The Role of an Arginine Enriched Oral Nutritional Supplement in the Prevention of Wound Complication in Patients Undergoing Lower Limb Revascularization
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Vascular Disease
- Sponsor
- University of Limerick
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- The number of incidents of wound infections in both groups of patients undergoing lower limb re vascularization.
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Mary Clarke Moloney
Clinical Operations Manager
University of Limerick
Eligibility Criteria
Inclusion Criteria
- •Patients scheduled for elective lower limb revascularization surgery
- •patients aged \>18 years.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
The number of incidents of wound infections in both groups of patients undergoing lower limb re vascularization.
Time Frame: 4 weeks
Secondary Outcomes
- Patient acceptability of the oral nutritional supplement.(4 weeks)
- Duration of post operative hospital stay(4 weeks)