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Healing pressure ulcers/injuries: Efficacy and cost effectiveness of nutrition interventions in the treatment of pressure ulcer/injuries

Do specific nutrition interventions improve healing of pressure ulcer/injuries compared to standard nutritional care in hospital inpatients

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000859583
Acronym
NIPIHR
Enrollment
131
Registered
2015-08-18
Start date
2013-01-10
Completion date
2014-05-30
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Multi-centre study investigating whether specific nutritional interventions improve pressure injury healing compared to standard care. Consenting eligible patients with pressure injuries stage 2 or greater at 5 south East Queensland hospitals will be randomized to receive standard ward based nutrition, intensive dietetic nutrition intervention or prescription of a wound healing formula. Data will be collected at baseline and weekly including a range of relevant demographic, nutritional and pressure ulcer measurements.

Interventions

Patients will be randomized to one of the following groups: a. Standard nutritional care by clinical team that may or may not include dietetic intervention, high protein/energy diet and/or nutritional supplement. b. intensive individualised nutritional intervention provided by an associate investigator site dietitian aimed to meet estimated nutritional requirements of patients on a daily basis, which will likely include a high protein/energy diet and supplements (but not including wound healin

Patients will be randomized to one of the following groups: a. Standard nutritional care by clinical team that may or may not include dietetic intervention, high protein/energy diet and/or nutritional supplement. b. intensive individualised nutritional intervention provided by an associate investigator site dietitian aimed to meet estimated nutritional requirements of patients on a daily basis, which will likely include a high protein/energy diet and supplements (but not including wound healing supplements). Estimated nutritional requirements will be determined at 1.2g protein/kg and 30 KCal/kg per day. Patient will be reviewed by a dietitian for appox 20-30 minutes 3-4 times per week to assess intake and modify nutritional care plan if required. c. standard care as described above, plus the provision of a nutritional supplements developed specifically to enhance wound healing ie complete oral liquid nutritional formulas enriched with Arginine, Vitamin C and Zinc. Supplements will be prescribed based on manufacturers recommendations ie 2 or 3 200-250ml tetrapaks daily. Patients will be given a choice of two different brands of supplements based on their preferences. Supplement A contains per 200ml bottle: 20g protein (of which arginine is 3.0g), 250 KCal, 9 mg Zinc, 250 mg Vitamin C Recommended dose is 3 200ml bottles per day. Supplement B contains per 250ml tetrapak: 21 g protein (of which arginine is 4.5g), 250 KCal, 15 mg Zinc, 250 mg Vitamin C. Recommended dose is 2 250 ml tetrapaks per day. Duration of interventions will be for the duration of patient hospital stay. Compliance with interventions will be monitored through data collection of food and fluid (including supplement) intake.

Sponsors

Royal Brisbane & Women's Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Inpatients (adults) of 5 acute hospitals with pressure ulcer/injury stage 2 or greater.

Exclusion criteria

Stage 1 of deep tissue pressure injury Patients unable to receive nutrition via enteral route Patients inappropriate for intensive nutrition support ie palliative care Patients unable to follow nutrition support advise ie cognitively impaired Pregnancy Previously recruited to study

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026