Rapid IMF™: Does it improve cross infection precautions in maxillofacial trauma surgery?
| ISRCTN | ISRCTN37523564 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37523564 |
| Secondary identifying numbers | N0226132769 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 14/07/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr N Pigadas
Scientific
Scientific
New Cross Hospital
Wednesfield Road
Wolverhampton
West Midlands
WV10 0QP
United Kingdom
| Phone | +44 (0)1902 695408 |
|---|---|
| npigadas@doctors.org.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 | Treatment |
| Scientific title | |
| Study objectives | Study hypothesis amended as of 2nd January 2008: Glove perforations and percutaneous injuries occur commonly during the treatment of facial fractures, especially during Inter-Maxillary Fixation (IMF) with wires. The Rapid IMFTM device does not use any wires and may provide better cross infection control than wiring methods. Study hypothesis provided at time of registration: An assessment of the glove perforation and percutaneous injury rate when rapid immobilisation mandibular fracture (IMF)/traditional wiring IMF techniques are used/will be carried out - to identify the safest technique. |
| Ethics approval(s) | Each of the participating Oral and Maxillofacial Units obtained approval from their Local Research Ethics Committees (LREC) as follows: 1. Oral and Maxillofacial Unit of Manchester Royal Infirmary (Central Manchester and Manchester Children's University Hospitals NHS Trust): Central Manchester LREC, approved on 9 September 2002 (ref: 02/CM/242) 2. Oral and Maxillofacial Unit of Wythenshawe Hospital (University Hospital of South Manchester NHS Trust): South Manchester LREC, approved on 10 October 2002 (ref: 02/SM/349) 3. Oral and Maxillofacial Unit of Leicester Royal Infirmary: Leicester LREC |
| Health condition(s) or problem(s) studied | Oral and maxillofacial surgery |
| Intervention | 20 patients in each of 3 Units (total 60) will be treated with Rapid IMF™. 20 controls in each Unit (total 60) will be treated with eyelet wires. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | The incidence of perforations/operation specific to the type of IMF |
| Secondary outcome measures | Secondary outcome measures added as of 2nd January 2008: 1. Number and types of exposure sustained by the surgeon, the assistant and the scrub nurse and their cause 2. Incidence of unnoticed glove perforations 3. Time and degree of difficulty for IMF application 4. Numbers of surgical complications |
| Overall study start date | 01/11/2002 |
| Completion date | 01/11/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 120 |
| Key inclusion criteria | Inclusion criteria amended as of 2nd January 2008: 1. Age 18 and over 2. Provision of written informed consent 3. Dentate patients with fractures of the mandible which require ORIF, where post operative Inter-Maxillary Fixation is not considered necessary and temporary intraoperative Inter-Maxillary Fixation could be achieved with either Eyelet wiring or Rapid IMF™ (as judged by the investigator) Inclusion criteria provided at time of registration: 1. Patients undergoing open reduction and internal fixation (ORIF) of mandibular fractures 2. Twenty patients in each unit (60) will be treated with Rapid IMF 3. Twenty controls in each unit (60) will be treated with Eyelet wires |
| Key exclusion criteria | Exclusion criteria added as of 2nd January 2008: 1. Decreased level of consciousness 2. Learning difficulties and history of significant psychiatric or somatic disease, which may interfere with the detection of complications and assessment of functional result, as judged by the investigator |
| Date of first enrolment | 01/11/2002 |
| Date of final enrolment | 01/11/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
New Cross Hospital
West Midlands
WV10 0QP
United Kingdom
WV10 0QP
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
South Manchester University Hospitals NHS Trust (UK)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | abstract P580 | 01/09/2004 | No | No |
