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Ultrasound to Prevent Leg Wound Complications in Heart Bypass.

Primary Purpose

Surgical Wound Infection, Coronary Artery Bypass

Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Ultrasound imaging of the long saphenous vein
Sponsored by
University Hospitals Bristol and Weston NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Wound Infection focused on measuring surgical site infection, long saphenous vein, coronary artery bypass grafting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University Hospital Bristol NHS FT

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pre-operative ultrasound imaging

Current protocol

Arm 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.

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

Outcomes

Primary Outcome Measures

Surgical site infection at the conduit harvest site
The ASEPSIS tool is a well established tool to quantify wound healing disturbances.

Secondary Outcome Measures

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.
Time taken to harvest a suitable conduit.
The time to harvest a suitable conduit will be recorded during CABG surgery.
Length of lower limb vein harvest wounds.
Length of conduit harvest wounds will be measured after surgery to the nearest centimetre.
Blood loss from the vein harvest wound
The blood loss from the conduit harvest wound(s) will be measured during surgery by weighing swabs.
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.

Full Information

First Posted
December 1, 2014
Last Updated
May 1, 2019
Sponsor
University Hospitals Bristol and Weston NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02307084
Brief Title
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

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
Departure of Chief Investigator/Principal Investigator
Study Start Date
February 2015 (undefined)
Primary Completion Date
February 13, 2017 (Actual)
Study Completion Date
February 13, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospitals Bristol and Weston NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound Infection, Coronary Artery Bypass
Keywords
surgical site infection, long saphenous vein, coronary artery bypass grafting

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-operative ultrasound imaging
Arm Type
Experimental
Arm 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.
Arm Title
Current protocol
Arm Type
No Intervention
Arm Description
This group will not undergo pre-operative ultrasound imaging of the long saphenous vein in accordance with current Trust protocols.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound imaging of the long saphenous vein
Intervention Description
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.
Primary Outcome Measure Information:
Title
Surgical site infection at the conduit harvest site
Description
The ASEPSIS tool is a well established tool to quantify wound healing disturbances.
Time Frame
30 days of CABG surgery
Secondary Outcome Measure Information:
Title
Ability to identify abnormal segments of vein on ultrasound and direct surgical excision away from such areas.
Description
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 Frame
baseline
Title
Time taken to harvest a suitable conduit.
Description
The time to harvest a suitable conduit will be recorded during CABG surgery.
Time Frame
intraoperative
Title
Length of lower limb vein harvest wounds.
Description
Length of conduit harvest wounds will be measured after surgery to the nearest centimetre.
Time Frame
1 day Post-operation
Title
Blood loss from the vein harvest wound
Description
The blood loss from the conduit harvest wound(s) will be measured during surgery by weighing swabs.
Time Frame
intraoperative
Title
Patient questionnaire to assess wound/scar satisfaction and complications.
Description
An assessment of patient satisfaction and non-infective complications related to the conduit harvesting for CABG surgery.
Time Frame
30 days from surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reshat Reshat, PhD
Organizational Affiliation
University Hospital Bristol NHS FT
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Teresa Robinson, MSc
Organizational Affiliation
University Hospital Bristol NHS FT
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Bristol NHS FT
City
Bristol
ZIP/Postal Code
BS2 8HW
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Ultrasound to Prevent Leg Wound Complications in Heart Bypass.

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