The Role of an Arginine Enriched Oral Nutritional Supplement in the Prevention of Wound Complication in Patients Undergoing Lower Limb Revascularization
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- The number of incidents of wound infections in both groups of patients undergoing lower limb re vascularization.
研究概览
简要总结
The study aims to evaluate the efficacy of an arginine enriched oral nutritional supplement in the prevention of wound complications in the the wounds of patients post lower limb revascularization.
详细描述
Surgical incisions are associated with a number of possible complications. The reported incidence of surgical site infections at the groin after vascular procedures is between 3% and 30%. This incidence is up to five times higher than the expected incidence of infection in clean cases. Risk factors for postoperative surgical site infection in patients undergoing vascular surgery may include age, co-morbidities, use of prosthetic grafts and repeat operations.
A systematic review in 2011 concluded that arginine supplemented diets among perioperative patients were associated with a reduced rate of surgical infection and reduced overall length of hospital stay.
The study aims are to determine if taking an oral nutritional supplement reduces the rate of wound complications post lower limb revascularization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective lower limb revascularization surgery
- •patients aged >18 years.
排除标准
- •Patients unable to provide informed consent,
- •emergency cases,
- •seriously ill patients/unconscious patients,
- •chronic renal disease,
- •known inflammatory bowel disease,
- •known lactose intolerance and not using lactase,
- •known galactosemia,
- •pregnancy,
- •cows milk allergy.
研究组 & 干预措施
Arginine enriched oral nutritional supplement group
Patients randomised to the oral nutritional supplement group will continue their normal diet. In addition, this group will commence taking oral nutritional supplement twice daily 5 days prior to surgery and continued for 4 weeks post surgery. Intake of nutritional drink will be suspended during their fasting period prior to surgery and will commence once surgery is completed and group are able to tolerate food post surgery. Wound examination will take place at 1 and at 4 weeks post surgery by the tissue viability nurse specialist who will be blinded to the treatment. Patient adherence to the study protocol with the nutritional supplement regimen will be recorded daily by the patient for four the four weeks the supplement is provided.
干预措施: Arginine enriched oral nutritional supplement (Dietary Supplement)
Control
This group will continue on their normal diet before and after surgery. Normal diet will be suspended during their fasting period prior to surgery and will re commence once surgery is completed and group are able to tolerate food post surgery. Wound examination will take place at 1 and at 4 weeks post surgery by the tissue viability nurse specialist who will be blinded to the treatment.
结局指标
主要结局
The number of incidents of wound infections in both groups of patients undergoing lower limb re vascularization.
时间窗: 4 weeks
次要结局
- Patient acceptability of the oral nutritional supplement.(4 weeks)
- Duration of post operative hospital stay(4 weeks)
研究者
Mary Clarke Moloney
Clinical Operations Manager
University of Limerick