Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
16/08/2012
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 PJ McCann

ORCID ID

Contact details

Department of Oral & Maxillofacial Surgery
Leeds Dental Institute
Clarendon Way
The Worsley Building
Leeds
LS2 9LU
United Kingdom
+44 (0)113 233 6219

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436118104

Study information

Scientific title

Acronym

Study hypothesis

To assess the three surgical approaches to the FZ region in terms of adequacy of surgical access, level of difficulty, duration of procedure and level of scarring. To determine which incision gives best cosmetic result for our patients.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Frontozygomatic (FZ) fracture fixation

Intervention

Randomised controlled trial. Random allocation to:
1. Incision 1
2. Incision 2
3. Incision 3

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

1. Ease of surgery
2. Duration of surgery
3. Improved access surgically
4. Cosmetic outcome of surgery

Secondary outcome measures

Not provided at time of registration

Overall trial start date

30/08/2002

Overall trial end date

28/02/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Patients are self selected by their injury. Fractures requiring operation are included in the trial.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

30/08/2002

Recruitment end date

28/02/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Oral & Maxillofacial Surgery
Leeds
LS2 9LU
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Leeds Teaching 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

Publication citations

Additional files

Editorial Notes