Oral Nutritional Supplement in Reducing Surgical Site Infections

Not Applicable

Terminated

• Conditions: Peripheral Vascular Disease; Claudication
• Interventions: Dietary Supplement: Arginine enriched oral nutritional supplement

• 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

Arm && Interventions

Group	Intervention	Description
Arginine enriched oral nutritional supplement group	Arginine enriched oral nutritional supplement	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.

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