Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
26/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M Zafar

ORCID ID

Contact details

Cardiothoracic Theatres
Level 06
Derriford Hospital
Plymouth
PL6 8DH
United Kingdom
mhzafar40@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0185115619

Study information

Scientific title

Acronym

Study hypothesis

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

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

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

Phase

Not Specified

Drug names

Primary outcome measures

Post operative healing

Secondary outcome measures

Not provided at time of registration

Overall trial start date

25/10/2002

Overall trial end date

25/04/2003

Reason abandoned

Eligibility

Participant inclusion criteria

80 Patients undergoing CABG surgery will be enrolled into the study

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

80

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

25/10/2002

Recruitment end date

25/04/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cardiothoracic Theatres
Plymouth
PL6 8DH
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Plymouth Hospitals 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

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16305864

Publication citations

  1. Results

    Zafar M, John A, Khan Z, Allen SM, Marchbank AJ, Lewis CT, Dalrymple-Hay MJ, Kuo J, Unsworth-White J, Single-layer versus multiple-layer closure of leg wounds after long saphenous vein harvest: a prospective randomized trial., Ann. Thorac. Surg., 2005, 80, 6, 2162-2165, doi: 10.1016/j.athoracsur.2005.05.051.

Additional files

Editorial Notes