Oral Nutritional Supplement in Reducing Surgical Site Infections

The Role of an Arginine Enriched Oral Nutritional Supplement in the Prevention of Wound Complication in Patients Undergoing Lower Limb Revascularization

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02475525

Enrollment

Registered

2015-06-18

Start date

2015-06-30

Completion date

2017-02-01

Last updated

2018-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Claudication, Peripheral Vascular Disease

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.

Interventions

DIETARY_SUPPLEMENTArginine enriched oral nutritional supplement

oral nutritional supplement containing arginine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026