Status:
UNKNOWN
Individualized Nutritional Care Bundle for Home Nursing Patients With Pressure Injuries.
Lead Sponsor:
Changi General Hospital
Collaborating Sponsors:
Home Nursing Foundation (HNF)
Duke-NUS Graduate Medical School
Conditions:
Wounds and Injuries
Malnutrition
Eligibility:
All Genders
21+ years
Phase:
NA
Brief 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-e...
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, th...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT06078488
Start Date
October 23 2023
End Date
June 30 2025
Last Update
December 29 2023
Active Locations (1)
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1
Home Nursing Foundation
Singapore, Singapore