Contact information
Type
Scientific
Primary contact
Mr Michael Rosin
ORCID ID
Contact details
Cardiothoracic Department
UHCW NHS Trust
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
+44 02476 602020 ext 5540
mike.rosin@uhcw.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0295165886
Study information
Scientific title
Acronym
Study hypothesis
Is using one layer closure (skin stitch only) as effective as two layer closure (fat and skin stitch) in closing a leg wound following saphenous vein removal, in relation to wound healing, infection and pain?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Surgery: Saphenous vein harvesting
Intervention
One layer closure vs two layer closure
August 2008: trial stopped.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Determination of the best method of leg closure following vein harvesting for CABG
Secondary outcome measures
Not provided at time of registration
Overall trial start date
23/03/2005
Overall trial end date
22/10/2005
Reason abandoned
Eligibility
Participant inclusion criteria
The study will include 100 consecutive patients. Patients undergoing coronary artery bypass grafting at Walsgrave Hospital under the care of Mr Rosin and Mr Norton (Consultant Cardiothoracic Surgeons). Inclusion criteria: patients who require vein harvesting from both legs allowing equal incisions.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
100
Participant exclusion criteria
1. Patients who do not wish to take part in the study
2. Have their vein harvested not using the open technique
3. Have their vein harvested by another operator
4. Harvest is abandoned because of technical difficulties
5. Have limb neuropathy
6. Have skin changes due to arterial, venous or nerve disease
7. Have leg ulcers
8. Have recent limb skin or tissue infection
9. Have varicosities along the long saphenous vein
10. Have had previous lower limb injuries
Recruitment start date
23/03/2005
Recruitment end date
22/10/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cardiothoracic Department
Coventry
CV2 2DX
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
University Hospitals Coventry and Warwickshire NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary