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 |
| Protocol serial number | N0280141217 |
| Sponsor | Department of Health |
| Funder | Wirral Hospitals NHS Trust (UK), NHS R&D Support Funding |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | methotrexate |
| Primary outcome measure(s) |
1. Rate of wound infection |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| 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 sample size at registration | 400 |
| 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
- United Kingdom
- England
Study participating centre
Department of Orthopaedics
Wirral
CH49 5PE
United Kingdom
CH49 5PE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
