Immunonutrition Supplementation for Improved Burn Wound Healing in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Time to Complete Wound Closure
研究概览
简要总结
This pilot study aims to assess the feasibility of providing immunonutrition supplementation to older burn patients (age 55 and older) and its impact on burn wound healing. Supplements containing arginine and omega 3 fatty acids have been shown to have beneficial effects on healing in other types of wounds but data within the burn population remains limited. 20 participants will be randomized into two arms, immunonutrition or conventional supplement and can expect to be on study for 3 months.
详细描述
Studies performed previously in burn patients have had mixed patient cohorts with small sample sizes and these have failed to show any large improvements in wound healing. However, in older populations the investigators suspect that immunonutrition supplements may have a larger benefit to these patients as they often present with malnutrition and are more likely to struggle with delayed wound healing. In this pilot study, the investigators look to assess the impact of immunonutrition supplements the burn wound healing of adults over the age of 55 years with 1-15% total burn surface area (TBSA) partial thickness and full thickness burn injuries.
The primary outcome objective of the study will be time to complete wound closure. The secondary objectives include need for surgical grafting, length of inpatient stay, and infections including pneumonia, urinary tract infections, wound infections, and blood stream infections.
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
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has partial of full thickness thermal injury of 1-15% of total body surface area (TBSA)
- •Subject has an inpatient admission for their burn
- •Subject or authorized decision maker understands the study procedures and can provide informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator
排除标准
- •Subject with inhalation injury and/or intubation
- •Subject receiving immunosuppressive medications including chronic steroids, immune modulating medications, and chemotherapy prior to admission
- •Subject with pre-existing severe chronic liver disease or end stage renal disease
研究组 & 干预措施
Immunonutrition
Participants will consume a 6oz immunonutrition drink 2 times daily for 7 days and then once a day for remaining hospital stay.
干预措施: Impact Advanced Recovery (Dietary Supplement)
Conventional Supplement
Participants will consume a 6oz conventional supplement drink 3 times daily for 7 days and then once a day for remaining hospital stay.
干预措施: Boost High Protein (Dietary Supplement)
结局指标
主要结局
Time to Complete Wound Closure
时间窗: up to 3 months
次要结局
- Incidence of Surgical Grafting(up to 3 months)
- Length of Inpatient Stay(up to 3 months)
- Incidence of Infections(up to 3 months)