Grafts of autologous epithelial cells for non-healing mastoid cavities: a randomised clinical trial
| ISRCTN | ISRCTN85732710 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85732710 |
| Secondary identifying numbers | SPGS351 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 11/06/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Dr Robin Martin
Scientific
Scientific
Blond McIndoe Centre
Queen Victoria Hospital
East Grinstead
RH19 3DZ
United Kingdom
| Phone | +44 (0)1342 313088 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| 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(s) | Not provided at time of registration |
| 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 |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 31/03/1997 |
| Overall study end date | 31/03/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 100 |
| Participant inclusion criteria | 100 patients with mastoid cavities not healed 6 months after creation |
| 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
- England
- United Kingdom
Study participating centre
Blond McIndoe Centre
East Grinstead
RH19 3DZ
United Kingdom
RH19 3DZ
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive South East (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
