The Use of an Oral Mixture of Arginine, Glutamine and Beta-hydroxy-beta-methylbutyrate for Treatment of Pressure Ulcers

Not Applicable

• Conditions: Pressure Ulcers Stage III; Pressure Ulcer, Stage IV
• Interventions: Dietary Supplement: ABOUND

• Registration Number: NCT03038490
• Lead Sponsor: Our Lady of Maryknoll Hospital

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.

Study Timeline

• Study Start: 2016-12-01
• Status Verified: 2017-01
• Study First Submitted: 2017-01-28
• Study First Submitted QC: 2017-01-30
• Last Update Submitted: 2017-01-30
• Study First Posted: 2017-01-31
• Last Update Posted: 2017-01-31
• Primary Completion: 2019-09-30
• Study Completion: 2020-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
change in Pressure Ulcer Scale for Healing (PUSH)	4 weeks
percentage change in pressure ulcer area	4 weeks

Secondary Outcome Measures

Name	Time	Method
length of hospitalisation	six months
number of hospital admissions	six months

Trial Locations

Locations (1)

Our Lady of Maryknoll Hospital; 🇭🇰 Wong Tai Sin, Hong Kong