet plus 4.5g arginine supplement versus hospital diet plus 9g arginine supplement. | Inpatients with category 2, 3 or 4 pressure ulcers. |
| 3 weeks |
| Norris 1971140 | Oral zinc sulphate (200mg) capsules 3 times per day versus placebo. | People in a hospital with chronic disease and geriatric problems with non-superficial pressure ulcers. Diagnosis: brain damage after head injury (n=1), senile dementia n=1), subdural hematoma (n=1), paraplegia (n=4), multiple sclerosis (n=2), cerebral thrombosis (n=1), poliomyelitis (n=1), quadriplegia (n=1), brain damage after cardiac arrest (n=1), rheumatoid arthritis, amputee (n=1). |
| 12 weeks treatment then crossed over for another 12 weeks. |
| Ohura 2011142 | Protein, fat, carbohydrate versus same nutrition as before trial. | Tube fed people with stage 3 to 4 pressure ulcers. The majority of participants were older adults. |
| 12 weeks |
| Taylor 1974183 | Basic hospital diet plus 500mg ascorbic acid twice daily versus basic hospital diet plus placebo. | People undergoing surgery with pressure ulcers. Diagnosis fractured neck of femur n=9), rheumatoid arthritis (n=2), cerebrovascular accident (n=2), fractured pelvis (n=1), peripheral vascular disease (n=1), paraplegia (n=1), gastric ulcer (n=1), benign prostatic hypertrophy (n=1), diverticular disease (n=1), aortic aneurysm (n=1). |
| 1 month |
| Ter Riet 1995184 | Ascorbic acid supplementation (500mg twice daily) as effervescent tablets versus identical placebo which contained 10mg of ascorbic acid. | People from 11 nursing homes and 1 hospital with pressure ulcers (partial thickness skin loss or worse). Most people had nutritional deficiency on admission. |
| 12 weeks |
| Theilla 2012186,187 | Enteral nutritional formula enriched in fish oil and antioxidants versus isonitrogenous nutritional formula. | People in an intensive care unit with grade 2 or higher pressure ulcers |
| 28 days |
| Van Anholt 2010A198 | Oral nutritional supplement 250kcal, 28.4g carbohydrates (45% energy), 20g protein (30% energy), 3g arginine, 7g fat (25% energy), 238mg vitamin A, 250mg vitamin C, 38mg vitamin E, 1.5mg carotenoids, 9mg zinc, 64ug selenium, 1.35mg copper, 200ug folic acid versus non-caloric, flavoured placebo. | Non-malnourished people at health care centres, hospitals and long-term care facilities, aged 18 to 90 years with stage 3 to 4 pressure ulcers (EPUAP). |
| Maximum 8 weeks |
| Meaume 2009114 | 10g sachet of ornithine alpha-ketoglutarate versus 1 sachet of placebo. | Elderly people (geriatric, internal medicine, physical medicine and rehabilitation, trauma, plastic surgery, cardiology, neurology and dermatology settings) who had pressure ulcers of the heel of stage 2 or 3 (NPUAP classification). |
| 6 weeks. |
Table 24
Minimal important difference for continuous outcomes – baseline values.
Table 25
Clinical evidence profile: 500kcal, 34g protein, 6g arginine, 500mg vitamin C, 18mg zinc and standard hospital diet versus standard hospital diet.
Table 26
Clinical evidence profile: 250kcal, 28.4g carbohydrates, 20g protein, 3g arginine, 7g fat, vitamins, minerals and standard hospital diet versus standard hospital diet and placebo.
Table 27
Clinical evidence profile: 500kcal, 18g protein, 0g fat, 72mg vitamin C and 7.5mg zinc and standard hospital diet versus standard hospital diet for treating pressure ulcers.
Table 28
Clinical evidence profile: 500kcal, 21g protein, 0g fat 500mg vitamin C, 30mg zinc and 9g arginine and standard hospital diet versus standard hospital diet.
Table 29
Clinical evidence profile: 500kcal 21g protein, 0g fat, 500mg vitamin C, 30mg zinc, 9g of arginine and standard hospital diet versus 500kcal 18g protein, 0g fat, 72mg vitamin C and 7.5mg zinc and standard hospital diet.
Table 30
Clinical evidence profile: 4.38g protein, 2.23g fat, 15.62g carbohydrate, minerals and vitamins (per 100ml) and standard hospital diet versus standard hospital diet.
Table 31
Clinical evidence profile: very high protein dietary formula (92 to 150gms/day) versus high protein dietary formula (57 to 90 gms/day).
Table 32
Clinical evidence profile: 1000mg ascorbic acid (500mg twice daily) and standard hospital diet versus standard hospital diet and placebo.
Table 33
Clinical evidence profile: zinc sulfate versus placebo.
Table 34
Clinical evidence profile: concentrated, fortified, collagen protein hydrolysate versus placebo.
Table 35
Clinical evidence profile: ornithine alpha-ketoglutarate versus placebo.
Table 36
Clinical evidence profile: arginine 4.5g versus arginine 9g.
Table 37
Clinical evidence profile: arginine 4.5g in malnourished participants versus arginine 9g in malnourished participants.
Table 38
Clinical evidence profile: arginine 4.5g in well-nourished participants versus arginine 9g in well-nourished participants.
Table 39
Clinical evidence profile: nutritional formula with fish oil and macronutrients versus isocaloric control formula.
5.2.2. Economic evidence (adults)
5.2.2.1. Published literature
One study was included with a relevant comparison.80 This is summarised in the economic evidence profile below (Table 40). See also the study selection flow chart in Appendix D and study evidence table in Appendix H.
Table 40
Economic evidence profile: Nutritional supplement verses standard hospital diet.
5.2.2.2. Unit costs
In the absence of recent UK cost-effectiveness analysis, relevant unit costs are provided below to aid consideration of cost effectiveness. These costs represent costs per day of various supplements used in the treatment of pressure ulcers. These are the list prices, and the GDG acknowledged that the actual price paid is often much lower than those stated in the table below. The specific supplements included are illustrative only, and should not be interpreted as GDG recommendations.
Table 41
Unit cost estimates per day for nutritional supplements in a community setting.
Total costs depend on the duration and quantity of the nutritional supplementation that is required, and will vary greatly amongst participants. Monthly costs of vitamin C and protein supplementation would be £4 and £115 respectively.
5.2.3. Clinical evidence (neonates, infants, children and young people)
No RCTs or cohort studies were identified. Recommendations were developed using a modified Delphi consensus technique. Further details can be found in Appendix N.
5.2.4. Economic evidence (neonates, infants, children and young people)
No economic evidence was identified.
5.2.5. Evidence statements
5.2.5.1. Clinical (adults)
5.2.5.1.1. Supplement of 500kcal, 34g protein, 6g arginine, 500mg vitamin C, 18mg zinc in addition to a standard hospital diet versus standard hospital diet alone
- One study (n=28) showed a supplement of 500kcal, 34g protein, 6g arginine, 500mg vitamin C, 18mg zinc in addition to a standard hospital diet may be more clinically effective than standard hospital diet alone for complete healing of pressure ulcers (very low quality).
- One study (n=28) reported a supplement of 500kcal, 34g protein, 6g arginine, 500mg vitamin C, 18mg zinc in addition to a standard hospital diet may be more clinically effective and a standard hospital diet alone for reduction in ulcer size (%). The mean for the supplement was 72% and 45% for the standard hospital diet. No estimate of precision could be derived (very low quality).
- One study (n=28) showed a supplement of 500kcal, 34g protein, 6g arginine, 500mg vitamin C, 18mg zinc in addition to a standard hospital diet may be more clinically effective than standard hospital diet alone for reduction in ulcer size (cm2) (very low quality).
- One study (n=28) showed a supplement of 500kcal, 34g protein, 6g arginine, 500mg vitamin C, 18mg zinc in addition to a standard hospital diet is potentially more clinically effective than standard hospital diet alone for reducing mean PUSH tool scores (very low quality).
- One study (n=28) showed a standard hospital diet alone may be more clinically beneficial than a supplement of 500kcal, 34g protein, 6g arginine, 500mg vitamin C, 18mg zinc in addition to a standard hospital diet for reducing all-cause mortality (very low quality).
- No evidence was found for the following outcomes:
- Time to complete healing (time to event data)
- Rate of complete healing
- Rate in change of size of ulcer
- Pain (wound-related)
- Time in hospital
- Patient acceptability of supplements
- Side effects (nausea, vomiting, diarrhoea)
- Health-related quality of life
5.2.5.1.2. Supplement of 250kcal, 28.4g carbohydrates, 20g protein, 3g arginine, 7g fat, vitamins, minerals in addition to a standard hospital diet versus standard hospital diet and placebo
- One study (n=43) showed there may be no clinical difference between a supplement of 250kcal, 28.4g carbohydrates, 20g protein, 3g arginine, 7g fat, vitamins, minerals in addition to a standard hospital diet and a standard hospital diet and placebo for reducing mean PUSH tool score, the direction of the estimate of effect favoured the supplement. Imprecision could not be derived. (very low quality).
- One study (n=43) showed there may be no clinical difference between a supplement of 250kcal, 28.4g carbohydrates, 20g protein, 3g arginine, 7g fat, vitamins, minerals in addition to a standard hospital diet and a standard hospital diet and placebo for rate of reduction in ulcer size (cm2/week). The direction of the estimate of effect favoured the standard hospital diet and placebo. Imprecision could not be derived, (very low quality).
- One study (n=43) showed a supplement of 250kcal, 28.4g carbohydrates, 20g protein, 3g arginine, 7g fat, vitamins, minerals in addition to a standard hospital diet is potentially more clinically harmful than a standard hospital diet and placebo for adverse events related to the product (very low quality).
- One study (n=43) showed a supplement of 250kcal, 28.4g carbohydrates, 20g protein, 3g arginine, 7g fat, vitamins, minerals in addition to a standard hospital diet may be more clinically harmful than a standard hospital diet and placebo for adverse events related to the product (very low quality).
- One study (n=43) showed a supplement of 250kcal, 28.4g carbohydrates, 20g protein, 3g arginine, 7g fat, vitamins, minerals in addition to a standard hospital diet may be more clinically harmful compared to a standard hospital diet and placebo for diarrhoea (very low quality).
- One study (n=43) showed there may be no clinical difference between a supplement of 250kcal, 28.4g carbohydrates, 20g protein, 3g arginine, 7g fat, vitamins, minerals in addition to a standard hospital diet compared to a standard hospital diet and placebo for nausea. The direction of the estimate of effect favoured the supplement (very low quality).
- One study (n=43) showed there may be no clinical difference between a supplement of 250kcal, 28.4g carbohydrates, 20g protein, 3g arginine, 7g fat, vitamins, minerals in addition to a standard hospital diet compared to a standard hospital diet and placebo for vomiting. The direction of the estimate of effect favoured the supplement (very low quality).
- No evidence was found for the following outcomes:
- Time to complete healing (time to event data)
- Rate of complete healing
- Reduction in size of ulcer and volume of ulcer.
- Proportion of people completely healed
- Pain (pressure ulcer related)
- Time in hospital
- Patient acceptability of supplements
- Mortality (all-cause)
- Health-related quality of life
5.2.5.1.3. Supplement of 500kcal, 18g protein, 0g fat, 72mg vitamin C and 7.5mg zinc in addition to a standard hospital diet versus standard hospital diet
- One study (n=11) showed there may be no clinical difference between a supplement of 500kcal, 18g protein, 0g fat, 72mg vitamin C and 7.5mg zinc in addition to a standard hospital diet and a standard hospital diet for reducing PUSH tool scores by week 3. The direction of the estimate of effect favoured the supplement (very low quality).
- No evidence was found for the following outcomes:
- Time to complete healing (time to event data)
- Rate of complete healing
- Rate in change of size of ulcer
- Reduction in size of ulcer and volume of ulcer.
- Proportion of people completely healed
- Pain (pressure ulcer-related)
- Time in hospital
- Patient acceptability of supplements
- Side effects (nausea, vomiting, diarrhoea)
- Mortality (all-cause)
- Health-related quality of life
5.2.5.1.4. Supplement of 500kcal, 21g protein, 0g fat, 500mg vitamin C, 30mg zinc and 9g arginine and standard hospital diet versus standard hospital diet
- One study (n=11) showed a clinical benefit of a supplement of 500kcal, 21g protein, 0g fat, 500mg vitamin C, 30mg zinc and 9g arginine for reducing PUSH tool scores and standard hospital diet compared to a standard hospital diet alone (very low quality).
- No evidence was found for the following outcomes:
- Time to complete healing (time to event data)
- Rate of complete healing
- Rate in change of size of ulcer
- Reduction in size of ulcer and volume of ulcer.
- Proportion of people completely healed
- Pain (pressure ulcerrelated)
- Time in hospital
- Patient acceptability of supplements
- Side effects (nausea, vomiting, diarrhoea)
- Mortality (all-cause)
- Health-related quality of life
5.2.5.1.5. Supplement of 500kcal, 21g protein, 0g fat, 500mg vitamin C, 30mg zinc and 9g arginine versus supplement of 500kcal, 18g protein, 0g fat, 72mg vitamin C and 7.5mg zinc in addition to standard hospital diet
- One study (n=11) showed a clinical benefit of a supplement of 500kcal, 21g protein, 0g fat, 500mg vitamin C, 30mg zinc and 9g arginine for reducing PUSH tool scores compared to a supplement of 500kcal, 18g protein, 0g fat, 72mg vitamin C and 7.5mg zinc in addition to a standard hospital diet (very low quality).
- No evidence was found for the following outcomes:
- Time to complete healing (time to event data)
- Rate of complete healing
- Rate in change of size of ulcer
- Reduction in size of ulcer and volume of ulcer.
- Proportion of people completely healed
- Pain (pressure ulcer related)
- Time in hospital
- Patient acceptability of supplements
- Side effects (nausea, vomiting, diarrhoea)
- Mortality (all-cause)
- Health-related quality of life
5.2.5.1.6. Supplement of 4.38g protein, 2.23g fat, 15.62g carbohydrate, minerals and vitamins (per 100ml) and standard hospital diet versus standard hospital diet
- One study (n=50) showed there is potentially a clinical benefit for a supplement of 4.38g protein, 2.23g fat, 15.62g carbohydrate, minerals and vitamins (per 100ml) and standard hospital diet for complete healing of pressure ulcers when compared to a standard hospital diet (very low quality).
- One study (n=50) showed there is no clinical difference between a supplement of 4.38g protein, 2.23g fat, 15.62g carbohydrate, minerals and vitamins (per 100ml) and standard hospital compared to a standard hospital diet for reducing the mean ulcer size (cm2) (low quality).
- One study (n=50) showed a supplement of 4.38g protein, 2.23g fat, 15.62g carbohydrate, minerals and vitamins (per 100ml) and standard hospital diet may be clinically harmful for study-related adverse events when compared to a standard hospital diet (very low quality).
- No evidence was found for the following outcomes:
- Time to complete healing (time to event data)
- Rate of complete healing
- Rate in change of size of ulcer
- Pain (pressure ulcer related)
- Time in hospital
- Patient acceptability of supplements
- Mortality (all-cause)
- Health-related quality of life
5.2.5.1.7. Very high protein dietary formula (92 to 150gms/day) versus high protein dietary formula (57 to 90gms/day)
- One study (n=12) showed a very high protein dietary formula (92 to 150gms/day) is potentially more clinically effective for complete healing of pressure ulcers when compared to a high protein dietary formula (57 to 90gms/day) in long-term tube-fed people (very low quality).
- One study (n=12) reported a very high protein dietary formula (92 to 150gms/day) may be more clinically effective for reducing mean surface area (%) of pressure ulcers when compared to a high protein dietary formula (57 to 90gms/day) in long-term tube-fed people. No estimate of precision could be derived (very low quality).
- No evidence was found for the following outcomes:
- Time to complete healing (time to event data)
- Rate of complete healing
- Rate in change of size of ulcer
- Pain (pressure ulcer related)
- Time in hospital
- Patient acceptability of supplements
- Side effects (nausea, vomiting, diarrhoea)
- Mortality (all-cause)
- Health-related quality of life
5.2.5.1.8. Supplement of 1000mg ascorbic acid in addition to standard hospital diet versus hospital diet and placebo
- Two studies (n=108) showed there may be no clinical difference between a supplement of 1000mg ascorbic acid in addition to standard hospital diet and hospital diet and placebo for complete healing of pressure ulcers. The direction of estimate of effect favoured the standard hospital diet and placebo group (very low quality).
- One study (n=85) reported there may be no difference between a supplement of 1000mg ascorbic acid in addition to standard hospital diet and hospital diet and placebo for time to complete healing of pressure ulcers (very low quality).
- One study (n=20) showed a hospital diet and placebo were more clinically effective than a supplement of 1000mg ascorbic acid in addition to standard hospital diet for reducing mean surface area (%) (very low quality).
- One study (n=88) reported there is possibly no clinical difference between a supplement of 1000mg ascorbic acid in addition to standard hospital diet and hospital diet and placebo for rate of mean reduction in ulcer size (cm2/week). The direction of the estimate of effect favoured either intervention (very low quality).
- One study (n=88) reported there is possibly no clinical difference between a supplement of 1000mg ascorbic acid in addition to standard hospital diet and hospital diet and placebo for rate of mean reduction in ulcer size (%). The direction of the estimate of effect favoured either intervention (very low quality).
- One study (n=88) reported there may be no clinical difference between a supplement of 1000mg ascorbic acid in addition to standard hospital diet and hospital diet and placebo for rate of mean reduction in ulcer size (cm2/week/%). The direction of the estimate of effect favoured either intervention (very low quality).
- One study (n=88) reported there is potentially no clinical difference between a supplement of 1000mg ascorbic acid in addition to standard hospital diet and hospital diet and placebo for rate of mean reduction in ulcer volume (cm2/week/%). The direction of the estimate of effect favoured the supplement (very low quality).
- One study (n=88) reported there is potentially no clinical difference between a supplement of 1000mg ascorbic acid in addition to standard hospital diet and hospital diet and placebo for rate of mean healing velocity. The direction of the estimate of effect favoured the supplement (very low quality).
- One study (n=88) showed there may be no clinical difference between a supplement of 1000mg ascorbic acid in addition to standard hospital diet and hospital diet and placebo for mortality. The direction of the estimate of effect favoured the supplement (very low quality).
- No evidence was found for the following outcomes:
- Time to complete healing (time to event data)
- Rate of complete healing
- Pain (pressure ulcer related)
- Time in hospital
- Patient acceptability of supplements
- Side effects (nausea, vomiting, diarrhoea)
- Health-related quality of life
5.2.5.1.9. Zinc sulphate versus placebo
- One study (n=13) showed zinc sulphate may be more clinically effective for complete healing than placebo (very low quality).
- One study (n=13) showed there may be no clinical difference between zinc sulphate and placebo for mean reduction in pressure ulcer volume. The direction of the estimate of effect favoured zinc sulphate (very low quality).
- No evidence was found for the following outcomes:
- Time to complete healing (time to event data)
- Rate of complete healing
- Rate in change of size of ulcer
- Pain (pressure ulcer related)
- Time in hospital
- Patient acceptability of supplements
- Side effects (nausea, vomiting, diarrhoea)
- Mortality (all-cause)
- Health-related quality of life
5.2.5.1.10. Supplement of concentrated, fortified, collagen protein hydrolysate versus placebo
- One study (n=71) showed there is potentially no clinical difference between a supplement of concentrated, fortified, collagen protein hydrolysate when compared to placebo for reducing PUSH tool scores. The direction of the estimate of effect favours placebo (mean) (very low quality).
- One study (n=71) showed there is potentially no clinical difference between a supplement of concentrated, fortified, collagen protein hydrolysate when compared to placebo for reducing PUSH tool scores (%). The direction of the estimate of effect favours placebo (very low quality).
- One study (n=89) showed there may be no clinical difference between a supplement of concentrated, fortified, collagen protein hydrolysate when compared to placebo for all-cause mortality. The direction of the estimate of effect favoured the placebo (very low quality).
- No evidence was found for the following outcomes:
- Time to complete healing (time to event data)
- Rate of complete healing
- Rate in change of size of ulcer
- Reduction in size of ulcer and volume of ulcer.
- Proportion of people completely healed
- Pain (pressure ulcer related)
- Time in hospital
- Patient acceptability of supplements
- Side effects (nausea, vomiting, diarrhoea)
- Health-related quality of life
5.2.5.1.11. Ornithine alpha-ketoglutarate versus placebo
- One study (n=160) showed there is potentially no clinical difference between ornithine alpha-ketoglutarate and placebo for rate of complete healing of heel pressure ulcers (grade 2 or 3 pressure ulcers). The direction of the estimate of effect favoured ornithine alpha-ketoglutarate (very low quality).
- One study (n=160) showed no clinical difference between ornithine alpha-ketoglutarate and placebo for mean reduction in size (% reduction). The direction of the estimate of effect favoured ornithine alpha-ketoglutarate (very low quality).
- One study (n=160) showed no clinical difference between ornithine alpha-ketoglutarate and placebo for mean reduction in size (mean surface area reduction). The direction of the estimate of effect favoured ornithine alpha-ketoglutarate (very low quality).
- One study (n=160) showed no clinical difference between ornithine alpha-ketoglutarate and placebo for 90% reduction in heel pressure ulcers. The direction of the estimate of effect favoured ornithine alpha-ketoglutarate (low quality).
- One study (n=165) showed there may be no clinical difference between ornithine alpha-ketoglutarate and placebo for mortality. The direction of the estimate of effect favoured the placebo (very low quality).
- No evidence was found for the following outcomes:
- Time to complete healing (time to event data)
- Rate in change of size of ulcer
- Proportion of people completely healed
- Pain (pressure ulcer related)
- Time in hospital
- Patient acceptability of supplements
- Side effects (nausea, vomiting, diarrhoea)
- Health-related quality of life
5.2.5.1.12. Arginine 4.5g and Arginine 9g
- One study (n=23) reported there may be no difference between arginine 4.5g and arginine 9g for reducing PUSH tool scores. The direction of estimate of effect favoured arginine 4.5g. The clinical importance is unknown (very low quality).
- One study (n=unclear) reported there may be no difference between arginine 4.5g in malnourished patient and arginine 9g in malnourished people for reducing PUSH tool scores. The direction of estimate of effect favoured arginine 9g. The clinical importance is unknown (very low quality).
- One study (n=unclear) reported there may be no difference between arginine 4.5g in non-malnourished patient and arginine 9g in non-malnourished people for reducing PUSH tool scores. The direction of estimate of effect favoured arginine 9g. The clinical importance is unknown (very low quality).
- No evidence was found for the following outcomes:
- Time to complete healing (time to event data)
- Rate of complete healing
- Rate in change of size of ulcer
- Reduction in size of ulcer and volume of ulcer.
- Proportion of people completely healed
- Pain (pressure ulcer related)
- Time in hospital
- Patient acceptability of supplements
- Side effects (nausea, vomiting, diarrhoea)
- Mortality (all-cause)
- Health-related quality of life
5.2.5.1.13. Nutritional formula with fish oil versus macronutrients and an isocaloric control formula
- One study (n=40) reported there may be no difference between a nutritional formula with fish oil and macronutrients and an isocaloric control formula for increasing mean PUSH tool scores. The direction of estimate of effect favoured the isocaloric control formula. The clinical importance is unknown (very low quality).
- No evidence was found for the following outcomes:
- Time to complete healing (time to event data)
- Rate of complete healing
- Rate in change of size of ulcer
- Reduction in size of ulcer and volume of ulcer.
- Proportion of people completely healed
- Pain (pressure ulcer related)
- Time in hospital
- Patient acceptability of supplements
- Side effects (nausea, vomiting, diarrhoea)
- Mortality (all-cause)
- Health-related quality of life
5.2.5.2. Economic (adults)
- One cost-effectiveness analysis from Japan found that nutritional supplementation dominates standard hospital diet in the treatment of pressure ulcers (reduced costs and fewer pressure ulcer days).This study was deemed to be partially applicable and had potentially serious limitations.
5.2.5.3. Clinical (neonates, infants, children and young people)
No evidence was identified.
5.2.5.4. Economic (neonates, infants, children and young people)
No evidence was identified.
5.3. Recommendations and link to evidence
5.3.1. Adults
| Recommendations |
|
|---|---|
| Relative values of different outcomes | The GDG identified that the proportion of people with pressure ulcers completely healed, time to complete healing, reduction in size and volume and rate of reduction in size and volume of pressure ulcers were the most critical outcomes to inform decision making. The following were considered to be important outcomes; side effects, health related quality of life, time in hospital, mortality and acceptability of treatment. |
| Trade-off between clinical benefits and harms | The evidence was limited. Thirteen studies were identified but each of these looked at different supplement mixes. There was no strong evidence of a change in critical or important outcomes associated with the use of nutritional supplementation. A nutritional supplement of 500 calories, 34g protein, 6g arginine, 500mg vitamin C, 18mg zinc showed some benefit for complete healing, a higher mean reduction in the size of pressure ulcer and lower mortality rate. It was unclear if the population of this study had any nutritional deficiency. A nutritional supplement of 250 calories, 28.4g carbohydrates, 20g protein, 3g arginine, 7g fat, vitamins and minerals showed no benefits, showed a clinical harm from adverse events, including a higher incidence of diarrhoea, in a non-malnourished population. A nutritional supplement of 500 calories, 18g protein, 0g fat, 72mg vitamin C and 7.5mg zinc showed no benefit in PUSH tool scores. The PUSH tool monitors the length, width, amount of exudate and tissue type of a pressure ulcer, and is a method of predicting pressure ulcer healing in an elderly or spinal injured population. It was not clear if the population of this study had any nutritional deficiency. A nutritional supplement including 500 calories, 21g protein, 0g fat, 500mg vitamin C, 30mg zinc and 9g arginine showed a lower PUSH score (with lower being more beneficial). These supplements were all in addition to the standard hospital diet and compared to the standard hospital diet. When the 2 supplements were compared there to each other there was a clinical benefit of the supplement which included 500 calories, 21g protein, 0g fat, 500mg vitamin C, 30mg zinc and 9g arginine for reduction in PUSH tool scores. A study of tube fed people who received 4.38g protein, 2.23g fat, 15.6g carbohydrate, minerals and vitamins per 100ml in addition to the standard hospital diet showed a higher incidence of complete healing in the supplement group. However, the group also had a higher incidence of adverse events. A very high protein formula (92 to 150gm/day) given in addition to the standard hospital diet was clinically beneficial compared to an additional high protein formula (57g to 90 g per day) in long-term tube-fed people. However, it was unclear if the population of this study had any nutritional deficiency and the GDG were concerned that the clinical benefits were dependant on the protein content of the hospital diet. The study also had a very small sample size. Two studies were meta-analysed for 1000mg ascorbic acid supplementation in addition to the standard hospital diet in a population of people whom mostly had nutritional deficiencies. No difference was found except for a higher reduction in the surface area of the pressure ulcer in the group who received nutritional supplementation. When zinc sulphate 220mg was compared to placebo in a population of people with spinal cord injuries, in whom it was unclear if there was any nutritional deficiency, there was less complete healing of pressure ulcers in the zinc sulphate group. Yet, another study of zinc sulphate 200mg 3 times per day compared to placebo (lactose) showed a higher mean reduction in pressure ulcer volume. The GDG were uncertain of the clinical benefit of this outcome, particularly as these studies had very small sample sizes. There were no differences between a concentrated, fortified, collagen protein hydrolysate nutritional supplement compared to placebo, in an overweight population with no indication of nutritional deficiency. There were no differences for ornithine alpha-ketoglutarate compared to placebo and it was unclear if the population were nutritionally deficient. There were no differences reported between arginine 4.5g and arginine 9g for reducing PUSH tool scores. The GDG considered there to be insufficient evidence to support the use of nutritional supplements for people with press The GDG developed a corresponding recommendation to highlight that people who have a pressure ulcer should receive an assessment to identify the presence of any nutritional deficiency. The GDG considered that all people who have a pressure ulcer would benefit from maintaining an adequate nutritional status and information should be provided to these groups to help encourage this. |
| Economic considerations | The GDG considered 1 economic analysis from Japan which found that nutritional supplementation dominated a standard hospital diet amongst tube-fed, bed-ridden people with stage 3 to 4 pressure ulcers. However it was unclear whether the paitents were nutritionally deficient. The applicability of this study is limited as the study was conducted in Japan. The GDG discussed that the correction of nutritional deficiency is best practice and is an issue of patient safety. The GDG agreed that it was important for people to be provided with adequate nutrition, as the correction of nutritional deficiency has benefits which extend far beyond the treatment of pressure ulcers. The GDG considered the UK costs of nutritional supplements and agreed that whilst the list prices documented were not negligible, the actual prices paid for nutritional supplements were very low especially in hospitals, and the correction of nutritional deficiency can be achieved at low cost particularly with a ‘food first’ approach. The GDG felt there was limited additional benefit to providing extra nutritional supplementation where nutritional status was adequate and intake was meeting any additional losses. It was felt that, given the (albeit small) costs, it would not be cost-effective to do so. The GDG discussed the resource implications of nutritional assessment by a dietician or healthcare professional with the necessary skills and competencies. It was recognised that there is an economic implication associated with healthcare professional time, but that this was necessary in order to promote the efficient use of resources; that is, it is necessary to establish an individual's nutritional status in order to plan treatment accordingly. The GDG agreed that the cost of assessing the patient would be offset by efficiencies gained through appropriate treatment strategies, leading to reduced treatment costs overall, and improvements in quality of life. The additional costs of providing information are thought to be small, and justified by potentially large gains. |
| Quality of evidence | Overall, the quality of evidence for the effects of nutritional supplements for the management of pressure ulcers was of low quality because of study limitations. The GDG acknowledged that evidence was often difficult to interpret as nutritional interventions are rarely used in isolation and in clinical practice, are used with appropriate dressings, repositioning and pressure redistributing devices. There was also limited information about liquid losses from the pressure ulcer that would need replacing such as levels of exudative loss. The GDG highlighted that studies of nutritional supplementation do not always consider the consumption of supplements and overall calorie intake. These recommendations were based on GDG informal consensus after reviewing the evidence for nutritional supplements. |
| Other considerations | The GDG clearly stated that it was important people were provided with adequate nutrition, regardless of the effectiveness of nutritional supplementation in treating pressure ulcers. However, if people did not have a nutritional deficiency then there was limited evidence for additional nutritional supplementation as long as ongoing losses in energy and protein from exudate are also met. The GDG felt that people should be offered a nutritional assessment from a qualified practitioner so that a person's nutritional status can be determined. They also noted the importance of giving peopleand carers information and advice regarding nutrition so that they can ensure they are meeting their nutritional requirements and replacing any losses from the pressure ulcer. The GDG highlighted the importance of ensuring that people who are nutritionally deficient should be provided with appropriate nutritional supplementation to provide the correct level of nutrition, in line with NICE clinical guideline 32 'Nutrition support in adults: Oral nutrition support, enteral tube feeding and parenteral nutrition130. Recommendations on the provision of information to patients and carers can be found in NICE clinical guideline 138 ‘Patient experience in adult NHS services: improving the experience of care for people using adult NHS services.’ |
| Recommendations |
|
|---|---|
| Relative values of different outcomes | The GDG identified that the proportion of people with pressure ulcers completely healed, time to complete healing, reduction in size and volume and rate of reduction in size and volume of pressure ulcers were the most critical outcomes to inform decision making. Side effects, health related quality of life, time in hospital, mortality and acceptability of treatment were considered important outcomes. |
