Northumbria Arthroplasty Suture Study (NASS) - A randomised trial comparing standard suture vs. triclosan (antibacterial action) coated suture on rates of surgical site infection
| ISRCTN | ISRCTN17807356 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17807356 |
| Secondary identifying numbers | N/A |
- Submission date
- 04/02/2013
- Registration date
- 27/03/2013
- Last edited
- 04/10/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
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
Contact information
Scientific
Wansbeck General Hospital
Woodhorn Lane
Northumberland
Ashington
NE63 9JJ
United Kingdom
| mike.reed@nhs.net |
Study information
| Study design | Three site two arm assessor blinded randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Standard vs. triclosan coated suture in patients undergoing hip and knee replacement: an assessor blinded randomised controlled trial |
| Study acronym | NASS |
| Study objectives | 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(s) | NRES Committee Gateshead and South Tyneside Research Ethics Committee, 4th January 2008, ref: 07/H0901/62 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Triclosan |
| Primary outcome measure | 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 study start date | 01/05/2008 |
| Completion date | 01/04/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 2600 |
| Key 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 |
| Key exclusion criteria | Patients under 18 |
| Date of first enrolment | 01/05/2008 |
| Date of final enrolment | 01/04/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
NE63 9JJ
United Kingdom
Sponsor information
Hospital/treatment centre
Research and Development
North Tyneside General Hospital
Education Centre
Rake Lane
North Shields
NE29 8NH
England
United Kingdom
| Phone | +44 844 811 8111 ext 2842 |
|---|---|
| caroline.potts@northumbria-healthcare.nhs.uk | |
"ROR" |
https://ror.org/01gfeyd95 |
Funders
Funder type
Industry
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 14/07/2014 | Yes | No | |
| Results article | results | 01/03/2018 | Yes | No |
Editorial Notes
04/10/2018: Publication reference added.
