Condition category
Injury, Occupational Diseases, Poisoning
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
We are carrying out a study of patients who are undergoing an elective hip or knee replacement to compare different sutures used to close the surgical site wound. Our goal is to establish if the use of a triclosan coated suture will reduce the rate of surgical site infection. We will look at a number of patient characteristic such as age, gender, rates of infection, timing of surgery, and other characteristics. The study's findings should help to improve the well being of patients undergoing a hip and knee replacement in the UK, England and enhance the country's research base in orthopaedic infection.

Who can participate?
The study aims to recruit about 2600 patients, age > 18 years from 3 centers within Northumbria NHS trust. This study is based in a hospital setting.

What does the study involve?
Patients will be invited to participate in a study comparing two different sutures hip and knee replacement. Patients will be assigned to one of two groups. A process called ‘randomisation’, which is like a coin toss, will allocate the suture given to the patient based on a monthly assignment.
Group 1 will receive a standard suture (that used in normal practice) and group 2 will receive triclosan-coated (antibacterial action) suture (that is used in other areas of surgical practice). Both groups then have the same postoperative care and follow up. At the end of the study, we will compare the rates of surgical site infection between the groups. Patients will be given the same clinical care whether or not they are in the study.

What are the possible benefits and risks of participating?
The benefits of the study will potentially develop a positive change in treatment for this operation in a rigorous scientific manner. This may ultimately change management for this fracture in the NHS. There may be no difference in either group.
The risk is deemed low and is essentially the risks normally associated with operative intervention.

Where is the study run from?
The study has been set up and is sponsored by Northumbria NHS trust UK.

When is the study starting and how long is it expected to run for?
Recruitment started in May 2008 and follow up is expected to complete by December 2013. Participants will be enrolled on the study until around 2600 patients have been enrolled.

Who is funding the study?
Johnson & Johnson Medical Ltd, UK

Who is the main contact?
Mr Mike Reed,
Mr Andrew Sprowson,

Trial website

Contact information



Primary contact

Mr Mike Reed


Contact details

Wansbeck General Hospital
Woodhorn Lane
NE63 9JJ
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Standard vs. triclosan coated suture in patients undergoing hip and knee replacement: an assessor blinded randomised controlled trial



Study hypothesis

It is hypothesised that triclosan (antibacterial) coated sutures will reduce the rates of surgical site infection in patients undergoing total hip and knee replacement vs. standard of care suture.

The null hypothesis is that there will be reduction in surgical site infection between treatment groups.

Ethics approval

NRES Committee Gateshead and South Tyneside Research Ethics Committee, 4th January 2008, ref: 07/H0901/62

Study design

Three site two arm assessor blinded randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Surgical site infection / orthopaedics / hip replacement / knee replacement


1. Wounds closed with triclosan (antibacterial) coated suture.

2. Standard, with no technique modification needed.

Intervention type



Not Applicable

Drug names


Primary outcome measures

Superficial surgical site infection as defined by the Health Protection Agency (England)

Secondary outcome measures

1. Deep surgical site infection as defined by the Health Protection Agency (England)
2. Length of stay
3. Surgeon grade- consultant orthopaedic surgeon, Specialist trainee or core training doctor
4. Admission to high dependency unit
5. 30 and 90 day mortality
6. All complications will be recorded
7. A cost analysis will be performed.
All baseline data will be summarised descriptively by treatment group.

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Being listed for a total hip or knee replacement by an orthopaedic consultant working at the Trust.
2. Participants must be willing to provide fully-informed consent, or fulfil the above criteria.
3. All patients aged 18 and above, either sex, who require a total hip or knee replacement will be included in the study

Participant type


Age group




Target number of participants


Participant exclusion criteria

Patients under 18

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Wansbeck General Hospital
NE63 9JJ
United Kingdom

Sponsor information


Northumbria Healthcare NHS Foundation Trust (UK)

Sponsor details

Research and Development
North Tyneside General Hospital
Education Centre
Rake Lane
North Shields
NE29 8NH
United Kingdom
+44 844 811 8111 ext 2842

Sponsor type




Funder type


Funder name

Johnson & Johnson Medical Ltd. (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

2014 protocol in:

Publication citations

  1. Protocol

    Sprowson AP, Jensen CD, Parsons N, Partington P, Emmerson K, Carluke I, Asaad S, Pratt R, Muller S, Reed MR, The effect of triclosan coated sutures on rate of surgical site infection after hip and knee replacement: a protocol for a double-blind randomised controlled trial., BMC Musculoskelet Disord, 2014, 15, 237, doi: 10.1186/1471-2474-15-237.

Additional files

Editorial Notes