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.
Verified date | May 2019 |
Source | University Hospitals Bristol NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University Hospital Bristol NHS FT | Bristol |
Lead Sponsor | Collaborator |
---|---|
University Hospitals Bristol NHS Foundation Trust |
United Kingdom,
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 |
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