The effect of nasal mupirocin, prior to percutaneous endoscopic gastrostomy (PEG), upon peristomal colonisation and infection

ISRCTN	ISRCTN46568273
DOI	https://doi.org/10.1186/ISRCTN46568273
Protocol serial number	N0547127258
Sponsor	Department of Health
Funder	East Norfolk and Waveney Research Consortium (UK) - Norfolk and Norwich University Hospital/Norwich PCT

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

Mrs Judith McGovern
Scientific

Department of Gastroenterology
Norfolk and Norwich University Hospital NHS Trust
Colney
Norwich
NR4 7UY
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Does the treatment, nasal mupirocin, have an effect on peristomal infection rate following percutaneous endoscopic gastrostomy (PEG) placement?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Post-percutaneous endoscopic gastrostomy sepsis
Intervention	Nasal mupirocin versus standard care (no prophylactic antibiotics). Mupirocin was administered for 5 days before PEG insertion. Nasopharyngeal swabs, PEG site appearance and bacteriology were recorded up to 10 days post-PEG.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Mupirocin
Primary outcome measure(s)	Pilot: Will access the practicalities of the study design, the consistency of the scoring tool and also give an indication of the bacteriology of nasal colonisation, peristomal colonisation and infection within the proposed research setting. Main: The primary outcome measure is that of perstomal infection.
Key secondary outcome measure(s)	Secondary outcomes of peristomal colonisation and risk factors for methicillin resistant staphylococcus aureus (MRSA) colonisation will also be measured.
Completion date	01/12/2003

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	30
Key inclusion criteria	Pilot study of 20 patients recruited, pilot study of 10 controls
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/06/2003
Date of final enrolment	01/12/2003

Department of Gastroenterology

Norwich
NR4 7UY
United Kingdom

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