Pressure Ulcer
Conditions
Keywords
Pressure Ulcer Wound, Specialized Amino Acid Mixture
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 description
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 because the body is also able to make glutamine on its own. Certain medical conditions, including injuries, surgery, infections, and prolonged stress, can deplete glutamine levels. Since glutamine plays a key role in the immune system, a deficiency in this nutrient can significantly slow the healing process. Beta-hydroxy-Beta methylbutyrate (HMB) is a metabolite of leucine, an essential amino acid. HMB supplementation was associated with increased muscle mass accretion. HMB appears to assert its effect via inhibiting muscle proteolysis and modulating protein turnover. Recently, arginine has been found to accelerate wound healing in combination with HMB and glutamine. It was shown that healthy subjects who are supplemented orally with arginine had a significant rise in plasma arginine and ornithine levels that led to enhanced rate of collagen synthesis. In another recent study, a HMB/Arginine/Lysine mixture increased protein turnover in elderly patients over a year long period. However, there is no known randomised controlled trial done on patients with chronic hard to heal wounds in acute healthcare settings. AIM To compare pressure ulcer healing rates in patients supplemented with a commercial HMB/Arginine/Lysine mixture (Abound) and standard high protein, high energy iso-nitrogenous medical nutritional supplements versus patients supplemented with only standard high protein, high energy iso-nitrogenous medical nutritional supplements. OUTCOME INDICATORS * Percentage change in wound size (length, depth, area) * Percentage change in proportion of viable wound tissue (Refer to wound data collection for details) The study will take on a comparative, randomised controlled trial design.
Interventions
Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d
Sponsors
Study design
Eligibility
Inclusion criteria
* Patients with pressure ulcers stage II, III or IV, non-healing admitted to Changi General Hospital for \> 2 weeks * Patients who are able to attend outpatient follow-up appointments for dietary and wound review
Exclusion criteria
* Age \< 21 years old * Poorly controlled Diabetic Patients (HbA1c \>7.0%) * Patients on Total Parenteral Nutrition * Patients in MICU/ SICU/ Medically Unstable/ Palliative Care * Patients with severe Sepsis * Length of stay \< 2 weeks * Patients who require fluid restriction \< 1L/d * Patients on any other wound healing supplements (e.g. Zinc, Vitamin A and Vitamin C) * Patients with lower extremity ulcers with untreated peripheral vascular disease * Patients with deep tissue infection and/or requiring debridement of necrotic or sloughy tissue * Patients unable to attend outpatient follow-up appointments * Patients who cannot tolerate oral intake \> 70% EER and/or Fluid intake 30ml/kg BW * Patients who require protein restriction * Patients who are unable to give consent (absence of next-of-kin)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % Viable Tissue | 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 | week 0 to 1 | Percentage change in wound area after week 1 |
| % Wound Area Week 2 | Weeks 1 to 2 | Percentage change in wound area after week 2 |
Countries
Singapore
Participant flow
Recruitment details
26 subjects were recruited between June 2010 to June 2011 and all subjects were inpatients of Changi General Hospital. 23 subjects completed the trial.
Pre-assignment details
Subjects were randomly assigned to either arm after an initial assessment by PI and wound nurses. There is no wash out period for this trial
Participants by arm
| Arm | Count |
|---|---|
| Abound Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d | 12 |
| Placebo Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d | 14 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo | Abound | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 11 Participants | 21 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 1 Participants | 5 Participants |
| Age Continuous | 74.3 years STANDARD_DEVIATION 12.4 | 78.5 years STANDARD_DEVIATION 18.4 | 75.4 years STANDARD_DEVIATION 15.4 |
| Region of Enrollment Singapore | 14 participants | 12 participants | 26 participants |
| Sex: Female, Male Female | 6 Participants | 9 Participants | 15 Participants |
| Sex: Female, Male Male | 8 Participants | 3 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 14 |
| serious Total, serious adverse events | 0 / 12 | 0 / 14 |
Outcome results
% Viable Tissue
-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.
Time frame: weeks 1 to 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abound | % Viable Tissue | 43.06 Percentage of viable tissue | Standard Error 8.43 |
| Placebo | % Viable Tissue | 25.94 Percentage of viable tissue | Standard Error 6.68 |
% Wound Area Week 1
Percentage change in wound area after week 1
Time frame: week 0 to 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abound | % Wound Area Week 1 | -15.37 percent change | Standard Error 7.64 |
| Placebo | % Wound Area Week 1 | -13.68 percent change | Standard Error 7.68 |
% Wound Area Week 2
Percentage change in wound area after week 2
Time frame: Weeks 1 to 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abound | % Wound Area Week 2 | -27.50 Percentage change | Standard Error 10.11 |
| Placebo | % Wound Area Week 2 | -37.54 Percentage change | Standard Error 7.33 |