Surgical Wound InfectionNCT02307084
Ultrasound to Prevent Leg Wound Complications in Heart Bypass.
A study testing Ultrasound imaging of the long saphenous vein in people with Surgical Wound Infection and Coronary Artery Bypass, run by University Hospitals Bristol and Weston NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The long saphenous vein is traditionally harvested for use as a conduit in coronary artery bypass grafting surgery. Currently, the long saphenous vein is not imaged prior to surgery. This study aims to evaluate preoperative ultrasound mapping of the long saphenous vein to to improve patient and clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Wound Infection, Coronary Artery Bypass
- What is being tested?
- Ultrasound imaging of the long saphenous vein
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2015to 13 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
- Listed for CABG surgery with long saphenous vein harvesting.
- Aged over 18 years.
- Capable of providing informed consent.
- Five days or more to consider participation prior to surgery if an outpatient or 2 days if an inpatient referred by their consultant.
- Operative procedure to be undertaken at the Bristol Heart Institute.
Who cannot join
- Operation within 48h hours if an inpatient or 5 days if an outpatient.
- Aged below 18 years of age.
- Incapable of providing informed consent i.e. confirmed diagnosis of dementia or other mental health conditions or unconscious.
- Current participant in a different randomised control trial.
- Pregnancy
- Active cancer
- Immunosuppressed.
- Non-English speaker that requires a Trust translator.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital Bristol NHS FT
Bristol, BS2 8HW
About this study
Official title: An Investigation Into the Efficacy of Pre-operative Long Saphenous Vein Mapping Using Ultrasound for Use in Coronary Artery Bypass Grafting to Reduce Vein Harvest Site Complications.
The long saphenous vein is traditionally harvested for use as a conduit in coronary artery bypass grafting surgery. Currently, the long saphenous vein is not imaged prior to surgery. This study aims to evaluate preoperative ultrasound mapping of the long saphenous vein to to improve patient and clinical outcomes.
Read the detailed description
A vein from the leg is widely is widely harvested during coronary artery bypass grafting (CABG) surgery for bypass of diseased coronary arteries. This vein is called the long saphenous vein.
Currently, the long saphenous vein (LSV) is harvested blind by surgical practitioners with no imaging prior to surgery to decide on whether this vein is suitable for use in heart bypass surgery. This can result in fruitless incisions and result in additional unnecessary surgical wounds in the leg(s) to identify a suitable section of vein that can be used in the bypass operation. In these cases, excessive surgical trauma to the leg can increase the risk of a wound infection.
There is some evidence that ultrasound imaging of the LSV improves leg wound outcomes in patients having CABG surgery. Some studies have reported reductions in vein wound infection rates, vein harvest time, length of hospitalisation and length of wounds.
The purpose of this study will be to investigate the potential benefit of ultrasound imaging as a randomised control trial. One group will have ultrasound imaging of the long saphenous vein prior to heart bypass surgery. A second group will not undergo ultrasound imaging which is current practice at the Bristol Heart Institute.
Ultrasound imaging of the long saphenous vein will allow planning and selection of the most optimal segment of vein. This targeted approach will allow guidance of surgical incisions away from unsuitable segments and thus potentially improving leg wound outcomes.
The primary endpoint for this study will be to assess leg wound infection between the two randomised groups. Other endpoints that will be assessed are patient satisfaction, wound length, time taken to remove the vein, blood loss from the leg wound during surgery and the number of wounds in your leg.
- Conditions
- Surgical Wound Infection, Coronary Artery Bypass
- Being tested
- Ultrasound imaging of the long saphenous vein
- Keywords
- surgical site infection, long saphenous vein, coronary artery bypass grafting
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound imaging of the long saphenous veinProcedure or surgery
Ultrasound imaging of the long saphenous vein from the ankle to the saphenofemoral junction. This will allow assessment of vein calibre, branches and bifurcations, presence of thrombophlebitis and distribution. The presence of a proximal deep vein thrombosis will also be assessed.
| Study group | Role | What they receive |
|---|---|---|
| Pre-operative ultrasound imaging | Experimental | Subjects that are randomly allocated to this group will have ultrasound imaging assessment of the long saphenous vein in both legs. This will allow assessment of the suitability of the long saphenous vein and marking of the distribution prior to heart bypass surgery to allow targeted harvesting of a bypass conduit. Receives: Procedure: Ultrasound imaging of the long saphenous vein |
| Current protocol | No intervention | This group will not undergo pre-operative ultrasound imaging of the long saphenous vein in accordance with current Trust protocols. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection at the conduit harvest site
The ASEPSIS tool is a well established tool to quantify wound healing disturbances.
Measured: 30 days of CABG surgery
Secondary outcomes (5)
Ability to identify abnormal segments of vein on ultrasound and direct surgical excision away from such areas.
Applicable to the ultrasound imaged group only. The incidence of an abnormal segment of vein will be quantified and whether or not this has led to avoidance of unnecessary surgical excisions.
Measured: baseline
Time taken to harvest a suitable conduit.
The time to harvest a suitable conduit will be recorded during CABG surgery.
Measured: intraoperative
Length of lower limb vein harvest wounds.
Length of conduit harvest wounds will be measured after surgery to the nearest centimetre.
Measured: 1 day Post-operation
Blood loss from the vein harvest wound
The blood loss from the conduit harvest wound(s) will be measured during surgery by weighing swabs.
Measured: intraoperative
Patient questionnaire to assess wound/scar satisfaction and complications.
An assessment of patient satisfaction and non-infective complications related to the conduit harvesting for CABG surgery.
