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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02475525 |
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Date of registration:
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08/06/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Oral Nutritional Supplement in Reducing Surgical Site Infections
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Scientific title:
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The Role of an Arginine Enriched Oral Nutritional Supplement in the Prevention of Wound Complication in Patients Undergoing Lower Limb Revascularization |
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Date of first enrolment:
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June 2015 |
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Target sample size:
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6 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02475525 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Ireland
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Contacts
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Name:
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Mary Clarke Moloney |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Limerick |
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Name:
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Paul Burke |
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Address:
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Telephone:
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Email:
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Affiliation:
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UL Hospitals |
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Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Peripheral Vascular Disease
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Claudication
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Intervention(s)
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Dietary Supplement: Arginine enriched oral nutritional supplement
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Primary Outcome(s)
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The number of incidents of wound infections in both groups of patients undergoing lower limb re vascularization.
[Time Frame: 4 weeks]
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Secondary Outcome(s)
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Duration of post operative hospital stay
[Time Frame: 4 weeks]
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Patient acceptability of the oral nutritional supplement.
[Time Frame: 4 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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