Plain English Summary
Background and study aims
Although safer than ever, infections after hip and knee replacements remain a challenging problem. Managing such infections often requires a long course of treatment and can lead to unhappy patients with poor function of the joint. We are always looking for ways to prevent infection, as it has been proven that prevention, rather than treatment, provides the best outcome for our patients.
The purpose of this study is to find out whether sutures (stitches) coated with an antiseptic agent called triclosan are able to reduce infections within a surgical wound, in people having total hip and total knee replacements. Triclosan is not a new drug and has been used for more than 30 years in toothpaste, cosmetics and antiseptic soaps. Triclosan-coated sutures have been successfully used to reduce infections after heart surgery, abdominal surgery and neurosurgery. We hope that the use of triclosan-coated sutures will work in a similar way when used in total hip and total knee replacements.
Who can participate?
Patients aged 18 or over undergoing primary hip or knee replacements in the Department of Trauma and Orthopaedics at University College London Hospital can participate in the study.
What does the study involve?
The patients are randomly allocated to one of two groups. One group of participants will receive triclosan-coated sutures during surgery and a second group will receive an ordinary suture without triclosan. Neither the patient nor the investigator will know which group the patient will be in. At the end of the operation the deep layers of the wound will be stitched using either the triclosan-coated suture or the ordinary suture. The outside skin will be closed as normal, using clips for both groups. This is the only difference between the two groups. The patient will then receive our standard postoperative treatment for people undergoing total hip or total knee replacements. There will be an extra clinic for the patient to attend at the hospital 2 weeks after the operation for inspection of the wound and removal of the skin clips rather than having that done at the GP surgery. Additionally, at the time of discharge the patient will be given a simple yes/no questionnaire regarding their wound, which they will be asked to complete and return in a pre-paid envelope two months after the operation.
What are the possible benefits and risks of participating?
We do not know for certain if triclosan-coated sutures will improve the wound healing or reduce infection rates in total hip and total knee replacements. However, there is a chance that these sutures will improve recovery time and joint function for hip and knee replacements. There may not be any benefit to you directly if you are placed in the group which will receive an ordinary suture without triclosan.
Minimal inflammation of the surrounding tissues, localised irritation when skin sutures are left in place for greater than 7 days (sutures used in this study will only be used to close the deep layers of the wound), and slower absorption (>70 days) in tissues with poor blood supply as well as allergic reactions in the form of a rash or contact dermatitis have been reported with the use of triclosan. One study showed that triclosan-coated sutures increased the risk of wound separation in breast surgery. However, this was not supported by findings from other studies. Whilst rarely serious, the occurrence of any side effects will be sought while the patient is in hospital and at each subsequent hospital visit. The patient will be asked about hospitalisations, consultations with other medical practitioners and appropriate treatment will be provided according to the underlying problem.
Where is the study run from?
University College London Hospital (UK).
When is the study starting and how long is it expected to run for?
The study is planned to start in August 2013 and recruitment is estimated to be completed over 2 years.
Who is funding the study?
University College London is funding the study.
Who is the main contact?
Professor Fares Haddad, principal and chief investigator
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Protocol version 8
Study information
Scientific title
A randomised controlled trial of Polyglactin 910 Triclosan coated sutures versus standard Polyglactin 910 sutures in patients undergoing primary unilateral hip and knee arthroplasty
Acronym
Study hypothesis
The hypothesis is that triclosan coated sutures may be associated with better wound healing characteristics and fewer infections than standard sutures, and as a result may potentially be more appropriate for total hip and total knee arthroplasty wound closures.
Ethics approval
National Research Ethics Service (NRES) Committee London - Harrow approved the study on 03 June 2013
Study design
Single-centred double-blind 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
Primary total hip and knee replacement patients
Intervention
Participants will be randomly assigned to receive coated polyglactin 910 sutures with triclosan (Vicryl Plus; Ethicon, Inc.) or conventional sutures (coated polyglactin 910 ¨C Vicryl; Ethicon, Inc.).
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measures
Primary objective is to compare the healing characteristics for wounds closed using coated vicryl (polyglactin 910) plus triclosan, (Ethicon, Inc.) and coated vicryl (polyglactin 910) sutures in patients undergoing primary total hip or knee arthroplasties. The primary outcome will be the comparison of the healing characteristics of the study groups, using the ASEPSIS wound scoring method devised in 1986 by Wilson et al at University College London Hospitals.
Secondary outcome measures
Secondary objectives include recording data pertaining to demographics, procedure type, length of operating time, plus patient factors believed to influence wound healing and infection risk. Complications associated with using both sutures and their influence on early discharge will also be noted, as this may result in improved patient outcomes, cost effectiveness and long term prosthesis survival.
Overall trial start date
15/08/2013
Overall trial end date
15/08/2015
Reason abandoned
Eligibility
Participant inclusion criteria
Adult patients undergoing unilateral primary total hip or knee replacement
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
420
Participant exclusion criteria
1. Undergoing unilateral primary total hip or knee replacement for trauma
2. Undergoing a revision procedure or with a previous incision in the operative field
3. History of tendency for keloid formation
4. Allergy to triclosan/vicryl
5. Bleeding tendency (e.g. haemophilia and platelet disorders) or on regular anticoagulation treatment (e.g. warfarin, treatment dose of low molecular weight heparin (LMWH) or conventional heparin)
6. Underlying malignancy and immunocompromised status
7. Dementia and mental illnesses preventing informed consent
8. Children (age<18years)
Recruitment start date
15/08/2013
Recruitment end date
15/08/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University College London Hospital
London
NW1 2BU
United Kingdom
Funders
Funder type
University/education
Funder name
University College London (UK)
Alternative name(s)
UCL
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
United Kingdom
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