Condition category
Ear, Nose and Throat
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
11/06/2014
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

Dr Robin Martin

ORCID ID

Contact details

Blond McIndoe Centre
Queen Victoria Hospital
East Grinstead
RH19 3DZ
United Kingdom
+44 (0)1342 313088

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SPGS351

Study information

Scientific title

Acronym

Study hypothesis

To determine the effectiveness of autologous grafts of cultured buccal epithelial cells for non-healing mastoid cavities and to provide evidence that the trouble and costs of obtaining the cultured epithelial cells are necessary.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Ear, nose and throat diseases

Intervention

All patients to have biopsy taken and cells grown. Randomised to receive graft or no graft

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

31/03/1997

Overall trial end date

31/03/2000

Reason abandoned

Eligibility

Participant inclusion criteria

100 patients with mastoid cavities not healed 6 months after creation

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

100

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

31/03/1997

Recruitment end date

31/03/2000

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Blond McIndoe Centre
East Grinstead
RH19 3DZ
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive South East (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