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Oral Nutritional Supplement in Reducing Surgical Site Infections

Primary Purpose

Peripheral Vascular Disease, Claudication

Status
Terminated
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Arginine enriched oral nutritional supplement
Sponsored by
University of Limerick
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Peripheral Vascular Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University Hospital Limerick

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arginine enriched oral nutritional supplement group

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Patient acceptability of the oral nutritional supplement.
Duration of post operative hospital stay

Full Information

First Posted
June 8, 2015
Last Updated
May 1, 2018
Sponsor
University of Limerick
Collaborators
UL Hospitals, Limerick
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1. Study Identification

Unique Protocol Identification Number
NCT02475525
Brief Title
Oral Nutritional Supplement in Reducing Surgical Site Infections
Official Title
The Role of an Arginine Enriched Oral Nutritional Supplement in the Prevention of Wound Complication in Patients Undergoing Lower Limb Revascularization
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
Recruitment difficulties
Study Start Date
June 2015 (Actual)
Primary Completion Date
December 1, 2016 (Actual)
Study Completion Date
February 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Limerick
Collaborators
UL Hospitals, Limerick

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vascular Disease, Claudication

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arginine enriched oral nutritional supplement group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Arginine enriched oral nutritional supplement
Other Intervention Name(s)
CubitanTM
Intervention Description
oral nutritional supplement containing arginine
Primary Outcome Measure Information:
Title
The number of incidents of wound infections in both groups of patients undergoing lower limb re vascularization.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Patient acceptability of the oral nutritional supplement.
Time Frame
4 weeks
Title
Duration of post operative hospital stay
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Clarke Moloney
Organizational Affiliation
University of Limerick
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul Burke
Organizational Affiliation
UL Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Limerick
City
Limerick
Country
Ireland

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Oral Nutritional Supplement in Reducing Surgical Site Infections

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