Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

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

Contact information



Primary contact

Prof Fares Haddad


Contact details

University College London Hospital
235 Euston Road
United Kingdom

Additional identifiers

EudraCT number 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


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


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


Primary total hip and knee replacement patients


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



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


Overall trial end date


Reason abandoned


Participant inclusion criteria

Adult patients undergoing unilateral primary total hip or knee replacement

Participant type


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University College London Hospital
United Kingdom

Sponsor information


University College London (UK)

Sponsor details

UCLH/UCL Biomedical Research Unit
1st Floor
Maple House
149 Tottenham Court Road
United Kingdom

Sponsor type




Funder type


Funder name

University College London (UK)

Alternative name(s)


Funding Body Type

private sector organisation

Funding Body Subtype



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

Publication citations

Additional files

Editorial Notes