ISRCTN - ISRCTN17807356: Northumbria Arthroplasty Suture Study (NASS) - A randomised trial comparing standard suture vs. triclosan (antibacterial action) coated suture on rates of surgical site infection

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, mike.reed@nhs.net
Mr Andrew Sprowson, Andrew.sprowson@warwick.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mr Mike Reed

ORCID ID

Contact details

Wansbeck General Hospital
Woodhorn Lane
Northumberland
Ashington
NE63 9JJ
United Kingdom
mike.reed@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

NASS

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Surgical site infection / orthopaedics / hip replacement / knee replacement

Intervention

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

2. Standard, with no technique modification needed.

Intervention type

Drug

Phase

Not Applicable

Drug names

Triclosan

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

01/05/2008

Overall trial end date

01/04/2013

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

Target number of participants

2600

Participant exclusion criteria

Patients under 18

Recruitment start date

01/05/2008

Recruitment end date

01/04/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Wansbeck General Hospital
Ashington
NE63 9JJ
United Kingdom

Sponsor information

Organisation

Northumbria Healthcare NHS Foundation Trust (UK)

Sponsor type

Government

Website

Funders

Funder type

Industry

Funder name

Johnson & Johnson Medical Ltd. (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