| Trade off between clinical benefits and harms | No evidence was found for hydration for the treatment of pressure ulcers. The GDG felt that if a person's hydration is adequate then they would not require a hydration strategy to alter how they are being hydrated. The GDG also considered that it was unlikely that there would be any benefits to the provision of additional fluids in people with an adequate hydration status and that it was possible that the provision of additional fluids could result in harms to the individual. The GDG noted that medical opinion should be sought by any healthcare professional that has identified a person has less than adequate hydration status. |
| Economic considerations | Extra resources would be required to provide additional hydration strategies to individuals with adequate hydration. Given that the GDG felt that such additional strategies were not required, it would not be cost-effective to offer these. |
| Quality of evidence | This recommendation was based on GDG consensus as there was no evidence found. |
| Other considerations | There were no other considerations. |
5.3.2. Neonates, infants, children and young people
| Recommendations |
|
|---|---|
| Relative values of different outcomes | The GDG identified that the proportion of people with pressure ulcers completely healed, time to complete healing, reduction in size and volume and rate of reduction in size and volume of pressure ulcers were the most critical outcomes to inform decision making. |
| Trade-off between clinical benefits and harms | The GDG developed the statement that ‘Healthcare professionals should offer neonates, infants, children and young people with pressure ulcers a suitable age related nutritional assessment’ which was accepted during round 1 of the Delphi consensus survey at a consensus level of 100%. The GDG therefore used the statement to develop a recommendation that all neonates, infants, children and young people who have developed a pressure ulcer should have a suitable age related nutritional assessment. The GDG considered that it was important for healthcare professionals to identify whether any child who has had a pressure ulcer has an adequate nutritional intake, as correction of nutritional deficiency may improve the ability of the body to heal. The GDG considered that there is likely to be significant benefits to providing a nutritional assessment to this population, in the subsequent ability to heal, as well as other related improvements associated with identifying nutritional deficiencies. The GDG felt that any resource implications of providing an assessment would be outweighed by the subsequent benefits of identifying deficiency, in terms of both pressure ulcer treatment and other related health outcomes. Comments received from the Delphi consensus panel provided further support for the provision of a nutritional assessment for all people who have developed a pressure ulces, highlighting that the loss of protein from the wound may result in a decreased ability to heal and suboptimal nutritional status. |
| Economic considerations | There may be cost-implications of offering a nutritional assessment to neonates, infants, children and young people with pressure ulcers. However, such assessment will promote efficient allocation of resources, as it will allow nutritional supplementation to be targeted towards those who require it most. The GDG agreed that the cost of assessing the patient would be offset by efficiencies gained through appropriate treatment strategies, leading to reduced treatment costs overall, and improvements in quality of life. The GDG noted that nutritional status was a crucial issue of patient safety, and would have potentially large quality of life gains which would extend far beyond the treatment of pressure ulcers. |
| Quality of evidence | No evidence was identified on the use of nutritional interventions or hydration strategies for the treatment of pressure ulcers (randomised trials or cohort studies) in neonates, infants, children or young people. The GDG therefore used formal consensus methods (modified Delphi consensus) to develop statements to help inform the recommendation. One statement was included in Round 1 of the Delphi consensus survey, where it reached 100% consensus agreement. |
| Other considerations | Members of the Delphi consensus panel highlighted that healthcare professionals should take into account weight and ethnicity when assessing nutritional status. |
| Recommendations |
|
|---|---|
| Relative values of different outcomes | The GDG identified that the proportion of people with pressure ulcers completely healed, time to complete healing, reduction in size and volume and rate of reduction in size and volume of pressure ulcers were the most critical outcomes to inform decision making. |
| Trade-off between clinical benefits and harms | The GDG developed 2 statements for inclusion in the Delphi consensus survey: ‘Healthcare professionals should offer neonates, infants, children and young people with pressure ulcers, who are nutritionally deficient, correction of their nutritional deficiency’ and ‘Healthcare professionals should ensure that neonates, infants, children and young people with pressure ulcers have a diet that maintains adequate nutritional status, including that required for growth and wound healing’. The former statement was agreed in Round 1 of the Delphi consensus, at a consensus agreement level of 94%. The latter was also agreed in Round 1 of the Delphi consensus, at a level of 99%. The GDG agreed that for neonates, infants, children and young people who have pressure ulcers and who received a nutritional assessment identifing a nutritional deficiency, healthcare professionals should aim to correct the deficiency. The GDG considered that there were benefits in terms of pressure ulcer treatment and other health related outcomes to the correction of nutritional deficiency and that any harms, for example possible resource implications, were likely to be outweighed. A recommendation was therefore developed to highlight that any neonate, infant, child or young person who has a pressure ulcer should be provided with a diet which provides suitable nutrition to allow for growth and healing, as these requirements may be increased in these individuals. Qualitative responses gathered during Round 1 of the survey highlighted the importance of correcting a nutritional deficiency in conjunction with someone with appropriate expertise, namely a dietitian, with experience of working with the relevant population (either a paediatric