Condition category
Surgery
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
28/09/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes