Reduction of leg wound complications following coronary artery bypass grafting
| ISRCTN | ISRCTN47246088 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47246088 |
| Protocol serial number | N0185115619 |
| Sponsor | Department of Health (UK) |
| Funder | Plymouth Hospitals NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 26/10/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr M Zafar
Scientific
Scientific
Cardiothoracic Theatres
Level 06
Derriford Hospital
Plymouth
PL6 8DH
United Kingdom
| mhzafar40@hotmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To determine the best method for leg wound closure. The choice of wound closure technique may have important implications for post operative healing in these high risk cases, and also have an impact in other patients at lower risk for post operative morbidity. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Coronary artery bypass grafting (CABG) |
| Intervention | A prospective randomised controlled trial performed at the Southwest Cardiothoracic Centre. Recruitment of patients will be over a period of 6 months. Patients will be followed from the day of operation to the time of discharge from the hospital and for a period of 6 weeks thereafter. Patients will be randomised to two equal sized groups. Patients will be randomly assigned to one of two groups: 1. Single layer wound closure over Redivac drains 2. 2-layer closure +/- Redivac drains as indicated clinically. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Post operative healing |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 25/04/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 80 |
| Key inclusion criteria | 80 Patients undergoing CABG surgery will be enrolled into the study |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 25/10/2002 |
| Date of final enrolment | 25/04/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Cardiothoracic Theatres
Plymouth
PL6 8DH
United Kingdom
PL6 8DH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2005 | Yes | No |
