Grafts of autologous epithelial cells for non-healing mastoid cavities: a randomised clinical trial

ISRCTN	ISRCTN85732710
DOI	https://doi.org/10.1186/ISRCTN85732710
Protocol serial number	SPGS351
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive South East (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Robin Martin
Scientific

Blond McIndoe Centre
Queen Victoria Hospital
East Grinstead
RH19 3DZ
United Kingdom

Phone	+44 (0)1342 313088

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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
Health condition(s) or problem(s) studied	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(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/03/2000

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	100
Key inclusion criteria	100 patients with mastoid cavities not healed 6 months after creation
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	31/03/1997
Date of final enrolment	31/03/2000

Blond McIndoe Centre

East Grinstead
RH19 3DZ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan