Oral Nutritional Supplement in Reducing Surgical Site Infections

Not Applicable

Terminated

• Conditions: Peripheral Vascular Disease; Claudication

• Registration Number: NCT02475525
• Lead Sponsor: University of Limerick

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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-08
• Study First Submitted QC: 2015-06-17
• Study First Posted: 2015-06-18
• Primary Completion: 2016-12-01
• Study Completion: 2017-02-01
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-01
• Last Update Posted: 2018-05-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The number of incidents of wound infections in both groups of patients undergoing lower limb re vascularization.	4 weeks

Secondary Outcome Measures

Name	Time	Method
Patient acceptability of the oral nutritional supplement.	4 weeks
Duration of post operative hospital stay	4 weeks

Trial Locations

Locations (1)

University Hospital Limerick; 🇮🇪 Limerick, Ireland