Clinical trial NCT02307084: Ultrasound to Prevent Leg Wound Complications in Heart Bypass.
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Surgical Wound Infection
Coronary Artery Bypass
Keywords: surgical site infection
long saphenous vein
coronary artery bypass grafting
Lead sponsor: University Hospitals Bristol and Weston NHS Foundation Trust
Sponsor class: OTHER
First posted: 2014-12-03
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Surgical site infection at the conduit harvest site
timeFrame: 30 days of CABG surgery
Secondary outcomes:
measure: Ability to identify abnormal segments of vein on ultrasound and direct surgical excision away from such areas.
timeFrame: baseline
measure: Time taken to harvest a suitable conduit.
timeFrame: intraoperative
measure: Length of lower limb vein harvest wounds.
timeFrame: 1 day Post-operation
measure: Blood loss from the vein harvest wound
timeFrame: intraoperative
measure: Patient questionnaire to assess wound/scar satisfaction and complications.
timeFrame: 30 days from surgery
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: University Hospital Bristol NHS FT
Study officials:
affiliation: University Hospital Bristol NHS FT
name: Reshat Reshat, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Bristol NHS FT
name: Teresa Robinson, MSc
role: STUDY_DIRECTOR
References: