Effect of methotrexate in post-operative wound healing in rheumatoid patients undergoing foot and ankle surgery
| ISRCTN | ISRCTN86123456 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86123456 |
| Secondary identifying numbers | N0280141217 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 12/04/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Nick Emms
Scientific
Scientific
Department of Orthopaedics
Wirral Hospital NHS Trust
Arrowe Park Road
Upton
Wirral
CH49 5PE
United Kingdom
| Phone | +44 (0)151 678 5111 |
|---|---|
| nick.emms@ukonline.co.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | Does methotrexate affect post-operative wound healing in rheumatoid patients undergoing foot and ankle surgery? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | methotrexate |
| Primary outcome measure | 1. Rate of wound infection 2. Patient pain levels |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/05/2004 |
| Completion date | 01/05/2005 |
| Reason abandoned (if study stopped) | Poor recruitment |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Sample of 200 patients in each group. |
| Key inclusion criteria | Rheumatoid patients on methotrexate therapy undergoing foot and ankle surgery. |
| Key exclusion criteria | 1. Ongoing use of other immunosuppression agents. 2. Localised infection pre-operatively. |
| Date of first enrolment | 01/05/2004 |
| Date of final enrolment | 01/05/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Orthopaedics
Wirral
CH49 5PE
United Kingdom
CH49 5PE
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Wirral Hospitals NHS Trust (UK), NHS R&D Support Funding
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 |
