|
ISRCTN
|
ISRCTN85732710
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Grafts of autologous epithelial cells for non-healing mastoid cavities: a randomised clinical trial
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
SPGS351
|
|
Study hypothesis
|
To determine the effectiveness of autologous grafts of cultured buccal epithelial cells for non-healing mastoid cavilites 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
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Ear, nose and throat diseases
|
|
Participants - inclusion criteria
|
100 patients with mastoid cavities not healed 6 months after creation
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
31/03/1997
|
|
Anticipated end date
|
31/03/2000
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
100
|
|
Interventions
|
All patients to have biopsy taken and cells grown. Randomised to receive graft or no graft
|
|
Primary outcome measure(s)
|
Not provided at time of registration
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
NHS Executive South East (UK)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Robin
Martin
|
|
Address
|
Blond McIndoe Centre
Queen Victoria Hospital
|
|
City/town
|
East Grinstead
|
|
Zip/Postcode
|
RH19 3DZ
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)1342 313088
|
|
Email
|
|
|
Sponsor
|
NHS R&D Regional Programme Register - Department of Health (UK)
|
|
Address
|
The Department of Health
Richmond House
79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7307 2622
|
|
Fax
|
+44 (0)20 7307 2623
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.doh.gov.uk
|
|
Date applied
|
23/01/2004
|
|
Last edited
|
04/12/2008
|
|
Date ISRCTN assigned
|
23/01/2004
|
