Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0547127258
Study information
Scientific title
Acronym
Study hypothesis
Does the treatment, nasal mupirocin, have an effect on peristomal infection rate following percutaneous endoscopic gastrostomy (PEG) placement?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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 names
Mupirocin
Primary outcome measure
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.
Secondary outcome measures
Secondary outcomes of peristomal colonisation and risk factors for methicillin resistant staphylococcus aureus (MRSA) colonisation will also be measured.
Overall trial start date
01/06/2003
Overall trial end date
01/12/2003
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Pilot study of 20 patients recruited, pilot study of 10 controls
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
30
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/06/2003
Recruitment end date
01/12/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Gastroenterology
Norwich
NR4 7UY
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
East Norfolk and Waveney Research Consortium (UK) - Norfolk and Norwich University Hospital/Norwich PCT
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list