Ultrasound to Prevent Leg Wound Complications in Heart Bypass.

NCT ID: NCT02307084

Last Updated: 2019-05-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2017-02-13

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.

Conditions

Surgical Wound Infection; Coronary Artery Bypass

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Pre-operative ultrasound imaging

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.

Group Type: EXPERIMENTAL

Ultrasound imaging of the long saphenous vein

Intervention Type: PROCEDURE

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.

Current protocol

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ultrasound imaging of the long saphenous vein

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospitals Bristol and Weston NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Reshat Reshat, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Bristol NHS FT

Teresa Robinson, MSc

Role: STUDY_DIRECTOR

University Hospital Bristol NHS FT

Locations

University Hospital Bristol NHS FT

Bristol, , United Kingdom

Countries

United Kingdom

Other Identifiers

CS/2014/4661

Identifier Type: -

Identifier Source: org_study_id