Oral Nutritional Supplement in Reducing Surgical Site Infections

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-02-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Peripheral Vascular Disease Claudication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Arginine enriched oral nutritional supplement group

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.

Group Type EXPERIMENTAL

Arginine enriched oral nutritional supplement

Intervention Type DIETARY_SUPPLEMENT

oral nutritional supplement containing arginine

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Arginine enriched oral nutritional supplement

oral nutritional supplement containing arginine

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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CubitanTM

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No