Contact information
Type
Scientific
Primary contact
Mr N Pigadas
ORCID ID
Contact details
New Cross Hospital
Wednesfield Road
Wolverhampton
West Midlands
WV10 0QP
United Kingdom
+44 (0)1902 695408
npigadas@doctors.org.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0226132769
Study information
Scientific title
Acronym
Study hypothesis
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
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
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/11/2002
Overall trial end date
01/11/2004
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
120
Participant 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
Recruitment start date
01/11/2002
Recruitment end date
01/11/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
New Cross Hospital
West Midlands
WV10 0QP
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
South Manchester University Hospitals NHS Trust (UK)
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
Results presented at European Academy of cranio-maxillofacial surgery congress. France 2004