Wounds and InjuriesINCANCT06078488
Individualized Nutritional Care Bundle for Home Nursing Patients With Pressure Injuries.
A study testing Individualized and Protocolized Nutritional Care Bundle in people with Wounds and Injuries and Malnutrition, run by Changi General Hospital at 1 site in Singapore.
Trial summary
Objective: To evaluate the impact of an individualized nutrition intervention package on pressure injury healing rates, prevention of new pressure injuries, complications, quality of life, and cost-effectiveness in adult on home nursing care with pressure injuries staged II and above in Singapore. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Wounds and Injuries, Malnutrition, Nutritional Deficiency
- What is being tested?
- Individualized and Protocolized Nutritional Care Bundle
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteSingapore
- Study dates
- 23 Oct 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (age more than or equal to 21 years, any gender).
- Stage II, III, IV, and unstageable pressure injuries. For patients with multiple wounds, we will include all the pressure injuries (stages II and above) in the investigation.
- Able to provide written informed consent (patient or legal guardian).
- Be on oral and/or enteral nutritional support.
Who cannot join
- Known palliative care individuals with a lifespan of </= 3 months,
- Known septicaemia,
- Poorly controlled diabetes (glycated haemoglobin level > 8.5%17),
- Individuals on strict fluid restriction if the provision of additional oral or enteral nutrition supplements leads to excess intake, for the following conditions:
- Advanced renal disease not on dialysis (KDIGO [21, 22] Stage G4 with an estimared Glomerular Filtration Rate (eGFR) of 15-29 ml/min/1.73m2 and Stage G5 with an eGFR less than 15 ml/min/1.73m2
- Advanced decompensated alcoholic and non-alcoholic liver cirrhosis
- Heart failure with reduced ejection fraction requiring fluid restriction less than 800ml per day,
- 6. Previous (last chemotherapy or radiotherapy less than one year ago) or current neoplastic disease 7. Currently on immunosuppressive therapy, 8. Known allergy reaction to L-arginine, phenylketonuria 9. Presence of an infected wound (if it is the only pressure injury present on the participant) 10. Presence of untreated diagnosed osteomyelitis.
Trial locations and contacts
1 site in 1 country.
Precilla Lai, MSc contact
Singapore1 site, 1 recruiting
- Recruiting
Home Nursing Foundation
Singapore
Precilla Lai
About this study
Official title: Individualized Nutritional Care Bundle for Home Nursing Patients With Pressure Injuries - A Cluster-Randomized, Pragmatic Clinical Trial and Economic Evaluation.
Objective:
To evaluate the impact of an individualized nutrition intervention package on pressure injury healing rates, prevention of new pressure injuries, complications, quality of life, and cost-effectiveness in adult on home nursing care with pressure injuries staged II and above in Singapore.
Read more
Study Design:
A two-group, non-blinded, randomized, pragmatic clinical trial with a cost-effectiveness analysis.
Location/ Setting:
Community
Participants:
Adults (aged 21 years and above) receiving home nursing care with at least one pressure injury (Stage II, III, IV, or Unstageable).
190 subjects per arm
Intervention:
The intervention group will receive an individualized nutrition intervention package consisting of individualized nutritional supplementation, specialized nutritional education pamphlets, regular dietetic support via home visits or telehealth, and home nursing care by nurses trained in nutrition care.
The control group will receive specialized nutritional educational pamphlets, and home nursing care by nurses trained in nutrition care, with or without nutritional supplementation.
Outcome Measures:
Main outcomes of wound area reduction, and proportion of participants with >40% area reduction at 30 days, 60 days and 90 days. Secondary outcomes include proportion of participants and wounds with increasing severity of PI stages (e.g., stage II to stage III), improvement in Health-Related Quality of Life (HRQOL) and nutritional status, and incidence of wound infections at 30 days, 60 days and 90 days, proportion of participants with complete healing, mortality and unplanned hospital admissions.
Economic Evaluation:
The primary economic outcome will be the incremental cost-effectiveness ratio (ICER) per pressure injury prevented, with a time horizon of 1 year for intervention versus control during the period of intervention (3-months) and up to a year.
Statistical Analyses:
Individual patient level analysis will be performed as per our primary analysis, and we will also perform cluster level analysis. Hazard ratios (HR) will be determined using Cox proportional hazards models and their corresponding 95% Confidence Intervals (95%CI). Imbalances in individual level data will be accounted for using statistical adjustment in a Mixed-Effects Cox Regression model.
Hypothesis:
This study aims to provide evidence on the effectiveness and cost-effectiveness of a individualized and protocolized nutrition intervention package for pressure injury management in home care patients. The findings could inform the development of evidence-based guidelines and recommendations for nutritional care and education in this vulnerable population, ultimately leading to improved patient outcomes and reduced healthcare costs associated with pressure injuries.
Read the detailed description
Intervention:
- Individualized nutritional intervention
- receive an educational pamphlet on nutritional and wound care for patient/family based on the "The European Pressure Ulcer Advisory Panel, the National Pressure Injury Advisory Panel, and the Pan Pacific Pressure Injury Alliance Prevention and Treatment of Pressure Ulcers/Injuries: 2019 Clinical Practice Guideline", with an in-depth explanation by trained nursing staff and research dietitian.
- reinforcement of nutritional education (adequate calories/ protein/fluid intake, and compliance to consumption of supplements) by nurses on visits without dietitian.
- A dietetic consultation at baseline, 30 days, 60 days and 90 days of the intervention will be done by an experienced and trained dietitian on optimizing nutritional intake to meet energy/protein requirements. The dietetic consultation will be done via face-to-face home visits and/or teleconsultation (depending on patient and caregiver preference).
- additional high protein high energy (HPHE) supplementation (commercial ready-to-drink oral nutritional supplements, which are available in hospitals, pharmacies and retail outlets) prescribed for those participants who do not meet nutritional requirements (25-35kcal/kg/d and 1.2-2.0g protein/kg/d).
- a specialized nutritional supplement containing 4.5 g Arginine, 156 mg Vitamin C, 40.9 mg alpha-tocopherol equivalents (Vitamin E), 30 kcal will be administered twice a day via oral ingestion or tube feeding for 12 weeks (14 serves per week).
- adjustment of enteral feeding regimen will be made for those patients who have not seen a dietitian previously in their last hospital admission.
- Compliance to supplementation will be determined by recording the amount of leftover products by individuals / caregivers and confirmation of intake with the caregiver / family member during the dietitian or nursing visit at 30-day, 60-day and 90-day period.
Control:
- protocolized nutritional intervention
- receive an educational pamphlet on nutritional and wound care for patient/family based on the latest nursing and nutritional guidelines, with an in-depth explanation by trained nursing staff. The trained nurses will provide reinforcement of nutritional education on planned visits as per usual practice over the 90 days.
- Standard care and follow-up as per hospital care plans with dietitian/home nursing foundation calling hospital dietitian-in-charge of subject if necessary, for verbal advice as per usual practice.
- HPHE supplementation (commercial standard ready-to-drink oral nutritional supplements available in pharmacy) / dietary advice to meet nutritional requirements will be based on previous recommendations from hospital dietitian-in-charge/clinician review of subject.
Primary Outcome Measurements
- Change in Pressure Injury Area from Baseline: Measurement of the alteration in the surface area of the identified pressure injury (PI) at time points of 30, 60, 90 days, 6 months and 1 year post-intervention.
- Proportion of Participants with 40% or Greater Area Reduction: Calculation of the percentage of participants who exhibit a reduction in the PI area by at least 40% at the same time points.
Secondary Outcome Measurements
- Proportion with Increased Severity in Pressure Injury Stages
- Proportion with Complete Pressure Injury Healing
- Proportion with Improvement in Health-Related Quality of Life (HRQOL)
- Proportion with Nutritional Status Improvement
- Change in HRQOL (EQ-5D-5L Utility Values and VAS)
- Incidence of New Pressure Injury
- Incidence of Pressure Injury Wound Infections
- Mortality Rate
- Unplanned Hospital Admissions and Length of Stay
- Conditions
- Wounds and Injuries, Malnutrition, Nutritional Deficiency, Wound Healing Delayed, Nurse's Role
- Being tested
- Individualized and Protocolized Nutritional Care Bundle, Optimized Standard Care
- Keywords
- Pressure Injury, Nutritional Support, Community Nursing, Clinical Nutrition, Malnutrition
- Medical subject headings
- Wounds and Injuries, Malnutrition, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized and Protocolized Nutritional Care BundleOther
Education on nutritional and wound care for patient/family based on the latest guidelines based on the "The European Pressure Ulcer Advisory Panel, the National Pressure Injury Advisory Panel, and the Pan Pacific Pressure Injury Alliance Prevention and Treatment of Pressure Ulcers/Injuries: 2019 Clinical Practice Guideline". A dietetic consultation at baseline, week 4 and week 8 on optimizing nutritional intake to meet caloric/protein requirements, along with additional high protein high energy (HPHE) supplementation prescribed for those participants who do not meet nutritional requirements (25-35kcal/kg/d and 1.2-2.0g protein/kg/d). The dietetic consultation will be done via face-to-face home visits and/or telehealth. A specialised nutritional supplement containing 4.5 g Arginine, 156 mg Vitamin C, 40.9 mg alpha-tocopherol equivalents (Vitamin E), 30 kcal will be administered twice a day via oral ingestion or tube feeding (mixed in 100ml water) for 12 weeks.
Optimized Standard CareOther
Only receiving education and management from specialized nurses trained in nutritional management , with or without supplementation
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Individualized and Protocolized Nutrition Care Bundle with Nutritional Supplementation, Education and Support by Nurses trained in Nutritional Management and Dietitians. Receives: Other: Individualized and Protocolized Nutritional Care Bundle |
| Control | Experimental | Nursing Care by Nurses trained in Nutritional Management, with or without Supplements. Receives: Other: Optimized Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the area of pressure injury from baseline
Assessed by the change in wound area from baseline to the follow-up timepoints, measured with a 3D wound imaging device at the time of follow-up.
Measured: Baseline, 30 days, 60 days, 90 days, 6 months and 1 year
Percentage (%) of participants at time of follow-up with pressure injury wound area reduction of >/=40%
Percentage (%) of participants at time of follow-up with wound area reduction >/= 40%, at time of follow-up versus baseline, where the number of patients with wound area reduction >/= 40% at follow-up timeframe will be determined as a percentage of total number of participants in the study group.
Measured: Baseline, 30 days, 60 days, 90 days, 6 months and 1 year
Secondary outcomes (9)
Proportion of participants with complete wound healing of the main wound
Proportion of participants with complete wound healing of the main wound. Assessed by the number of participants with complete healing of a wound, determined by clinical assessment and pressure injury staging.
Measured: 30 days, 60 days, 90 days, 6 months and 1 year
Proportion of participants with increased severity of pressure injury (PI stage)
Proportion of participants with increased severity of pressure injury (PI stage). Assessed by the number of participants with increased severity of wound at follow-up. Severity of pressure injury determined by the increase in pressure injury staging, or increase in area of wound if pressure injury staging remains the same at the follow-up time points
Measured: 30 days, 60 days, 90 days, 6 months and 1 year
Proportion of participants with new wound infection
Proportion of participants with New wound infection. Assessed by the number of participants with a new wound infection(s) at follow-up, that is clinically diagnosed with confirmation from blood tests (e.g., C-Reactive Protein (CRP), renal and liver function tests).
Measured: 30 days, 60 days, 90 days, 6 months and 1 year
Change in Health-Related Quality of Life (HRQOL) utility scores from baseline to time of follow-up.
Change in HRQOL assessed by the change in the EuroQOL 5-Dimensions 5-Levels (EQ5D-5L) utility scores at follow-up from baseline for the overall population and age categories if appropriate, where change in scores expressed as mean differences or standardised mean differences.
Measured: 90 days, 6 months and 1 year
Change in Health-Related Quality of Life (HRQOL) Visual Analogue Scale (VAS) scores from baseline to time of follow-up.
Change in HRQOL assessed by the change in the EuroQOL 5-Dimensions 5-Levels (EQ5D-5L) Visual Analogue Scale (VAS) at follow-up from baseline for the overall population and age categories if appropriate, where change in scores expressed as mean differences or standardised mean differences.
Measured: 90 days, 6 months and 1 year
Change in Nutritional status.
Change in Nutritional status. Assessed using the Global Leadership Initiative on Malnutrition (GLIM) criteria, to determine the severity of malnutrition. Change in the nutritional status determined by direction of nutritional status shift from baseline to follow-up.
Measured: 30 days, 60 days, 90 days and 1 year
Change in Nutritional Intake.
