Individualized Nutritional Care Bundle for Home Nursing Patients With Pressure Injuries.
Launched by CHANGI GENERAL HOSPITAL · Oct 9, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how a personalized nutrition program can help adults receiving home nursing care heal from pressure injuries, which are sores caused by prolonged pressure on the skin. The program includes tailored nutritional supplements, educational materials, and support from dietitians and specially trained nurses. Researchers want to see if this approach not only helps wounds heal faster but also improves the overall quality of life for participants and is cost-effective.
To be eligible for this trial, participants must be adults aged 21 and older with at least one pressure injury that is Stage II or higher. They should also be able to provide consent and be on some form of nutritional support. Participants will be divided into two groups: one receiving the full nutrition program and the other receiving basic educational support and care. Throughout the study, which lasts for three months, participants can expect regular visits and support to help manage their nutrition and improve their healing process.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Adult (age more than or equal to 21 years, any gender).
- • 2. 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.
- • 3. Able to provide written informed consent (patient or legal guardian).
- • 4. Be on oral and/or enteral nutritional support.
- Exclusion Criteria:
- • 1. Known palliative care individuals with a lifespan of \</= 3 months,
- • 2. Known septicaemia,
- • 3. Poorly controlled diabetes (glycated haemoglobin level \> 8.5%17),
- 4. Individuals on strict fluid restriction if the provision of additional oral or enteral nutrition supplements leads to excess intake, for the following conditions:
- • 1. 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
- • 2. Advanced decompensated alcoholic and non-alcoholic liver cirrhosis
- • 3. 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.
About Changi General Hospital
Changi General Hospital (CGH) is a leading tertiary healthcare institution in Singapore, renowned for its commitment to providing high-quality patient care and advancing medical research. As a sponsor of clinical trials, CGH leverages its state-of-the-art facilities and multidisciplinary expertise to facilitate innovative research that aims to enhance treatment options and improve patient outcomes. The hospital is dedicated to upholding rigorous ethical standards and regulatory compliance while fostering collaboration with healthcare professionals and researchers to drive advancements in medical science. Through its clinical trials, CGH seeks to contribute to the global body of knowledge and translate research findings into practical applications for better healthcare delivery.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Singapore, , Singapore
Patients applied
Trial Officials
Alvin Wong, MSc
Principal Investigator
SingHealth Duke NUS
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported