Leg closure study following saphenous vein harvesting for coronary artery bypass surgery
| ISRCTN | ISRCTN38483584 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38483584 |
| Secondary identifying numbers | N0295165886 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 28/09/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Surgery
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
Contact information
Mr Michael Rosin
Scientific
Scientific
Cardiothoracic Department
UHCW NHS Trust
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
| Phone | +44 02476 602020 ext 5540 |
|---|---|
| mike.rosin@uhcw.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 | Determination of the best method of leg closure following vein harvesting for CABG |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 23/03/2005 |
| Completion date | 22/10/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Cardiothoracic Department
Coventry
CV2 2DX
United Kingdom
CV2 2DX
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
University Hospitals Coventry and Warwickshire NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
