Ultrasound to Prevent Leg Wound Complications in Heart Bypass.

Surgical Wound Infection Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02307084
• Other study ID #: CS/2014/4661
• Status: Terminated
• Phase: N/A
• Start date: February 2015
• Est. completion date: February 13, 2017

Study information

• Verified date: May 2019
• Source: University Hospitals Bristol NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Est. completion date: February 13, 2017
• Est. primary completion date: February 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Bypass
• Surgical Wound
• Surgical Wound Infection
• Wound Infection

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United Kingdom	University Hospital Bristol NHS FT	Bristol

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Bristol NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical site infection at the conduit harvest site	The ASEPSIS tool is a well established tool to quantify wound healing disturbances.	30 days of CABG surgery
Secondary	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.	baseline
Secondary	Time taken to harvest a suitable conduit.	The time to harvest a suitable conduit will be recorded during CABG surgery.	intraoperative
Secondary	Length of lower limb vein harvest wounds.	Length of conduit harvest wounds will be measured after surgery to the nearest centimetre.	1 day Post-operation
Secondary	Blood loss from the vein harvest wound	The blood loss from the conduit harvest wound(s) will be measured during surgery by weighing swabs.	intraoperative
Secondary	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.	30 days from surgery