Change in Nutritional Intake. Assessed by the change in average of energy, protein and selected micronutrient intake derived from 3day food records.
Measured: 30 days and 60 days
Mortality
Mortality assessed by the occurrence and time-to-event of all-cause mortality during the study period.
Measured: 30 days, 60 days, 90 days, 6 months and 1 year
Unplanned Hospital Admission
Unplanned hospital admission assessed by the occurrence and time-to-event of one or more admissions during the study period.
Measured: 30 days, 60 days, 90 days, 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start23 Oct 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Home Nursing Foundation (HNF), Duke-NUS Graduate Medical School, Temasek Foundation
- Responsible party
- Sponsor
- Investigators
- Alvin Wong, MSc, Principal investigator, SingHealth Duke NUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078488
- Sponsor's protocol ID
- INCA
- Acronym
- INCA
- Status last verified
- Oct 2023
- First submitted
- 31 Jul 2023
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Munoz N, Posthauer ME, Cereda E, Schols JMGA, Haesler E. The Role of Nutrition for Pressure Injury Prevention and Healing: The 2019 International Clinical Practice Guideline Recommendations. Adv Skin Wound Care. 2020 Mar;33(3):123-136. doi: 10.1097/01.ASW.0000653144.90739.ad.
PubMed 32058438European Pressure Ulcer Advisory Panel, National Pressure Injury Advisory Panel, and Pan Pacific Pressure Injury Alliance, Prevention and Treatment of Pressure Ulcers/Injuries: Quick Reference Guide., E. Haesler, Editor. 2019
Graves, N. and H. Zheng, The prevalence and incidence of chronic wounds: a literature review. Wound Practice & Research: Journal of the Australian Wound Management Association, 2014. 22(1): p. 4-12
Goh OQ, Ganesan G, Graves N, Ng YZ, Harding K, Tan KB. Incidence of chronic wounds in Singapore, a multiethnic Asian country, between 2000 and 2017: a retrospective cohort study using a nationwide claims database. BMJ Open. 2020 Sep 25;10(9):e039411. doi: 10.1136/bmjopen-2020-039411.
PubMed 32978205Zhan C, Miller MR. Excess length of stay, charges, and mortality attributable to medical injuries during hospitalization. JAMA. 2003 Oct 8;290(14):1868-74. doi: 10.1001/jama.290.14.1868.
PubMed 14532315Lo ZJ, Lim X, Eng D, Car J, Hong Q, Yong E, Zhang L, Chandrasekar S, Tan GWL, Chan YM, Sim SC, Oei CW, Zhang X, Dharmawan A, Ng YZ, Harding K, Upton Z, Yap CW, Heng BH. Clinical and economic burden of wound care in the tropics: a 5-year institutional population health review. Int Wound J. 2020 Jun;17(3):790-803. doi: 10.1111/iwj.13333. Epub 2020 Mar 9.
PubMed 32149471Langer G, Fink A. Nutritional interventions for preventing and treating pressure ulcers. Cochrane Database Syst Rev. 2014 Jun 12;2014(6):CD003216. doi: 10.1002/14651858.CD003216.pub2.
PubMed 24919719Chaboyer W, Bucknall T, Webster J, McInnes E, Gillespie BM, Banks M, Whitty JA, Thalib L, Roberts S, Tallott M, Cullum N, Wallis M. The effect of a patient centred care bundle intervention on pressure ulcer incidence (INTACT): A cluster randomised trial. Int J Nurs Stud. 2016 Dec;64:63-71. doi: 10.1016/j.ijnurstu.2016.09.015. Epub 2016 Sep 23.
PubMed 27693836Cereda E, Klersy C, Andreola M, Pisati R, Schols JM, Caccialanza R, D'Andrea F; OligoElement Sore Trial (OEST) Study Group. Cost-effectiveness of a disease-specific oral nutritional support for pressure ulcer healing. Clin Nutr. 2017 Feb;36(1):246-252. doi: 10.1016/j.clnu.2015.11.012. Epub 2015 Dec 2.
PubMed 26703983Cereda E, Klersy C, Serioli M, Crespi A, D'Andrea F; OligoElement Sore Trial Study Group. A nutritional formula enriched with arginine, zinc, and antioxidants for the healing of pressure ulcers: a randomized trial. Ann Intern Med. 2015 Feb 3;162(3):167-74. doi: 10.7326/M14-0696.