dietitian or a dietitian with appropriate experience of working with neonates, infants, children or young people). The GDG felt that this was appropriate and that involving a paediatric dietitian was likely to be necessary as many healthcare professionals would not have relevant expertise to provide suitable nutritional supplementation. A recommendation was therefore developed to highlight that before offering correction of a nutritional deficiency in neonates, infants, children and young people with pressure ulcers, there should be a discussion with a dietitian with suitable experience of working with these populations. The GDG also discussed whether neonates, infants, children and young people with an adequate nutritional status, but who have developed a pressure ulcer, should be offered further nutritional supplementation, specifically for treatment of the pressure ulcer. The GDG felt that there should be discussed with a dietitian before providing further supplementation in this situation. A recommendation was therefore developed to reflect this. |
| Economic considerations | The GDG considered the UK costs of nutritional supplements and agreed that whilst the list prices documented were not negligible, the actual prices paid for nutritional supplements were very low, and correction of nutritional deficiency can be achieved at low cost. Discussion with a suitable dietician will allow the correct nutrients to be provided, and is expected to promote clinically and cost-effective treatment. The GDG discussed that ensuring neonates, infants, children and young people are offered a diet adequate nutrition for growth and healing is best practice and is an issue of patient safety. The GDG highlighted that provision of adequate nutrition has benefits which extend far beyond treatment of pressure ulcers. |
| Quality of evidence | No evidence was identified on the use of nutritional interventions or hydration strategies for the treatment of pressure ulcers(randomised trials or cohort studies) in neonates, infants, children or young people. The GDG therefore used formal consensus methods (modified Delphi consensus) to develop statements to help inform the recommendation. Two statements were included in Round 1 of the survey, where they reached 94% and 99% consensus agreement. |
| Other considerations | Panel members highlighted that some clinical conditions or situations (for example, those entering end of life care) may not benefit from the correction of nutritional deficiency and in these situations, care should be considered on a case by case basis. |
| Recommendations |
|
|---|---|
| Relative values of different outcomes | The GDG identified that the proportion of people with pressure ulcers completely healed, time to complete healing, reduction in size and volume and rate of reduction in size and volume of pressure ulcers were the most critical outcomes to inform decision making. |
| Trade-off between clinical benefits and harms | The GDG developed 1 statement for inclusion in the Delphi consensus survey: ‘Healthcare professionals should not offer hydrational supplementation to neonates, infants, children or young people at risk of developing pressure ulcers, where hydrational intake is adequate for developmental age and associated fluid losses. The statement was not agreed in Round 1 of the Delphi consensus. The GDG discussed the qualitative responses received during Round 1 and identified that there was general agreement on the principles underlying the statement. The GDG therefore amended the statement to clarify that the statement refers to any supplementation specifically for pressure ulcer prevention in those neonates, infants, children and young people who have sufficient hydration. The statement was therefore amended to ‘Healthcare professionals should ensure that neonates, infants, children and young people have adequate hydration for age, growth and healing. Where there is any doubt, seek medical advice.’ The statement was included in Round 2 of the Delphi consensus and was accepted by the panel. Qualitative responses received during Round 2 of the survey generally agreed that the statement highlighted that over-hydration was often considered to be a problem. Comments also noted that any assessment of fluid balance should account for any additional fluid requirements needed for wound healing. As such, the GDG discussed these issues and felt that 2 recommendations were needed, to ensure that neonates, infants, children and young people who have developed pressure ulcers are offered an assessment of fluid balance and to highlighted that anyone who has a pressure ulcer is provided with adequate hydration to account for their age, growth and healing. The GDG felt that where inadequate hydration was identified in an assessment, all healthcare professionals should seek further advice from a suitable healthcare professional, likely to be a medical doctor. The GDG therefore amended the recommendation to reflect this and did not feel that it was appropriate to develop a recommendation on the correction of any fluid deficiency. |
| Economic considerations | There may be cost-implications of assessing fluid balance and ensuring adequate hydration in those with pressure ulcers. However, such assessment will promote efficient allocation of resources, as it will allow hydration strategies to be targeted towards those who require them. In addition, the GDG discussed that ensuring adequate hydration for growth and healing is best practice and is an issue of patient safety, and would have potentially large quality of life gains which would extend far beyond the treatment of pressure ulcers. |
| Quality of evidence | No evidence was identified on the use of nutritional interventions or hydration strategies for the treatment of pressure ulcers (randomised trials or cohort studies) in neonates, infants, children or young people. The GDG therefore used formal consensus methods (modified Delphi consensus) to develop statements to help inform the recommendation. 1 statement was included in Round 1 of the Delphi consensus survey that reached 47% consensus agreement. The statement was amended and included in Round 2 of the survey, where it was agreed at a consensus level of 97%. |
| Other considerations | Recommendations on the use of intravenous fluids in neonates, infants, children and young people will be included in the NICE clinical guideline ‘Intravenous fluids in children’, currently in development. |
- Nutrition and hydration - The Prevention and Management of Pressure Ulcers in Pr...Nutrition and hydration - The Prevention and Management of Pressure Ulcers in Primary and Secondary Care
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