100% Whey Protein Based Diet In Enhancing Pressure Ulcer Healing- A Pilot Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Percentage Reduction in Wound Surface Area
研究概览
简要总结
This study seeks to evaluate if a 100% whey protein based diet enhances pressure ulcer healing.
详细描述
A pressure ulcer is defined as an area of localized damage to the skin and underlying tissues caused by pressure, shear, friction, and/or a combination of these. The most common sites for pressure ulcers are the sacrum, heels, ischial tuberosities, greater trochanters, and lateral malleoli.
In Singapore, the prevalence of pressure ulcers was 18.1%, while the incidence was 8.1% in a tertiary hospital in Singapore in 2002. With a rapidly ageing population in Singapore, the prevalence of pressure ulcers is expected to increase further.
Pressure ulcers are associated with serious medical complications, prolonged hospital stay and frequent re-admissions. Patients with pressure ulcers generally have significantly poorer physical function, are less able to perform self-care, and are less mobile. A new pressure ulcer is estimated to increase a patient's hospital stay by nearly a factor of five. Furthermore, pressure ulcers are also correlated with more than two fold rates of increased mortality independent of the source of the ulcer. Pressure ulcers are one of the patient safety indicators reflecting quality of life according to the Agency for Healthcare Research and Quality. Besides affecting the quality of life of patients, pressure ulcers are also associated with the increased utilisation of healthcare resources resulting in a high cost burden to healthcare systems worldwide.
Pressure ulcers occur in individuals with limited mobility due to pressure, or pressure in combination with shear, which decreases circulation and causes tissue damage. Elderly patients and patients with specific predisposing conditions such as hip fractures are particularly at risk. In addition, patients whom are malnourished are not only at risk of pressure ulcers but also have impaired wound healing. Patients with pressure ulcers tend to have negative energy balance and current guidelines recommend the assessment of nutritional status when progress for pressure ulcers closure does not occur and the use of oral nutritional supplements when an oral diet is not sufficient to meet requirements. In particular, nutritional care in wound healing should be directed at ensuring adequate supply of proteins and calories. Major guidelines currently recommend a minimum calorie intake of 30-35 kilocalories per kg per day and protein intake of 1.25-1.5g per kg per day for adults with a pressure ulcer who are assessed as being at risk of malnutrition.
Currently, there is paucity of studies demonstrating the effect whey protein has on wound healing in humans. The effect of whey protein on wound healing has only been studied in diabetic rats which has shown to accelerate closure and the healing process of their wounds. It was postulated that the healing property of whey was due to its ability to limit prolonged inflammation (reduction in IL-6, TNF-alpha, IL-1b and IL-10) and elevating the antioxidant defence system (by up-regulating glutathione and superoxide dismutase).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any age, gender or ethnicity.
- •Admitted for subacute wound care.
- •Diagnosed with stage 3 or 4 pressure ulcer.
- •Wound surface area > 4cm2.
排除标准
- •Prognosis of less than 1 year.
- •Diagnosed with osteomyelitis of the wound.
- •Allergy to soy or corn.
- •Chronic Kidney Disease Stage 4 or
- •Participants who are already consuming oral nutritional supplements and are not willing to convert to Peptamen® if allocated to the intervention arm.
- •Participants who are currently consuming Peptamen® or another 100% whey protein oral nutritional supplement.
- •Dislikes the taste of milk.
结局指标
主要结局
Percentage Reduction in Wound Surface Area
时间窗: 4 weeks
Percentage reduction in wound surface area = \[Surface area at baseline - Surface area after 4 weeks\] / \[Surface area at baseline\] %
Pressure Ulcer Score for Healing (PUSH) Score
时间窗: 4 weeks
The Pressure Ulcer Scale for Healing (PUSH Tool) was developed by the National Pressure Ulcer Advisory Panel (NPUAP) as a quick, reliable tool to monitor the change in pressure ulcer status over time. The total score ranges from 0 (best condition) to 17 (worst condition) and is derived from 3 parameters (product of length and width of wound, exudate amount, and tissue type).
次要结局
- Amount of Peptamen® and Beneprotein® consumed(4 weeks)
研究者
JIANG SONG'EN, JEFFREY
Principal Investigator
St Luke's Hospital, Singapore
