Clinical Trial: The Use of Specialised Amino Acid Mixture in Pressure Ulcer Wound Healing Rates- A Placebo Controlled Trial

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Use of Specialised Amino Acid Mixture in Pressure Ulcer Wound Healing Rates-A Placebo Controlled Trial

Brief Summary: This research aims to address the gap in the studies done and test the effects of a commercial mixture of 7 g of Arginine, 7 g Glutamine and 1.2 g HMB* twice a day on hard to heal pressure ulcers in an Asian patient cohort in an acute healthcare setting.

Detailed Summary:

Pressure ulcers are defined as areas of localised damage to the skin, muscle or underlying tissue, caused by shear, friction or unrelieved pressure, usually over bony prominences. They are associated with many health conditions that cause prolonged bed rest, immobility, inactivity or poor sensation and can significantly contribute to morbidity and mortality, particularly in the aged population. International prevalence rates range widely from 4.6%- 83.6% due to methodological differences and classification systems. In Singapore, a study on the prevalence of pressure ulcers in 3 hospitals revealed a prevalence of 9% to 14%.

Pressure ulcers often fail to heal in a timely and orderly manner, resulting in a chronic non-healing wound. Many intrinsic and extrinsic factors have been identified that can disrupt the wound healing processes of haemostasis, inflammation, proliferation, angiogenesis and remodelling. One of the factors gaining more interest for its impact on wound healing processes is nutritional status.

Arginine is a semi-essential amino acid because even though the body normally makes enough of it, supplementation is sometimes needed during critical illness and severe trauma. There have been numerous research studies focusing on using arginine to enhance wound healing and pressure ulcer prevention. It is required for promotion of nitrogen balance, cell proliferation, T lymphocyte function and collagen accumulation. It also changes into nitric oxide, which is known for its vasodilatory and angiogenic properties.

Glutamine is conditionally essential amino acid because it can be manufactured in the body, but under extreme physical stress the demand for glutamine exceeds the body's ability to make it. Adequate amounts of glutamine are generally obtained through diet alone
Sponsor: Changi General Hospital

Current Primary Outcome:

• % Viable Tissue [ Time Frame: weeks 1 to 2 ]

  -Percentage viable tissue after 2 weeks

  The estimated change in proportion of viable and non-viable tissue was determined using area derived from planimetry via acetate tracings. The description of viable tissue was taken to mean granulating (red) or epithelising (pink) tissue, and non-viable tissue were taken as necrotic (black) or sloughy (green or yellow) tissue.

• % Wound Area Week 1 [ Time Frame: week 0 to 1 ]
  Percentage change in wound area after week 1
• % Wound Area Week 2 [ Time Frame: Weeks 1 to 2 ]
  Percentage change in wound area after week 2

Original Primary Outcome:

• wound size [ Time Frame: week 1, week 2, week 3 & Week 4 ]
  -Percentage change in wound size (length, depth, area)
• viable wound tissue [ Time Frame: Week 1, week 2, week 3 & week 4 ]
  Percentage change in proportion of viable wound tissue

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Changi General Hospital

Dates:
Date Received: March 18, 2010
Date Started: April 2010
Date Completion:
Last Updated: June 14, 2013
Last Verified: June 2013