Peripheral Vascular DiseaseNCT02475525
Oral Nutritional Supplement in Reducing Surgical Site Infections
A study testing Arginine enriched oral nutritional supplement in people with Peripheral Vascular Disease and Claudication, run by University of Limerick at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Disease, Claudication
- What is being tested?
- Arginine enriched oral nutritional supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteIreland
- Study dates
- Jun 2015to 1 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective lower limb revascularization surgery
- patients aged >18 years.
Who cannot join
- 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,
Show all 9Show fewer
- known galactosemia,
- pregnancy,
- cows milk allergy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of an Arginine Enriched Oral Nutritional Supplement in the Prevention of Wound Complication in Patients Undergoing Lower Limb Revascularization
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.
Read the 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.
- Conditions
- Peripheral Vascular Disease, Claudication
- Being tested
- Arginine enriched oral nutritional supplement
- Medical subject headings
- Peripheral Vascular Diseases, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arginine enriched oral nutritional supplementDietary supplement
Also called CubitanTM
oral nutritional supplement containing arginine
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of incidents of wound infections in both groups of patients undergoing lower limb re vascularization.
Measured: 4 weeks
Secondary outcomes (2)
Patient acceptability of the oral nutritional supplement.
Measured: 4 weeks
Duration of post operative hospital stay
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study startJun 2015
- Primary completion1 Dec 2016
- Study completion1 Feb 2017
Why it stopped: Recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Limerick
- Sponsor type
- University, hospital or other
- Collaborators
- UL Hospitals, Limerick
- Responsible party
- Principal investigator, Mary Clarke Moloney, University of Limerick
- Investigators
- Mary Clarke Moloney, Principal investigator, University of LimerickPaul Burke, Principal investigator, UL Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475525
- Sponsor's protocol ID
- ONS2015
- Status last verified
- May 2018
- First submitted
- 8 Jun 2015
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of an Arginine Enriched Oral Nutritional Supplement in the Prevention of Wound Complication in Patients Undergoing Lower Limb Revascularization
- ClinicalTrials.gov ID
- NCT02475525
- Acronym / sponsor ID
- ONS2015
- Conditions
- Peripheral Vascular Disease, Claudication
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of LimerickUniversity, hospital or other
- Collaborators
- UL Hospitals, Limerick
- Study start
- Jun 2015 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 18 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arginine enriched oral nutritional supplement group | Experimental | Dietary Supplement: Arginine enriched oral nutritional supplementPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for elective lower limb revascularization surgery
- patients aged >18 years.
Key exclusion criteria (9 listed)
- Patients unable to provide informed consent,
- emergency cases,
- seriously ill patients/unconscious patients,
- chronic renal disease,
- known inflammatory bowel disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arginine enriched oral nutritional supplementAlso: CubitanTMoral nutritional supplement containing arginine | Dietary supplement | Arginine enriched oral nutritional supplement group |
Primary outcome
The number of incidents of wound infections in both groups of patients undergoing lower limb re vascularization.
Time frame: 4 weeks
2 secondary outcomes
Patient acceptability of the oral nutritional supplement.
Time frame: 4 weeks
Duration of post operative hospital stay
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Clarke Moloney principal investigator
University of Limerick
Paul Burke principal investigator
UL Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arginine enriched oral nutritional supplement in people with Peripheral Vascular Disease and Claudication, run by University of Limerick at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of incidents of wound infections in both groups of patients undergoing lower limb re vascularization. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2018.