PubMed 25643304Wong A, Chew A, Wang CM, Ong L, Zhang SH, Young S. The use of a specialised amino acid mixture for pressure ulcers: a placebo-controlled trial. J Wound Care. 2014 May;23(5):259-60, 262-4, 266-9. doi: 10.12968/jowc.2014.23.5.259.
PubMed 24810310Wong A, Goh G, Banks MD, Bauer JD. Economic Evaluation of Nutrition Support in the Prevention and Treatment of Pressure Ulcers in Acute and Chronic Care Settings: A Systematic Review. JPEN J Parenter Enteral Nutr. 2019 Mar;43(3):376-400. doi: 10.1002/jpen.1431. Epub 2018 Sep 12.
PubMed 30207386Husereau D, Drummond M, Augustovski F, de Bekker-Grob E, Briggs AH, Carswell C, Caulley L, Chaiyakunapruk N, Greenberg D, Loder E, Mauskopf J, Mullins CD, Petrou S, Pwu RF, Staniszewska S; CHEERS 2022 ISPOR Good Research Practices Task Force. Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) Statement: Updated Reporting Guidance for Health Economic Evaluations. Value Health. 2022 Jan;25(1):3-9. doi: 10.1016/j.jval.2021.11.1351.
PubMed 35031096Sanders GD, Neumann PJ, Basu A, Brock DW, Feeny D, Krahn M, Kuntz KM, Meltzer DO, Owens DK, Prosser LA, Salomon JA, Sculpher MJ, Trikalinos TA, Russell LB, Siegel JE, Ganiats TG. Recommendations for Conduct, Methodological Practices, and Reporting of Cost-effectiveness Analyses: Second Panel on Cost-Effectiveness in Health and Medicine. JAMA. 2016 Sep 13;316(10):1093-103. doi: 10.1001/jama.2016.12195.
PubMed 27623463
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Nutritional Care Bundle for Home Nursing Patients With Pressure Injuries - A Cluster-Randomized, Pragmatic Clinical Trial and Economic Evaluation.
- ClinicalTrials.gov ID
- NCT06078488
- Acronym / sponsor ID
- INCA / INCA
- Conditions
- Wounds and Injuries, Malnutrition, Nutritional Deficiency, Wound Healing Delayed, Nurse's Role
- Keywords
- Pressure Injury, Nutritional Support, Community Nursing, Clinical Nutrition, Malnutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Collaborators
- Home Nursing Foundation (HNF), Duke-NUS Graduate Medical School, Temasek Foundation
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective:
To evaluate the impact of an individualized nutrition intervention package on pressure injury healing rates, prevention of new pressure injuries, complications, quality of life, and cost-effectiveness in adult on home nursing care with pressure injuries staged II and above in Singapore.
Study Design:
A two-group, non-blinded, randomized, pragmatic clinical trial with a cost-effectiveness analysis.
Location/ Setting:
Community
Participants:
Adults (aged 21 years and above) receiving home nursing care with at least one pressure injury (Stage II, III, IV, or Unstageable).
190 subjects per arm
Intervention:
The intervention group will receive an individualized nutrition intervention package consisting of individualized nutritional supplementation, specialized nutritional education pamphlets, regular dietetic support via home visits or telehealth, and home nursing care by nurses trained in nutrition care.
The control group will receive specialized nutritional educational pamphlets, and home nursing care by nurses trained in nutrition care, with or without nutritional supplementation.
Outcome Measures:
Main outcomes of wound area reduction, and proportion of participants with >40% area reduction at 30 days, 60 days and 90 days. Secondary outcomes include proportion of participants and wounds with increasing severity of PI stages (e.g., stage II to stage III), improvement in Health-Related Quality of Life (HRQOL) and nutritional status, and incidence of wound infections at 30 days, 60 days and 90 days, proportion of participants with complete healing, mortality and unplanned hospital admissions.
Economic Evaluation:
The primary economic outcome will be the incremental cost-effectiveness ratio (ICER) per pressure injury prevented, with a time horizon of 1 year for intervention versus control during the period of intervention (3-months) and up to a year.
Statistical Analyses:
Individual patient level analysis will be performed as per our primary analysis, and we will also perform cluster level analysis. Hazard ratios (HR) will be determined using Cox proportional hazards models and their corresponding 95% Confidence Intervals (95%CI). Imbalances in individual level data will be accounted for using statistical adjustment in a Mixed-Effects Cox Regression model.
Hypothesis:
This study aims to provide evidence on the effectiveness and cost-effectiveness of a individualized and protocolized nutrition intervention package for pressure injury management in home care patients. The findings could inform the development of evidence-based guidelines and recommendations for nutritional care and education in this vulnerable population, ultimately leading to improved patient outcomes and reduced healthcare costs associated with pressure injuries.
Detailed description
Intervention:
- Individualized nutritional intervention
- receive an educational pamphlet on nutritional and wound care for patient/family based on the "The European Pressure Ulcer Advisory Panel, the National Pressure Injury Advisory Panel, and the Pan Pacific Pressure Injury Alliance Prevention and Treatment of Pressure Ulcers/Injuries: 2019 Clinical Practice Guideline", with an in-depth explanation by trained nursing staff and research dietitian.
- reinforcement of nutritional education (adequate calories/ protein/fluid intake, and compliance to consumption of supplements) by nurses on visits without dietitian.
- A dietetic consultation at baseline, 30 days, 60 days and 90 days of the intervention will be done by an experienced and trained dietitian on optimizing nutritional intake to meet energy/protein requirements. The dietetic consultation will be done via face-to-face home visits and/or teleconsultation (depending on patient and caregiver preference).
- additional high protein high energy (HPHE) supplementation (commercial ready-to-drink oral nutritional supplements, which are available in hospitals, pharmacies and retail outlets) prescribed for those participants who do not meet nutritional requirements (25-35kcal/kg/d and 1.2-2.0g protein/kg/d).
- a specialized nutritional supplement containing 4.5 g Arginine, 156 mg Vitamin C, 40.9 mg alpha-tocopherol equivalents (Vitamin E), 30 kcal will be administered twice a day via oral ingestion or tube feeding for 12 weeks (14 serves per week).
- adjustment of enteral feeding regimen will be made for those patients who have not seen a dietitian previously in their last hospital admission.
- Compliance to supplementation will be determined by recording the amount of leftover products by individuals / caregivers and confirmation of intake with the caregiver / family member during the dietitian or nursing visit at 30-day, 60-day and 90-day period.
Control:
- protocolized nutritional intervention
- receive an educational pamphlet on nutritional and wound care for patient/family based on the latest nursing and nutritional guidelines, with an in-depth explanation by trained nursing staff. The trained nurses will provide reinforcement of nutritional education on planned visits as per usual practice over the 90 days.
- Standard care and follow-up as per hospital care plans with dietitian/home nursing foundation calling hospital dietitian-in-charge of subject if necessary, for verbal advice as per usual practice.
- HPHE supplementation (commercial standard ready-to-drink oral nutritional supplements available in pharmacy) / dietary advice to meet nutritional requirements will be based on previous recommendations from hospital dietitian-in-charge/clinician review of subject.
Primary Outcome Measurements
- Change in Pressure Injury Area from Baseline: Measurement of the alteration in the surface area of the identified pressure injury (PI) at time points of 30, 60, 90 days, 6 months and 1 year post-intervention.
- Proportion of Participants with 40% or Greater Area Reduction: Calculation of the percentage of participants who exhibit a reduction in the PI area by at least 40% at the same time points.
Secondary Outcome Measurements
- Proportion with Increased Severity in Pressure Injury Stages
- Proportion with Complete Pressure Injury Healing
- Proportion with Improvement in Health-Related Quality of Life (HRQOL)
- Proportion with Nutritional Status Improvement
- Change in HRQOL (EQ-5D-5L Utility Values and VAS)
- Incidence of New Pressure Injury
- Incidence of Pressure Injury Wound Infections
- Mortality Rate
- Unplanned Hospital Admissions and Length of Stay
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Individualized and Protocolized Nutritional Care BundleIndividualized and Protocolized Nutrition Care Bundle with Nutritional Supplementation, Education and Support by Nurses trained in Nutritional Management and Dietitians. |
| Control | Experimental | Other: Optimized Standard CareNursing Care by Nurses trained in Nutritional Management, with or without Supplements. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult (age more than or equal to 21 years, any gender).
