Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Nick Emms

ORCID ID

Contact details

Department of Orthopaedics
Wirral Hospital NHS Trust
Arrowe Park Road
Upton
Wirral
CH49 5PE
United Kingdom
+44 (0)151 678 5111
nick.emms@ukonline.co.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0280141217

Study information

Scientific title

Acronym

Study hypothesis

Does methotrexate affect post-operative wound healing in rheumatoid patients undergoing foot and ankle surgery?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Surgery: Foot and ankle

Intervention

Group A: continuous methotrexate therapy for two weeks during perioperative period
Group B: omit methotrexate therapy for two weeks during perioperative period

Added September 2008: trial stopped due to poor recruitment.

Intervention type

Drug

Phase

Not Specified

Drug names

methotrexate

Primary outcome measures

1. Rate of wound infection
2. Patient pain levels

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/05/2004

Overall trial end date

01/05/2005

Reason abandoned

Poor recruitment

Eligibility

Participant inclusion criteria

Rheumatoid patients on methotrexate therapy undergoing foot and ankle surgery.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Sample of 200 patients in each group.

Participant exclusion criteria

1. Ongoing use of other immunosuppression agents.
2. Localised infection pre-operatively.

Recruitment start date

01/05/2004

Recruitment end date

01/05/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Orthopaedics
Wirral
CH49 5PE
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Wirral Hospitals NHS Trust (UK), NHS R&D Support Funding

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

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Editorial Notes