Ultrasound to Prevent Leg Wound Complications in Heart Bypass.

Not Applicable

Terminated

• Conditions: Surgical Wound Infection; Coronary Artery Bypass
• Interventions: Procedure: Ultrasound imaging of the long saphenous vein

• Registration Number: NCT02307084
• Lead Sponsor: University Hospitals Bristol and Weston NHS Foundation Trust

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.

Study Timeline

• Study First Submitted: 2014-12-01
• Study First Submitted QC: 2014-12-02
• Study First Posted: 2014-12-03
• Study Start: 2015-02
• Primary Completion: 2017-02-13
• Study Completion: 2017-02-13
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-01
• Last Update Posted: 2019-05-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 55

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pre-operative ultrasound imaging	Ultrasound imaging of the long saphenous vein	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.

Primary Outcome Measures

Name	Time	Method
Surgical site infection at the conduit harvest site	30 days of CABG surgery	The ASEPSIS tool is a well established tool to quantify wound healing disturbances.

Secondary Outcome Measures

Name	Time	Method
Patient questionnaire to assess wound/scar satisfaction and complications.	30 days from surgery	An assessment of patient satisfaction and non-infective complications related to the conduit harvesting for CABG surgery.
Ability to identify abnormal segments of vein on ultrasound and direct surgical excision away from such areas.	baseline	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.
Time taken to harvest a suitable conduit.	intraoperative	The time to harvest a suitable conduit will be recorded during CABG surgery.
Length of lower limb vein harvest wounds.	1 day Post-operation	Length of conduit harvest wounds will be measured after surgery to the nearest centimetre.
Blood loss from the vein harvest wound	intraoperative	The blood loss from the conduit harvest wound(s) will be measured during surgery by weighing swabs.

Trial Locations

Locations (1)

University Hospital Bristol NHS FT; 🇬🇧 Bristol, United Kingdom