- Stage II, III, IV, and unstageable pressure injuries. For patients with multiple wounds, we will include all the pressure injuries (stages II and above) in the investigation.
- Able to provide written informed consent (patient or legal guardian).
- Be on oral and/or enteral nutritional support.
Key exclusion criteria (8 listed)
- Known palliative care individuals with a lifespan of </= 3 months,
- Known septicaemia,
- Poorly controlled diabetes (glycated haemoglobin level > 8.5%17),
- Individuals on strict fluid restriction if the provision of additional oral or enteral nutrition supplements leads to excess intake, for the following conditions:
- 6. Previous (last chemotherapy or radiotherapy less than one year ago) or current neoplastic disease 7. Currently on immunosuppressive therapy, 8. Known allergy reaction to L-arginine, phenylketonuria 9. Presence of an infected wound (if it is the only pressure injury present on the participant) 10. Presence of untreated diagnosed osteomyelitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized and Protocolized Nutritional Care BundleEducation on nutritional and wound care for patient/family based on the latest guidelines based on the "The European Pressure Ulcer Advisory Panel, the National Pressure Injury Advisory Panel, and the Pan Pacific Pressure Injury Alliance Prevention and Treatment of Pressure Ulcers/Injuries: 2019 Clinical Practice Guideline". A dietetic consultation at baseline, week 4 and week 8 on optimizing nutritional intake to meet caloric/protein requirements, along with additional high protein high energy (HPHE) supplementation prescribed for those participants who do not meet nutritional requirements (25-35kcal/kg/d and 1.2-2.0g protein/kg/d). The dietetic consultation will be done via face-to-face home visits and/or telehealth. A specialised nutritional supplement containing 4.5 g Arginine, 156 mg Vitamin C, 40.9 mg alpha-tocopherol equivalents (Vitamin E), 30 kcal will be administered twice a day via oral ingestion or tube feeding (mixed in 100ml water) for 12 weeks. | Other | Intervention |
| Optimized Standard CareOnly receiving education and management from specialized nurses trained in nutritional management , with or without supplementation | Other | Control |
Primary outcome
Change in the area of pressure injury from baseline
Time frame: Baseline, 30 days, 60 days, 90 days, 6 months and 1 year
Assessed by the change in wound area from baseline to the follow-up timepoints, measured with a 3D wound imaging device at the time of follow-up.
Percentage (%) of participants at time of follow-up with pressure injury wound area reduction of >/=40%
Time frame: Baseline, 30 days, 60 days, 90 days, 6 months and 1 year
Percentage (%) of participants at time of follow-up with wound area reduction >/= 40%, at time of follow-up versus baseline, where the number of patients with wound area reduction >/= 40% at follow-up timeframe will be determined as a percentage of total number of participants in the study group.
9 secondary outcomes
Proportion of participants with complete wound healing of the main wound
Time frame: 30 days, 60 days, 90 days, 6 months and 1 year
Proportion of participants with increased severity of pressure injury (PI stage)
Time frame: 30 days, 60 days, 90 days, 6 months and 1 year
Proportion of participants with new wound infection
Time frame: 30 days, 60 days, 90 days, 6 months and 1 year
Change in Health-Related Quality of Life (HRQOL) utility scores from baseline to time of follow-up.
Time frame: 90 days, 6 months and 1 year
Change in Health-Related Quality of Life (HRQOL) Visual Analogue Scale (VAS) scores from baseline to time of follow-up.
Time frame: 90 days, 6 months and 1 year
Change in Nutritional status.
Time frame: 30 days, 60 days, 90 days and 1 year
Change in Nutritional Intake.
Time frame: 30 days and 60 days
Mortality
Time frame: 30 days, 60 days, 90 days, 6 months and 1 year
Unplanned Hospital Admission
Time frame: 30 days, 60 days, 90 days, 6 months and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Background: PubMed 32058438Munoz N, Posthauer ME, Cereda E, Schols JMGA, Haesler E. The Role of Nutrition for Pressure Injury Prevention and Healing: The 2019 International Clinical Practice Guideline Recommendations. Adv Skin Wound Care. 2020 Mar;33(3):123-136. doi: 10.1097/01.ASW.0000653144.90739.ad.
- BackgroundEuropean Pressure Ulcer Advisory Panel, National Pressure Injury Advisory Panel, and Pan Pacific Pressure Injury Alliance, Prevention and Treatment of Pressure Ulcers/Injuries: Quick Reference Guide., E. Haesler, Editor. 2019
- BackgroundGraves, N. and H. Zheng, The prevalence and incidence of chronic wounds: a literature review. Wound Practice & Research: Journal of the Australian Wound Management Association, 2014. 22(1): p. 4-12
- Background: PubMed 32978205Goh OQ, Ganesan G, Graves N, Ng YZ, Harding K, Tan KB. Incidence of chronic wounds in Singapore, a multiethnic Asian country, between 2000 and 2017: a retrospective cohort study using a nationwide claims database. BMJ Open. 2020 Sep 25;10(9):e039411. doi: 10.1136/bmjopen-2020-039411.
- Background: PubMed 14532315Zhan C, Miller MR. Excess length of stay, charges, and mortality attributable to medical injuries during hospitalization. JAMA. 2003 Oct 8;290(14):1868-74. doi: 10.1001/jama.290.14.1868.
- Background: PubMed 32149471Lo ZJ, Lim X, Eng D, Car J, Hong Q, Yong E, Zhang L, Chandrasekar S, Tan GWL, Chan YM, Sim SC, Oei CW, Zhang X, Dharmawan A, Ng YZ, Harding K, Upton Z, Yap CW, Heng BH. Clinical and economic burden of wound care in the tropics: a 5-year institutional population health review. Int Wound J. 2020 Jun;17(3):790-803. doi: 10.1111/iwj.13333. Epub 2020 Mar 9.
- Background: PubMed 24919719Langer G, Fink A. Nutritional interventions for preventing and treating pressure ulcers. Cochrane Database Syst Rev. 2014 Jun 12;2014(6):CD003216. doi: 10.1002/14651858.CD003216.pub2.
- Background: PubMed 27693836Chaboyer W, Bucknall T, Webster J, McInnes E, Gillespie BM, Banks M, Whitty JA, Thalib L, Roberts S, Tallott M, Cullum N, Wallis M. The effect of a patient centred care bundle intervention on pressure ulcer incidence (INTACT): A cluster randomised trial. Int J Nurs Stud. 2016 Dec;64:63-71. doi: 10.1016/j.ijnurstu.2016.09.015. Epub 2016 Sep 23.
- Background: PubMed 26703983Cereda E, Klersy C, Andreola M, Pisati R, Schols JM, Caccialanza R, D'Andrea F; OligoElement Sore Trial (OEST) Study Group. Cost-effectiveness of a disease-specific oral nutritional support for pressure ulcer healing. Clin Nutr. 2017 Feb;36(1):246-252. doi: 10.1016/j.clnu.2015.11.012. Epub 2015 Dec 2.
- Background: PubMed 25643304Cereda E, Klersy C, Serioli M, Crespi A, D'Andrea F; OligoElement Sore Trial Study Group. A nutritional formula enriched with arginine, zinc, and antioxidants for the healing of pressure ulcers: a randomized trial. Ann Intern Med. 2015 Feb 3;162(3):167-74. doi: 10.7326/M14-0696.
- Background: PubMed 24810310Wong A, Chew A, Wang CM, Ong L, Zhang SH, Young S. The use of a specialised amino acid mixture for pressure ulcers: a placebo-controlled trial. J Wound Care. 2014 May;23(5):259-60, 262-4, 266-9. doi: 10.12968/jowc.2014.23.5.259.
- Background: PubMed 30207386Wong A, Goh G, Banks MD, Bauer JD. Economic Evaluation of Nutrition Support in the Prevention and Treatment of Pressure Ulcers in Acute and Chronic Care Settings: A Systematic Review. JPEN J Parenter Enteral Nutr. 2019 Mar;43(3):376-400. doi: 10.1002/jpen.1431. Epub 2018 Sep 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Precilla Lai, MSc contact
Alvin Wong, MSc principal investigator
SingHealth Duke NUS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized and Protocolized Nutritional Care Bundle in people with Wounds and Injuries and Malnutrition, run by Changi General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alvin Wong, MSc ((65)64268775, alvin_wong@cgh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the area of pressure injury from baseline (time frame: Baseline, 30 days, 60 days, 90 days, 6 months and 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06078488, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2023.