Ultrasound to Prevent Leg Wound Complications in Heart Bypass.

University Hospitals Bristol and Weston NHS Foundation Trust

Status: Terminated

Conditions: Coronary Artery Bypass; Surgical Wound Infection

Treatments: Procedure: Ultrasound imaging of the long saphenous vein

Study type: Interventional

Funder types: Other

Identifiers

NCT02307084

CS/2014/4661

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

Pre-operative ultrasound imaging

Experimental group

Description:

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.

Treatment:

Procedure: Ultrasound imaging of the long saphenous vein

Current protocol

No Intervention group

Description:

This group will not undergo pre-operative ultrasound imaging of the long saphenous vein in accordance with current Trust protocols.