Measured: 30 days from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startFeb 2015
- Primary completion13 Feb 2017
- Study completion13 Feb 2017
Why it stopped: Departure of Chief Investigator/Principal Investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Wound InfectionStudies 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
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Bristol and Weston NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reshat Reshat, PhD, Principal investigator, University Hospital Bristol NHS FTTeresa Robinson, MSc, Study director, University Hospital Bristol NHS FT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02307084
- Sponsor's protocol ID
- CS/2014/4661
- Status last verified
- May 2019
- First submitted
- 1 Dec 2014
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation Into the Efficacy of Pre-operative Long Saphenous Vein Mapping Using Ultrasound for Use in Coronary Artery Bypass Grafting to Reduce Vein Harvest Site Complications.
- ClinicalTrials.gov ID
- NCT02307084
- Acronym / sponsor ID
- CS/2014/4661
- Conditions
- Surgical Wound Infection, Coronary Artery Bypass
- Keywords
- surgical site infection, long saphenous vein, coronary artery bypass grafting
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Departure of Chief Investigator/Principal Investigator
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University Hospitals Bristol and Weston NHS Foundation TrustUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- 13 Feb 2017 (actual)
- Study completion
- 13 Feb 2017 (actual)
- First posted
- 3 Dec 2014 (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 long saphenous vein is traditionally harvested for use as a conduit in coronary artery bypass grafting surgery. Currently, the long saphenous vein is not imaged prior to surgery. This study aims to evaluate preoperative ultrasound mapping of the long saphenous vein to to improve patient and clinical outcomes.
Detailed description
A vein from the leg is widely is widely harvested during coronary artery bypass grafting (CABG) surgery for bypass of diseased coronary arteries. This vein is called the long saphenous vein.
Currently, the long saphenous vein (LSV) is harvested blind by surgical practitioners with no imaging prior to surgery to decide on whether this vein is suitable for use in heart bypass surgery. This can result in fruitless incisions and result in additional unnecessary surgical wounds in the leg(s) to identify a suitable section of vein that can be used in the bypass operation. In these cases, excessive surgical trauma to the leg can increase the risk of a wound infection.
There is some evidence that ultrasound imaging of the LSV improves leg wound outcomes in patients having CABG surgery. Some studies have reported reductions in vein wound infection rates, vein harvest time, length of hospitalisation and length of wounds.
The purpose of this study will be to investigate the potential benefit of ultrasound imaging as a randomised control trial. One group will have ultrasound imaging of the long saphenous vein prior to heart bypass surgery. A second group will not undergo ultrasound imaging which is current practice at the Bristol Heart Institute.
Ultrasound imaging of the long saphenous vein will allow planning and selection of the most optimal segment of vein. This targeted approach will allow guidance of surgical incisions away from unsuitable segments and thus potentially improving leg wound outcomes.
The primary endpoint for this study will be to assess leg wound infection between the two randomised groups. Other endpoints that will be assessed are patient satisfaction, wound length, time taken to remove the vein, blood loss from the leg wound during surgery and the number of wounds in your leg.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-operative ultrasound imaging | Experimental | Procedure: Ultrasound imaging of the long saphenous veinSubjects that are randomly allocated to this group will have ultrasound imaging assessment of the long saphenous vein in both legs. This will allow assessment of the suitability of the long saphenous vein and marking of the distribution prior to heart bypass surgery to allow targeted harvesting of a bypass conduit. |
| Current protocol | No intervention | –This group will not undergo pre-operative ultrasound imaging of the long saphenous vein in accordance with current Trust protocols. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Listed for CABG surgery with long saphenous vein harvesting.
- Aged over 18 years.
- Capable of providing informed consent.
- Five days or more to consider participation prior to surgery if an outpatient or 2 days if an inpatient referred by their consultant.
- Operative procedure to be undertaken at the Bristol Heart Institute.
Key exclusion criteria (8 listed)
- Operation within 48h hours if an inpatient or 5 days if an outpatient.
- Aged below 18 years of age.
- Incapable of providing informed consent i.e. confirmed diagnosis of dementia or other mental health conditions or unconscious.
- Current participant in a different randomised control trial.
- Pregnancy
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 |
|---|---|---|
| Ultrasound imaging of the long saphenous veinUltrasound imaging of the long saphenous vein from the ankle to the saphenofemoral junction. This will allow assessment of vein calibre, branches and bifurcations, presence of thrombophlebitis and distribution. The presence of a proximal deep vein thrombosis will also be assessed. | Procedure or surgery | Pre-operative ultrasound imaging |
Primary outcome
Surgical site infection at the conduit harvest site
Time frame: 30 days of CABG surgery
The ASEPSIS tool is a well established tool to quantify wound healing disturbances.
5 secondary outcomes
Ability to identify abnormal segments of vein on ultrasound and direct surgical excision away from such areas.
Time frame: baseline
Time taken to harvest a suitable conduit.
Time frame: intraoperative
Length of lower limb vein harvest wounds.
Time frame: 1 day Post-operation
Blood loss from the vein harvest wound
Time frame: intraoperative
Patient questionnaire to assess wound/scar satisfaction and complications.
Time frame: 30 days from surgery
Results and safety
The study was stopped early (reason given: Departure of Chief Investigator/Principal Investigator). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
- Individual participant dataSharing planned: No
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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.
Reshat Reshat, PhD principal investigator
University Hospital Bristol NHS FT
Teresa Robinson, MSc study director
University Hospital Bristol NHS FT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound imaging of the long saphenous vein in people with Surgical Wound Infection and Coronary Artery Bypass, run by University Hospitals Bristol and Weston NHS Foundation Trust at 1 site in United Kingdom.
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 5 inclusion and 8 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 3 May 2019. 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 United Kingdom. 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: Departure of Chief Investigator/Principal Investigator). 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?
Surgical site infection at the conduit harvest site (time frame: 30 days of CABG surgery). 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 3 May 2019.