Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
14/07/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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

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

Publication citations

Additional files

Editorial Notes