Leg closure study following saphenous vein harvesting for coronary artery bypass surgery

ISRCTN	ISRCTN38483584
DOI	https://doi.org/10.1186/ISRCTN38483584
Protocol serial number	N0295165886
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funder	University Hospitals Coventry and Warwickshire NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Mr Michael Rosin
Scientific

Cardiothoracic Department
UHCW NHS Trust
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Phone	+44 02476 602020 ext 5540
Email	mike.rosin@uhcw.nhs.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Saphenous vein harvesting
Intervention	One layer closure vs two layer closure August 2008: trial stopped.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Determination of the best method of leg closure following vein harvesting for CABG
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	22/10/2005

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	100
Key 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.
Key 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
Date of first enrolment	23/03/2005
Date of final enrolment	22/10/2005

Cardiothoracic Department

Coventry
CV2 2DX
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan