Clinical trial NCT03038490: The Use of an Oral Mixture of Arginine, Glutamine and Beta-hydroxy-beta-methylbutyrate for Treatment of Pressure Ulcers
Official title: The Use of an Oral Mixture of Arginine, Glutamine and Beta-hydroxy-beta-methylbutyrate for the Treatment of Pressure Ulcers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pressure Ulcers Stage III
Pressure Ulcer, Stage IV
Lead sponsor: Our Lady of Maryknoll Hospital
Sponsor class: OTHER
Collaborators: name: Wong Tai Sin Hospital
First posted: 2017-01-31
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate whether an oral nutritional supplement of a mixture of arginine, glutamine and HMB for a maximum period of four weeks is more beneficial than the standard dietary approach to the healing of pressure ulcers, and to examine whether the use of it can reduce admissions and length of hospitalizations for these patients.

Detailed description: All patients would be assessed by a dietitian to ensure them receiving nutritional support of at least 30 kcal/kg/day and of at least 1.2 g/kg/day of protein regardless of feeding method. During the study period, vitamin C and zinc supplement would not be given. Nutritional supplement other than that provided by the dietitian to meet the energy and protein requirement would not be given. The pressure ulcers would be cared according to the "Basic nursing standards for patient care: Wound dressing - Version 5" published by the Hospital Authority Head Office.

The treatment group would also be given 2 Sackets of a mixture of arginine, glutamine and HMB (ABOUND) every day for a maximum period of 4 weeks, either orally or via enteral feeding.

Eligibility criteria: Inclusion Criteria:

1. Inpatients of medical and geriatric wards of OLMH and WTSH
2. Aged 18 and older with stage III - IV lesions
3. Patients fed orally or through feeding tubes were included

Exclusion Criteria:

1. Patients with history of using the nutritional supplement (ABOUND) in previous three months
2. Patients with cellulitis, wounds with purulent discharge or osteomyelitis or sepsis
3. Patients requiring protein restriction
4. Patients with poorly controlled diabetes mellitus (latest HbA1C \> 8.5) (healing process may be affected
5. Patients under palliative care

Primary outcomes:
measure: percentage change in pressure ulcer area
timeFrame: 4 weeks
measure: change in Pressure Ulcer Scale for Healing (PUSH)
timeFrame: 4 weeks
Secondary outcomes:
measure: number of hospital admissions
timeFrame: six months
measure: length of hospitalisation
timeFrame: six months
Other outcomes:
Locations:
city: Wong Tai Sin
country: Hong Kong
facility: Our Lady of Maryknoll Hospital
Study officials:
References:
citation: Cereda E, Gini A, Pedrolli C, Vanotti A. Disease-specific, versus standard, nutritional support for the treatment of pressure ulcers in institutionalized older adults: a randomized controlled trial. J Am Geriatr Soc. 2009 Aug;57(8):1395-402. doi: 10.1111/j.1532-5415.2009.02351.x. Epub 2009 Jun 25.
citation: Wong 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.
citation: Cereda 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.