Oral Nutritional Supplement in Reducing Surgical Site Infections

NCT02475525 | Terminated DMC

• 1 other identifier: ONS2015
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Vascular Disease; Claudication

Outcome Measures

Primary Outcomes (1)

• The number of incidents of wound infections in both groups of patients undergoing lower limb re vascularization.

  4 weeks

Secondary Outcomes (2)

• Patient acceptability of the oral nutritional supplement.

  4 weeks

• Duration of post operative hospital stay

  4 weeks

Study Arms (2)

Arginine enriched oral nutritional supplement group

EXPERIMENTAL

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.

Dietary Supplement: Arginine enriched oral nutritional supplement

Control

NO INTERVENTION

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.

Interventions

Arginine enriched oral nutritional supplement DIETARY_SUPPLEMENT

oral nutritional supplement containing arginine

Also known as: CubitanTM

Arginine enriched oral nutritional supplement group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for elective lower limb revascularization surgery
• patients aged \>18 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Limerick: lead
• UL Hospitals, Limerick: collaborator

Study Sites (1)

University Hospital Limerick

Limerick, Ireland

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases; Intermittent Claudication

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Peripheral Arterial Disease; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mary Clarke Moloney

  University of Limerick

  PRINCIPAL INVESTIGATOR

• Paul Burke

  UL Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Operations Manager

Study Record Dates

• First Submitted: June 8, 2015
• First Posted: June 18, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: February 1, 2017
• Last Updated: May 4, 2018

Record last verified: 2018-05

Locations

IE (1)