A prospective study of the incidence of MRSA peristomal infections following gastrostomy insertion and whether infection can be prevented by prophylactic teicoplanin or inserting the tube radiologically.

ISRCTN	ISRCTN37334290
DOI	https://doi.org/10.1186/ISRCTN37334290
Protocol serial number	N0202140085
Sponsor	Department of Health
Funder	Royal Cornwall Hospitals NHS Trust (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 Iain Murray
Scientific

Royal Cornwall Hospitals NHS Trust
Treliske
Truro
TR1 3LJ
United Kingdom

Phone	+44
Email	Iain.Murray@rcht.cornwall.nhs.uk

Primary study design	Interventional
Study design	Prospective randomised pilot study
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	How many patients develop MRSA infection to their gastrostomy site using our present antibiotic prophylaxis and whether infection can be prevented by the use of intravenous teicoplanin or by inserting the gastrostomy tube radiologically rather than endoscopically?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Signs and Symptoms: MRSA peristomal infections
Intervention	Use of intravenous teicoplanin or inserting the gastrostomy tube radiologically rather than endoscopically. Added May 2008: Randomised: 1. RIG + cefotaxime 2. PEG + cefotaxime 3. PEG + teicoplanin
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	teicoplanin
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2006
Reason abandoned (if study stopped)	Interim results no reduction in MRSA infection rate provided either by use of teicoplanin or with the tube being inserted radiologically rather than endoscopically.

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	240
Key inclusion criteria	Added May 2008: 1. Subjects over 16 years 2. Referred for PEG/RIG 3. Informed written consent
Key exclusion criteria	Added May 2008: 1. Oropharyngeal cancer 2. Already taking antibiotics
Date of first enrolment	01/06/2004
Date of final enrolment	31/12/2006

Royal Cornwall Hospitals NHS Trust

Truro
TR1 3LJ
United Kingdom

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